Guidelines

Clinicians who care for patients with rheumatic and musculoskeletal diseases (RMDs) can now refer to a new set of strategies and points to consider from a European League Against Rheumatism (EULAR) task force in building a patient-centered approach to improve adherence to treatments.

Nonadherence to treatments is concerning given that 30%-80% of patients who have RMDs are thought to not follow a recommended treatment plan according to their physicians’ instructions, according to first author Valentin Ritschl of the Medical University of Vienna and colleagues.

“The problem of poor adherence is addressed in some EULAR recommendations/points to consider on the management of specific health conditions or on the role of professionals,” Mr. Ritschl said in an interview. “However, all these recommendations focus on limited aspects of nonadherence and do not cover the multifaceted nature of this phenomenon.”

Mr. Ritschl and colleagues conducted an extensive systematic literature review, the results of which they presented to a task force consisting of a panel of international experts hailing from 12 different countries. The task force included rheumatologists and other health professionals in rheumatology, as well as patient representatives.

The collaboration resulted in investigators crafting a definition of adherence in addition to drafting four overarching principles and nine points to consider, which were published Dec. 18 in Annals of the Rheumatic Diseases.

They defined adherence as “the extent to which a person’s behavior corresponds with the agreed prescription, of pharmacological or nonpharmacological treatments, by a health care provider.”

The four overarching principles emphasize the following concepts: that adherence affects outcomes in people who have RMDs; the importance of shared decision-making, with the understanding that the adherence describes the patient’s behavior “following an agreed prescription”; that numerous factors can affect adherence; and the notion of adherence being a dynamic process that, consequently, requires continuous evaluation.

Among the nine points to consider, Mr. Ritschl and coauthors encouraged all health care providers involved in caring for RMD patients to assume responsibility for promoting adherence. Practitioners should also strive to create an ongoing, open dialogue to discuss adherence, especially in cases in which the patient’s RMD is not well controlled. The patient-centered recommendations include taking into account the patient’s goals and preferences because these greatly contribute to the patient’s ability to adhere to any medication regimen. Another arm of that exploration also requires the medical professional to evaluate any circumstances that could bear a negative effect on the patient’s adherence – whether it be medication access issues related to cost or availability, or functional challenges such as memory, motivation, or complexity of the medication regimen.

SDI Productions/E+

Mr. Ritschl believed the task force’s recommendations will add value and help improve overall outcomes in RMD population management.

“Until today, there are no recommendations or points to consider developed in order to support our patients to be adherent to the agreed treatment plan,” he said. “In our project/initiative, we therefore developed for the first time points to consider to detect, assess, and manage nonadherence in people with RMDs.”

Additionally, the recommendations offer some strategic insights to help improve clinical trials because the deleterious effects of nonadherence also affect study results.

Looking ahead, Mr. Ritschl said randomized, controlled trials are necessary to test strategies that might improve adherence. He strongly emphasized the importance of designing future research studies that are heavily patient centered and effective for shared decision-making.

The project was funded by EULAR. Mr. Ritschl reported having no disclosures, but many of his coauthors reported financial relationships with pharmaceutical companies.

SOURCE: Ritschl V et al. Ann Rheum Dis. 2020 Dec 18. doi: 10.1136/annrheumdis-2020-218986.

Clinicians who care for patients with rheumatic and musculoskeletal diseases (RMDs) can now refer to a new set of strategies and points to consider from a European League Against Rheumatism (EULAR) task force in building a patient-centered approach to improve adherence to treatments.

Nonadherence to treatments is concerning given that 30%-80% of patients who have RMDs are thought to not follow a recommended treatment plan according to their physicians’ instructions, according to first author Valentin Ritschl of the Medical University of Vienna and colleagues.

“The problem of poor adherence is addressed in some EULAR recommendations/points to consider on the management of specific health conditions or on the role of professionals,” Mr. Ritschl said in an interview. “However, all these recommendations focus on limited aspects of nonadherence and do not cover the multifaceted nature of this phenomenon.”

Mr. Ritschl and colleagues conducted an extensive systematic literature review, the results of which they presented to a task force consisting of a panel of international experts hailing from 12 different countries. The task force included rheumatologists and other health professionals in rheumatology, as well as patient representatives.

The collaboration resulted in investigators crafting a definition of adherence in addition to drafting four overarching principles and nine points to consider, which were published Dec. 18 in Annals of the Rheumatic Diseases.

They defined adherence as “the extent to which a person’s behavior corresponds with the agreed prescription, of pharmacological or nonpharmacological treatments, by a health care provider.”

The four overarching principles emphasize the following concepts: that adherence affects outcomes in people who have RMDs; the importance of shared decision-making, with the understanding that the adherence describes the patient’s behavior “following an agreed prescription”; that numerous factors can affect adherence; and the notion of adherence being a dynamic process that, consequently, requires continuous evaluation.

Among the nine points to consider, Mr. Ritschl and coauthors encouraged all health care providers involved in caring for RMD patients to assume responsibility for promoting adherence. Practitioners should also strive to create an ongoing, open dialogue to discuss adherence, especially in cases in which the patient’s RMD is not well controlled. The patient-centered recommendations include taking into account the patient’s goals and preferences because these greatly contribute to the patient’s ability to adhere to any medication regimen. Another arm of that exploration also requires the medical professional to evaluate any circumstances that could bear a negative effect on the patient’s adherence – whether it be medication access issues related to cost or availability, or functional challenges such as memory, motivation, or complexity of the medication regimen.

SDI Productions/E+

Mr. Ritschl believed the task force’s recommendations will add value and help improve overall outcomes in RMD population management.

“Until today, there are no recommendations or points to consider developed in order to support our patients to be adherent to the agreed treatment plan,” he said. “In our project/initiative, we therefore developed for the first time points to consider to detect, assess, and manage nonadherence in people with RMDs.”

Additionally, the recommendations offer some strategic insights to help improve clinical trials because the deleterious effects of nonadherence also affect study results.

Looking ahead, Mr. Ritschl said randomized, controlled trials are necessary to test strategies that might improve adherence. He strongly emphasized the importance of designing future research studies that are heavily patient centered and effective for shared decision-making.

The project was funded by EULAR. Mr. Ritschl reported having no disclosures, but many of his coauthors reported financial relationships with pharmaceutical companies.

SOURCE: Ritschl V et al. Ann Rheum Dis. 2020 Dec 18. doi: 10.1136/annrheumdis-2020-218986.

Clinicians who care for patients with rheumatic and musculoskeletal diseases (RMDs) can now refer to a new set of strategies and points to consider from a European League Against Rheumatism (EULAR) task force in building a patient-centered approach to improve adherence to treatments.

Nonadherence to treatments is concerning given that 30%-80% of patients who have RMDs are thought to not follow a recommended treatment plan according to their physicians’ instructions, according to first author Valentin Ritschl of the Medical University of Vienna and colleagues.

“The problem of poor adherence is addressed in some EULAR recommendations/points to consider on the management of specific health conditions or on the role of professionals,” Mr. Ritschl said in an interview. “However, all these recommendations focus on limited aspects of nonadherence and do not cover the multifaceted nature of this phenomenon.”

Mr. Ritschl and colleagues conducted an extensive systematic literature review, the results of which they presented to a task force consisting of a panel of international experts hailing from 12 different countries. The task force included rheumatologists and other health professionals in rheumatology, as well as patient representatives.

The collaboration resulted in investigators crafting a definition of adherence in addition to drafting four overarching principles and nine points to consider, which were published Dec. 18 in Annals of the Rheumatic Diseases.

They defined adherence as “the extent to which a person’s behavior corresponds with the agreed prescription, of pharmacological or nonpharmacological treatments, by a health care provider.”

The four overarching principles emphasize the following concepts: that adherence affects outcomes in people who have RMDs; the importance of shared decision-making, with the understanding that the adherence describes the patient’s behavior “following an agreed prescription”; that numerous factors can affect adherence; and the notion of adherence being a dynamic process that, consequently, requires continuous evaluation.

Among the nine points to consider, Mr. Ritschl and coauthors encouraged all health care providers involved in caring for RMD patients to assume responsibility for promoting adherence. Practitioners should also strive to create an ongoing, open dialogue to discuss adherence, especially in cases in which the patient’s RMD is not well controlled. The patient-centered recommendations include taking into account the patient’s goals and preferences because these greatly contribute to the patient’s ability to adhere to any medication regimen. Another arm of that exploration also requires the medical professional to evaluate any circumstances that could bear a negative effect on the patient’s adherence – whether it be medication access issues related to cost or availability, or functional challenges such as memory, motivation, or complexity of the medication regimen.

SDI Productions/E+

Mr. Ritschl believed the task force’s recommendations will add value and help improve overall outcomes in RMD population management.

“Until today, there are no recommendations or points to consider developed in order to support our patients to be adherent to the agreed treatment plan,” he said. “In our project/initiative, we therefore developed for the first time points to consider to detect, assess, and manage nonadherence in people with RMDs.”

Additionally, the recommendations offer some strategic insights to help improve clinical trials because the deleterious effects of nonadherence also affect study results.

Looking ahead, Mr. Ritschl said randomized, controlled trials are necessary to test strategies that might improve adherence. He strongly emphasized the importance of designing future research studies that are heavily patient centered and effective for shared decision-making.

The project was funded by EULAR. Mr. Ritschl reported having no disclosures, but many of his coauthors reported financial relationships with pharmaceutical companies.

SOURCE: Ritschl V et al. Ann Rheum Dis. 2020 Dec 18. doi: 10.1136/annrheumdis-2020-218986.

For 2021, the American Diabetes Association offers new guidance on assessing patients’ financial and social barriers to care, especially given the COVID-19 pandemic, individualizing treatment of patients with type 2 diabetes, and use of diabetes technology.

As it does every year, the annual update incorporates new clinical information that has become available since the last guideline, with occasional revisions during the year as needed. “Standards of Medical Care in Diabetes – 2021,” was published online as a supplement to Diabetes Care.

The new standards advise that patients be assessed for food and housing insecurity, social support, and “cost-related medication nonadherence,” and those found to have difficulty referred to appropriate community resources.

“Clinicians need to be sensitive to the fact that patients may have very good reasons for not taking their medication, [as in] if they can’t afford it,” ADA chief science & medical officer Robert A. Gabbay, MD, PhD, said in an interview.

Dr. Gabbay noted that “a heightened awareness” of social determinants of health is weaved throughout the 2021 standards because of the pandemic, with information on the topic derived from a July 2020 joint consensus statement in Diabetes Care, endorsed by a number of other societies, as well as a November publication also in Diabetes Care.

“We made several recommendations that speak to social determinants of health, placing an emphasis on engaging in conversations around this subject and screening for related issues such as food insecurity that weren’t there previously,” he said.

“Screening tools are suggested. It helped us to have an in-depth scientific review of the literature to know the prevalence of this in people with diabetes. ... Having the science to put it in was a key step,” Dr. Gabbay noted.
 

Consider kidney, heart disease in type 2 treatment individualization

Recent data from trials such as CREDENCE and DAPA-HF, among others, have been added to inform the choice of pharmacologic treatment in patients with type 2 diabetes with comorbid diabetic kidney disease and chronic heart failure.

“ADA has been advocating individualization of treatment based on comorbidities for a while, but we’ve taken more steps in that direction. Beyond lifestyle for all individuals with type 2 diabetes, clinicians want to think early on about which comorbidities patients have and then think about the appropriate treatment based on that,” Dr. Gabbay said.

And for the third year in a row, the section on cardiovascular disease and risk management has been endorsed by the American College of Cardiology.

“All the things in that section are very much aligned with ACC and that’s been a great partnership,” Dr. Gabbay said.

Now, ADA is in discussions with other professional societies representing relevant specialties to create further such unified messages.

“What we all want to avoid is having multiple different guidelines. We want to speak with one voice and find common ground as much as possible. … It makes it much easier for clinicians to know what to do. That’s the goal of all this,” he noted.
 

Diabetes technology: The rise of CGM during pandemic and beyond

New information about continuous glucose monitoring (CGM) has been added to the diabetes technology section. Use of CGM is now recommended for anyone with diabetes who takes multiple daily injections or uses an insulin pump, regardless of age or diabetes type. The document provides expanded advice on use of time in range data for glycemic monitoring, particularly during the COVID-19 pandemic when remote monitoring is preferable.

Insurers are increasingly covering CGM for patients on insulin, but it’s far from universal. While the ultimate goal is to ensure access to CGM for everyone with diabetes, those treated with multiple daily insulin doses are the priority for now.

“Our hope is that as there’s greater evidence there will be more movement towards coverage. There are still so many people for whom it’s quite clear they would benefit because they’re on insulin but don’t have access to it. That’s an important area that ADA is advocating for, and it’s reflected in the standards of care,” Dr. Gabbay said.

In another technology-related revision, the term “blinded” CGM has been replaced with “professional CGM,” because clinic-based use of the devices can be “blinded” to the patient or monitored in real-time by both the patient and clinician. Also, a new recommendation has been added to address skin reactions associated with diabetes technology use.

Information about use of CGM in hospital settings during the COVID-19 pandemic has also been added in the technology section.

The COVID-19 pandemic comes up again in the section on vaccines.

“We mention that people with diabetes should be considered high priority [for COVID-19 vaccines], and that’s something that ADA is strongly advocating for because 40% of COVID-19 deaths have been in people with diabetes,” Dr. Gabbay said.

Dr. Gabbay reported being on the advisory boards of Onduo, Health Reveal, Vida Health, Lark, and Form Health.

A version of this article originally appeared on Medscape.com.

For 2021, the American Diabetes Association offers new guidance on assessing patients’ financial and social barriers to care, especially given the COVID-19 pandemic, individualizing treatment of patients with type 2 diabetes, and use of diabetes technology.

As it does every year, the annual update incorporates new clinical information that has become available since the last guideline, with occasional revisions during the year as needed. “Standards of Medical Care in Diabetes – 2021,” was published online as a supplement to Diabetes Care.

The new standards advise that patients be assessed for food and housing insecurity, social support, and “cost-related medication nonadherence,” and those found to have difficulty referred to appropriate community resources.

“Clinicians need to be sensitive to the fact that patients may have very good reasons for not taking their medication, [as in] if they can’t afford it,” ADA chief science & medical officer Robert A. Gabbay, MD, PhD, said in an interview.

Dr. Gabbay noted that “a heightened awareness” of social determinants of health is weaved throughout the 2021 standards because of the pandemic, with information on the topic derived from a July 2020 joint consensus statement in Diabetes Care, endorsed by a number of other societies, as well as a November publication also in Diabetes Care.

“We made several recommendations that speak to social determinants of health, placing an emphasis on engaging in conversations around this subject and screening for related issues such as food insecurity that weren’t there previously,” he said.

“Screening tools are suggested. It helped us to have an in-depth scientific review of the literature to know the prevalence of this in people with diabetes. ... Having the science to put it in was a key step,” Dr. Gabbay noted.
 

Consider kidney, heart disease in type 2 treatment individualization

Recent data from trials such as CREDENCE and DAPA-HF, among others, have been added to inform the choice of pharmacologic treatment in patients with type 2 diabetes with comorbid diabetic kidney disease and chronic heart failure.

“ADA has been advocating individualization of treatment based on comorbidities for a while, but we’ve taken more steps in that direction. Beyond lifestyle for all individuals with type 2 diabetes, clinicians want to think early on about which comorbidities patients have and then think about the appropriate treatment based on that,” Dr. Gabbay said.

And for the third year in a row, the section on cardiovascular disease and risk management has been endorsed by the American College of Cardiology.

“All the things in that section are very much aligned with ACC and that’s been a great partnership,” Dr. Gabbay said.

Now, ADA is in discussions with other professional societies representing relevant specialties to create further such unified messages.

“What we all want to avoid is having multiple different guidelines. We want to speak with one voice and find common ground as much as possible. … It makes it much easier for clinicians to know what to do. That’s the goal of all this,” he noted.
 

Diabetes technology: The rise of CGM during pandemic and beyond

New information about continuous glucose monitoring (CGM) has been added to the diabetes technology section. Use of CGM is now recommended for anyone with diabetes who takes multiple daily injections or uses an insulin pump, regardless of age or diabetes type. The document provides expanded advice on use of time in range data for glycemic monitoring, particularly during the COVID-19 pandemic when remote monitoring is preferable.

Insurers are increasingly covering CGM for patients on insulin, but it’s far from universal. While the ultimate goal is to ensure access to CGM for everyone with diabetes, those treated with multiple daily insulin doses are the priority for now.

“Our hope is that as there’s greater evidence there will be more movement towards coverage. There are still so many people for whom it’s quite clear they would benefit because they’re on insulin but don’t have access to it. That’s an important area that ADA is advocating for, and it’s reflected in the standards of care,” Dr. Gabbay said.

In another technology-related revision, the term “blinded” CGM has been replaced with “professional CGM,” because clinic-based use of the devices can be “blinded” to the patient or monitored in real-time by both the patient and clinician. Also, a new recommendation has been added to address skin reactions associated with diabetes technology use.

Information about use of CGM in hospital settings during the COVID-19 pandemic has also been added in the technology section.

The COVID-19 pandemic comes up again in the section on vaccines.

“We mention that people with diabetes should be considered high priority [for COVID-19 vaccines], and that’s something that ADA is strongly advocating for because 40% of COVID-19 deaths have been in people with diabetes,” Dr. Gabbay said.

Dr. Gabbay reported being on the advisory boards of Onduo, Health Reveal, Vida Health, Lark, and Form Health.

A version of this article originally appeared on Medscape.com.

For 2021, the American Diabetes Association offers new guidance on assessing patients’ financial and social barriers to care, especially given the COVID-19 pandemic, individualizing treatment of patients with type 2 diabetes, and use of diabetes technology.

As it does every year, the annual update incorporates new clinical information that has become available since the last guideline, with occasional revisions during the year as needed. “Standards of Medical Care in Diabetes – 2021,” was published online as a supplement to Diabetes Care.

The new standards advise that patients be assessed for food and housing insecurity, social support, and “cost-related medication nonadherence,” and those found to have difficulty referred to appropriate community resources.

“Clinicians need to be sensitive to the fact that patients may have very good reasons for not taking their medication, [as in] if they can’t afford it,” ADA chief science & medical officer Robert A. Gabbay, MD, PhD, said in an interview.

Dr. Gabbay noted that “a heightened awareness” of social determinants of health is weaved throughout the 2021 standards because of the pandemic, with information on the topic derived from a July 2020 joint consensus statement in Diabetes Care, endorsed by a number of other societies, as well as a November publication also in Diabetes Care.

“We made several recommendations that speak to social determinants of health, placing an emphasis on engaging in conversations around this subject and screening for related issues such as food insecurity that weren’t there previously,” he said.

“Screening tools are suggested. It helped us to have an in-depth scientific review of the literature to know the prevalence of this in people with diabetes. ... Having the science to put it in was a key step,” Dr. Gabbay noted.
 

Consider kidney, heart disease in type 2 treatment individualization

Recent data from trials such as CREDENCE and DAPA-HF, among others, have been added to inform the choice of pharmacologic treatment in patients with type 2 diabetes with comorbid diabetic kidney disease and chronic heart failure.

“ADA has been advocating individualization of treatment based on comorbidities for a while, but we’ve taken more steps in that direction. Beyond lifestyle for all individuals with type 2 diabetes, clinicians want to think early on about which comorbidities patients have and then think about the appropriate treatment based on that,” Dr. Gabbay said.

And for the third year in a row, the section on cardiovascular disease and risk management has been endorsed by the American College of Cardiology.

“All the things in that section are very much aligned with ACC and that’s been a great partnership,” Dr. Gabbay said.

Now, ADA is in discussions with other professional societies representing relevant specialties to create further such unified messages.

“What we all want to avoid is having multiple different guidelines. We want to speak with one voice and find common ground as much as possible. … It makes it much easier for clinicians to know what to do. That’s the goal of all this,” he noted.
 

Diabetes technology: The rise of CGM during pandemic and beyond

New information about continuous glucose monitoring (CGM) has been added to the diabetes technology section. Use of CGM is now recommended for anyone with diabetes who takes multiple daily injections or uses an insulin pump, regardless of age or diabetes type. The document provides expanded advice on use of time in range data for glycemic monitoring, particularly during the COVID-19 pandemic when remote monitoring is preferable.

Insurers are increasingly covering CGM for patients on insulin, but it’s far from universal. While the ultimate goal is to ensure access to CGM for everyone with diabetes, those treated with multiple daily insulin doses are the priority for now.

“Our hope is that as there’s greater evidence there will be more movement towards coverage. There are still so many people for whom it’s quite clear they would benefit because they’re on insulin but don’t have access to it. That’s an important area that ADA is advocating for, and it’s reflected in the standards of care,” Dr. Gabbay said.

In another technology-related revision, the term “blinded” CGM has been replaced with “professional CGM,” because clinic-based use of the devices can be “blinded” to the patient or monitored in real-time by both the patient and clinician. Also, a new recommendation has been added to address skin reactions associated with diabetes technology use.

Information about use of CGM in hospital settings during the COVID-19 pandemic has also been added in the technology section.

The COVID-19 pandemic comes up again in the section on vaccines.

“We mention that people with diabetes should be considered high priority [for COVID-19 vaccines], and that’s something that ADA is strongly advocating for because 40% of COVID-19 deaths have been in people with diabetes,” Dr. Gabbay said.

Dr. Gabbay reported being on the advisory boards of Onduo, Health Reveal, Vida Health, Lark, and Form Health.

A version of this article originally appeared on Medscape.com.

The American College of Cardiology and American Heart Association Task Force on Performance Measures have made two changes to performance measures for adults with atrial fibrillation or atrial flutter.

The 2020 Update to the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults With Atrial Fibrillation or Atrial Flutter was published online Dec. 7 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes. It was developed in collaboration with the Heart Rhythm Society.

Both performance measure changes were prompted by, and are in accordance with, the 2019 ACC/AHA/Heart Rhythm Society atrial fibrillation guideline focused update issued in January 2019, and reported by this news organization at that time.

The first change is the clarification that valvular atrial fibrillation is atrial fibrillation with either moderate or severe mitral stenosis or a mechanical heart valve. This change is incorporated into all the performance measures.

The second change, which only applies to the performance measure of anticoagulation prescribed, is the separation of a male and female threshold for the CHA₂DS₂-VASc score.

This threshold is now a score higher than 1 for men and higher than 2 for women, further demonstrating that the risk for stroke differs for men and women with atrial fibrillation or atrial flutter, the ACC/AHA noted in a press release.

“Successful implementation of these updated performance measures by clinicians and healthcare organizations will lead to quality improvement for adult patients with atrial fibrillation or atrial flutter,” they said.

A version of this article originally appeared on Medscape.com.

The American College of Cardiology and American Heart Association Task Force on Performance Measures have made two changes to performance measures for adults with atrial fibrillation or atrial flutter.

The 2020 Update to the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults With Atrial Fibrillation or Atrial Flutter was published online Dec. 7 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes. It was developed in collaboration with the Heart Rhythm Society.

Both performance measure changes were prompted by, and are in accordance with, the 2019 ACC/AHA/Heart Rhythm Society atrial fibrillation guideline focused update issued in January 2019, and reported by this news organization at that time.

The first change is the clarification that valvular atrial fibrillation is atrial fibrillation with either moderate or severe mitral stenosis or a mechanical heart valve. This change is incorporated into all the performance measures.

The second change, which only applies to the performance measure of anticoagulation prescribed, is the separation of a male and female threshold for the CHA₂DS₂-VASc score.

This threshold is now a score higher than 1 for men and higher than 2 for women, further demonstrating that the risk for stroke differs for men and women with atrial fibrillation or atrial flutter, the ACC/AHA noted in a press release.

“Successful implementation of these updated performance measures by clinicians and healthcare organizations will lead to quality improvement for adult patients with atrial fibrillation or atrial flutter,” they said.

A version of this article originally appeared on Medscape.com.

The American College of Cardiology and American Heart Association Task Force on Performance Measures have made two changes to performance measures for adults with atrial fibrillation or atrial flutter.

The 2020 Update to the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults With Atrial Fibrillation or Atrial Flutter was published online Dec. 7 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes. It was developed in collaboration with the Heart Rhythm Society.

Both performance measure changes were prompted by, and are in accordance with, the 2019 ACC/AHA/Heart Rhythm Society atrial fibrillation guideline focused update issued in January 2019, and reported by this news organization at that time.

The first change is the clarification that valvular atrial fibrillation is atrial fibrillation with either moderate or severe mitral stenosis or a mechanical heart valve. This change is incorporated into all the performance measures.

The second change, which only applies to the performance measure of anticoagulation prescribed, is the separation of a male and female threshold for the CHA₂DS₂-VASc score.

This threshold is now a score higher than 1 for men and higher than 2 for women, further demonstrating that the risk for stroke differs for men and women with atrial fibrillation or atrial flutter, the ACC/AHA noted in a press release.

“Successful implementation of these updated performance measures by clinicians and healthcare organizations will lead to quality improvement for adult patients with atrial fibrillation or atrial flutter,” they said.

A version of this article originally appeared on Medscape.com.

New clinical practice guidelines on Lyme disease place a strong emphasis on antibody testing to assess for rheumatologic and neurologic syndromes. “Diagnostically, we recommend testing via antibodies, and an index of antibodies in cerebrospinal fluid [CSF] versus serum. Importantly, we recommend against using polymerase chain reaction [PCR] in CSF,” Jeffrey A. Rumbaugh, MD, PhD, a coauthor of the guidelines and a member of the American Academy of Neurology, said in an interview.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

The Infectious Diseases Society of America, AAN, and the American College of Rheumatology convened a multidisciplinary panel to develop the 43 recommendations, seeking input from 12 additional medical specialties, and patients. The panel conducted a systematic review of available evidence on preventing, diagnosing, and treating Lyme disease, using the Grading of Recommendations Assessment, Development and Evaluation model to evaluate clinical evidence and strength of recommendations. The guidelines were simultaneous published in Clinical Infectious Diseases, Neurology, Arthritis & Rheumatology, and Arthritis Care & Research.

This is the first time these organizations have collaborated on joint Lyme disease guidelines, which focus mainly on neurologic, cardiac, and rheumatologic manifestations.

“We are very excited to provide these updated guidelines to assist clinicians working in numerous medical specialties around the country, and even the world, as they care for patients suffering from Lyme disease,” Dr. Rumbaugh said.
 

When to use and not to use PCR

Guideline authors called for specific testing regimens depending on presentation of symptoms. Generally, they advised that individuals with a skin rash suggestive of early disease seek a clinical diagnosis instead of laboratory testing.

Recommendations on Lyme arthritis support previous IDSA guidelines published in 2006, Linda K. Bockenstedt, MD, professor of medicine at Yale University, New Haven, Conn., and a coauthor of the guidelines, said in an interview.

To evaluate for potential Lyme arthritis, clinicians should choose serum antibody testing over PCR or culture of blood or synovial fluid/tissue. However, if a doctor is assessing a seropositive patient for Lyme arthritis diagnosis but needs more information for treatment decisions, the authors recommended PCR applied to synovial fluid or tissue over Borrelia culture.

“Synovial fluid can be analyzed by PCR, but sensitivity is generally lower than serology,” Dr. Bockenstedt explained. Additionally, culture of joint fluid or synovial tissue for Lyme spirochetes has 0% sensitivity in multiple studies. “For these reasons, we recommend serum antibody testing over PCR of joint fluid or other methods for an initial diagnosis.”

Serum antibody testing over PCR or culture is also recommended for identifying Lyme neuroborreliosis in the peripheral nervous system (PNS) or CNS.

Despite the recent popularity of Lyme PCR testing in hospitals and labs, “with Lyme at least, antibodies are better in the CSF,” Dr. Rumbaugh said. Studies have shown that “most patients with even early neurologic Lyme disease are seropositive by conventional antibody testing at time of initial clinical presentation, and that intrathecal antibody production, as demonstrated by an elevated CSF:serum index, is highly specific for CNS involvement.”

If done correctly, antibody testing is both sensitive and specific for neurologic Lyme disease. “On the other hand, sensitivity of Lyme PCR performed on CSF has been only in the 5%-17% range in studies. Incidentally, Lyme PCR on blood is also not sensitive and therefore not recommended,” Dr. Rumbaugh said.

Guideline authors recommended testing in patients with the following conditions: acute neurologic disorders such as meningitis, painful radiculoneuritis, mononeuropathy multiplex; evidence of spinal cord or brain inflammation; and acute myocarditis/pericarditis of unknown cause in an appropriate epidemiologic setting.

They did not recommend testing in patients with typical amyotrophic lateral sclerosis; relapsing remitting multiple sclerosis; Parkinson’s disease, dementia, or cognitive decline; new-onset seizures; other neurologic syndromes or those lacking clinical or epidemiologic history that would support a diagnosis of Lyme disease; and patients with chronic cardiomyopathy of unknown cause.

The authors also called for judicious use of electrocardiogram to screen for Lyme carditis, recommending it only in patients signs or symptoms of this condition. However, patients at risk for or showing signs of severe cardiac complications of Lyme disease should be hospitalized and monitored via ECG.

Timelines for antibiotics

Most patients with Lyme disease should receive oral antibiotics, although duration times vary depending on the disease state. “We recommend that prophylactic antibiotic therapy be given to adults and children only within 72 hours of removal of an identified high-risk tick bite, but not for bites that are equivocal risk or low risk,” according to the guideline authors.

Specific antibiotic treatment regimens by condition are as follows: 10-14 days for early-stage disease, 14 days for Lyme carditis, 14-21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis.

“Despite arthritis occurring late in the course of infection, treatment with a 28-day course of oral antibiotic is effective, although the rates of complete resolution of joint swelling can vary,” Dr. Bockenstedt said. Clinicians may consider a second 28-day course of oral antibiotics or a 2- to 4-week course of ceftriaxone in patients with persistent swelling, after an initial course of oral antibiotics.

Citing knowledge gaps, the authors made no recommendation on secondary antibiotic treatment for unresolved Lyme arthritis. Rheumatologists can play an important role in the care of this small subset of patients, Dr. Bockenstedt noted. “Studies of patients with ‘postantibiotic Lyme arthritis’ show that they can be treated successfully with intra-articular steroids, nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, biologic response modifiers, and even synovectomy with successful outcomes.” Some of these therapies also work in cases where first courses of oral and intravenous antibiotics are unsuccessful.

“Antibiotic therapy for longer than 8 weeks is not expected to provide additional benefit to patients with persistent arthritis if that treatment has included one course of IV therapy,” the authors clarified.

For patients with Lyme disease–associated meningitis, cranial neuropathy, radiculoneuropathy, or other PNS manifestations, the authors recommended intravenous ceftriaxone, cefotaxime, penicillin G, or oral doxycycline over other antimicrobials.

“For most neurologic presentations, oral doxycycline is just as effective as appropriate IV antibiotics,” Dr. Rumbaugh said. “The exception is the relatively rare situation where the patient is felt to have parenchymal involvement of brain or spinal cord, in which case the guidelines recommend IV antibiotics over oral antibiotics.” In the studies, there was no statistically significant difference between oral or intravenous regimens in response rate or risk of adverse effects.

Patients with nonspecific symptoms such as fatigue, pain, or cognitive impairment following treatment should not receive additional antibiotic therapy if there’s no evidence of treatment failure or infection. These two markers “would include objective signs of disease activity, such as arthritis, meningitis, or neuropathy,” the guideline authors wrote in comments accompanying the recommendation.

Clinicians caring for patients with symptomatic bradycardia caused by Lyme carditis should consider temporary pacing measures instead of a permanent pacemaker. For patients hospitalized with Lyme carditis, “we suggest initially using IV ceftriaxone over oral antibiotics until there is evidence of clinical improvement, then switching to oral antibiotics to complete treatment,” they advised. Outpatients with this condition should receive oral antibiotics instead of intravenous antibiotics.

Advice on antibodies testing ‘particularly cogent’

For individuals without expertise in these areas, the recommendations are clear and useful, Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy), said in an interview.

“As a rheumatologist, I would have appreciated literature references for some of the recommendations but, nevertheless, find these useful. I applaud the care with which the evidence was gathered and the general formatting, which tried to review multiple possible scenarios surrounding Lyme arthritis,” said Dr. Furst, offering a third-party perspective.

The advice on using antibodies tests to make a diagnosis of Lyme arthritis “is particularly cogent and more useful than trying to culture these fastidious organisms,” he added.

The IDSA, AAN, and ACR provided support for the guideline. Dr. Bockenstedt reported receiving research funding from the National Institutes of Health and the Gordon and the Llura Gund Foundation and remuneration from L2 Diagnostics for investigator-initiated NIH-sponsored research. Dr. Rumbaugh had no conflicts of interest to disclose. Dr. Furst reported no conflicts of interest in commenting on these guidelines.

SOURCE: Rumbaugh JA et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1215.

New clinical practice guidelines on Lyme disease place a strong emphasis on antibody testing to assess for rheumatologic and neurologic syndromes. “Diagnostically, we recommend testing via antibodies, and an index of antibodies in cerebrospinal fluid [CSF] versus serum. Importantly, we recommend against using polymerase chain reaction [PCR] in CSF,” Jeffrey A. Rumbaugh, MD, PhD, a coauthor of the guidelines and a member of the American Academy of Neurology, said in an interview.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

The Infectious Diseases Society of America, AAN, and the American College of Rheumatology convened a multidisciplinary panel to develop the 43 recommendations, seeking input from 12 additional medical specialties, and patients. The panel conducted a systematic review of available evidence on preventing, diagnosing, and treating Lyme disease, using the Grading of Recommendations Assessment, Development and Evaluation model to evaluate clinical evidence and strength of recommendations. The guidelines were simultaneous published in Clinical Infectious Diseases, Neurology, Arthritis & Rheumatology, and Arthritis Care & Research.

This is the first time these organizations have collaborated on joint Lyme disease guidelines, which focus mainly on neurologic, cardiac, and rheumatologic manifestations.

“We are very excited to provide these updated guidelines to assist clinicians working in numerous medical specialties around the country, and even the world, as they care for patients suffering from Lyme disease,” Dr. Rumbaugh said.
 

When to use and not to use PCR

Guideline authors called for specific testing regimens depending on presentation of symptoms. Generally, they advised that individuals with a skin rash suggestive of early disease seek a clinical diagnosis instead of laboratory testing.

Recommendations on Lyme arthritis support previous IDSA guidelines published in 2006, Linda K. Bockenstedt, MD, professor of medicine at Yale University, New Haven, Conn., and a coauthor of the guidelines, said in an interview.

To evaluate for potential Lyme arthritis, clinicians should choose serum antibody testing over PCR or culture of blood or synovial fluid/tissue. However, if a doctor is assessing a seropositive patient for Lyme arthritis diagnosis but needs more information for treatment decisions, the authors recommended PCR applied to synovial fluid or tissue over Borrelia culture.

“Synovial fluid can be analyzed by PCR, but sensitivity is generally lower than serology,” Dr. Bockenstedt explained. Additionally, culture of joint fluid or synovial tissue for Lyme spirochetes has 0% sensitivity in multiple studies. “For these reasons, we recommend serum antibody testing over PCR of joint fluid or other methods for an initial diagnosis.”

Serum antibody testing over PCR or culture is also recommended for identifying Lyme neuroborreliosis in the peripheral nervous system (PNS) or CNS.

Despite the recent popularity of Lyme PCR testing in hospitals and labs, “with Lyme at least, antibodies are better in the CSF,” Dr. Rumbaugh said. Studies have shown that “most patients with even early neurologic Lyme disease are seropositive by conventional antibody testing at time of initial clinical presentation, and that intrathecal antibody production, as demonstrated by an elevated CSF:serum index, is highly specific for CNS involvement.”

If done correctly, antibody testing is both sensitive and specific for neurologic Lyme disease. “On the other hand, sensitivity of Lyme PCR performed on CSF has been only in the 5%-17% range in studies. Incidentally, Lyme PCR on blood is also not sensitive and therefore not recommended,” Dr. Rumbaugh said.

Guideline authors recommended testing in patients with the following conditions: acute neurologic disorders such as meningitis, painful radiculoneuritis, mononeuropathy multiplex; evidence of spinal cord or brain inflammation; and acute myocarditis/pericarditis of unknown cause in an appropriate epidemiologic setting.

They did not recommend testing in patients with typical amyotrophic lateral sclerosis; relapsing remitting multiple sclerosis; Parkinson’s disease, dementia, or cognitive decline; new-onset seizures; other neurologic syndromes or those lacking clinical or epidemiologic history that would support a diagnosis of Lyme disease; and patients with chronic cardiomyopathy of unknown cause.

The authors also called for judicious use of electrocardiogram to screen for Lyme carditis, recommending it only in patients signs or symptoms of this condition. However, patients at risk for or showing signs of severe cardiac complications of Lyme disease should be hospitalized and monitored via ECG.

Timelines for antibiotics

Most patients with Lyme disease should receive oral antibiotics, although duration times vary depending on the disease state. “We recommend that prophylactic antibiotic therapy be given to adults and children only within 72 hours of removal of an identified high-risk tick bite, but not for bites that are equivocal risk or low risk,” according to the guideline authors.

Specific antibiotic treatment regimens by condition are as follows: 10-14 days for early-stage disease, 14 days for Lyme carditis, 14-21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis.

“Despite arthritis occurring late in the course of infection, treatment with a 28-day course of oral antibiotic is effective, although the rates of complete resolution of joint swelling can vary,” Dr. Bockenstedt said. Clinicians may consider a second 28-day course of oral antibiotics or a 2- to 4-week course of ceftriaxone in patients with persistent swelling, after an initial course of oral antibiotics.

Citing knowledge gaps, the authors made no recommendation on secondary antibiotic treatment for unresolved Lyme arthritis. Rheumatologists can play an important role in the care of this small subset of patients, Dr. Bockenstedt noted. “Studies of patients with ‘postantibiotic Lyme arthritis’ show that they can be treated successfully with intra-articular steroids, nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, biologic response modifiers, and even synovectomy with successful outcomes.” Some of these therapies also work in cases where first courses of oral and intravenous antibiotics are unsuccessful.

“Antibiotic therapy for longer than 8 weeks is not expected to provide additional benefit to patients with persistent arthritis if that treatment has included one course of IV therapy,” the authors clarified.

For patients with Lyme disease–associated meningitis, cranial neuropathy, radiculoneuropathy, or other PNS manifestations, the authors recommended intravenous ceftriaxone, cefotaxime, penicillin G, or oral doxycycline over other antimicrobials.

“For most neurologic presentations, oral doxycycline is just as effective as appropriate IV antibiotics,” Dr. Rumbaugh said. “The exception is the relatively rare situation where the patient is felt to have parenchymal involvement of brain or spinal cord, in which case the guidelines recommend IV antibiotics over oral antibiotics.” In the studies, there was no statistically significant difference between oral or intravenous regimens in response rate or risk of adverse effects.

Patients with nonspecific symptoms such as fatigue, pain, or cognitive impairment following treatment should not receive additional antibiotic therapy if there’s no evidence of treatment failure or infection. These two markers “would include objective signs of disease activity, such as arthritis, meningitis, or neuropathy,” the guideline authors wrote in comments accompanying the recommendation.

Clinicians caring for patients with symptomatic bradycardia caused by Lyme carditis should consider temporary pacing measures instead of a permanent pacemaker. For patients hospitalized with Lyme carditis, “we suggest initially using IV ceftriaxone over oral antibiotics until there is evidence of clinical improvement, then switching to oral antibiotics to complete treatment,” they advised. Outpatients with this condition should receive oral antibiotics instead of intravenous antibiotics.

Advice on antibodies testing ‘particularly cogent’

For individuals without expertise in these areas, the recommendations are clear and useful, Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy), said in an interview.

“As a rheumatologist, I would have appreciated literature references for some of the recommendations but, nevertheless, find these useful. I applaud the care with which the evidence was gathered and the general formatting, which tried to review multiple possible scenarios surrounding Lyme arthritis,” said Dr. Furst, offering a third-party perspective.

The advice on using antibodies tests to make a diagnosis of Lyme arthritis “is particularly cogent and more useful than trying to culture these fastidious organisms,” he added.

The IDSA, AAN, and ACR provided support for the guideline. Dr. Bockenstedt reported receiving research funding from the National Institutes of Health and the Gordon and the Llura Gund Foundation and remuneration from L2 Diagnostics for investigator-initiated NIH-sponsored research. Dr. Rumbaugh had no conflicts of interest to disclose. Dr. Furst reported no conflicts of interest in commenting on these guidelines.

SOURCE: Rumbaugh JA et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1215.

New clinical practice guidelines on Lyme disease place a strong emphasis on antibody testing to assess for rheumatologic and neurologic syndromes. “Diagnostically, we recommend testing via antibodies, and an index of antibodies in cerebrospinal fluid [CSF] versus serum. Importantly, we recommend against using polymerase chain reaction [PCR] in CSF,” Jeffrey A. Rumbaugh, MD, PhD, a coauthor of the guidelines and a member of the American Academy of Neurology, said in an interview.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

The Infectious Diseases Society of America, AAN, and the American College of Rheumatology convened a multidisciplinary panel to develop the 43 recommendations, seeking input from 12 additional medical specialties, and patients. The panel conducted a systematic review of available evidence on preventing, diagnosing, and treating Lyme disease, using the Grading of Recommendations Assessment, Development and Evaluation model to evaluate clinical evidence and strength of recommendations. The guidelines were simultaneous published in Clinical Infectious Diseases, Neurology, Arthritis & Rheumatology, and Arthritis Care & Research.

This is the first time these organizations have collaborated on joint Lyme disease guidelines, which focus mainly on neurologic, cardiac, and rheumatologic manifestations.

“We are very excited to provide these updated guidelines to assist clinicians working in numerous medical specialties around the country, and even the world, as they care for patients suffering from Lyme disease,” Dr. Rumbaugh said.
 

When to use and not to use PCR

Guideline authors called for specific testing regimens depending on presentation of symptoms. Generally, they advised that individuals with a skin rash suggestive of early disease seek a clinical diagnosis instead of laboratory testing.

Recommendations on Lyme arthritis support previous IDSA guidelines published in 2006, Linda K. Bockenstedt, MD, professor of medicine at Yale University, New Haven, Conn., and a coauthor of the guidelines, said in an interview.

To evaluate for potential Lyme arthritis, clinicians should choose serum antibody testing over PCR or culture of blood or synovial fluid/tissue. However, if a doctor is assessing a seropositive patient for Lyme arthritis diagnosis but needs more information for treatment decisions, the authors recommended PCR applied to synovial fluid or tissue over Borrelia culture.

“Synovial fluid can be analyzed by PCR, but sensitivity is generally lower than serology,” Dr. Bockenstedt explained. Additionally, culture of joint fluid or synovial tissue for Lyme spirochetes has 0% sensitivity in multiple studies. “For these reasons, we recommend serum antibody testing over PCR of joint fluid or other methods for an initial diagnosis.”

Serum antibody testing over PCR or culture is also recommended for identifying Lyme neuroborreliosis in the peripheral nervous system (PNS) or CNS.

Despite the recent popularity of Lyme PCR testing in hospitals and labs, “with Lyme at least, antibodies are better in the CSF,” Dr. Rumbaugh said. Studies have shown that “most patients with even early neurologic Lyme disease are seropositive by conventional antibody testing at time of initial clinical presentation, and that intrathecal antibody production, as demonstrated by an elevated CSF:serum index, is highly specific for CNS involvement.”

If done correctly, antibody testing is both sensitive and specific for neurologic Lyme disease. “On the other hand, sensitivity of Lyme PCR performed on CSF has been only in the 5%-17% range in studies. Incidentally, Lyme PCR on blood is also not sensitive and therefore not recommended,” Dr. Rumbaugh said.

Guideline authors recommended testing in patients with the following conditions: acute neurologic disorders such as meningitis, painful radiculoneuritis, mononeuropathy multiplex; evidence of spinal cord or brain inflammation; and acute myocarditis/pericarditis of unknown cause in an appropriate epidemiologic setting.

They did not recommend testing in patients with typical amyotrophic lateral sclerosis; relapsing remitting multiple sclerosis; Parkinson’s disease, dementia, or cognitive decline; new-onset seizures; other neurologic syndromes or those lacking clinical or epidemiologic history that would support a diagnosis of Lyme disease; and patients with chronic cardiomyopathy of unknown cause.

The authors also called for judicious use of electrocardiogram to screen for Lyme carditis, recommending it only in patients signs or symptoms of this condition. However, patients at risk for or showing signs of severe cardiac complications of Lyme disease should be hospitalized and monitored via ECG.

Timelines for antibiotics

Most patients with Lyme disease should receive oral antibiotics, although duration times vary depending on the disease state. “We recommend that prophylactic antibiotic therapy be given to adults and children only within 72 hours of removal of an identified high-risk tick bite, but not for bites that are equivocal risk or low risk,” according to the guideline authors.

Specific antibiotic treatment regimens by condition are as follows: 10-14 days for early-stage disease, 14 days for Lyme carditis, 14-21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis.

“Despite arthritis occurring late in the course of infection, treatment with a 28-day course of oral antibiotic is effective, although the rates of complete resolution of joint swelling can vary,” Dr. Bockenstedt said. Clinicians may consider a second 28-day course of oral antibiotics or a 2- to 4-week course of ceftriaxone in patients with persistent swelling, after an initial course of oral antibiotics.

Citing knowledge gaps, the authors made no recommendation on secondary antibiotic treatment for unresolved Lyme arthritis. Rheumatologists can play an important role in the care of this small subset of patients, Dr. Bockenstedt noted. “Studies of patients with ‘postantibiotic Lyme arthritis’ show that they can be treated successfully with intra-articular steroids, nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, biologic response modifiers, and even synovectomy with successful outcomes.” Some of these therapies also work in cases where first courses of oral and intravenous antibiotics are unsuccessful.

“Antibiotic therapy for longer than 8 weeks is not expected to provide additional benefit to patients with persistent arthritis if that treatment has included one course of IV therapy,” the authors clarified.

For patients with Lyme disease–associated meningitis, cranial neuropathy, radiculoneuropathy, or other PNS manifestations, the authors recommended intravenous ceftriaxone, cefotaxime, penicillin G, or oral doxycycline over other antimicrobials.

“For most neurologic presentations, oral doxycycline is just as effective as appropriate IV antibiotics,” Dr. Rumbaugh said. “The exception is the relatively rare situation where the patient is felt to have parenchymal involvement of brain or spinal cord, in which case the guidelines recommend IV antibiotics over oral antibiotics.” In the studies, there was no statistically significant difference between oral or intravenous regimens in response rate or risk of adverse effects.

Patients with nonspecific symptoms such as fatigue, pain, or cognitive impairment following treatment should not receive additional antibiotic therapy if there’s no evidence of treatment failure or infection. These two markers “would include objective signs of disease activity, such as arthritis, meningitis, or neuropathy,” the guideline authors wrote in comments accompanying the recommendation.

Clinicians caring for patients with symptomatic bradycardia caused by Lyme carditis should consider temporary pacing measures instead of a permanent pacemaker. For patients hospitalized with Lyme carditis, “we suggest initially using IV ceftriaxone over oral antibiotics until there is evidence of clinical improvement, then switching to oral antibiotics to complete treatment,” they advised. Outpatients with this condition should receive oral antibiotics instead of intravenous antibiotics.

Advice on antibodies testing ‘particularly cogent’

For individuals without expertise in these areas, the recommendations are clear and useful, Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy), said in an interview.

“As a rheumatologist, I would have appreciated literature references for some of the recommendations but, nevertheless, find these useful. I applaud the care with which the evidence was gathered and the general formatting, which tried to review multiple possible scenarios surrounding Lyme arthritis,” said Dr. Furst, offering a third-party perspective.

The advice on using antibodies tests to make a diagnosis of Lyme arthritis “is particularly cogent and more useful than trying to culture these fastidious organisms,” he added.

The IDSA, AAN, and ACR provided support for the guideline. Dr. Bockenstedt reported receiving research funding from the National Institutes of Health and the Gordon and the Llura Gund Foundation and remuneration from L2 Diagnostics for investigator-initiated NIH-sponsored research. Dr. Rumbaugh had no conflicts of interest to disclose. Dr. Furst reported no conflicts of interest in commenting on these guidelines.

SOURCE: Rumbaugh JA et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1215.

The American Gastroenterological Association has published a Clinical Practice Update for management of inflammatory bowel disease (IBD) in elderly patients, including 15 best practice advice statements.

According to lead author Ashwin N. Ananthakrishnan, MD, MPH, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues, this topic is becoming increasingly relevant, as the population is aging, and prevalence of IBD among elderly is rising approximately 5% per year.

“Up to 15% of IBD in North America and Asia is diagnosed after the age of 60 years,” the investigators wrote in Gastroenterology.

Dr. Ananthakrishnan and colleagues noted that “care of elderly IBD patients poses unique challenges with respect to diagnosis and therapeutic decision-making.”

Challenges include greater frequency of comorbidities, increased risk of infection with anti–tumor necrosis factor therapy, increased risk of lymphoma with thiopurine therapy, greater likelihood of surgical complications, and, for Crohn’s disease, an elevated mortality rate, according to the update.

Another challenge is a lack of data.

“It should be noted that most clinical data to inform these practices are based on observational data or indirect evidence as elderly IBD patients comprise a very small proportion of subjects enrolled in IBD clinical trials or long-term pharmacovigilance initiatives,” the investigators wrote.

With this in mind, the update offers guidance for diagnosis, treatment, and ongoing health maintenance.
 

Diagnosis

Dr. Ananthakrishnan and colleagues first suggested that clinicians remain vigilant for IBD in elderly people, in consideration of the 15% prevalence rate in this subpopulation.

For elderly individuals with a low probability of IBD, the investigators recommended fecal calprotectin or lactoferrin to determine if endoscopy is needed. For elderly patients with chronic diarrhea or hematochezia, plus moderate to high suspicion of IBD, colorectal neoplasia, or microscopic colitis, they recommended colonoscopy.

Lastly, the expert panel suggested that elderly patients presenting with segmental left-sided colitis and diverticulosis may also have Crohn’s disease or IBD unclassified.
 

Treatment

The clinical practice update offers 10 best practice statements for treating elderly patients with IBD. There is a recurring emphasis on treatment personalization, which should be informed by patient goals and priorities, risk/presence of severe disease, chronological age, functional status, independence, comorbidities, frailty, and several other age-associated risk factors (e.g., venous thromboembolism).

Concerning specific therapies, the investigators cautioned against systemic corticosteroids for maintenance therapy; instead, nonsystemic corticosteroids (e.g., budesonide) are favored, or possibly early biological therapy if budesonide is not indicated. When selecting a biologic, Dr. Ananthakrishnan and colleagues recommended those associated with a lower risk of malignancy and infection (e.g., ustekinumab or vedolizumab).

The advantages of thiopurine monotherapy being oral, relatively inexpensive compared to biologicals and having a long track record of success in maintenance of remission must be balanced against the need for ongoing serological monitoring, and increased risk of some malignancies.

Finally, the expert panel recommended that all elderly patients receive multidisciplinary care, which may include primary care providers, mental health professionals, nutritionists, and other specialists. It may also be productive to consult with family and caregivers during treatment planning.

Health maintenance

The last two best practice advice statements concern health maintenance.

First, the investigators recommended that elderly patients with IBD adhere to vaccination schedules, including herpes zoster, pneumococcus, and influenza vaccines, ideally, before starting immunosuppression.

Second, Dr. Ananthakrishnan and colleagues advised that cessation of colorectal cancer surveillance may be considered in elderly patients with IBD; however, this decision should take into account a variety of factors, including comorbidities, age, life expectancy, likelihood of endoscopic resection, and surgical candidacy.

The review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed relationships with Gilead, Sun Pharma, Kyn Therapeutics, and others.

SOURCE: Ananthakrishnan AN et al. Gastroenterology. 2020 Sep 30. doi: 10.1053/j.gastro.2020.08.060.

This story was updated on 12/4/2020.

The American Gastroenterological Association has published a Clinical Practice Update for management of inflammatory bowel disease (IBD) in elderly patients, including 15 best practice advice statements.

According to lead author Ashwin N. Ananthakrishnan, MD, MPH, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues, this topic is becoming increasingly relevant, as the population is aging, and prevalence of IBD among elderly is rising approximately 5% per year.

“Up to 15% of IBD in North America and Asia is diagnosed after the age of 60 years,” the investigators wrote in Gastroenterology.

Dr. Ananthakrishnan and colleagues noted that “care of elderly IBD patients poses unique challenges with respect to diagnosis and therapeutic decision-making.”

Challenges include greater frequency of comorbidities, increased risk of infection with anti–tumor necrosis factor therapy, increased risk of lymphoma with thiopurine therapy, greater likelihood of surgical complications, and, for Crohn’s disease, an elevated mortality rate, according to the update.

Another challenge is a lack of data.

“It should be noted that most clinical data to inform these practices are based on observational data or indirect evidence as elderly IBD patients comprise a very small proportion of subjects enrolled in IBD clinical trials or long-term pharmacovigilance initiatives,” the investigators wrote.

With this in mind, the update offers guidance for diagnosis, treatment, and ongoing health maintenance.
 

Diagnosis

Dr. Ananthakrishnan and colleagues first suggested that clinicians remain vigilant for IBD in elderly people, in consideration of the 15% prevalence rate in this subpopulation.

For elderly individuals with a low probability of IBD, the investigators recommended fecal calprotectin or lactoferrin to determine if endoscopy is needed. For elderly patients with chronic diarrhea or hematochezia, plus moderate to high suspicion of IBD, colorectal neoplasia, or microscopic colitis, they recommended colonoscopy.

Lastly, the expert panel suggested that elderly patients presenting with segmental left-sided colitis and diverticulosis may also have Crohn’s disease or IBD unclassified.
 

Treatment

The clinical practice update offers 10 best practice statements for treating elderly patients with IBD. There is a recurring emphasis on treatment personalization, which should be informed by patient goals and priorities, risk/presence of severe disease, chronological age, functional status, independence, comorbidities, frailty, and several other age-associated risk factors (e.g., venous thromboembolism).

Concerning specific therapies, the investigators cautioned against systemic corticosteroids for maintenance therapy; instead, nonsystemic corticosteroids (e.g., budesonide) are favored, or possibly early biological therapy if budesonide is not indicated. When selecting a biologic, Dr. Ananthakrishnan and colleagues recommended those associated with a lower risk of malignancy and infection (e.g., ustekinumab or vedolizumab).

The advantages of thiopurine monotherapy being oral, relatively inexpensive compared to biologicals and having a long track record of success in maintenance of remission must be balanced against the need for ongoing serological monitoring, and increased risk of some malignancies.

Finally, the expert panel recommended that all elderly patients receive multidisciplinary care, which may include primary care providers, mental health professionals, nutritionists, and other specialists. It may also be productive to consult with family and caregivers during treatment planning.

Health maintenance

The last two best practice advice statements concern health maintenance.

First, the investigators recommended that elderly patients with IBD adhere to vaccination schedules, including herpes zoster, pneumococcus, and influenza vaccines, ideally, before starting immunosuppression.

Second, Dr. Ananthakrishnan and colleagues advised that cessation of colorectal cancer surveillance may be considered in elderly patients with IBD; however, this decision should take into account a variety of factors, including comorbidities, age, life expectancy, likelihood of endoscopic resection, and surgical candidacy.

The review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed relationships with Gilead, Sun Pharma, Kyn Therapeutics, and others.

SOURCE: Ananthakrishnan AN et al. Gastroenterology. 2020 Sep 30. doi: 10.1053/j.gastro.2020.08.060.

This story was updated on 12/4/2020.

The American Gastroenterological Association has published a Clinical Practice Update for management of inflammatory bowel disease (IBD) in elderly patients, including 15 best practice advice statements.

According to lead author Ashwin N. Ananthakrishnan, MD, MPH, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues, this topic is becoming increasingly relevant, as the population is aging, and prevalence of IBD among elderly is rising approximately 5% per year.

“Up to 15% of IBD in North America and Asia is diagnosed after the age of 60 years,” the investigators wrote in Gastroenterology.

Dr. Ananthakrishnan and colleagues noted that “care of elderly IBD patients poses unique challenges with respect to diagnosis and therapeutic decision-making.”

Challenges include greater frequency of comorbidities, increased risk of infection with anti–tumor necrosis factor therapy, increased risk of lymphoma with thiopurine therapy, greater likelihood of surgical complications, and, for Crohn’s disease, an elevated mortality rate, according to the update.

Another challenge is a lack of data.

“It should be noted that most clinical data to inform these practices are based on observational data or indirect evidence as elderly IBD patients comprise a very small proportion of subjects enrolled in IBD clinical trials or long-term pharmacovigilance initiatives,” the investigators wrote.

With this in mind, the update offers guidance for diagnosis, treatment, and ongoing health maintenance.
 

Diagnosis

Dr. Ananthakrishnan and colleagues first suggested that clinicians remain vigilant for IBD in elderly people, in consideration of the 15% prevalence rate in this subpopulation.

For elderly individuals with a low probability of IBD, the investigators recommended fecal calprotectin or lactoferrin to determine if endoscopy is needed. For elderly patients with chronic diarrhea or hematochezia, plus moderate to high suspicion of IBD, colorectal neoplasia, or microscopic colitis, they recommended colonoscopy.

Lastly, the expert panel suggested that elderly patients presenting with segmental left-sided colitis and diverticulosis may also have Crohn’s disease or IBD unclassified.
 

Treatment

The clinical practice update offers 10 best practice statements for treating elderly patients with IBD. There is a recurring emphasis on treatment personalization, which should be informed by patient goals and priorities, risk/presence of severe disease, chronological age, functional status, independence, comorbidities, frailty, and several other age-associated risk factors (e.g., venous thromboembolism).

Concerning specific therapies, the investigators cautioned against systemic corticosteroids for maintenance therapy; instead, nonsystemic corticosteroids (e.g., budesonide) are favored, or possibly early biological therapy if budesonide is not indicated. When selecting a biologic, Dr. Ananthakrishnan and colleagues recommended those associated with a lower risk of malignancy and infection (e.g., ustekinumab or vedolizumab).

The advantages of thiopurine monotherapy being oral, relatively inexpensive compared to biologicals and having a long track record of success in maintenance of remission must be balanced against the need for ongoing serological monitoring, and increased risk of some malignancies.

Finally, the expert panel recommended that all elderly patients receive multidisciplinary care, which may include primary care providers, mental health professionals, nutritionists, and other specialists. It may also be productive to consult with family and caregivers during treatment planning.

Health maintenance

The last two best practice advice statements concern health maintenance.

First, the investigators recommended that elderly patients with IBD adhere to vaccination schedules, including herpes zoster, pneumococcus, and influenza vaccines, ideally, before starting immunosuppression.

Second, Dr. Ananthakrishnan and colleagues advised that cessation of colorectal cancer surveillance may be considered in elderly patients with IBD; however, this decision should take into account a variety of factors, including comorbidities, age, life expectancy, likelihood of endoscopic resection, and surgical candidacy.

The review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed relationships with Gilead, Sun Pharma, Kyn Therapeutics, and others.

SOURCE: Ananthakrishnan AN et al. Gastroenterology. 2020 Sep 30. doi: 10.1053/j.gastro.2020.08.060.

This story was updated on 12/4/2020.

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

An infectious disease expert panel cautions against routine use of bamlanivimab (Eli Lilly) and notes that remdesivir (Veklury) can shorten the clinical course of COVID-19 – which could be critical “as hospitals fill up” across the United States.

The group also said the monoclonal antibodies approved for emergency use by the Food and Drug Administration and still in development hold promise, although more clinical trial data are needed.

These and other recommendations appear in updated guidelines from the Infectious Diseases Society of America, released Nov. 18 and Nov. 22.
 

A conditional ‘no’ on routine bamlanivimab

“The guideline panel gave a conditional recommendation against the routine use of bamlanivimab,” Adarsh Bhimraj, MD, cochair of the IDSA COVID-19 Treatment and Management Guidelines Expert Panel, said.

On Nov. 10, the FDA issued an emergency-use authorization (EUA) for bamlanivimab for use in ambulatory patients with mild to moderate COVID-19.

“We did have a remark that it may be used in patients who have increased risk of severe COVID-19, as it is outlined in the FDA emergency-use authorization issued last week,” he said. He added that use should follow an informed discussion between provider and patient, one in which “the patient puts a very high value on the uncertain benefits and a low value on uncertain adverse events.”

The panel’s rationale was based in part on interim analysis of the phase 2 BLAZE-1 trial, which found 1.6% of people randomly assigned to bamlanivimab had an emergency department visit or hospitalization compared with 6.3% of those receiving a placebo.

“We thought the estimate was too fragile because the number in each arm was very low. Even a small change in these numbers could make the difference nonsignificant,” said Bhimraj, head of the neurologic infectious diseases section in the department of infectious diseases at the Cleveland (Ohio) Clinic.
 

Awaiting more data on antibody combination

On November 21, the FDA granted an EUA to the casirivimab and imbdevimab monoclonal antibody combination (Regeneron), indicated to treated mild to moderate COVID-19.

“Surprisingly, the preliminary results released in the EUA look a lot like bamlanivimab,” Dr. Bhimraj said.

Unlike bamlanivimab, for which trial details were published, the panel does not yet have the totality of data on casirivimab and imbdevimab, and therefore is not yet making a recommendation. “We want to be cautious as a guideline panel. We are anxiously awaiting the full publication,” he added.

“I do think these monoclonal antibodies show potential for benefit, but as Dr. Bhimraj said, it’s very difficult with the relatively small numbers we’re talking about,” said Rajesh T. Gandhi, MD, cochair of the IDSA COVID-19 Treatment and Management Guidelines Expert Panel.

Remaining questions include the degree of efficacy these antibody therapies will have, as well as which patients are most likely to benefit, added Dr. Gandhi, who is also a professor of medicine at Harvard Medical School and director of HIV Clinical Services and Education at Massachusetts General Hospital, both in Boston.

Furthermore, although there appear to be adequate supplies of remdesivir and dexamethasone, for example, availability and distribution of monoclonal antibodies could present logistic challenges. Prioritizing which high-risk patients receive this therapy and ensuring equity and access to communities most affected by COVID-19, including minority and low socioeconomic populations, need to be addressed, Dr. Gandhi said.  
 

Remdesivir recommended to shorten hospital stays

The panel’s recommendations regarding the use of remdesivir “has largely remained the same,” Dr. Gandhi said. Evidence indicates recovery is faster with remdesivir at 10 days vs 15 days in people taking a placebo.

In the ACTT-1 trial, for example, participants in the treatment group recovered in a median 10 days versus 15 days in the placebo group.

Therefore, the IDSA panel continues to recommend remdesivir treatment for hospitalized patients with COVID-19.

“As hospitals around the United States fill up, the IDSA panel believes the effect of remdesivir on speeding up recovery could be an important benefit, and that is why we continue to suggest its use,” Dr. Gandhi said.

When asked about the World Health Organization–sponsored trial that showed no benefit in terms of mortality, he replied, “Remdesivir is not a home run – we need better drugs.”
 

A recommendation against lopinavir and ritonavir

In contrast, the panel recommends against use of the lopinavir/ritonavir protease inhibitor combination therapy, based in part on data from a preprint of the Solidarity study.

The open-label Solidarity trial in 30 countries, sponsored by WHO, assessed hydroxychloroquine, interferon, lopinavir/ritonavir, and remdesivir in people hospitalized with COVID-19.

None of these drugs showed an effect on mortality, Dr. Gandhi said. “Better medicines that improve survival are clearly needed.”

Dexamethasone remains the only agent demonstrated to reduce mortality in people hospitalized with COVID-19, he added.
 

Tocilizumab not for routine use

After critical review of the studies that have emerged since the last IDSA recommendation regarding tocilizumab (Actemra) in September, “the panel still stood with the recommendation against routine use of tocilizumab in hospitalized patients with COVID-19,” Dr. Bhimraj said.

The guidance is based on trials including COVACTA and EMPACTA. Treatment with tocilizumab was not associated with significant differences in mortality. In these and other studies, “we did not really find a significant difference, and that was the reason for the conditional recommendation against routine use of tocilizumab in hospitalized patients,” Dr. Bhimraj said.

Also, although the trials were blinded, “we know treatment with tocilizumab can cause a reduction in C-reactive protein levels,” which could indicate to researchers which participants were receiving active treatment versus placebo, he said.
 

Jury still out on baricitinib, remdesivir combination

The FDA granted an EUA to the combination of remdesivir and baricitinib (Olumiant) on Nov. 19. However, the IDSA panel is reserving its recommendation on this therapeutic combination until more data emerge.

“We still don’t have complete results of the ACTT-2 study, and the information we do have is what is available in the EUA,” Dr. Bhimraj said. The panel expects to issue guidance once the totality of data become available.

Unanswered questions include why investigators chose a 4-mg dose of baricitinib – twice the 2-mg dose commonly used for treating rheumatoid arthritis – and how many patients in the trial also were treated with steroids.

Dr. Gandhi agreed that the proportion of patients taking a steroid is “really an important consideration.” He added that dexamethasone has become standard of care because it reduces mortality, as well as the number of people requiring oxygen. He said it will be important to know how the baricitinib/remdesivir combination compares with dexamethasone.

“You don’t want to give a drug with less certain benefit over a drug for which there is more certain benefit,” Dr. Gandhi said.
 

Future possibilities

“The monoclonal antibodies are important to continue studying, particularly in combinations,” Dr. Gandhi said. Researchers are investigating formulations other than IV infusion to make therapy more convenient. For example, a subcutaneous injection like insulin would make administration at home more of a possibility.

Investigators are also looking at oral antiviral therapy, inhaled antivirals, and the promise of using interferon therapy. Dr. Gandhi added there is also “a lot of work around medications to reduce the excess inflammation that drives very severe COVID-19.”
 

‘Exciting news’ on AstraZeneca vaccine

Although not part of the IDSA guidelines, “we saw the news from AstraZeneca this morning, which is exciting,” Dr. Gandhi said during a media briefing.

Unlike the Pfizer and Moderna messenger RNA vaccines, which use the genetic material of the virus to make the virus proteins that elicit an immune response, the AstraZeneca/Oxford University vaccine uses a viral vector to carry the SARS-CoV-2 protein, to which the body produces an immune response.

“I’m thrilled that several different vaccines are showing important effects at rates higher than the FDA benchmark of 50%, and these are well exceeding that,” Dr. Gandhi said.

“One interesting thing from the [AstraZeneca] press release is they show asymptomatic infection being reduced,” he added. “That is critical because we know a lot of transmission of SARS-CoV-2 comes from asymptomatic people.”
 

Reasons for optimism

In response to a question about whether the experts feel more optimistic about COVID-19, Dr. Bhimraj said he is cautiously optimistic. “We have made tremendous progress in therapeutic agents, and in how the world has come together in the middle of a catastrophe to collaborate, setting our differences apart, to do trials. That is commendable.”

Dr. Gandhi said he felt more optimistic than he did in the spring. He pointed out that physicians and researchers know a lot more about potential blood clotting complications, how to support patients through severe COVID-19 and keep them off a ventilator whenever possible, and how to provide dexamethasone to reduce the risk of death.

Those benefits are in hospitalized patients, however, and “we need ways to prevent people from getting into the hospital, and that is why we are looking at the monoclonal antibodies,” Dr. Gandhi said. “If borne out in larger trials, that will be a major advance.”

“We need to keep our focus on prevention and go back to our idea of flattening the curve. That is critical so our health care systems do not get overwhelmed during this massive surge we are in,” Dr. Gandhi said. “So masking and social distancing are just as important as they always have been.”

Dr. Bhimraj disclosed no relevant financial relationships. Dr. Gandhi has no disclosures for the past 12 months; in the past 3 years, he has served on scientific advisory boards for Gilead and Merck.

This article first appeared on Medscape.com.

An infectious disease expert panel cautions against routine use of bamlanivimab (Eli Lilly) and notes that remdesivir (Veklury) can shorten the clinical course of COVID-19 – which could be critical “as hospitals fill up” across the United States.

The group also said the monoclonal antibodies approved for emergency use by the Food and Drug Administration and still in development hold promise, although more clinical trial data are needed.

These and other recommendations appear in updated guidelines from the Infectious Diseases Society of America, released Nov. 18 and Nov. 22.
 

A conditional ‘no’ on routine bamlanivimab

“The guideline panel gave a conditional recommendation against the routine use of bamlanivimab,” Adarsh Bhimraj, MD, cochair of the IDSA COVID-19 Treatment and Management Guidelines Expert Panel, said.

On Nov. 10, the FDA issued an emergency-use authorization (EUA) for bamlanivimab for use in ambulatory patients with mild to moderate COVID-19.

“We did have a remark that it may be used in patients who have increased risk of severe COVID-19, as it is outlined in the FDA emergency-use authorization issued last week,” he said. He added that use should follow an informed discussion between provider and patient, one in which “the patient puts a very high value on the uncertain benefits and a low value on uncertain adverse events.”

The panel’s rationale was based in part on interim analysis of the phase 2 BLAZE-1 trial, which found 1.6% of people randomly assigned to bamlanivimab had an emergency department visit or hospitalization compared with 6.3% of those receiving a placebo.

“We thought the estimate was too fragile because the number in each arm was very low. Even a small change in these numbers could make the difference nonsignificant,” said Bhimraj, head of the neurologic infectious diseases section in the department of infectious diseases at the Cleveland (Ohio) Clinic.
 

Awaiting more data on antibody combination

On November 21, the FDA granted an EUA to the casirivimab and imbdevimab monoclonal antibody combination (Regeneron), indicated to treated mild to moderate COVID-19.

“Surprisingly, the preliminary results released in the EUA look a lot like bamlanivimab,” Dr. Bhimraj said.

Unlike bamlanivimab, for which trial details were published, the panel does not yet have the totality of data on casirivimab and imbdevimab, and therefore is not yet making a recommendation. “We want to be cautious as a guideline panel. We are anxiously awaiting the full publication,” he added.

“I do think these monoclonal antibodies show potential for benefit, but as Dr. Bhimraj said, it’s very difficult with the relatively small numbers we’re talking about,” said Rajesh T. Gandhi, MD, cochair of the IDSA COVID-19 Treatment and Management Guidelines Expert Panel.

Remaining questions include the degree of efficacy these antibody therapies will have, as well as which patients are most likely to benefit, added Dr. Gandhi, who is also a professor of medicine at Harvard Medical School and director of HIV Clinical Services and Education at Massachusetts General Hospital, both in Boston.

Furthermore, although there appear to be adequate supplies of remdesivir and dexamethasone, for example, availability and distribution of monoclonal antibodies could present logistic challenges. Prioritizing which high-risk patients receive this therapy and ensuring equity and access to communities most affected by COVID-19, including minority and low socioeconomic populations, need to be addressed, Dr. Gandhi said.  
 

Remdesivir recommended to shorten hospital stays

The panel’s recommendations regarding the use of remdesivir “has largely remained the same,” Dr. Gandhi said. Evidence indicates recovery is faster with remdesivir at 10 days vs 15 days in people taking a placebo.

In the ACTT-1 trial, for example, participants in the treatment group recovered in a median 10 days versus 15 days in the placebo group.

Therefore, the IDSA panel continues to recommend remdesivir treatment for hospitalized patients with COVID-19.

“As hospitals around the United States fill up, the IDSA panel believes the effect of remdesivir on speeding up recovery could be an important benefit, and that is why we continue to suggest its use,” Dr. Gandhi said.

When asked about the World Health Organization–sponsored trial that showed no benefit in terms of mortality, he replied, “Remdesivir is not a home run – we need better drugs.”
 

A recommendation against lopinavir and ritonavir

In contrast, the panel recommends against use of the lopinavir/ritonavir protease inhibitor combination therapy, based in part on data from a preprint of the Solidarity study.

The open-label Solidarity trial in 30 countries, sponsored by WHO, assessed hydroxychloroquine, interferon, lopinavir/ritonavir, and remdesivir in people hospitalized with COVID-19.

None of these drugs showed an effect on mortality, Dr. Gandhi said. “Better medicines that improve survival are clearly needed.”

Dexamethasone remains the only agent demonstrated to reduce mortality in people hospitalized with COVID-19, he added.
 

Tocilizumab not for routine use

After critical review of the studies that have emerged since the last IDSA recommendation regarding tocilizumab (Actemra) in September, “the panel still stood with the recommendation against routine use of tocilizumab in hospitalized patients with COVID-19,” Dr. Bhimraj said.

The guidance is based on trials including COVACTA and EMPACTA. Treatment with tocilizumab was not associated with significant differences in mortality. In these and other studies, “we did not really find a significant difference, and that was the reason for the conditional recommendation against routine use of tocilizumab in hospitalized patients,” Dr. Bhimraj said.

Also, although the trials were blinded, “we know treatment with tocilizumab can cause a reduction in C-reactive protein levels,” which could indicate to researchers which participants were receiving active treatment versus placebo, he said.
 

Jury still out on baricitinib, remdesivir combination

The FDA granted an EUA to the combination of remdesivir and baricitinib (Olumiant) on Nov. 19. However, the IDSA panel is reserving its recommendation on this therapeutic combination until more data emerge.

“We still don’t have complete results of the ACTT-2 study, and the information we do have is what is available in the EUA,” Dr. Bhimraj said. The panel expects to issue guidance once the totality of data become available.

Unanswered questions include why investigators chose a 4-mg dose of baricitinib – twice the 2-mg dose commonly used for treating rheumatoid arthritis – and how many patients in the trial also were treated with steroids.

Dr. Gandhi agreed that the proportion of patients taking a steroid is “really an important consideration.” He added that dexamethasone has become standard of care because it reduces mortality, as well as the number of people requiring oxygen. He said it will be important to know how the baricitinib/remdesivir combination compares with dexamethasone.

“You don’t want to give a drug with less certain benefit over a drug for which there is more certain benefit,” Dr. Gandhi said.
 

Future possibilities

“The monoclonal antibodies are important to continue studying, particularly in combinations,” Dr. Gandhi said. Researchers are investigating formulations other than IV infusion to make therapy more convenient. For example, a subcutaneous injection like insulin would make administration at home more of a possibility.

Investigators are also looking at oral antiviral therapy, inhaled antivirals, and the promise of using interferon therapy. Dr. Gandhi added there is also “a lot of work around medications to reduce the excess inflammation that drives very severe COVID-19.”
 

‘Exciting news’ on AstraZeneca vaccine

Although not part of the IDSA guidelines, “we saw the news from AstraZeneca this morning, which is exciting,” Dr. Gandhi said during a media briefing.

Unlike the Pfizer and Moderna messenger RNA vaccines, which use the genetic material of the virus to make the virus proteins that elicit an immune response, the AstraZeneca/Oxford University vaccine uses a viral vector to carry the SARS-CoV-2 protein, to which the body produces an immune response.

“I’m thrilled that several different vaccines are showing important effects at rates higher than the FDA benchmark of 50%, and these are well exceeding that,” Dr. Gandhi said.

“One interesting thing from the [AstraZeneca] press release is they show asymptomatic infection being reduced,” he added. “That is critical because we know a lot of transmission of SARS-CoV-2 comes from asymptomatic people.”
 

Reasons for optimism

In response to a question about whether the experts feel more optimistic about COVID-19, Dr. Bhimraj said he is cautiously optimistic. “We have made tremendous progress in therapeutic agents, and in how the world has come together in the middle of a catastrophe to collaborate, setting our differences apart, to do trials. That is commendable.”

Dr. Gandhi said he felt more optimistic than he did in the spring. He pointed out that physicians and researchers know a lot more about potential blood clotting complications, how to support patients through severe COVID-19 and keep them off a ventilator whenever possible, and how to provide dexamethasone to reduce the risk of death.

Those benefits are in hospitalized patients, however, and “we need ways to prevent people from getting into the hospital, and that is why we are looking at the monoclonal antibodies,” Dr. Gandhi said. “If borne out in larger trials, that will be a major advance.”

“We need to keep our focus on prevention and go back to our idea of flattening the curve. That is critical so our health care systems do not get overwhelmed during this massive surge we are in,” Dr. Gandhi said. “So masking and social distancing are just as important as they always have been.”

Dr. Bhimraj disclosed no relevant financial relationships. Dr. Gandhi has no disclosures for the past 12 months; in the past 3 years, he has served on scientific advisory boards for Gilead and Merck.

This article first appeared on Medscape.com.

An infectious disease expert panel cautions against routine use of bamlanivimab (Eli Lilly) and notes that remdesivir (Veklury) can shorten the clinical course of COVID-19 – which could be critical “as hospitals fill up” across the United States.

The group also said the monoclonal antibodies approved for emergency use by the Food and Drug Administration and still in development hold promise, although more clinical trial data are needed.

These and other recommendations appear in updated guidelines from the Infectious Diseases Society of America, released Nov. 18 and Nov. 22.
 

A conditional ‘no’ on routine bamlanivimab

“The guideline panel gave a conditional recommendation against the routine use of bamlanivimab,” Adarsh Bhimraj, MD, cochair of the IDSA COVID-19 Treatment and Management Guidelines Expert Panel, said.

On Nov. 10, the FDA issued an emergency-use authorization (EUA) for bamlanivimab for use in ambulatory patients with mild to moderate COVID-19.

“We did have a remark that it may be used in patients who have increased risk of severe COVID-19, as it is outlined in the FDA emergency-use authorization issued last week,” he said. He added that use should follow an informed discussion between provider and patient, one in which “the patient puts a very high value on the uncertain benefits and a low value on uncertain adverse events.”

The panel’s rationale was based in part on interim analysis of the phase 2 BLAZE-1 trial, which found 1.6% of people randomly assigned to bamlanivimab had an emergency department visit or hospitalization compared with 6.3% of those receiving a placebo.

“We thought the estimate was too fragile because the number in each arm was very low. Even a small change in these numbers could make the difference nonsignificant,” said Bhimraj, head of the neurologic infectious diseases section in the department of infectious diseases at the Cleveland (Ohio) Clinic.
 

Awaiting more data on antibody combination

On November 21, the FDA granted an EUA to the casirivimab and imbdevimab monoclonal antibody combination (Regeneron), indicated to treated mild to moderate COVID-19.

“Surprisingly, the preliminary results released in the EUA look a lot like bamlanivimab,” Dr. Bhimraj said.

Unlike bamlanivimab, for which trial details were published, the panel does not yet have the totality of data on casirivimab and imbdevimab, and therefore is not yet making a recommendation. “We want to be cautious as a guideline panel. We are anxiously awaiting the full publication,” he added.

“I do think these monoclonal antibodies show potential for benefit, but as Dr. Bhimraj said, it’s very difficult with the relatively small numbers we’re talking about,” said Rajesh T. Gandhi, MD, cochair of the IDSA COVID-19 Treatment and Management Guidelines Expert Panel.

Remaining questions include the degree of efficacy these antibody therapies will have, as well as which patients are most likely to benefit, added Dr. Gandhi, who is also a professor of medicine at Harvard Medical School and director of HIV Clinical Services and Education at Massachusetts General Hospital, both in Boston.

Furthermore, although there appear to be adequate supplies of remdesivir and dexamethasone, for example, availability and distribution of monoclonal antibodies could present logistic challenges. Prioritizing which high-risk patients receive this therapy and ensuring equity and access to communities most affected by COVID-19, including minority and low socioeconomic populations, need to be addressed, Dr. Gandhi said.  
 

Remdesivir recommended to shorten hospital stays

The panel’s recommendations regarding the use of remdesivir “has largely remained the same,” Dr. Gandhi said. Evidence indicates recovery is faster with remdesivir at 10 days vs 15 days in people taking a placebo.

In the ACTT-1 trial, for example, participants in the treatment group recovered in a median 10 days versus 15 days in the placebo group.

Therefore, the IDSA panel continues to recommend remdesivir treatment for hospitalized patients with COVID-19.

“As hospitals around the United States fill up, the IDSA panel believes the effect of remdesivir on speeding up recovery could be an important benefit, and that is why we continue to suggest its use,” Dr. Gandhi said.

When asked about the World Health Organization–sponsored trial that showed no benefit in terms of mortality, he replied, “Remdesivir is not a home run – we need better drugs.”
 

A recommendation against lopinavir and ritonavir

In contrast, the panel recommends against use of the lopinavir/ritonavir protease inhibitor combination therapy, based in part on data from a preprint of the Solidarity study.

The open-label Solidarity trial in 30 countries, sponsored by WHO, assessed hydroxychloroquine, interferon, lopinavir/ritonavir, and remdesivir in people hospitalized with COVID-19.

None of these drugs showed an effect on mortality, Dr. Gandhi said. “Better medicines that improve survival are clearly needed.”

Dexamethasone remains the only agent demonstrated to reduce mortality in people hospitalized with COVID-19, he added.
 

Tocilizumab not for routine use

After critical review of the studies that have emerged since the last IDSA recommendation regarding tocilizumab (Actemra) in September, “the panel still stood with the recommendation against routine use of tocilizumab in hospitalized patients with COVID-19,” Dr. Bhimraj said.

The guidance is based on trials including COVACTA and EMPACTA. Treatment with tocilizumab was not associated with significant differences in mortality. In these and other studies, “we did not really find a significant difference, and that was the reason for the conditional recommendation against routine use of tocilizumab in hospitalized patients,” Dr. Bhimraj said.

Also, although the trials were blinded, “we know treatment with tocilizumab can cause a reduction in C-reactive protein levels,” which could indicate to researchers which participants were receiving active treatment versus placebo, he said.
 

Jury still out on baricitinib, remdesivir combination

The FDA granted an EUA to the combination of remdesivir and baricitinib (Olumiant) on Nov. 19. However, the IDSA panel is reserving its recommendation on this therapeutic combination until more data emerge.

“We still don’t have complete results of the ACTT-2 study, and the information we do have is what is available in the EUA,” Dr. Bhimraj said. The panel expects to issue guidance once the totality of data become available.

Unanswered questions include why investigators chose a 4-mg dose of baricitinib – twice the 2-mg dose commonly used for treating rheumatoid arthritis – and how many patients in the trial also were treated with steroids.

Dr. Gandhi agreed that the proportion of patients taking a steroid is “really an important consideration.” He added that dexamethasone has become standard of care because it reduces mortality, as well as the number of people requiring oxygen. He said it will be important to know how the baricitinib/remdesivir combination compares with dexamethasone.

“You don’t want to give a drug with less certain benefit over a drug for which there is more certain benefit,” Dr. Gandhi said.
 

Future possibilities

“The monoclonal antibodies are important to continue studying, particularly in combinations,” Dr. Gandhi said. Researchers are investigating formulations other than IV infusion to make therapy more convenient. For example, a subcutaneous injection like insulin would make administration at home more of a possibility.

Investigators are also looking at oral antiviral therapy, inhaled antivirals, and the promise of using interferon therapy. Dr. Gandhi added there is also “a lot of work around medications to reduce the excess inflammation that drives very severe COVID-19.”
 

‘Exciting news’ on AstraZeneca vaccine

Although not part of the IDSA guidelines, “we saw the news from AstraZeneca this morning, which is exciting,” Dr. Gandhi said during a media briefing.

Unlike the Pfizer and Moderna messenger RNA vaccines, which use the genetic material of the virus to make the virus proteins that elicit an immune response, the AstraZeneca/Oxford University vaccine uses a viral vector to carry the SARS-CoV-2 protein, to which the body produces an immune response.

“I’m thrilled that several different vaccines are showing important effects at rates higher than the FDA benchmark of 50%, and these are well exceeding that,” Dr. Gandhi said.

“One interesting thing from the [AstraZeneca] press release is they show asymptomatic infection being reduced,” he added. “That is critical because we know a lot of transmission of SARS-CoV-2 comes from asymptomatic people.”
 

Reasons for optimism

In response to a question about whether the experts feel more optimistic about COVID-19, Dr. Bhimraj said he is cautiously optimistic. “We have made tremendous progress in therapeutic agents, and in how the world has come together in the middle of a catastrophe to collaborate, setting our differences apart, to do trials. That is commendable.”

Dr. Gandhi said he felt more optimistic than he did in the spring. He pointed out that physicians and researchers know a lot more about potential blood clotting complications, how to support patients through severe COVID-19 and keep them off a ventilator whenever possible, and how to provide dexamethasone to reduce the risk of death.

Those benefits are in hospitalized patients, however, and “we need ways to prevent people from getting into the hospital, and that is why we are looking at the monoclonal antibodies,” Dr. Gandhi said. “If borne out in larger trials, that will be a major advance.”

“We need to keep our focus on prevention and go back to our idea of flattening the curve. That is critical so our health care systems do not get overwhelmed during this massive surge we are in,” Dr. Gandhi said. “So masking and social distancing are just as important as they always have been.”

Dr. Bhimraj disclosed no relevant financial relationships. Dr. Gandhi has no disclosures for the past 12 months; in the past 3 years, he has served on scientific advisory boards for Gilead and Merck.

This article first appeared on Medscape.com.

Greater involvement of the patient and family in decision-making, clarity on the role of genetic testing and parameters for team-oriented care, and use of high-volume specialty centers are cornerstones of the first update in almost a decade of the American Heart Association/American College of Cardiology guideline for patients with hypertrophic cardiomyopathy (HCM).

The update lists 133 recommendations for HCM care in six categories: shared decision-making; role of high-volume HCM centers; diagnosis, initial evaluation, and follow-up; risk assessment and prevention of sudden cardiac death (SCD); management of HCM; and lifestyle considerations for patients.

“The guideline puts the patient front and center in the shared decision-making process and emphasizes the importance of incorporating patient’s lifestyle choices and preferences when making complex, life-altering decisions,” writing committee vice chair Seema Mital, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, said in an interview.

The fully updated guideline, authored by a joint committee of the AHA and ACC with input from other specialty societies, has been published online in the Journal of the American College of Cardiology. It replaces the 2011 guideline.

Another key component of the update is the strong recommendation to utilize multidisciplinary care, said Matthew W. Martinez, MD, a writing committee member and sports cardiologists at Morristown (N.J.) Medical Center. “This is not only as a part of shared decision-making, but really in care for the patients,” he said, “that there’s a level of expertise that is provided by centers of excellence who handle HCM, and we did lay out some recommendations with regards to surgery, imaging, interventionists, and management with electrophysiology, and the care of athletes with potential for HCM and pregnant women.”

The update ranks recommendations by class of recommendation (COR), ranging from strong benefit much greater than risk to harm with risk exceeding benefit, and level of evidence (LOE). The recommendation for shared decision making, for example, carries at COR of 1, the highest rating, and a mid-level LOE of B-NR, meaning from nonrandomized studies. Patients who need septal reduction therapy (SRT) should be referred to a comprehensive or primary HCM center – a recommendation with a COR of 1 but an LOE of C-LD, meaning there are limited data.
 

From diagnosis to follow-up

The most extensive list of recommendations falls under the category covering diagnosis, initial evaluation and follow-up. They include a three-generation family history as part of the initial diagnostic assessment (COR, 1; LOE, B-NR), high-level recommendations for use of transthoracic echocardiogram in the initial work-up, every 1 or 2 years or when the patient’s status changes in confirmed cases, as well as parameters for using other imaging and diagnostic tests. Cardiovascular MRI, for example, is indicated when echocardiography is inconclusive (COR, 1; LOE, B-NR) and in other scenarios. When echocardiography is inconclusive but cardiac MRI isn’t available, cardiac CT is an option, albeit at a lower level of evidence (COR, 2b; LOE, C-LD).

Heart rhythm assessment has a high level of recommendation in multiple scenarios, even in first-degree relatives of HCM patients. Invasive hemodynamic assessment is in order for candidates of SRT whose left ventricular (LV) outflow tract obstruction status is unknown. This category also sets parameters for angiography, and exercise stress testing.

The most extensive recommendations for diagnosis and follow-up cover genetic testing; it consists of nine high-level recommendations.

“The guideline highlights not only the importance of genetic testing of an affected patient and genetic screening of family members, but also emphasizes ongoing reassessment of variant classification as this may evolve with time and change how we recommend ongoing family screening,” Dr. Mital noted.

“The guideline proposes initiating screening of family members at the earliest regardless of age given HCM can manifest at any age in affected families,” she added.

The guideline notes that the usefulness of genetic testing to evaluate the risk of sudden cardiac death (SCD) is uncertain. There’s even guidance for implementing those test results. Further testing is recommended for patients who are genotype positive and phenotype negative for HCM (COR, 1; LOE, B-NR). Those same patients may participate in competitive sports (COR, 2a; LOE, C-LD), but a pacemaker isn’t recommended as a primary prevention (COR, 3 [no benefit]; LOE, B-NR).
 

Risk evaluation and prevention

For SCD risk evaluation and prevention, the guideline spells out five components for the initial and follow-up evaluations (COR, 1; LOE, B-NR). That includes maximal LV wall thickness, ejection fraction, and LV apical aneurysm. The section include multiple recommendations for patient selection for placement of an implantable cardioverter-defibrillator (ICD). For example, it’s recommended for patient’s who’ve had a heart attack or sustained ventricular tachycardia (COR, 1; LOE, B-NR), but not so much for patients without risk factors or for participating in sports (COR, 3 [harm]; LOE, B-NR). The guideline even provides recommendations for selecting an ICD.

Management recommendations address when medical therapy is indicated, including which therapies are indicated for specific scenarios, as well as higher level interventions such as SRT for severely symptomatic patients with obstructive HCM (COR, 2b; LOE, C-LD) and surgical myectomy with ablation in patients with HCM and atrial fibrillation (COR, 2a; LOE, B-NR). This section also provides recommendations for managing patients with HCM and ventricular arrhythmias or advanced heart failure.

The guideline also includes a host of lifestyle considerations. Mild to moderate exercise is beneficial (COR, 1; LOE, B-NR), but athletes with HCM should consult with an “expert provider” (COR, 1; LOE, C, meaning based on expert opinion). Truck drivers, pilots and people who do strenuous physical labor with HCM should meet specific standards.

These recommendations again emphasize the role of shared decision-making, said Dr. Martinez. “It’s not a cookie-cutter discussion. It is taking all of the information, incorporating what the patient’s needs are, and then making sure you appropriately tell them what are the risks of exercising and not exercising. I have as many discussions through the day about what the risks of exercise are as I do the risks of not exercising.”
 

Refining nomenclature, pathophysiology

The writing committee addressed the nomenclature for HCM. The use of HCM to describe increased LV wall thickness linked to systemic diseases or secondary to LV hypertrophy “can lead to confusion,” the committee stated, so other cardiac or systemic causes of LV hypertrophy shouldn’t be labeled HCM. Other etiologies can cause secondary LV hypertrophy that can overlap with HCM; clinical markers and testing can help differentiate these mimickers from HCM. When echocardiography is inconclusive, cardiovascular MRI is indicated (COR, 1; LOE, B-NR).

The guideline update also provides clarity on the pathophysiology of HCM: It consists of dynamic LV outflow tract obstruction, mitral regurgitation, diastolic dysfunction, myocardial ischemia, arrhythmias, or autonomic dysfunction. “For a given patient with HCM, the clinical outcome may be dominated by one of these components or may be the result of a complex interplay,” the guideline states. The clinical evaluation should consider all these conditions.

This update also provides “clear separation” between care of HCM with and without obstruction, Dr. Martinez said. “The role of advanced therapies and referrals with advanced treatment options such as heart transplantation or CRT therapy in this group is different than before, recognizing that people with obstruction have symptoms that may be similar to those without obstruction, and the individual should be [thoroughly] investigated to make sure that you can discern between those two groups to make appropriate recommendations.”

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, and Society for Cardiovascular Magnetic Resonance. It’s also been endorsed by the Pediatric & Congenital Electrophysiology Society.

Dr. Mital and Dr. Martinez have no relevant financial relationships to disclose.

SOURCE: Mital S et al. J Am Coll Cardiol. 2020 Nov 20. doi: 10.1016/j.jacc.2020.08.044.

Greater involvement of the patient and family in decision-making, clarity on the role of genetic testing and parameters for team-oriented care, and use of high-volume specialty centers are cornerstones of the first update in almost a decade of the American Heart Association/American College of Cardiology guideline for patients with hypertrophic cardiomyopathy (HCM).

The update lists 133 recommendations for HCM care in six categories: shared decision-making; role of high-volume HCM centers; diagnosis, initial evaluation, and follow-up; risk assessment and prevention of sudden cardiac death (SCD); management of HCM; and lifestyle considerations for patients.

“The guideline puts the patient front and center in the shared decision-making process and emphasizes the importance of incorporating patient’s lifestyle choices and preferences when making complex, life-altering decisions,” writing committee vice chair Seema Mital, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, said in an interview.

The fully updated guideline, authored by a joint committee of the AHA and ACC with input from other specialty societies, has been published online in the Journal of the American College of Cardiology. It replaces the 2011 guideline.

Another key component of the update is the strong recommendation to utilize multidisciplinary care, said Matthew W. Martinez, MD, a writing committee member and sports cardiologists at Morristown (N.J.) Medical Center. “This is not only as a part of shared decision-making, but really in care for the patients,” he said, “that there’s a level of expertise that is provided by centers of excellence who handle HCM, and we did lay out some recommendations with regards to surgery, imaging, interventionists, and management with electrophysiology, and the care of athletes with potential for HCM and pregnant women.”

The update ranks recommendations by class of recommendation (COR), ranging from strong benefit much greater than risk to harm with risk exceeding benefit, and level of evidence (LOE). The recommendation for shared decision making, for example, carries at COR of 1, the highest rating, and a mid-level LOE of B-NR, meaning from nonrandomized studies. Patients who need septal reduction therapy (SRT) should be referred to a comprehensive or primary HCM center – a recommendation with a COR of 1 but an LOE of C-LD, meaning there are limited data.
 

From diagnosis to follow-up

The most extensive list of recommendations falls under the category covering diagnosis, initial evaluation and follow-up. They include a three-generation family history as part of the initial diagnostic assessment (COR, 1; LOE, B-NR), high-level recommendations for use of transthoracic echocardiogram in the initial work-up, every 1 or 2 years or when the patient’s status changes in confirmed cases, as well as parameters for using other imaging and diagnostic tests. Cardiovascular MRI, for example, is indicated when echocardiography is inconclusive (COR, 1; LOE, B-NR) and in other scenarios. When echocardiography is inconclusive but cardiac MRI isn’t available, cardiac CT is an option, albeit at a lower level of evidence (COR, 2b; LOE, C-LD).

Heart rhythm assessment has a high level of recommendation in multiple scenarios, even in first-degree relatives of HCM patients. Invasive hemodynamic assessment is in order for candidates of SRT whose left ventricular (LV) outflow tract obstruction status is unknown. This category also sets parameters for angiography, and exercise stress testing.

The most extensive recommendations for diagnosis and follow-up cover genetic testing; it consists of nine high-level recommendations.

“The guideline highlights not only the importance of genetic testing of an affected patient and genetic screening of family members, but also emphasizes ongoing reassessment of variant classification as this may evolve with time and change how we recommend ongoing family screening,” Dr. Mital noted.

“The guideline proposes initiating screening of family members at the earliest regardless of age given HCM can manifest at any age in affected families,” she added.

The guideline notes that the usefulness of genetic testing to evaluate the risk of sudden cardiac death (SCD) is uncertain. There’s even guidance for implementing those test results. Further testing is recommended for patients who are genotype positive and phenotype negative for HCM (COR, 1; LOE, B-NR). Those same patients may participate in competitive sports (COR, 2a; LOE, C-LD), but a pacemaker isn’t recommended as a primary prevention (COR, 3 [no benefit]; LOE, B-NR).
 

Risk evaluation and prevention

For SCD risk evaluation and prevention, the guideline spells out five components for the initial and follow-up evaluations (COR, 1; LOE, B-NR). That includes maximal LV wall thickness, ejection fraction, and LV apical aneurysm. The section include multiple recommendations for patient selection for placement of an implantable cardioverter-defibrillator (ICD). For example, it’s recommended for patient’s who’ve had a heart attack or sustained ventricular tachycardia (COR, 1; LOE, B-NR), but not so much for patients without risk factors or for participating in sports (COR, 3 [harm]; LOE, B-NR). The guideline even provides recommendations for selecting an ICD.

Management recommendations address when medical therapy is indicated, including which therapies are indicated for specific scenarios, as well as higher level interventions such as SRT for severely symptomatic patients with obstructive HCM (COR, 2b; LOE, C-LD) and surgical myectomy with ablation in patients with HCM and atrial fibrillation (COR, 2a; LOE, B-NR). This section also provides recommendations for managing patients with HCM and ventricular arrhythmias or advanced heart failure.

The guideline also includes a host of lifestyle considerations. Mild to moderate exercise is beneficial (COR, 1; LOE, B-NR), but athletes with HCM should consult with an “expert provider” (COR, 1; LOE, C, meaning based on expert opinion). Truck drivers, pilots and people who do strenuous physical labor with HCM should meet specific standards.

These recommendations again emphasize the role of shared decision-making, said Dr. Martinez. “It’s not a cookie-cutter discussion. It is taking all of the information, incorporating what the patient’s needs are, and then making sure you appropriately tell them what are the risks of exercising and not exercising. I have as many discussions through the day about what the risks of exercise are as I do the risks of not exercising.”
 

Refining nomenclature, pathophysiology

The writing committee addressed the nomenclature for HCM. The use of HCM to describe increased LV wall thickness linked to systemic diseases or secondary to LV hypertrophy “can lead to confusion,” the committee stated, so other cardiac or systemic causes of LV hypertrophy shouldn’t be labeled HCM. Other etiologies can cause secondary LV hypertrophy that can overlap with HCM; clinical markers and testing can help differentiate these mimickers from HCM. When echocardiography is inconclusive, cardiovascular MRI is indicated (COR, 1; LOE, B-NR).

The guideline update also provides clarity on the pathophysiology of HCM: It consists of dynamic LV outflow tract obstruction, mitral regurgitation, diastolic dysfunction, myocardial ischemia, arrhythmias, or autonomic dysfunction. “For a given patient with HCM, the clinical outcome may be dominated by one of these components or may be the result of a complex interplay,” the guideline states. The clinical evaluation should consider all these conditions.

This update also provides “clear separation” between care of HCM with and without obstruction, Dr. Martinez said. “The role of advanced therapies and referrals with advanced treatment options such as heart transplantation or CRT therapy in this group is different than before, recognizing that people with obstruction have symptoms that may be similar to those without obstruction, and the individual should be [thoroughly] investigated to make sure that you can discern between those two groups to make appropriate recommendations.”

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, and Society for Cardiovascular Magnetic Resonance. It’s also been endorsed by the Pediatric & Congenital Electrophysiology Society.

Dr. Mital and Dr. Martinez have no relevant financial relationships to disclose.

SOURCE: Mital S et al. J Am Coll Cardiol. 2020 Nov 20. doi: 10.1016/j.jacc.2020.08.044.

Greater involvement of the patient and family in decision-making, clarity on the role of genetic testing and parameters for team-oriented care, and use of high-volume specialty centers are cornerstones of the first update in almost a decade of the American Heart Association/American College of Cardiology guideline for patients with hypertrophic cardiomyopathy (HCM).

The update lists 133 recommendations for HCM care in six categories: shared decision-making; role of high-volume HCM centers; diagnosis, initial evaluation, and follow-up; risk assessment and prevention of sudden cardiac death (SCD); management of HCM; and lifestyle considerations for patients.

“The guideline puts the patient front and center in the shared decision-making process and emphasizes the importance of incorporating patient’s lifestyle choices and preferences when making complex, life-altering decisions,” writing committee vice chair Seema Mital, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, said in an interview.

The fully updated guideline, authored by a joint committee of the AHA and ACC with input from other specialty societies, has been published online in the Journal of the American College of Cardiology. It replaces the 2011 guideline.

Another key component of the update is the strong recommendation to utilize multidisciplinary care, said Matthew W. Martinez, MD, a writing committee member and sports cardiologists at Morristown (N.J.) Medical Center. “This is not only as a part of shared decision-making, but really in care for the patients,” he said, “that there’s a level of expertise that is provided by centers of excellence who handle HCM, and we did lay out some recommendations with regards to surgery, imaging, interventionists, and management with electrophysiology, and the care of athletes with potential for HCM and pregnant women.”

The update ranks recommendations by class of recommendation (COR), ranging from strong benefit much greater than risk to harm with risk exceeding benefit, and level of evidence (LOE). The recommendation for shared decision making, for example, carries at COR of 1, the highest rating, and a mid-level LOE of B-NR, meaning from nonrandomized studies. Patients who need septal reduction therapy (SRT) should be referred to a comprehensive or primary HCM center – a recommendation with a COR of 1 but an LOE of C-LD, meaning there are limited data.
 

From diagnosis to follow-up

The most extensive list of recommendations falls under the category covering diagnosis, initial evaluation and follow-up. They include a three-generation family history as part of the initial diagnostic assessment (COR, 1; LOE, B-NR), high-level recommendations for use of transthoracic echocardiogram in the initial work-up, every 1 or 2 years or when the patient’s status changes in confirmed cases, as well as parameters for using other imaging and diagnostic tests. Cardiovascular MRI, for example, is indicated when echocardiography is inconclusive (COR, 1; LOE, B-NR) and in other scenarios. When echocardiography is inconclusive but cardiac MRI isn’t available, cardiac CT is an option, albeit at a lower level of evidence (COR, 2b; LOE, C-LD).

Heart rhythm assessment has a high level of recommendation in multiple scenarios, even in first-degree relatives of HCM patients. Invasive hemodynamic assessment is in order for candidates of SRT whose left ventricular (LV) outflow tract obstruction status is unknown. This category also sets parameters for angiography, and exercise stress testing.

The most extensive recommendations for diagnosis and follow-up cover genetic testing; it consists of nine high-level recommendations.

“The guideline highlights not only the importance of genetic testing of an affected patient and genetic screening of family members, but also emphasizes ongoing reassessment of variant classification as this may evolve with time and change how we recommend ongoing family screening,” Dr. Mital noted.

“The guideline proposes initiating screening of family members at the earliest regardless of age given HCM can manifest at any age in affected families,” she added.

The guideline notes that the usefulness of genetic testing to evaluate the risk of sudden cardiac death (SCD) is uncertain. There’s even guidance for implementing those test results. Further testing is recommended for patients who are genotype positive and phenotype negative for HCM (COR, 1; LOE, B-NR). Those same patients may participate in competitive sports (COR, 2a; LOE, C-LD), but a pacemaker isn’t recommended as a primary prevention (COR, 3 [no benefit]; LOE, B-NR).
 

Risk evaluation and prevention

For SCD risk evaluation and prevention, the guideline spells out five components for the initial and follow-up evaluations (COR, 1; LOE, B-NR). That includes maximal LV wall thickness, ejection fraction, and LV apical aneurysm. The section include multiple recommendations for patient selection for placement of an implantable cardioverter-defibrillator (ICD). For example, it’s recommended for patient’s who’ve had a heart attack or sustained ventricular tachycardia (COR, 1; LOE, B-NR), but not so much for patients without risk factors or for participating in sports (COR, 3 [harm]; LOE, B-NR). The guideline even provides recommendations for selecting an ICD.

Management recommendations address when medical therapy is indicated, including which therapies are indicated for specific scenarios, as well as higher level interventions such as SRT for severely symptomatic patients with obstructive HCM (COR, 2b; LOE, C-LD) and surgical myectomy with ablation in patients with HCM and atrial fibrillation (COR, 2a; LOE, B-NR). This section also provides recommendations for managing patients with HCM and ventricular arrhythmias or advanced heart failure.

The guideline also includes a host of lifestyle considerations. Mild to moderate exercise is beneficial (COR, 1; LOE, B-NR), but athletes with HCM should consult with an “expert provider” (COR, 1; LOE, C, meaning based on expert opinion). Truck drivers, pilots and people who do strenuous physical labor with HCM should meet specific standards.

These recommendations again emphasize the role of shared decision-making, said Dr. Martinez. “It’s not a cookie-cutter discussion. It is taking all of the information, incorporating what the patient’s needs are, and then making sure you appropriately tell them what are the risks of exercising and not exercising. I have as many discussions through the day about what the risks of exercise are as I do the risks of not exercising.”
 

Refining nomenclature, pathophysiology

The writing committee addressed the nomenclature for HCM. The use of HCM to describe increased LV wall thickness linked to systemic diseases or secondary to LV hypertrophy “can lead to confusion,” the committee stated, so other cardiac or systemic causes of LV hypertrophy shouldn’t be labeled HCM. Other etiologies can cause secondary LV hypertrophy that can overlap with HCM; clinical markers and testing can help differentiate these mimickers from HCM. When echocardiography is inconclusive, cardiovascular MRI is indicated (COR, 1; LOE, B-NR).

The guideline update also provides clarity on the pathophysiology of HCM: It consists of dynamic LV outflow tract obstruction, mitral regurgitation, diastolic dysfunction, myocardial ischemia, arrhythmias, or autonomic dysfunction. “For a given patient with HCM, the clinical outcome may be dominated by one of these components or may be the result of a complex interplay,” the guideline states. The clinical evaluation should consider all these conditions.

This update also provides “clear separation” between care of HCM with and without obstruction, Dr. Martinez said. “The role of advanced therapies and referrals with advanced treatment options such as heart transplantation or CRT therapy in this group is different than before, recognizing that people with obstruction have symptoms that may be similar to those without obstruction, and the individual should be [thoroughly] investigated to make sure that you can discern between those two groups to make appropriate recommendations.”

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, and Society for Cardiovascular Magnetic Resonance. It’s also been endorsed by the Pediatric & Congenital Electrophysiology Society.

Dr. Mital and Dr. Martinez have no relevant financial relationships to disclose.

SOURCE: Mital S et al. J Am Coll Cardiol. 2020 Nov 20. doi: 10.1016/j.jacc.2020.08.044.

A new guideline from the Kidney Disease: Improving Global Outcomes group addressing issues around diabetes management in patients with chronic kidney disease (CKD) has just been published in synopsis form in Annals of Internal Medicine.

The full guideline, including 12 recommendations and 48 practice points for clinicians caring for patients with diabetes and CKD, was published last month in Kidney International and on the KDIGO website.

More than 40% of people with diabetes develop CKD, and a significant number develop kidney failure requiring dialysis or transplant. This is the first guidance from KDIGO to address the comorbidity.

The new synopsis is aimed at primary care and nonnephrology specialist clinicians who manage patients with diabetes and CKD, in addition to nephrologists, first author Sankar D. Navaneethan, MD, said in an interview.

“Most of these patients are in the hands of primary care, endocrinology, and cardiology. We want to emphasize when they see patients with different severities of kidney disease [is] what are some of the things they have to be cognizant of,” said Dr. Navaneethan, professor of medicine and director of clinical research in the section of nephrology at Baylor College of Medicine, Houston.

The synopsis summarizes key recommendations from the larger guidance regarding comprehensive care needs, glycemic monitoring and targets, lifestyle interventions, glucose-lowering therapies, and educational/integrated care approaches.

It does not depart from prior diabetes guidelines, but it does provide advice for specific situations relevant to CKD, such as the limitations of hemoglobin A1c when estimated glomerular filtration rate (eGFR) drops below 30 mL/min per 1.73m², and dietary protein consumption. It is based on published evidence up until February 2020.

For the nephrologist audience in particular, Dr. Navaneethan said, “we wanted to highlight team-based care, interacting with other specialists and working with them.”

“We [nephrologists] are more used to team-based care in dialysis patients. ... So we wanted to highlight that self-management programs and team-based care are important for empowering patients.”

“As nephrologists, we might not be comfortable starting patients on an SGLT2 [sodium-glucose cotransporter 2] inhibitor. We may need to reach out to our endocrinology or primary care colleagues and learn from them,” he explained.
 

RAS inhibitor use, smoking cessation, glycemic targets

Under “comprehensive care,” the guideline panel recommends treatment with an ACE inhibitor or an angiotensin II receptor blocker – renin-angiotensin system (RAS) blockade – for patients with diabetes, hypertension, and albuminuria (albumin-creatinine ratio >30 mg/g).

These medications should be titrated to the highest approved tolerated dose, with close monitoring of serum potassium and serum creatinine levels within 2-4 weeks of initiation or change in dose.

The document guides clinicians on that monitoring, as well as on RAS blockade use in patient subgroups, use of alternative agents, and mitigation of adverse effects.

Patients with diabetes and CKD who use tobacco should be advised to quit.

The group recommended A1c to monitor glycemic control in patients with diabetes and CKD not receiving dialysis.

However, when eGFR is below 30 mL/min per 1.73m2, A1c levels tend to be lower because of shortened erythrocyte lifespan, which interpretation should take into account. Continuous glucose monitoring can be used as an alternative because it is not affected by CKD.

Glycemic targets should be individualized depending on hypoglycemia risk, ranging from 6.5% to 8.0% for A1c or time in range of 70-180 mg/dL for continuous glucose monitoring readings.
 

SGLT2 inhibitors, metformin, and GLP-1 agonists

The panel also recommends treatment with both metformin and an SGLT2 inhibitor for patients with type 2 diabetes, CKD, and an eGFR ≥30 mL/min per 1.73m2.

For those who do not achieve glycemic targets or who cannot take those medications, a long-acting glucagonlike peptide–1 receptor agonist can be used instead.

Clinical trial data are summarized for the SGLT2 inhibitor canagliflozin supporting its use in patients with CKD specifically, along with mitigation of adverse events. Last year, the Food and Drug Administration approved this agent to slow the progression of diabetic nephropathy based on the CREDENCE study.

Results from the DAPA-CKD trial showing CKD reduction with another SGLT2 inhibitor, dapagliflozin, were not available at the time the new document was written, nor was the recent study showing diabetic CKD benefit for the novel mineralocorticoid receptor antagonist finerenone, Dr. Navaneethan noted.

The panel determined that there is insufficient evidence for adding other glucose-lowering agents to insulin in patients with type 1 diabetes and CKD.
 

Lifestyle interventions: Dietary protein, sodium, and physical activity

Most of the dietary guidance for patients with diabetes and CKD is the same as for the general population, including a recommendation to eat a diet high in vegetables, fruits, whole grains, fiber, legumes, plant-based proteins, unsaturated fats, and nuts, and lower in processed meats, refined carbohydrates, and sweetened beverages.

However, the guideline details two key areas that differ, one with regard to protein intake and the other on sodium.

Although lower protein intake had been advised in the past for patients with CKD, clinical trial evidence has not shown protein restriction to reduce glomerular hyperfiltration or slow kidney disease progression.

Therefore, the same level recommended for the general population – 0.8 g/kg per day – is also advised for those with diabetes and CKD who are not on dialysis.

Those who are on dialysis can increase daily protein intake to 1.0-1.2 g/kg per day to offset catabolism and negative nitrogen imbalance.

Because kidney function decline is associated with sodium retention that can raise cardiovascular risk, sodium should be limited to less than 2 g/day (or less than 90 mmol or 5 g of sodium chloride per day).

The panel also recommended moderate-intensity physical activity for at least 150 minutes per week or to tolerance.

“We wanted to emphasize how important lifestyle is. It’s the foundation you want to build on. You can take medications without all these other things – exercise, diet, weight loss – but they won’t be nearly as effective,” Dr. Navaneethan commented.
 

Self-management education, team-based care

The final section of the synopsis advises that people with diabetes and CKD receive structured self-management educational programs, and that “policy makers and institutional decision-makers implement team-based, integrated care focused on risk evaluation and patient empowerment to provide comprehensive care in patients with diabetes and CKD.”

Despite limited data for those measures specifically in patients with diabetes and CKD, “the working group believed that well-informed patients would choose self-management as the cornerstone of any chronic care model; therefore, a high value was placed on the potential benefits of self-management education programs in persons with diabetes and CKD.”

And regarding team-based care, “despite a paucity of direct evidence, the working group judged that multidisciplinary integrated care for patients with diabetes and CKD would represent a good investment.”

The guidelines will likely be updated in the next 1-2 years, Dr. Navaneethan said in an interview.

Dr. Navaneethan has reported receiving consultancy fees from Bayer, Boehringer Ingelheim, Reata, and Tricida, and research support from Keryx.

A version of this article originally appeared on Medscape.com.

A new guideline from the Kidney Disease: Improving Global Outcomes group addressing issues around diabetes management in patients with chronic kidney disease (CKD) has just been published in synopsis form in Annals of Internal Medicine.

The full guideline, including 12 recommendations and 48 practice points for clinicians caring for patients with diabetes and CKD, was published last month in Kidney International and on the KDIGO website.

More than 40% of people with diabetes develop CKD, and a significant number develop kidney failure requiring dialysis or transplant. This is the first guidance from KDIGO to address the comorbidity.

The new synopsis is aimed at primary care and nonnephrology specialist clinicians who manage patients with diabetes and CKD, in addition to nephrologists, first author Sankar D. Navaneethan, MD, said in an interview.

“Most of these patients are in the hands of primary care, endocrinology, and cardiology. We want to emphasize when they see patients with different severities of kidney disease [is] what are some of the things they have to be cognizant of,” said Dr. Navaneethan, professor of medicine and director of clinical research in the section of nephrology at Baylor College of Medicine, Houston.

The synopsis summarizes key recommendations from the larger guidance regarding comprehensive care needs, glycemic monitoring and targets, lifestyle interventions, glucose-lowering therapies, and educational/integrated care approaches.

It does not depart from prior diabetes guidelines, but it does provide advice for specific situations relevant to CKD, such as the limitations of hemoglobin A1c when estimated glomerular filtration rate (eGFR) drops below 30 mL/min per 1.73m², and dietary protein consumption. It is based on published evidence up until February 2020.

For the nephrologist audience in particular, Dr. Navaneethan said, “we wanted to highlight team-based care, interacting with other specialists and working with them.”

“We [nephrologists] are more used to team-based care in dialysis patients. ... So we wanted to highlight that self-management programs and team-based care are important for empowering patients.”

“As nephrologists, we might not be comfortable starting patients on an SGLT2 [sodium-glucose cotransporter 2] inhibitor. We may need to reach out to our endocrinology or primary care colleagues and learn from them,” he explained.
 

RAS inhibitor use, smoking cessation, glycemic targets

Under “comprehensive care,” the guideline panel recommends treatment with an ACE inhibitor or an angiotensin II receptor blocker – renin-angiotensin system (RAS) blockade – for patients with diabetes, hypertension, and albuminuria (albumin-creatinine ratio >30 mg/g).

These medications should be titrated to the highest approved tolerated dose, with close monitoring of serum potassium and serum creatinine levels within 2-4 weeks of initiation or change in dose.

The document guides clinicians on that monitoring, as well as on RAS blockade use in patient subgroups, use of alternative agents, and mitigation of adverse effects.

Patients with diabetes and CKD who use tobacco should be advised to quit.

The group recommended A1c to monitor glycemic control in patients with diabetes and CKD not receiving dialysis.

However, when eGFR is below 30 mL/min per 1.73m2, A1c levels tend to be lower because of shortened erythrocyte lifespan, which interpretation should take into account. Continuous glucose monitoring can be used as an alternative because it is not affected by CKD.

Glycemic targets should be individualized depending on hypoglycemia risk, ranging from 6.5% to 8.0% for A1c or time in range of 70-180 mg/dL for continuous glucose monitoring readings.
 

SGLT2 inhibitors, metformin, and GLP-1 agonists

The panel also recommends treatment with both metformin and an SGLT2 inhibitor for patients with type 2 diabetes, CKD, and an eGFR ≥30 mL/min per 1.73m2.

For those who do not achieve glycemic targets or who cannot take those medications, a long-acting glucagonlike peptide–1 receptor agonist can be used instead.

Clinical trial data are summarized for the SGLT2 inhibitor canagliflozin supporting its use in patients with CKD specifically, along with mitigation of adverse events. Last year, the Food and Drug Administration approved this agent to slow the progression of diabetic nephropathy based on the CREDENCE study.

Results from the DAPA-CKD trial showing CKD reduction with another SGLT2 inhibitor, dapagliflozin, were not available at the time the new document was written, nor was the recent study showing diabetic CKD benefit for the novel mineralocorticoid receptor antagonist finerenone, Dr. Navaneethan noted.

The panel determined that there is insufficient evidence for adding other glucose-lowering agents to insulin in patients with type 1 diabetes and CKD.
 

Lifestyle interventions: Dietary protein, sodium, and physical activity

Most of the dietary guidance for patients with diabetes and CKD is the same as for the general population, including a recommendation to eat a diet high in vegetables, fruits, whole grains, fiber, legumes, plant-based proteins, unsaturated fats, and nuts, and lower in processed meats, refined carbohydrates, and sweetened beverages.

However, the guideline details two key areas that differ, one with regard to protein intake and the other on sodium.

Although lower protein intake had been advised in the past for patients with CKD, clinical trial evidence has not shown protein restriction to reduce glomerular hyperfiltration or slow kidney disease progression.

Therefore, the same level recommended for the general population – 0.8 g/kg per day – is also advised for those with diabetes and CKD who are not on dialysis.

Those who are on dialysis can increase daily protein intake to 1.0-1.2 g/kg per day to offset catabolism and negative nitrogen imbalance.

Because kidney function decline is associated with sodium retention that can raise cardiovascular risk, sodium should be limited to less than 2 g/day (or less than 90 mmol or 5 g of sodium chloride per day).

The panel also recommended moderate-intensity physical activity for at least 150 minutes per week or to tolerance.

“We wanted to emphasize how important lifestyle is. It’s the foundation you want to build on. You can take medications without all these other things – exercise, diet, weight loss – but they won’t be nearly as effective,” Dr. Navaneethan commented.
 

Self-management education, team-based care

The final section of the synopsis advises that people with diabetes and CKD receive structured self-management educational programs, and that “policy makers and institutional decision-makers implement team-based, integrated care focused on risk evaluation and patient empowerment to provide comprehensive care in patients with diabetes and CKD.”

Despite limited data for those measures specifically in patients with diabetes and CKD, “the working group believed that well-informed patients would choose self-management as the cornerstone of any chronic care model; therefore, a high value was placed on the potential benefits of self-management education programs in persons with diabetes and CKD.”

And regarding team-based care, “despite a paucity of direct evidence, the working group judged that multidisciplinary integrated care for patients with diabetes and CKD would represent a good investment.”

The guidelines will likely be updated in the next 1-2 years, Dr. Navaneethan said in an interview.

Dr. Navaneethan has reported receiving consultancy fees from Bayer, Boehringer Ingelheim, Reata, and Tricida, and research support from Keryx.

A version of this article originally appeared on Medscape.com.

A new guideline from the Kidney Disease: Improving Global Outcomes group addressing issues around diabetes management in patients with chronic kidney disease (CKD) has just been published in synopsis form in Annals of Internal Medicine.

The full guideline, including 12 recommendations and 48 practice points for clinicians caring for patients with diabetes and CKD, was published last month in Kidney International and on the KDIGO website.

More than 40% of people with diabetes develop CKD, and a significant number develop kidney failure requiring dialysis or transplant. This is the first guidance from KDIGO to address the comorbidity.

The new synopsis is aimed at primary care and nonnephrology specialist clinicians who manage patients with diabetes and CKD, in addition to nephrologists, first author Sankar D. Navaneethan, MD, said in an interview.

“Most of these patients are in the hands of primary care, endocrinology, and cardiology. We want to emphasize when they see patients with different severities of kidney disease [is] what are some of the things they have to be cognizant of,” said Dr. Navaneethan, professor of medicine and director of clinical research in the section of nephrology at Baylor College of Medicine, Houston.

The synopsis summarizes key recommendations from the larger guidance regarding comprehensive care needs, glycemic monitoring and targets, lifestyle interventions, glucose-lowering therapies, and educational/integrated care approaches.

It does not depart from prior diabetes guidelines, but it does provide advice for specific situations relevant to CKD, such as the limitations of hemoglobin A1c when estimated glomerular filtration rate (eGFR) drops below 30 mL/min per 1.73m², and dietary protein consumption. It is based on published evidence up until February 2020.

For the nephrologist audience in particular, Dr. Navaneethan said, “we wanted to highlight team-based care, interacting with other specialists and working with them.”

“We [nephrologists] are more used to team-based care in dialysis patients. ... So we wanted to highlight that self-management programs and team-based care are important for empowering patients.”

“As nephrologists, we might not be comfortable starting patients on an SGLT2 [sodium-glucose cotransporter 2] inhibitor. We may need to reach out to our endocrinology or primary care colleagues and learn from them,” he explained.
 

RAS inhibitor use, smoking cessation, glycemic targets

Under “comprehensive care,” the guideline panel recommends treatment with an ACE inhibitor or an angiotensin II receptor blocker – renin-angiotensin system (RAS) blockade – for patients with diabetes, hypertension, and albuminuria (albumin-creatinine ratio >30 mg/g).

These medications should be titrated to the highest approved tolerated dose, with close monitoring of serum potassium and serum creatinine levels within 2-4 weeks of initiation or change in dose.

The document guides clinicians on that monitoring, as well as on RAS blockade use in patient subgroups, use of alternative agents, and mitigation of adverse effects.

Patients with diabetes and CKD who use tobacco should be advised to quit.

The group recommended A1c to monitor glycemic control in patients with diabetes and CKD not receiving dialysis.

However, when eGFR is below 30 mL/min per 1.73m2, A1c levels tend to be lower because of shortened erythrocyte lifespan, which interpretation should take into account. Continuous glucose monitoring can be used as an alternative because it is not affected by CKD.

Glycemic targets should be individualized depending on hypoglycemia risk, ranging from 6.5% to 8.0% for A1c or time in range of 70-180 mg/dL for continuous glucose monitoring readings.
 

SGLT2 inhibitors, metformin, and GLP-1 agonists

The panel also recommends treatment with both metformin and an SGLT2 inhibitor for patients with type 2 diabetes, CKD, and an eGFR ≥30 mL/min per 1.73m2.

For those who do not achieve glycemic targets or who cannot take those medications, a long-acting glucagonlike peptide–1 receptor agonist can be used instead.

Clinical trial data are summarized for the SGLT2 inhibitor canagliflozin supporting its use in patients with CKD specifically, along with mitigation of adverse events. Last year, the Food and Drug Administration approved this agent to slow the progression of diabetic nephropathy based on the CREDENCE study.

Results from the DAPA-CKD trial showing CKD reduction with another SGLT2 inhibitor, dapagliflozin, were not available at the time the new document was written, nor was the recent study showing diabetic CKD benefit for the novel mineralocorticoid receptor antagonist finerenone, Dr. Navaneethan noted.

The panel determined that there is insufficient evidence for adding other glucose-lowering agents to insulin in patients with type 1 diabetes and CKD.
 

Lifestyle interventions: Dietary protein, sodium, and physical activity

Most of the dietary guidance for patients with diabetes and CKD is the same as for the general population, including a recommendation to eat a diet high in vegetables, fruits, whole grains, fiber, legumes, plant-based proteins, unsaturated fats, and nuts, and lower in processed meats, refined carbohydrates, and sweetened beverages.

However, the guideline details two key areas that differ, one with regard to protein intake and the other on sodium.

Although lower protein intake had been advised in the past for patients with CKD, clinical trial evidence has not shown protein restriction to reduce glomerular hyperfiltration or slow kidney disease progression.

Therefore, the same level recommended for the general population – 0.8 g/kg per day – is also advised for those with diabetes and CKD who are not on dialysis.

Those who are on dialysis can increase daily protein intake to 1.0-1.2 g/kg per day to offset catabolism and negative nitrogen imbalance.

Because kidney function decline is associated with sodium retention that can raise cardiovascular risk, sodium should be limited to less than 2 g/day (or less than 90 mmol or 5 g of sodium chloride per day).

The panel also recommended moderate-intensity physical activity for at least 150 minutes per week or to tolerance.

“We wanted to emphasize how important lifestyle is. It’s the foundation you want to build on. You can take medications without all these other things – exercise, diet, weight loss – but they won’t be nearly as effective,” Dr. Navaneethan commented.
 

Self-management education, team-based care

The final section of the synopsis advises that people with diabetes and CKD receive structured self-management educational programs, and that “policy makers and institutional decision-makers implement team-based, integrated care focused on risk evaluation and patient empowerment to provide comprehensive care in patients with diabetes and CKD.”

Despite limited data for those measures specifically in patients with diabetes and CKD, “the working group believed that well-informed patients would choose self-management as the cornerstone of any chronic care model; therefore, a high value was placed on the potential benefits of self-management education programs in persons with diabetes and CKD.”

And regarding team-based care, “despite a paucity of direct evidence, the working group judged that multidisciplinary integrated care for patients with diabetes and CKD would represent a good investment.”

The guidelines will likely be updated in the next 1-2 years, Dr. Navaneethan said in an interview.

Dr. Navaneethan has reported receiving consultancy fees from Bayer, Boehringer Ingelheim, Reata, and Tricida, and research support from Keryx.

A version of this article originally appeared on Medscape.com.

A draft guideline for the management of patients with juvenile idiopathic arthritis reflects changes in therapy away from reliance on NSAIDs and glucocorticoids and toward earlier introduction of biologic disease-modifying antirheumatic drugs (DMARDs).

The guideline, described in an oral session during the virtual annual meeting of the American College of Rheumatology, contains weighted recommendations for the treatment of JIA, including therapeutic approaches for oligoarthritis, tempromandibular joint (TMJ) arthritis, and systemic JIA (sJIA). The recommendations were the result of expert consensus and literature review using GRADE methodology, with input from clinicians, as well as patients and parents.

“Although evidence remains very low and many recommendations are conditional, the inclusion of parents and patients in the decision-making process strengthens their validity,” said project principal investigator Karen Onel, MD, of the Hospital for Special Surgery and Weill Cornell Medicine, both in New York.

She added that “it’s important to remember that these guidelines are meant to be guidelines; clinical care remains in the hands of the provider and the patient, and we endorse the importance of shared decision-making in coming to these agreements.”

Dr. Onel outlined key recommendations for patients for whom a diagnosis of JIA has already been made and who have no contraindications to recommended therapies. The strength of the recommendations (strong or conditional) and evidence levels (high, moderate, low, very low) were also reported.
 

Oligoarthritis with fewer than five involved joints

For these patients, intra-articular glucocorticoids (IAGC) are recommended as a part of initial therapy (strong, very low evidence).

Triamcinolone acetonide is the preferred agent in this situation (strong, low evidence).

The guideline also has a conditional recommendation (very low evidence) for a trial of consistent NSAIDS as part of initial therapy and a conditional recommendation against oral glucocorticoids for initial therapy (very low evidence).

Patients with no or incomplete responses or intolerance to NSAIDS and/or IAGC may be tried on a nonbiologic DMARD (strong, very low evidence), with methotrexate as the preferred agent (conditional, low evidence).

If the patient has no response or an inadequate response to at least one nonbiologic DMARD, biologic DMARDs are recommended (strong, very low evidence), with no preferred agent.

The guideline also conditionally recommends (all with very low evidence) using risk factors and validated disease activity measures to guide treatment decisions, as well as imaging guidance of joints that are difficult to access or to localize the distribution of inflammation.
 

TMJ arthritis

For patients with temporomandibular joint arthritis, isolated or not, IAGCs are conditionally recommended as part of initial therapy (very low evidence) with no preferred agents. The guideline also conditionally recommends in favor of a trial of consistent NSAIDs, and against oral glucocorticoids in initial therapy (evidence for both very low).

Recommendations for patients with TMJ with no or an incomplete response to the initial therapy are the same as for patients with oligoarthritis, with no preferred agent.
 

sJIA without macrophage activation syndrome

For patients with sJIA without macrophage activation syndrome (MAS), NSAIDS are conditionally recommended as initial monotherapy (very low evidence). Biologic DMARDS (including interleukin-1 and IL-6 inhibitors) are also recommended, conditionally, as initial monotherapy, with no preferred agent.

If the patient has an inadequate response or intolerance to NSAIDS and at least one nonbiologic DMARD, a single biologic DMARD is recommended over a combination of nonbiologic therapies (strong, very low evidence).

“However, there have been reports of emergent, highly severe lung disease associated with the use of biologics in children with systemic JIA, especially in those who are young, with chronic macrophage activation syndrome, and those with trisomy 21. More information is needed to clarify the safety of these agents,” Dr. Onel said.

There is a conditional recommendation against oral glucocorticoids as initial monotherapy, and strong recommendation against nonbiologic DMARDs as initial monotherapy (both very low evidence).

sJIA with MAS

“Macrophage activation syndrome is a major cause of morbidity and mortality for children with sJIA. Cytokine storm and secondary hemophagocytic syndrome can be seen with any rheumatic disease, but are most commonly seen with sJIA,” she said.

The features of MAS include fever, high ferritin levels, cytopenias, elevated liver-function test results, and high triglyceride levels.

For these patients, glucocorticoids are recommended as initial monotherapy (conditional, very low evidence). Biologic DMARDs (IL-1 and IL-6 inhibitors) are recommended over calcineurin inhibitors for achieving inactive disease and resolution of MAS (conditional, very low evidence). There is no preferred agent.

For patients with residual arthritis and an incomplete response to IL-1 or IL-6 inhibitors, biologic and nonbiologic DMARDs are recommended over chronic glucocorticoids (strong, very low evidence). There is no preferred agent.

After an MAS inactive disease state has been attained, the guideline recommends tapering and discontinuing glucocorticoids (strong, very low evidence) and the same for biologic DMARDs (conditional, very low evidence).
 

All children with JIA

In addition to the recommendations on specific clinical situations, the guideline includes recommendations for all children with JIA on medication monitoring, laboratory testing, and infection screening, as well as immunization and nonpharmacologic management.

A rheumatologist who was not involved in development of the guidelines commented on the importance of optimal management of JIA.

“Children are not immune from devastating rheumatic diseases, and the largest group is juvenile idiopathic arthritis. In my clinic, I have patients in their 30s, 40s, and 50s who have adult persistence of their arthritis from JIA who have permanent joint damage and even ongoing hard-to-control disease, and it has to do with the lack of therapies in the 1990s,” said Donald Thomas, MD, from Arthritis and Pain Associates of Prince George’s County (Md.).

“Today when we get a young adult transitioned from the pediatric clinic they’re usually in remission or have low disease activity because these treatments have paralleled those of our adult RA patients. Yet they do [provide clinicians with] unique challenges, with stunting of growth, macrophage activiation syndrome, and having to work with family members of the patient,” he said at a press briefing he moderated following the presentation of RA and JIA guidelines.

Eyal Muscal, MD, associate professor of pediatrics and rheumatology at Baylor College of Medicine, Houston, said in an interview that the guidelines clarify recommendations about earlier use of targeted therapies, primarily biologics.

“This will not change care, but hopefully remind all to adopt such strategies. Yet earlier utilization of often expensive biologic agents is delayed by administrative and insurance hurdles in the U.S. and access to these medications globally. I hope the guidelines will enhance advocacy on a state, national, and global stage,” he said when asked for comment.

The guideline development process is supported by ACR. Dr. Onel, Dr. Thomas, and Dr. Muscal reported no relevant conflicts of interest.

SOURCE: Onel K et al. ACR 2020, Presented November 8.

A draft guideline for the management of patients with juvenile idiopathic arthritis reflects changes in therapy away from reliance on NSAIDs and glucocorticoids and toward earlier introduction of biologic disease-modifying antirheumatic drugs (DMARDs).

The guideline, described in an oral session during the virtual annual meeting of the American College of Rheumatology, contains weighted recommendations for the treatment of JIA, including therapeutic approaches for oligoarthritis, tempromandibular joint (TMJ) arthritis, and systemic JIA (sJIA). The recommendations were the result of expert consensus and literature review using GRADE methodology, with input from clinicians, as well as patients and parents.

“Although evidence remains very low and many recommendations are conditional, the inclusion of parents and patients in the decision-making process strengthens their validity,” said project principal investigator Karen Onel, MD, of the Hospital for Special Surgery and Weill Cornell Medicine, both in New York.

She added that “it’s important to remember that these guidelines are meant to be guidelines; clinical care remains in the hands of the provider and the patient, and we endorse the importance of shared decision-making in coming to these agreements.”

Dr. Onel outlined key recommendations for patients for whom a diagnosis of JIA has already been made and who have no contraindications to recommended therapies. The strength of the recommendations (strong or conditional) and evidence levels (high, moderate, low, very low) were also reported.
 

Oligoarthritis with fewer than five involved joints

For these patients, intra-articular glucocorticoids (IAGC) are recommended as a part of initial therapy (strong, very low evidence).

Triamcinolone acetonide is the preferred agent in this situation (strong, low evidence).

The guideline also has a conditional recommendation (very low evidence) for a trial of consistent NSAIDS as part of initial therapy and a conditional recommendation against oral glucocorticoids for initial therapy (very low evidence).

Patients with no or incomplete responses or intolerance to NSAIDS and/or IAGC may be tried on a nonbiologic DMARD (strong, very low evidence), with methotrexate as the preferred agent (conditional, low evidence).

If the patient has no response or an inadequate response to at least one nonbiologic DMARD, biologic DMARDs are recommended (strong, very low evidence), with no preferred agent.

The guideline also conditionally recommends (all with very low evidence) using risk factors and validated disease activity measures to guide treatment decisions, as well as imaging guidance of joints that are difficult to access or to localize the distribution of inflammation.
 

TMJ arthritis

For patients with temporomandibular joint arthritis, isolated or not, IAGCs are conditionally recommended as part of initial therapy (very low evidence) with no preferred agents. The guideline also conditionally recommends in favor of a trial of consistent NSAIDs, and against oral glucocorticoids in initial therapy (evidence for both very low).

Recommendations for patients with TMJ with no or an incomplete response to the initial therapy are the same as for patients with oligoarthritis, with no preferred agent.
 

sJIA without macrophage activation syndrome

For patients with sJIA without macrophage activation syndrome (MAS), NSAIDS are conditionally recommended as initial monotherapy (very low evidence). Biologic DMARDS (including interleukin-1 and IL-6 inhibitors) are also recommended, conditionally, as initial monotherapy, with no preferred agent.

If the patient has an inadequate response or intolerance to NSAIDS and at least one nonbiologic DMARD, a single biologic DMARD is recommended over a combination of nonbiologic therapies (strong, very low evidence).

“However, there have been reports of emergent, highly severe lung disease associated with the use of biologics in children with systemic JIA, especially in those who are young, with chronic macrophage activation syndrome, and those with trisomy 21. More information is needed to clarify the safety of these agents,” Dr. Onel said.

There is a conditional recommendation against oral glucocorticoids as initial monotherapy, and strong recommendation against nonbiologic DMARDs as initial monotherapy (both very low evidence).

sJIA with MAS

“Macrophage activation syndrome is a major cause of morbidity and mortality for children with sJIA. Cytokine storm and secondary hemophagocytic syndrome can be seen with any rheumatic disease, but are most commonly seen with sJIA,” she said.

The features of MAS include fever, high ferritin levels, cytopenias, elevated liver-function test results, and high triglyceride levels.

For these patients, glucocorticoids are recommended as initial monotherapy (conditional, very low evidence). Biologic DMARDs (IL-1 and IL-6 inhibitors) are recommended over calcineurin inhibitors for achieving inactive disease and resolution of MAS (conditional, very low evidence). There is no preferred agent.

For patients with residual arthritis and an incomplete response to IL-1 or IL-6 inhibitors, biologic and nonbiologic DMARDs are recommended over chronic glucocorticoids (strong, very low evidence). There is no preferred agent.

After an MAS inactive disease state has been attained, the guideline recommends tapering and discontinuing glucocorticoids (strong, very low evidence) and the same for biologic DMARDs (conditional, very low evidence).
 

All children with JIA

In addition to the recommendations on specific clinical situations, the guideline includes recommendations for all children with JIA on medication monitoring, laboratory testing, and infection screening, as well as immunization and nonpharmacologic management.

A rheumatologist who was not involved in development of the guidelines commented on the importance of optimal management of JIA.

“Children are not immune from devastating rheumatic diseases, and the largest group is juvenile idiopathic arthritis. In my clinic, I have patients in their 30s, 40s, and 50s who have adult persistence of their arthritis from JIA who have permanent joint damage and even ongoing hard-to-control disease, and it has to do with the lack of therapies in the 1990s,” said Donald Thomas, MD, from Arthritis and Pain Associates of Prince George’s County (Md.).

“Today when we get a young adult transitioned from the pediatric clinic they’re usually in remission or have low disease activity because these treatments have paralleled those of our adult RA patients. Yet they do [provide clinicians with] unique challenges, with stunting of growth, macrophage activiation syndrome, and having to work with family members of the patient,” he said at a press briefing he moderated following the presentation of RA and JIA guidelines.

Eyal Muscal, MD, associate professor of pediatrics and rheumatology at Baylor College of Medicine, Houston, said in an interview that the guidelines clarify recommendations about earlier use of targeted therapies, primarily biologics.

“This will not change care, but hopefully remind all to adopt such strategies. Yet earlier utilization of often expensive biologic agents is delayed by administrative and insurance hurdles in the U.S. and access to these medications globally. I hope the guidelines will enhance advocacy on a state, national, and global stage,” he said when asked for comment.

The guideline development process is supported by ACR. Dr. Onel, Dr. Thomas, and Dr. Muscal reported no relevant conflicts of interest.

SOURCE: Onel K et al. ACR 2020, Presented November 8.

A draft guideline for the management of patients with juvenile idiopathic arthritis reflects changes in therapy away from reliance on NSAIDs and glucocorticoids and toward earlier introduction of biologic disease-modifying antirheumatic drugs (DMARDs).

The guideline, described in an oral session during the virtual annual meeting of the American College of Rheumatology, contains weighted recommendations for the treatment of JIA, including therapeutic approaches for oligoarthritis, tempromandibular joint (TMJ) arthritis, and systemic JIA (sJIA). The recommendations were the result of expert consensus and literature review using GRADE methodology, with input from clinicians, as well as patients and parents.

“Although evidence remains very low and many recommendations are conditional, the inclusion of parents and patients in the decision-making process strengthens their validity,” said project principal investigator Karen Onel, MD, of the Hospital for Special Surgery and Weill Cornell Medicine, both in New York.

She added that “it’s important to remember that these guidelines are meant to be guidelines; clinical care remains in the hands of the provider and the patient, and we endorse the importance of shared decision-making in coming to these agreements.”

Dr. Onel outlined key recommendations for patients for whom a diagnosis of JIA has already been made and who have no contraindications to recommended therapies. The strength of the recommendations (strong or conditional) and evidence levels (high, moderate, low, very low) were also reported.
 

Oligoarthritis with fewer than five involved joints

For these patients, intra-articular glucocorticoids (IAGC) are recommended as a part of initial therapy (strong, very low evidence).

Triamcinolone acetonide is the preferred agent in this situation (strong, low evidence).

The guideline also has a conditional recommendation (very low evidence) for a trial of consistent NSAIDS as part of initial therapy and a conditional recommendation against oral glucocorticoids for initial therapy (very low evidence).

Patients with no or incomplete responses or intolerance to NSAIDS and/or IAGC may be tried on a nonbiologic DMARD (strong, very low evidence), with methotrexate as the preferred agent (conditional, low evidence).

If the patient has no response or an inadequate response to at least one nonbiologic DMARD, biologic DMARDs are recommended (strong, very low evidence), with no preferred agent.

The guideline also conditionally recommends (all with very low evidence) using risk factors and validated disease activity measures to guide treatment decisions, as well as imaging guidance of joints that are difficult to access or to localize the distribution of inflammation.
 

TMJ arthritis

For patients with temporomandibular joint arthritis, isolated or not, IAGCs are conditionally recommended as part of initial therapy (very low evidence) with no preferred agents. The guideline also conditionally recommends in favor of a trial of consistent NSAIDs, and against oral glucocorticoids in initial therapy (evidence for both very low).

Recommendations for patients with TMJ with no or an incomplete response to the initial therapy are the same as for patients with oligoarthritis, with no preferred agent.
 

sJIA without macrophage activation syndrome

For patients with sJIA without macrophage activation syndrome (MAS), NSAIDS are conditionally recommended as initial monotherapy (very low evidence). Biologic DMARDS (including interleukin-1 and IL-6 inhibitors) are also recommended, conditionally, as initial monotherapy, with no preferred agent.

If the patient has an inadequate response or intolerance to NSAIDS and at least one nonbiologic DMARD, a single biologic DMARD is recommended over a combination of nonbiologic therapies (strong, very low evidence).

“However, there have been reports of emergent, highly severe lung disease associated with the use of biologics in children with systemic JIA, especially in those who are young, with chronic macrophage activation syndrome, and those with trisomy 21. More information is needed to clarify the safety of these agents,” Dr. Onel said.

There is a conditional recommendation against oral glucocorticoids as initial monotherapy, and strong recommendation against nonbiologic DMARDs as initial monotherapy (both very low evidence).

sJIA with MAS

“Macrophage activation syndrome is a major cause of morbidity and mortality for children with sJIA. Cytokine storm and secondary hemophagocytic syndrome can be seen with any rheumatic disease, but are most commonly seen with sJIA,” she said.

The features of MAS include fever, high ferritin levels, cytopenias, elevated liver-function test results, and high triglyceride levels.

For these patients, glucocorticoids are recommended as initial monotherapy (conditional, very low evidence). Biologic DMARDs (IL-1 and IL-6 inhibitors) are recommended over calcineurin inhibitors for achieving inactive disease and resolution of MAS (conditional, very low evidence). There is no preferred agent.

For patients with residual arthritis and an incomplete response to IL-1 or IL-6 inhibitors, biologic and nonbiologic DMARDs are recommended over chronic glucocorticoids (strong, very low evidence). There is no preferred agent.

After an MAS inactive disease state has been attained, the guideline recommends tapering and discontinuing glucocorticoids (strong, very low evidence) and the same for biologic DMARDs (conditional, very low evidence).
 

All children with JIA

In addition to the recommendations on specific clinical situations, the guideline includes recommendations for all children with JIA on medication monitoring, laboratory testing, and infection screening, as well as immunization and nonpharmacologic management.

A rheumatologist who was not involved in development of the guidelines commented on the importance of optimal management of JIA.

“Children are not immune from devastating rheumatic diseases, and the largest group is juvenile idiopathic arthritis. In my clinic, I have patients in their 30s, 40s, and 50s who have adult persistence of their arthritis from JIA who have permanent joint damage and even ongoing hard-to-control disease, and it has to do with the lack of therapies in the 1990s,” said Donald Thomas, MD, from Arthritis and Pain Associates of Prince George’s County (Md.).

“Today when we get a young adult transitioned from the pediatric clinic they’re usually in remission or have low disease activity because these treatments have paralleled those of our adult RA patients. Yet they do [provide clinicians with] unique challenges, with stunting of growth, macrophage activiation syndrome, and having to work with family members of the patient,” he said at a press briefing he moderated following the presentation of RA and JIA guidelines.

Eyal Muscal, MD, associate professor of pediatrics and rheumatology at Baylor College of Medicine, Houston, said in an interview that the guidelines clarify recommendations about earlier use of targeted therapies, primarily biologics.

“This will not change care, but hopefully remind all to adopt such strategies. Yet earlier utilization of often expensive biologic agents is delayed by administrative and insurance hurdles in the U.S. and access to these medications globally. I hope the guidelines will enhance advocacy on a state, national, and global stage,” he said when asked for comment.

The guideline development process is supported by ACR. Dr. Onel, Dr. Thomas, and Dr. Muscal reported no relevant conflicts of interest.

SOURCE: Onel K et al. ACR 2020, Presented November 8.