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Slow-to-moderate weight loss better than rapid with antiobesity drugs in OA
TOPLINE:
Individuals with overweight or obesity and knee or hip osteoarthritis (OA) who used antiobesity medications and achieved slow-to-moderate weight loss had a lower risk for all-cause mortality than did those with weight gain or stable weight in a population-based cohort study emulating a randomized controlled trial. Patients who rapidly lost weight had mortality similar to those with weight gain or stable weight.
METHODOLOGY:
- The researchers used the IQVIA Medical Research Database to identify overweight or obese individuals with knee or hip OA; they conducted a hypothetical trial comparing the effects of slow-to-moderate weight loss (defined as 2%-10% of body weight) and rapid weight loss (defined as 5% or more of body weight) within 1 year of starting antiobesity medications.
- The final analysis included patients with a mean age of 60.9 years who met the criteria for treatment adherence to orlistat (n = 3028), sibutramine (n = 2919), or rimonabant (n = 797).
- The primary outcome was all-cause mortality over a 5-year follow-up period; secondary outcomes included hypertension, type 2 diabetes, and venous thromboembolism.
TAKEAWAY:
- All-cause mortality at 5 years was 5.3% with weight gain or stable weight, 4.0% with slow to moderate weight loss, and 5.4% with rapid weight loss.
- Hazard ratios for all-cause mortality were 0.72 (95% CI, 0.56-0.92) for slow to moderate weight loss and 0.99 (95% CI, 0.67-1.44) for the rapid weight loss group.
- Weight loss was associated with the secondary outcomes of reduced hypertension, type 2 diabetes, and venous thromboembolism in a dose-dependent manner.
- A slightly increased risk for cardiovascular disease occurred in the rapid weight loss group, compared with the weight gain or stable group, but this difference was not significant.
IN PRACTICE:
“Our finding that gradual weight loss by antiobesity medications lowers all-cause mortality, if confirmed by future studies, could guide policy-making and improve the well-being of patients with overweight or obesity and knee or hip OA,” the researchers wrote.
SOURCE:
The lead author on the study was Jie Wei, MD, of Central South University, Changsha, China. The study was published online in Arthritis & Rheumatology.
LIMITATIONS:
Study limitations included the inability to control for factors such as exercise, diet, and disease severity; the inability to assess the risk for cause-specific mortality; and the inability to account for the impact of pain reduction and improved function as a result of weight loss.
DISCLOSURES:
The study was supported by the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, the Natural Science Foundation of Hunan Province, the Central South University Innovation-Driven Research Programme, and the Science and Technology Innovation Program of Hunan Province. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Individuals with overweight or obesity and knee or hip osteoarthritis (OA) who used antiobesity medications and achieved slow-to-moderate weight loss had a lower risk for all-cause mortality than did those with weight gain or stable weight in a population-based cohort study emulating a randomized controlled trial. Patients who rapidly lost weight had mortality similar to those with weight gain or stable weight.
METHODOLOGY:
- The researchers used the IQVIA Medical Research Database to identify overweight or obese individuals with knee or hip OA; they conducted a hypothetical trial comparing the effects of slow-to-moderate weight loss (defined as 2%-10% of body weight) and rapid weight loss (defined as 5% or more of body weight) within 1 year of starting antiobesity medications.
- The final analysis included patients with a mean age of 60.9 years who met the criteria for treatment adherence to orlistat (n = 3028), sibutramine (n = 2919), or rimonabant (n = 797).
- The primary outcome was all-cause mortality over a 5-year follow-up period; secondary outcomes included hypertension, type 2 diabetes, and venous thromboembolism.
TAKEAWAY:
- All-cause mortality at 5 years was 5.3% with weight gain or stable weight, 4.0% with slow to moderate weight loss, and 5.4% with rapid weight loss.
- Hazard ratios for all-cause mortality were 0.72 (95% CI, 0.56-0.92) for slow to moderate weight loss and 0.99 (95% CI, 0.67-1.44) for the rapid weight loss group.
- Weight loss was associated with the secondary outcomes of reduced hypertension, type 2 diabetes, and venous thromboembolism in a dose-dependent manner.
- A slightly increased risk for cardiovascular disease occurred in the rapid weight loss group, compared with the weight gain or stable group, but this difference was not significant.
IN PRACTICE:
“Our finding that gradual weight loss by antiobesity medications lowers all-cause mortality, if confirmed by future studies, could guide policy-making and improve the well-being of patients with overweight or obesity and knee or hip OA,” the researchers wrote.
SOURCE:
The lead author on the study was Jie Wei, MD, of Central South University, Changsha, China. The study was published online in Arthritis & Rheumatology.
LIMITATIONS:
Study limitations included the inability to control for factors such as exercise, diet, and disease severity; the inability to assess the risk for cause-specific mortality; and the inability to account for the impact of pain reduction and improved function as a result of weight loss.
DISCLOSURES:
The study was supported by the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, the Natural Science Foundation of Hunan Province, the Central South University Innovation-Driven Research Programme, and the Science and Technology Innovation Program of Hunan Province. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Individuals with overweight or obesity and knee or hip osteoarthritis (OA) who used antiobesity medications and achieved slow-to-moderate weight loss had a lower risk for all-cause mortality than did those with weight gain or stable weight in a population-based cohort study emulating a randomized controlled trial. Patients who rapidly lost weight had mortality similar to those with weight gain or stable weight.
METHODOLOGY:
- The researchers used the IQVIA Medical Research Database to identify overweight or obese individuals with knee or hip OA; they conducted a hypothetical trial comparing the effects of slow-to-moderate weight loss (defined as 2%-10% of body weight) and rapid weight loss (defined as 5% or more of body weight) within 1 year of starting antiobesity medications.
- The final analysis included patients with a mean age of 60.9 years who met the criteria for treatment adherence to orlistat (n = 3028), sibutramine (n = 2919), or rimonabant (n = 797).
- The primary outcome was all-cause mortality over a 5-year follow-up period; secondary outcomes included hypertension, type 2 diabetes, and venous thromboembolism.
TAKEAWAY:
- All-cause mortality at 5 years was 5.3% with weight gain or stable weight, 4.0% with slow to moderate weight loss, and 5.4% with rapid weight loss.
- Hazard ratios for all-cause mortality were 0.72 (95% CI, 0.56-0.92) for slow to moderate weight loss and 0.99 (95% CI, 0.67-1.44) for the rapid weight loss group.
- Weight loss was associated with the secondary outcomes of reduced hypertension, type 2 diabetes, and venous thromboembolism in a dose-dependent manner.
- A slightly increased risk for cardiovascular disease occurred in the rapid weight loss group, compared with the weight gain or stable group, but this difference was not significant.
IN PRACTICE:
“Our finding that gradual weight loss by antiobesity medications lowers all-cause mortality, if confirmed by future studies, could guide policy-making and improve the well-being of patients with overweight or obesity and knee or hip OA,” the researchers wrote.
SOURCE:
The lead author on the study was Jie Wei, MD, of Central South University, Changsha, China. The study was published online in Arthritis & Rheumatology.
LIMITATIONS:
Study limitations included the inability to control for factors such as exercise, diet, and disease severity; the inability to assess the risk for cause-specific mortality; and the inability to account for the impact of pain reduction and improved function as a result of weight loss.
DISCLOSURES:
The study was supported by the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, the Natural Science Foundation of Hunan Province, the Central South University Innovation-Driven Research Programme, and the Science and Technology Innovation Program of Hunan Province. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Teen and young adult rheumatology patients report gaps in sexual health counseling
SAN DIEGO — Only half of teens and young adults on teratogenic medication report being asked about sexual activity by their rheumatologist, and 38% did not know that their medication would be harmful to a fetus, according to a new survey.
While pediatric rheumatology providers may think that health screenings and contraceptive counseling are happening elsewhere, “this study suggests that a lot of patients are being missed, including those on teratogens,” noted Brittany M. Huynh, MD, MPH, a pediatric rheumatology fellow at the Indiana University School of Medicine in Indianapolis. She led the study and presented the findings at the American College of Rheumatology annual meeting.
For the study, Dr. Huynh and colleagues recruited patients aged 14-23 years who were assigned female at birth and were followed at pediatric rheumatology clinics affiliated with Indiana University. Participants completed a one-time survey between October 2020 and July 2022 and were asked about their sexual reproductive health experience and knowledge. Notably, all but four surveys were completed prior to the US Supreme Court Dobbs decision overturning Roe v. Wade.
Of responses from 108 participants, the most common diagnoses were juvenile idiopathic arthritis (52%) and systemic lupus erythematosus (16%). About one third (36%) of patients were on teratogenic medication, with the most common being methotrexate. About three fourths (76%) were White, and the average age of respondents was 16.7.
Most participants (82%) said they had been asked about sexual activity by a health care provider, but only 38% said their pediatric rheumatologist discussed this topic with them. Of the 39 patients on teratogenic medication, 54% said they had been asked about sexual activity by their pediatric rheumatologist, and only 51% said they had received teratogenicity counseling.
A larger percentage (85%) of this group reported receiving sexual activity screenings by any provider, but there was little difference in counseling about teratogenic medication.
This suggests that this type of risk counseling “is almost exclusively done by (pediatric rheumatologists), if at all,” Dr. Huynh noted during her presentation.
In total, 56% of all patients said a provider had talked to them about how to prevent pregnancy, and 20% said they had been counseled about how to get and use emergency contraception. Only 6% of patients said their pediatric rheumatologist had discussed emergency contraception during appointments.
Although sexual activity screenings were associated with current teratogen use, pregnancy prevention counseling and emergency contraceptive counseling were not associated with teratogen use or reported sexual activity.
The survey also revealed that there were gaps in knowledge about the health effects of rheumatic medication. Of the patients on teratogens, 38% did not know that their medication could harm a fetus if they became pregnant. Only 9% of patients not on teratogens correctly answered that their medication would not harm a fetus.
Previous studies have also shown that rheumatology patients do not know that their medications can be teratogenic, noted Cuoghi Edens, MD, a rheumatologist at the University of Chicago, who sees both adult and pediatric patients. She was not involved with the study. The larger challenge is how to best educate patients, she said.
While hopefully a patient’s primary care provider is discussing these issues with them, these patients often see their rheumatologist more frequently and more consistently than other providers, Dr. Edens said.
“We are sometimes the continuity of care for the patient versus their primary care, even though it should be a group effort of trying to some of these questions,” she said.
Conducting reproductive health screenings in pediatric rheumatology clinics can be difficult though, Dr. Edens noted, not only because of time constraints but also because parents often attend appointments with their child and likely have been for years. These screenings are most accurate when done one-on-one, so pivoting and removing the parents from the room can be awkward for providers, Dr. Edens said.
She advised that starting these conversations early on can be one way to ease into talking about reproductive health. In her own practice, Dr. Huynh sets aside time during appointments to speak with adolescent patients privately.
“We always discuss teratogenic medication. I always talk to them about the fact that I’m going to be doing pregnancy testing with their other screening labs because of the risks associated,” she said. “I also specifically set time aside for patients on teratogens to talk about emergency contraception and offer a prescription, if they’re interested.”
Dr. Huynh emphasized that providing easy access to emergency contraception is key. The ACR reproductive health guidelines — although geared toward adults — recommend discussing emergency contraception with patients, and Dr. Huynh advocates writing prescriptions for interested patients.
“They can fill it and have it easily accessible, so that there are no additional barriers, particularly for people who have these higher risks,” she said.
While emergency contraceptives are also available over the counter, it can be awkward for young people to ask for them, she said, and they can be expensive if not covered under insurance. Providing a prescription is one way to avoid those issues, Dr. Huynh said.
“Certainly, you have to have some parent buy-in, because if there is going to be a script, it’s probably going to be under insurance,” she said. “But in my experience, parents are happy to have it around as long as you’re talking it through with them as well as the young person.”
Dr. Huynh and Dr. Edens had no disclosures.
A version of this article appeared on Medscape.com.
SAN DIEGO — Only half of teens and young adults on teratogenic medication report being asked about sexual activity by their rheumatologist, and 38% did not know that their medication would be harmful to a fetus, according to a new survey.
While pediatric rheumatology providers may think that health screenings and contraceptive counseling are happening elsewhere, “this study suggests that a lot of patients are being missed, including those on teratogens,” noted Brittany M. Huynh, MD, MPH, a pediatric rheumatology fellow at the Indiana University School of Medicine in Indianapolis. She led the study and presented the findings at the American College of Rheumatology annual meeting.
For the study, Dr. Huynh and colleagues recruited patients aged 14-23 years who were assigned female at birth and were followed at pediatric rheumatology clinics affiliated with Indiana University. Participants completed a one-time survey between October 2020 and July 2022 and were asked about their sexual reproductive health experience and knowledge. Notably, all but four surveys were completed prior to the US Supreme Court Dobbs decision overturning Roe v. Wade.
Of responses from 108 participants, the most common diagnoses were juvenile idiopathic arthritis (52%) and systemic lupus erythematosus (16%). About one third (36%) of patients were on teratogenic medication, with the most common being methotrexate. About three fourths (76%) were White, and the average age of respondents was 16.7.
Most participants (82%) said they had been asked about sexual activity by a health care provider, but only 38% said their pediatric rheumatologist discussed this topic with them. Of the 39 patients on teratogenic medication, 54% said they had been asked about sexual activity by their pediatric rheumatologist, and only 51% said they had received teratogenicity counseling.
A larger percentage (85%) of this group reported receiving sexual activity screenings by any provider, but there was little difference in counseling about teratogenic medication.
This suggests that this type of risk counseling “is almost exclusively done by (pediatric rheumatologists), if at all,” Dr. Huynh noted during her presentation.
In total, 56% of all patients said a provider had talked to them about how to prevent pregnancy, and 20% said they had been counseled about how to get and use emergency contraception. Only 6% of patients said their pediatric rheumatologist had discussed emergency contraception during appointments.
Although sexual activity screenings were associated with current teratogen use, pregnancy prevention counseling and emergency contraceptive counseling were not associated with teratogen use or reported sexual activity.
The survey also revealed that there were gaps in knowledge about the health effects of rheumatic medication. Of the patients on teratogens, 38% did not know that their medication could harm a fetus if they became pregnant. Only 9% of patients not on teratogens correctly answered that their medication would not harm a fetus.
Previous studies have also shown that rheumatology patients do not know that their medications can be teratogenic, noted Cuoghi Edens, MD, a rheumatologist at the University of Chicago, who sees both adult and pediatric patients. She was not involved with the study. The larger challenge is how to best educate patients, she said.
While hopefully a patient’s primary care provider is discussing these issues with them, these patients often see their rheumatologist more frequently and more consistently than other providers, Dr. Edens said.
“We are sometimes the continuity of care for the patient versus their primary care, even though it should be a group effort of trying to some of these questions,” she said.
Conducting reproductive health screenings in pediatric rheumatology clinics can be difficult though, Dr. Edens noted, not only because of time constraints but also because parents often attend appointments with their child and likely have been for years. These screenings are most accurate when done one-on-one, so pivoting and removing the parents from the room can be awkward for providers, Dr. Edens said.
She advised that starting these conversations early on can be one way to ease into talking about reproductive health. In her own practice, Dr. Huynh sets aside time during appointments to speak with adolescent patients privately.
“We always discuss teratogenic medication. I always talk to them about the fact that I’m going to be doing pregnancy testing with their other screening labs because of the risks associated,” she said. “I also specifically set time aside for patients on teratogens to talk about emergency contraception and offer a prescription, if they’re interested.”
Dr. Huynh emphasized that providing easy access to emergency contraception is key. The ACR reproductive health guidelines — although geared toward adults — recommend discussing emergency contraception with patients, and Dr. Huynh advocates writing prescriptions for interested patients.
“They can fill it and have it easily accessible, so that there are no additional barriers, particularly for people who have these higher risks,” she said.
While emergency contraceptives are also available over the counter, it can be awkward for young people to ask for them, she said, and they can be expensive if not covered under insurance. Providing a prescription is one way to avoid those issues, Dr. Huynh said.
“Certainly, you have to have some parent buy-in, because if there is going to be a script, it’s probably going to be under insurance,” she said. “But in my experience, parents are happy to have it around as long as you’re talking it through with them as well as the young person.”
Dr. Huynh and Dr. Edens had no disclosures.
A version of this article appeared on Medscape.com.
SAN DIEGO — Only half of teens and young adults on teratogenic medication report being asked about sexual activity by their rheumatologist, and 38% did not know that their medication would be harmful to a fetus, according to a new survey.
While pediatric rheumatology providers may think that health screenings and contraceptive counseling are happening elsewhere, “this study suggests that a lot of patients are being missed, including those on teratogens,” noted Brittany M. Huynh, MD, MPH, a pediatric rheumatology fellow at the Indiana University School of Medicine in Indianapolis. She led the study and presented the findings at the American College of Rheumatology annual meeting.
For the study, Dr. Huynh and colleagues recruited patients aged 14-23 years who were assigned female at birth and were followed at pediatric rheumatology clinics affiliated with Indiana University. Participants completed a one-time survey between October 2020 and July 2022 and were asked about their sexual reproductive health experience and knowledge. Notably, all but four surveys were completed prior to the US Supreme Court Dobbs decision overturning Roe v. Wade.
Of responses from 108 participants, the most common diagnoses were juvenile idiopathic arthritis (52%) and systemic lupus erythematosus (16%). About one third (36%) of patients were on teratogenic medication, with the most common being methotrexate. About three fourths (76%) were White, and the average age of respondents was 16.7.
Most participants (82%) said they had been asked about sexual activity by a health care provider, but only 38% said their pediatric rheumatologist discussed this topic with them. Of the 39 patients on teratogenic medication, 54% said they had been asked about sexual activity by their pediatric rheumatologist, and only 51% said they had received teratogenicity counseling.
A larger percentage (85%) of this group reported receiving sexual activity screenings by any provider, but there was little difference in counseling about teratogenic medication.
This suggests that this type of risk counseling “is almost exclusively done by (pediatric rheumatologists), if at all,” Dr. Huynh noted during her presentation.
In total, 56% of all patients said a provider had talked to them about how to prevent pregnancy, and 20% said they had been counseled about how to get and use emergency contraception. Only 6% of patients said their pediatric rheumatologist had discussed emergency contraception during appointments.
Although sexual activity screenings were associated with current teratogen use, pregnancy prevention counseling and emergency contraceptive counseling were not associated with teratogen use or reported sexual activity.
The survey also revealed that there were gaps in knowledge about the health effects of rheumatic medication. Of the patients on teratogens, 38% did not know that their medication could harm a fetus if they became pregnant. Only 9% of patients not on teratogens correctly answered that their medication would not harm a fetus.
Previous studies have also shown that rheumatology patients do not know that their medications can be teratogenic, noted Cuoghi Edens, MD, a rheumatologist at the University of Chicago, who sees both adult and pediatric patients. She was not involved with the study. The larger challenge is how to best educate patients, she said.
While hopefully a patient’s primary care provider is discussing these issues with them, these patients often see their rheumatologist more frequently and more consistently than other providers, Dr. Edens said.
“We are sometimes the continuity of care for the patient versus their primary care, even though it should be a group effort of trying to some of these questions,” she said.
Conducting reproductive health screenings in pediatric rheumatology clinics can be difficult though, Dr. Edens noted, not only because of time constraints but also because parents often attend appointments with their child and likely have been for years. These screenings are most accurate when done one-on-one, so pivoting and removing the parents from the room can be awkward for providers, Dr. Edens said.
She advised that starting these conversations early on can be one way to ease into talking about reproductive health. In her own practice, Dr. Huynh sets aside time during appointments to speak with adolescent patients privately.
“We always discuss teratogenic medication. I always talk to them about the fact that I’m going to be doing pregnancy testing with their other screening labs because of the risks associated,” she said. “I also specifically set time aside for patients on teratogens to talk about emergency contraception and offer a prescription, if they’re interested.”
Dr. Huynh emphasized that providing easy access to emergency contraception is key. The ACR reproductive health guidelines — although geared toward adults — recommend discussing emergency contraception with patients, and Dr. Huynh advocates writing prescriptions for interested patients.
“They can fill it and have it easily accessible, so that there are no additional barriers, particularly for people who have these higher risks,” she said.
While emergency contraceptives are also available over the counter, it can be awkward for young people to ask for them, she said, and they can be expensive if not covered under insurance. Providing a prescription is one way to avoid those issues, Dr. Huynh said.
“Certainly, you have to have some parent buy-in, because if there is going to be a script, it’s probably going to be under insurance,” she said. “But in my experience, parents are happy to have it around as long as you’re talking it through with them as well as the young person.”
Dr. Huynh and Dr. Edens had no disclosures.
A version of this article appeared on Medscape.com.
FROM ACR 2023
Supercharge your medical practice with ChatGPT: Here’s why you should upgrade
Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.
Let me walk you through it.
ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.
Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.
Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.
Here are some of the best ways to incorporate ChatGPT Plus into your practice.
Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.
Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.
Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.
Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.
Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.
Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.
Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.
Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.
Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.
Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.
While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.
I would love to hear your comments on this column or on future topics. Contact me at [email protected].
Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.
A version of this article appeared on Medscape.com.
Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.
Let me walk you through it.
ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.
Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.
Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.
Here are some of the best ways to incorporate ChatGPT Plus into your practice.
Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.
Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.
Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.
Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.
Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.
Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.
Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.
Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.
Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.
Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.
While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.
I would love to hear your comments on this column or on future topics. Contact me at [email protected].
Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.
A version of this article appeared on Medscape.com.
Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.
Let me walk you through it.
ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.
Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.
Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.
Here are some of the best ways to incorporate ChatGPT Plus into your practice.
Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.
Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.
Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.
Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.
Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.
Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.
Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.
Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.
Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.
Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.
While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.
I would love to hear your comments on this column or on future topics. Contact me at [email protected].
Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.
A version of this article appeared on Medscape.com.
Electronic Health Records — Recent Survey Results
I have been writing about electronic health records since the mid-1990s. While the basic concept has always been sound, I have always been (and continue to be) a critic of its implementation, which I have compared to the work of the Underpants Gnomes from the television show South Park.
You may recall that Phase One of the Gnomes’ grand scheme was to collect underpants, and Phase Three was to reap enormous profits. Unfortunately, they never quite figured out Phase Two.
EHR’s problems have run a similar course, ever since George W. Bush introduced the EHR Incentive Program (later renamed the Promoting Interoperability Program) in 2000. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” That was the ultimate goal — Phase Three, if you will — but nearly a quarter-century later, we are still struggling with Phase Two.
According to the results of a recent survey by this news organization, progress has been made, but issues with usability, reliability, and patient privacy remain.
surveys, respectively. But 56% of them continue to worry about harmful effects from incorrect or misdirected information as a result of inputs from multiple sources, and the rapid turnover of staff that is doing the inputting. Many doctors worry about the potential for incorrect medications and “rule out” diagnoses getting embedded in some patients’ records and undermining future care.
The lack of information sharing among different EHR systems has been the technology’s greatest unmet promise, according to the survey. A lack of interoperability was cited as the most common reason for switching EHR systems. Other reasons included difficulties in clinical documentation and extracting data for quality reporting, as well as the inability to merge inpatient and outpatient records.
A clear majority (72%) felt EHR systems are getting easier to use. The recent decrease in government mandates has freed vendors to work on improving ease of documentation and information retrieval. The incorporation of virtual assistants and other artificial intelligence–based features (as I discussed in two recent columns) have also contributed to improved overall usability. Some newer applications even allow users to build workarounds to compensate for inherent deficiencies in the system.
Physicians tended to be most praiseworthy of functions related to electronic prescribing and retrieval of individual patient data. They felt that much more improvement was needed in helpful prompt features, internal messaging, and communications from patients.
The survey found that 38% of physicians “always” or “often” copy and paste information in patient charts, with another 37% doing so “occasionally.” Noting some of the problems inherent in copy and paste, such as note bloat, internal inconsistencies, error propagation, and documentation in the wrong patient chart, the survey authors suggest that EHR developers could help by shifting away from timelines that appear as one long note. They could also add functionality to allow new information to be displayed as updates on a digital chart.
Improvement is also needed in the way the EHR affects patient interactions, according to the survey results. Physicians are still often forced to click to a different screen to find lab results, another for current medications, and still another for past notes, all while trying to communicate with the patient. Such issues are likely to decrease in the next few years as doctors gain the ability to give voice commands to AI-based system add-ons to obtain this information.
Security concerns seem to be decreasing. In this year’s survey, nearly half of all physicians voiced no EHR privacy problems or concerns, even though a recent review of medical literature concluded that security risks remain meaningful. Those who did have privacy concerns were mostly worried about hackers and other unauthorized access to patient information.
The survey found that around 40% of EHR systems are not using patient portals to post lab results, diagnoses and procedure notes, or prescriptions. However, other physicians complained that their systems were too prompt in posting results, so that patients often received them before the doctor did. This is certainly another area where improvement at both extremes is necessary.
Other areas in which physicians saw a need for improvement were in system reliability, user training, and ongoing customer service. And among the dwindling ranks of physicians with no EHR experience, the most common reasons given for refusing to invest in an EHR system were affordability and interference with the doctor-patient relationship.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
I have been writing about electronic health records since the mid-1990s. While the basic concept has always been sound, I have always been (and continue to be) a critic of its implementation, which I have compared to the work of the Underpants Gnomes from the television show South Park.
You may recall that Phase One of the Gnomes’ grand scheme was to collect underpants, and Phase Three was to reap enormous profits. Unfortunately, they never quite figured out Phase Two.
EHR’s problems have run a similar course, ever since George W. Bush introduced the EHR Incentive Program (later renamed the Promoting Interoperability Program) in 2000. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” That was the ultimate goal — Phase Three, if you will — but nearly a quarter-century later, we are still struggling with Phase Two.
According to the results of a recent survey by this news organization, progress has been made, but issues with usability, reliability, and patient privacy remain.
surveys, respectively. But 56% of them continue to worry about harmful effects from incorrect or misdirected information as a result of inputs from multiple sources, and the rapid turnover of staff that is doing the inputting. Many doctors worry about the potential for incorrect medications and “rule out” diagnoses getting embedded in some patients’ records and undermining future care.
The lack of information sharing among different EHR systems has been the technology’s greatest unmet promise, according to the survey. A lack of interoperability was cited as the most common reason for switching EHR systems. Other reasons included difficulties in clinical documentation and extracting data for quality reporting, as well as the inability to merge inpatient and outpatient records.
A clear majority (72%) felt EHR systems are getting easier to use. The recent decrease in government mandates has freed vendors to work on improving ease of documentation and information retrieval. The incorporation of virtual assistants and other artificial intelligence–based features (as I discussed in two recent columns) have also contributed to improved overall usability. Some newer applications even allow users to build workarounds to compensate for inherent deficiencies in the system.
Physicians tended to be most praiseworthy of functions related to electronic prescribing and retrieval of individual patient data. They felt that much more improvement was needed in helpful prompt features, internal messaging, and communications from patients.
The survey found that 38% of physicians “always” or “often” copy and paste information in patient charts, with another 37% doing so “occasionally.” Noting some of the problems inherent in copy and paste, such as note bloat, internal inconsistencies, error propagation, and documentation in the wrong patient chart, the survey authors suggest that EHR developers could help by shifting away from timelines that appear as one long note. They could also add functionality to allow new information to be displayed as updates on a digital chart.
Improvement is also needed in the way the EHR affects patient interactions, according to the survey results. Physicians are still often forced to click to a different screen to find lab results, another for current medications, and still another for past notes, all while trying to communicate with the patient. Such issues are likely to decrease in the next few years as doctors gain the ability to give voice commands to AI-based system add-ons to obtain this information.
Security concerns seem to be decreasing. In this year’s survey, nearly half of all physicians voiced no EHR privacy problems or concerns, even though a recent review of medical literature concluded that security risks remain meaningful. Those who did have privacy concerns were mostly worried about hackers and other unauthorized access to patient information.
The survey found that around 40% of EHR systems are not using patient portals to post lab results, diagnoses and procedure notes, or prescriptions. However, other physicians complained that their systems were too prompt in posting results, so that patients often received them before the doctor did. This is certainly another area where improvement at both extremes is necessary.
Other areas in which physicians saw a need for improvement were in system reliability, user training, and ongoing customer service. And among the dwindling ranks of physicians with no EHR experience, the most common reasons given for refusing to invest in an EHR system were affordability and interference with the doctor-patient relationship.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
I have been writing about electronic health records since the mid-1990s. While the basic concept has always been sound, I have always been (and continue to be) a critic of its implementation, which I have compared to the work of the Underpants Gnomes from the television show South Park.
You may recall that Phase One of the Gnomes’ grand scheme was to collect underpants, and Phase Three was to reap enormous profits. Unfortunately, they never quite figured out Phase Two.
EHR’s problems have run a similar course, ever since George W. Bush introduced the EHR Incentive Program (later renamed the Promoting Interoperability Program) in 2000. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” That was the ultimate goal — Phase Three, if you will — but nearly a quarter-century later, we are still struggling with Phase Two.
According to the results of a recent survey by this news organization, progress has been made, but issues with usability, reliability, and patient privacy remain.
surveys, respectively. But 56% of them continue to worry about harmful effects from incorrect or misdirected information as a result of inputs from multiple sources, and the rapid turnover of staff that is doing the inputting. Many doctors worry about the potential for incorrect medications and “rule out” diagnoses getting embedded in some patients’ records and undermining future care.
The lack of information sharing among different EHR systems has been the technology’s greatest unmet promise, according to the survey. A lack of interoperability was cited as the most common reason for switching EHR systems. Other reasons included difficulties in clinical documentation and extracting data for quality reporting, as well as the inability to merge inpatient and outpatient records.
A clear majority (72%) felt EHR systems are getting easier to use. The recent decrease in government mandates has freed vendors to work on improving ease of documentation and information retrieval. The incorporation of virtual assistants and other artificial intelligence–based features (as I discussed in two recent columns) have also contributed to improved overall usability. Some newer applications even allow users to build workarounds to compensate for inherent deficiencies in the system.
Physicians tended to be most praiseworthy of functions related to electronic prescribing and retrieval of individual patient data. They felt that much more improvement was needed in helpful prompt features, internal messaging, and communications from patients.
The survey found that 38% of physicians “always” or “often” copy and paste information in patient charts, with another 37% doing so “occasionally.” Noting some of the problems inherent in copy and paste, such as note bloat, internal inconsistencies, error propagation, and documentation in the wrong patient chart, the survey authors suggest that EHR developers could help by shifting away from timelines that appear as one long note. They could also add functionality to allow new information to be displayed as updates on a digital chart.
Improvement is also needed in the way the EHR affects patient interactions, according to the survey results. Physicians are still often forced to click to a different screen to find lab results, another for current medications, and still another for past notes, all while trying to communicate with the patient. Such issues are likely to decrease in the next few years as doctors gain the ability to give voice commands to AI-based system add-ons to obtain this information.
Security concerns seem to be decreasing. In this year’s survey, nearly half of all physicians voiced no EHR privacy problems or concerns, even though a recent review of medical literature concluded that security risks remain meaningful. Those who did have privacy concerns were mostly worried about hackers and other unauthorized access to patient information.
The survey found that around 40% of EHR systems are not using patient portals to post lab results, diagnoses and procedure notes, or prescriptions. However, other physicians complained that their systems were too prompt in posting results, so that patients often received them before the doctor did. This is certainly another area where improvement at both extremes is necessary.
Other areas in which physicians saw a need for improvement were in system reliability, user training, and ongoing customer service. And among the dwindling ranks of physicians with no EHR experience, the most common reasons given for refusing to invest in an EHR system were affordability and interference with the doctor-patient relationship.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Federal program offers free COVID, flu at-home tests, treatments
The U.S. government has expanded a program offering free COVID-19 and flu tests and treatment.
The Home Test to Treat program is virtual and offers at-home rapid tests, telehealth sessions, and at-home treatments to people nationwide. The program is a collaboration among the National Institutes of Health, the Administration for Strategic Preparedness and Response, and the CDC. It began as a pilot program in some locations this year.
“With its expansion, the Home Test to Treat program will now offer free testing, telehealth and treatment for both COVID-19 and for influenza (flu) A and B,” the NIH said in a press release. “It is the first public health program that includes home testing technology at such a scale for both COVID-19 and flu.”
The news release says that anyone 18 or over with a current positive test for COVID-19 or flu can get free telehealth care and medicine delivered to their home.
Adults who don’t have COVID-19 or the flu can get free tests if they are uninsured or are enrolled in Medicare, Medicaid, the Veterans Affairs health care system, or Indian Health Services. If they test positive later, they can get free telehealth care and, if prescribed, treatment.
“I think that these [telehealth] delivery mechanisms are going to be absolutely crucial to unburden the in-person offices and the lines that we have and wait times,” said Michael Mina, MD, chief science officer at eMed, the company that helped implement the new Home Test to Treat program, to ABC News.
ABC notes that COVID tests can also be ordered at covidtests.gov – four tests per household or eight for those who have yet to order any this fall.
A version of this article appeared on WebMD.com .
The U.S. government has expanded a program offering free COVID-19 and flu tests and treatment.
The Home Test to Treat program is virtual and offers at-home rapid tests, telehealth sessions, and at-home treatments to people nationwide. The program is a collaboration among the National Institutes of Health, the Administration for Strategic Preparedness and Response, and the CDC. It began as a pilot program in some locations this year.
“With its expansion, the Home Test to Treat program will now offer free testing, telehealth and treatment for both COVID-19 and for influenza (flu) A and B,” the NIH said in a press release. “It is the first public health program that includes home testing technology at such a scale for both COVID-19 and flu.”
The news release says that anyone 18 or over with a current positive test for COVID-19 or flu can get free telehealth care and medicine delivered to their home.
Adults who don’t have COVID-19 or the flu can get free tests if they are uninsured or are enrolled in Medicare, Medicaid, the Veterans Affairs health care system, or Indian Health Services. If they test positive later, they can get free telehealth care and, if prescribed, treatment.
“I think that these [telehealth] delivery mechanisms are going to be absolutely crucial to unburden the in-person offices and the lines that we have and wait times,” said Michael Mina, MD, chief science officer at eMed, the company that helped implement the new Home Test to Treat program, to ABC News.
ABC notes that COVID tests can also be ordered at covidtests.gov – four tests per household or eight for those who have yet to order any this fall.
A version of this article appeared on WebMD.com .
The U.S. government has expanded a program offering free COVID-19 and flu tests and treatment.
The Home Test to Treat program is virtual and offers at-home rapid tests, telehealth sessions, and at-home treatments to people nationwide. The program is a collaboration among the National Institutes of Health, the Administration for Strategic Preparedness and Response, and the CDC. It began as a pilot program in some locations this year.
“With its expansion, the Home Test to Treat program will now offer free testing, telehealth and treatment for both COVID-19 and for influenza (flu) A and B,” the NIH said in a press release. “It is the first public health program that includes home testing technology at such a scale for both COVID-19 and flu.”
The news release says that anyone 18 or over with a current positive test for COVID-19 or flu can get free telehealth care and medicine delivered to their home.
Adults who don’t have COVID-19 or the flu can get free tests if they are uninsured or are enrolled in Medicare, Medicaid, the Veterans Affairs health care system, or Indian Health Services. If they test positive later, they can get free telehealth care and, if prescribed, treatment.
“I think that these [telehealth] delivery mechanisms are going to be absolutely crucial to unburden the in-person offices and the lines that we have and wait times,” said Michael Mina, MD, chief science officer at eMed, the company that helped implement the new Home Test to Treat program, to ABC News.
ABC notes that COVID tests can also be ordered at covidtests.gov – four tests per household or eight for those who have yet to order any this fall.
A version of this article appeared on WebMD.com .
Researchers making strides to better understand RA-associated interstitial lung disease
SAN DIEGO — Clinically significant interstitial lung disease (ILD) is believed to occur in 5%-10% of patients with rheumatoid arthritis (RA), but robust data are lacking on how to best predict which patients face the highest risk for RA-associated ILD. However, the results of several studies presented at the American College of Rheumatology annual meeting indicate that researchers are making strides in this field of rheumatologic care.
Adding Genetic Factors Improves ILD Risk Prediction
In the realm of risk stratification, Austin M. Wheeler, MD, a rheumatology fellow at the University of Nebraska Medical Center, Omaha, discussed the development and validation of a combined clinical and genetic risk score for ILD. “There is clear and well documented phenotypic and genetic overlap of ILD with idiopathic pulmonary fibrosis (IPF),” Dr. Wheeler said. “A number of clinical risk factors have been described for RA-ILD, including older age, male sex, smoking history, higher disease activity, and seropositivity. There are also well-documented genetic risk factors for RA-ILD. The MUC5B genetic variant is the strongest risk factor for IPF, and it’s been described in RA-ILD as well.”
A recently published study indicated that a genetic risk score without the MUC5B variant improved predictive ability for IPF and interstitial lung abnormalities better than using the MUC5B variant alone, “but no prior attempts have been made at developing a composite genetic risk score in RA-ILD” using both genetic and clinical risk factors, he said.
For the current study, Dr. Wheeler and colleagues drew from 2,386 participants in the Veterans Affairs Rheumatoid Arthritis (VARA) Registry, a multicenter, prospective cohort of US veterans with rheumatologist-diagnosed RA and who fulfilled the 1987 ACR classification criteria. The researchers validated ILD through a systematic review of medical records, including clinical diagnosis of ILD plus either imaging or lung biopsy findings, and collected whole genome data that included 12 single nucleotide polymorphisms (SNPs) previously identified to be associated with risk for RA-ILD. They then used a meta-analytic approach to create pooled associations for each of those respective SNPs using data from the VARA registry participants as well as participants from the past study where the SNPs were first identified. “Those pooled associations were what we used for our effects size within the genetic risk score,” which ended up using five of the SNPs, Dr. Wheeler explained. Next, he and his colleagues combined the genetic risk score with clinical risk factors including age, sex, smoking history, disease activity, and rheumatoid factor (RF) positivity to create their combined risk score.
The mean age of the cohort was 70 years, 89% were male, 78% had a smoking history, and 78% were anti–cyclic citrullinated peptide (CCP) antibody positive. Of the 2,386 participants, 224 (9.4%) had RA-ILD. The full composite risk score had the highest area under the receiver operating curve (AUC) of 0.67, compared with an AUC of 0.623 using the clinical factors alone, 0.651 using the clinical factors plus only the MUC5B variant, and 0.654 using the composite score minus only the MUC5B variant. These AUCs show that “the combined risk score performs better than clinical factors even without the inclusion of the MUC5B variant in the score, which is notable because it supports the importance of further investigation into polygenic risk scores in RA-ILD as there is clearly more at play in a patient’s overall genetic risk,” Dr. Wheeler said.
As an example of the composite score’s ability to discriminate between people with and without RA-ILD, a cutpoint of 0.05 gave a sensitivity of 90.2% and would have eliminated about 25% of the cohort from unnecessary high-resolution CT scans and pulmonary function tests, he said.
“This study demonstrates the potential utility of genetic risk scores in RA-ILD identification and supports further investigation into individual risk stratification and screening,” he concluded. “This isn’t ready for clinical applicability by any means, but I think it serves as a proof of concept of the idea of a genetic risk score in RA-ILD.”
Biomarker Score Investigated
In a separate abstract, Brent Luedders, MD, assistant professor of rheumatology and immunology at the University of Nebraska Medical Center, and colleagues set out to determine if a previously derived biomarker score is associated with prevalent and incident ILD in the same VARA Registry cohort. An abstract presented at the ACR 2022 annual meeting found that a panel derived from IPF peripheral biomarkers was significantly associated with RA-ILD, including matrix metalloproteinase (MMP)-2, -7, and -9, eotaxin, macrophage-derived chemokine (MDC), monocyte chemoattractant protein-1 (MCP-1), fms-like tyrosine kinase 3 ligand (Flt3L) and interleukin-8 (IL-8). For the current analysis, Dr. Luedders and colleagues measured the concentrations of seven biomarkers (MMP-7, MMP-9, eotaxin, MDC, MCP-1, Flt3L, IL-8) from serum/plasma samples collected from VARA’s participants at enrollment to develop a score based on the concentrations of each biomarker.
Baseline characteristics were similar between the groups, although those with prevalent RA-ILD were slightly older than those without ILD, and those who developed incident ILD during follow-up had slightly higher RA disease activity at the time of enrollment. When the researchers examined the association of the biomarker score with prevalent RA-ILD as a continuous measure, they found an adjusted OR of 1.08 for prevalent RA-ILD for each 1-point increase in the biomarker score. “When this was divided into quartiles, we found that the highest quartile of the biomarker score was associated with an adjusted odds ratio of 2.31 for prevalent RA-ILD,” Dr. Luedders said. “We saw a significant P for trend of < .001, suggesting a dose-response relationship, in which higher scores had higher risk.” Similar associations were observed for incident RA-ILD, in which participants with the highest quartile had an adjusted hazard ratio of 2.26 for incident RA-ILD.
The AUC of 0.653 that was obtained with clinical factors did not significantly improve with inclusion of the biomarker score, rising to only 0.669. “In receiver operating characteristic analysis, the addition of the biomarker score to clinical variables (age, sex, race, smoking status, anti-CCP positivity, and RA disease activity by DAS28) did not lead to a significant increase in the area under the curve. Therefore, further work is needed to identify combinations of clinical, biomarker, and other factors to accurately predict which people with RA will develop ILD,” he said.
Dr. Luedders acknowledged certain limitations of the results, including the fact that MMP-2 was not measured in this cohort and thus not included in the score. “This was an observational study with usual care; therefore, the absence of systemic evaluation for ILD may miss early or mild RA-ILD cases,” he added. “Similarly, a male predominance may limit the generalizability, and we have limited information on the RA-ILD pattern.” He concluded that the study results “support the shared pathogenesis of IPF and RA-ILD. However, we found that this score has limited discriminative performance, compared to clinical risk factors alone.”
Drilling Down on ILD Subtypes
In a poster abstract presentation at the meeting, Gregory Campbell McDermott, MD, MPH, a rheumatologist at Brigham and Women’s Hospital, Boston, highlighted results from a study that investigated differences in demographic, serologic, and lifestyle factors for RA-ILD and the major subtypes of RA-ILD: usual interstitial pneumonia (UIP) and nonspecific interstitial pneumonia (NSIP). “Historically, RA-ILD has been studied as a single entity, even though we increasingly recognized that there are lots of different subtypes that fall under the umbrella of RA-ILD,” Dr. McDermott said in an interview. “We are also learning that the different subtypes probably have both prognostic and potentially therapeutic implications. For example, the UIP subtype, which is the most fibrotic subtype, has the worst prognosis but also may be a potential target for antifibrotic therapies. We’ve been trying to see if we can identify factors that are associated with specific subtypes, in particular the UIP subtype which has the worst prognosis.”
He and his colleagues examined 208 patients with RA-ILD with a mean age of 51 years and 547 patients with RA but no ILD with a mean age of 49 years from two RA cohorts comprising 3,328 patients: the Mass General Brigham Biobank RA Cohort and the Brigham RA Sequential Study (BRASS). Of the 208 RA-ILD cases, nearly half (48%) were RA-UIP, 18% were RA-NSIP, 8% were organizing pneumonia, 3% were respiratory bronchiolitis-ILD, and 23% were other/indeterminate. After conducting multivariable adjusted analyses, the researchers found that RA-ILD was associated with male sex (OR, 1.58; 95% CI, 1.09-2.23), seropositivity for RF and/or anti-CCP (OR, 2.22; 95% CI, 1.51-3.24) and being an ever smoker (OR, 1.70; 95% CI, 1.13-2.54). Having all three of these risk factors was strongly associated with RA-ILD (OR, 6.04; 95% CI, 2.92-12.47) and with RA-UIP in particular (OR, 7.1). “We found that a lot of the traditional RA-ILD risk factors like male sex, history of smoking, and seropositive status were most strongly associated with a UIP pattern,” Dr. McDermott said. “We think this is a first step in trying to understand how these different ILD subtypes may have different risk factors, pathogenesis, and potentially different treatments, prevention, and screening strategies.”
While clinicians wait for guidelines on systemic autoimmune rheumatic disease-associated ILD that are expected to be published by the ACR in 2024, he added that “we probably shouldn’t screen every single person with RA for ILD, but we need to identify people who have symptoms or findings on clinical exam. This study wasn’t designed to look specifically at who is at high risk, but I think we are moving toward that question: Who is high risk, and who’s asymptomatic [but] may need more screening?”
He pointed out limitations of the study, including its retrospective design and the fact that imaging was done for clinical purposes, “so it’s probably a higher risk group to begin with than the whole RA population,” he said. “We also didn’t have data on RA disease activity or erosions, some of these other measures that we think are important for understanding the full RA disease phenotype in these patients.”
Dr. Wheeler reported having no disclosures. Dr. Luedders reported that his study was supported by the VA, the Rheumatology Research Foundation, and the University of Nebraska Medical Center Mentored Scholars Program. Dr. McDermott reported that his study was supported by the Rheumatology Research Foundation.
SAN DIEGO — Clinically significant interstitial lung disease (ILD) is believed to occur in 5%-10% of patients with rheumatoid arthritis (RA), but robust data are lacking on how to best predict which patients face the highest risk for RA-associated ILD. However, the results of several studies presented at the American College of Rheumatology annual meeting indicate that researchers are making strides in this field of rheumatologic care.
Adding Genetic Factors Improves ILD Risk Prediction
In the realm of risk stratification, Austin M. Wheeler, MD, a rheumatology fellow at the University of Nebraska Medical Center, Omaha, discussed the development and validation of a combined clinical and genetic risk score for ILD. “There is clear and well documented phenotypic and genetic overlap of ILD with idiopathic pulmonary fibrosis (IPF),” Dr. Wheeler said. “A number of clinical risk factors have been described for RA-ILD, including older age, male sex, smoking history, higher disease activity, and seropositivity. There are also well-documented genetic risk factors for RA-ILD. The MUC5B genetic variant is the strongest risk factor for IPF, and it’s been described in RA-ILD as well.”
A recently published study indicated that a genetic risk score without the MUC5B variant improved predictive ability for IPF and interstitial lung abnormalities better than using the MUC5B variant alone, “but no prior attempts have been made at developing a composite genetic risk score in RA-ILD” using both genetic and clinical risk factors, he said.
For the current study, Dr. Wheeler and colleagues drew from 2,386 participants in the Veterans Affairs Rheumatoid Arthritis (VARA) Registry, a multicenter, prospective cohort of US veterans with rheumatologist-diagnosed RA and who fulfilled the 1987 ACR classification criteria. The researchers validated ILD through a systematic review of medical records, including clinical diagnosis of ILD plus either imaging or lung biopsy findings, and collected whole genome data that included 12 single nucleotide polymorphisms (SNPs) previously identified to be associated with risk for RA-ILD. They then used a meta-analytic approach to create pooled associations for each of those respective SNPs using data from the VARA registry participants as well as participants from the past study where the SNPs were first identified. “Those pooled associations were what we used for our effects size within the genetic risk score,” which ended up using five of the SNPs, Dr. Wheeler explained. Next, he and his colleagues combined the genetic risk score with clinical risk factors including age, sex, smoking history, disease activity, and rheumatoid factor (RF) positivity to create their combined risk score.
The mean age of the cohort was 70 years, 89% were male, 78% had a smoking history, and 78% were anti–cyclic citrullinated peptide (CCP) antibody positive. Of the 2,386 participants, 224 (9.4%) had RA-ILD. The full composite risk score had the highest area under the receiver operating curve (AUC) of 0.67, compared with an AUC of 0.623 using the clinical factors alone, 0.651 using the clinical factors plus only the MUC5B variant, and 0.654 using the composite score minus only the MUC5B variant. These AUCs show that “the combined risk score performs better than clinical factors even without the inclusion of the MUC5B variant in the score, which is notable because it supports the importance of further investigation into polygenic risk scores in RA-ILD as there is clearly more at play in a patient’s overall genetic risk,” Dr. Wheeler said.
As an example of the composite score’s ability to discriminate between people with and without RA-ILD, a cutpoint of 0.05 gave a sensitivity of 90.2% and would have eliminated about 25% of the cohort from unnecessary high-resolution CT scans and pulmonary function tests, he said.
“This study demonstrates the potential utility of genetic risk scores in RA-ILD identification and supports further investigation into individual risk stratification and screening,” he concluded. “This isn’t ready for clinical applicability by any means, but I think it serves as a proof of concept of the idea of a genetic risk score in RA-ILD.”
Biomarker Score Investigated
In a separate abstract, Brent Luedders, MD, assistant professor of rheumatology and immunology at the University of Nebraska Medical Center, and colleagues set out to determine if a previously derived biomarker score is associated with prevalent and incident ILD in the same VARA Registry cohort. An abstract presented at the ACR 2022 annual meeting found that a panel derived from IPF peripheral biomarkers was significantly associated with RA-ILD, including matrix metalloproteinase (MMP)-2, -7, and -9, eotaxin, macrophage-derived chemokine (MDC), monocyte chemoattractant protein-1 (MCP-1), fms-like tyrosine kinase 3 ligand (Flt3L) and interleukin-8 (IL-8). For the current analysis, Dr. Luedders and colleagues measured the concentrations of seven biomarkers (MMP-7, MMP-9, eotaxin, MDC, MCP-1, Flt3L, IL-8) from serum/plasma samples collected from VARA’s participants at enrollment to develop a score based on the concentrations of each biomarker.
Baseline characteristics were similar between the groups, although those with prevalent RA-ILD were slightly older than those without ILD, and those who developed incident ILD during follow-up had slightly higher RA disease activity at the time of enrollment. When the researchers examined the association of the biomarker score with prevalent RA-ILD as a continuous measure, they found an adjusted OR of 1.08 for prevalent RA-ILD for each 1-point increase in the biomarker score. “When this was divided into quartiles, we found that the highest quartile of the biomarker score was associated with an adjusted odds ratio of 2.31 for prevalent RA-ILD,” Dr. Luedders said. “We saw a significant P for trend of < .001, suggesting a dose-response relationship, in which higher scores had higher risk.” Similar associations were observed for incident RA-ILD, in which participants with the highest quartile had an adjusted hazard ratio of 2.26 for incident RA-ILD.
The AUC of 0.653 that was obtained with clinical factors did not significantly improve with inclusion of the biomarker score, rising to only 0.669. “In receiver operating characteristic analysis, the addition of the biomarker score to clinical variables (age, sex, race, smoking status, anti-CCP positivity, and RA disease activity by DAS28) did not lead to a significant increase in the area under the curve. Therefore, further work is needed to identify combinations of clinical, biomarker, and other factors to accurately predict which people with RA will develop ILD,” he said.
Dr. Luedders acknowledged certain limitations of the results, including the fact that MMP-2 was not measured in this cohort and thus not included in the score. “This was an observational study with usual care; therefore, the absence of systemic evaluation for ILD may miss early or mild RA-ILD cases,” he added. “Similarly, a male predominance may limit the generalizability, and we have limited information on the RA-ILD pattern.” He concluded that the study results “support the shared pathogenesis of IPF and RA-ILD. However, we found that this score has limited discriminative performance, compared to clinical risk factors alone.”
Drilling Down on ILD Subtypes
In a poster abstract presentation at the meeting, Gregory Campbell McDermott, MD, MPH, a rheumatologist at Brigham and Women’s Hospital, Boston, highlighted results from a study that investigated differences in demographic, serologic, and lifestyle factors for RA-ILD and the major subtypes of RA-ILD: usual interstitial pneumonia (UIP) and nonspecific interstitial pneumonia (NSIP). “Historically, RA-ILD has been studied as a single entity, even though we increasingly recognized that there are lots of different subtypes that fall under the umbrella of RA-ILD,” Dr. McDermott said in an interview. “We are also learning that the different subtypes probably have both prognostic and potentially therapeutic implications. For example, the UIP subtype, which is the most fibrotic subtype, has the worst prognosis but also may be a potential target for antifibrotic therapies. We’ve been trying to see if we can identify factors that are associated with specific subtypes, in particular the UIP subtype which has the worst prognosis.”
He and his colleagues examined 208 patients with RA-ILD with a mean age of 51 years and 547 patients with RA but no ILD with a mean age of 49 years from two RA cohorts comprising 3,328 patients: the Mass General Brigham Biobank RA Cohort and the Brigham RA Sequential Study (BRASS). Of the 208 RA-ILD cases, nearly half (48%) were RA-UIP, 18% were RA-NSIP, 8% were organizing pneumonia, 3% were respiratory bronchiolitis-ILD, and 23% were other/indeterminate. After conducting multivariable adjusted analyses, the researchers found that RA-ILD was associated with male sex (OR, 1.58; 95% CI, 1.09-2.23), seropositivity for RF and/or anti-CCP (OR, 2.22; 95% CI, 1.51-3.24) and being an ever smoker (OR, 1.70; 95% CI, 1.13-2.54). Having all three of these risk factors was strongly associated with RA-ILD (OR, 6.04; 95% CI, 2.92-12.47) and with RA-UIP in particular (OR, 7.1). “We found that a lot of the traditional RA-ILD risk factors like male sex, history of smoking, and seropositive status were most strongly associated with a UIP pattern,” Dr. McDermott said. “We think this is a first step in trying to understand how these different ILD subtypes may have different risk factors, pathogenesis, and potentially different treatments, prevention, and screening strategies.”
While clinicians wait for guidelines on systemic autoimmune rheumatic disease-associated ILD that are expected to be published by the ACR in 2024, he added that “we probably shouldn’t screen every single person with RA for ILD, but we need to identify people who have symptoms or findings on clinical exam. This study wasn’t designed to look specifically at who is at high risk, but I think we are moving toward that question: Who is high risk, and who’s asymptomatic [but] may need more screening?”
He pointed out limitations of the study, including its retrospective design and the fact that imaging was done for clinical purposes, “so it’s probably a higher risk group to begin with than the whole RA population,” he said. “We also didn’t have data on RA disease activity or erosions, some of these other measures that we think are important for understanding the full RA disease phenotype in these patients.”
Dr. Wheeler reported having no disclosures. Dr. Luedders reported that his study was supported by the VA, the Rheumatology Research Foundation, and the University of Nebraska Medical Center Mentored Scholars Program. Dr. McDermott reported that his study was supported by the Rheumatology Research Foundation.
SAN DIEGO — Clinically significant interstitial lung disease (ILD) is believed to occur in 5%-10% of patients with rheumatoid arthritis (RA), but robust data are lacking on how to best predict which patients face the highest risk for RA-associated ILD. However, the results of several studies presented at the American College of Rheumatology annual meeting indicate that researchers are making strides in this field of rheumatologic care.
Adding Genetic Factors Improves ILD Risk Prediction
In the realm of risk stratification, Austin M. Wheeler, MD, a rheumatology fellow at the University of Nebraska Medical Center, Omaha, discussed the development and validation of a combined clinical and genetic risk score for ILD. “There is clear and well documented phenotypic and genetic overlap of ILD with idiopathic pulmonary fibrosis (IPF),” Dr. Wheeler said. “A number of clinical risk factors have been described for RA-ILD, including older age, male sex, smoking history, higher disease activity, and seropositivity. There are also well-documented genetic risk factors for RA-ILD. The MUC5B genetic variant is the strongest risk factor for IPF, and it’s been described in RA-ILD as well.”
A recently published study indicated that a genetic risk score without the MUC5B variant improved predictive ability for IPF and interstitial lung abnormalities better than using the MUC5B variant alone, “but no prior attempts have been made at developing a composite genetic risk score in RA-ILD” using both genetic and clinical risk factors, he said.
For the current study, Dr. Wheeler and colleagues drew from 2,386 participants in the Veterans Affairs Rheumatoid Arthritis (VARA) Registry, a multicenter, prospective cohort of US veterans with rheumatologist-diagnosed RA and who fulfilled the 1987 ACR classification criteria. The researchers validated ILD through a systematic review of medical records, including clinical diagnosis of ILD plus either imaging or lung biopsy findings, and collected whole genome data that included 12 single nucleotide polymorphisms (SNPs) previously identified to be associated with risk for RA-ILD. They then used a meta-analytic approach to create pooled associations for each of those respective SNPs using data from the VARA registry participants as well as participants from the past study where the SNPs were first identified. “Those pooled associations were what we used for our effects size within the genetic risk score,” which ended up using five of the SNPs, Dr. Wheeler explained. Next, he and his colleagues combined the genetic risk score with clinical risk factors including age, sex, smoking history, disease activity, and rheumatoid factor (RF) positivity to create their combined risk score.
The mean age of the cohort was 70 years, 89% were male, 78% had a smoking history, and 78% were anti–cyclic citrullinated peptide (CCP) antibody positive. Of the 2,386 participants, 224 (9.4%) had RA-ILD. The full composite risk score had the highest area under the receiver operating curve (AUC) of 0.67, compared with an AUC of 0.623 using the clinical factors alone, 0.651 using the clinical factors plus only the MUC5B variant, and 0.654 using the composite score minus only the MUC5B variant. These AUCs show that “the combined risk score performs better than clinical factors even without the inclusion of the MUC5B variant in the score, which is notable because it supports the importance of further investigation into polygenic risk scores in RA-ILD as there is clearly more at play in a patient’s overall genetic risk,” Dr. Wheeler said.
As an example of the composite score’s ability to discriminate between people with and without RA-ILD, a cutpoint of 0.05 gave a sensitivity of 90.2% and would have eliminated about 25% of the cohort from unnecessary high-resolution CT scans and pulmonary function tests, he said.
“This study demonstrates the potential utility of genetic risk scores in RA-ILD identification and supports further investigation into individual risk stratification and screening,” he concluded. “This isn’t ready for clinical applicability by any means, but I think it serves as a proof of concept of the idea of a genetic risk score in RA-ILD.”
Biomarker Score Investigated
In a separate abstract, Brent Luedders, MD, assistant professor of rheumatology and immunology at the University of Nebraska Medical Center, and colleagues set out to determine if a previously derived biomarker score is associated with prevalent and incident ILD in the same VARA Registry cohort. An abstract presented at the ACR 2022 annual meeting found that a panel derived from IPF peripheral biomarkers was significantly associated with RA-ILD, including matrix metalloproteinase (MMP)-2, -7, and -9, eotaxin, macrophage-derived chemokine (MDC), monocyte chemoattractant protein-1 (MCP-1), fms-like tyrosine kinase 3 ligand (Flt3L) and interleukin-8 (IL-8). For the current analysis, Dr. Luedders and colleagues measured the concentrations of seven biomarkers (MMP-7, MMP-9, eotaxin, MDC, MCP-1, Flt3L, IL-8) from serum/plasma samples collected from VARA’s participants at enrollment to develop a score based on the concentrations of each biomarker.
Baseline characteristics were similar between the groups, although those with prevalent RA-ILD were slightly older than those without ILD, and those who developed incident ILD during follow-up had slightly higher RA disease activity at the time of enrollment. When the researchers examined the association of the biomarker score with prevalent RA-ILD as a continuous measure, they found an adjusted OR of 1.08 for prevalent RA-ILD for each 1-point increase in the biomarker score. “When this was divided into quartiles, we found that the highest quartile of the biomarker score was associated with an adjusted odds ratio of 2.31 for prevalent RA-ILD,” Dr. Luedders said. “We saw a significant P for trend of < .001, suggesting a dose-response relationship, in which higher scores had higher risk.” Similar associations were observed for incident RA-ILD, in which participants with the highest quartile had an adjusted hazard ratio of 2.26 for incident RA-ILD.
The AUC of 0.653 that was obtained with clinical factors did not significantly improve with inclusion of the biomarker score, rising to only 0.669. “In receiver operating characteristic analysis, the addition of the biomarker score to clinical variables (age, sex, race, smoking status, anti-CCP positivity, and RA disease activity by DAS28) did not lead to a significant increase in the area under the curve. Therefore, further work is needed to identify combinations of clinical, biomarker, and other factors to accurately predict which people with RA will develop ILD,” he said.
Dr. Luedders acknowledged certain limitations of the results, including the fact that MMP-2 was not measured in this cohort and thus not included in the score. “This was an observational study with usual care; therefore, the absence of systemic evaluation for ILD may miss early or mild RA-ILD cases,” he added. “Similarly, a male predominance may limit the generalizability, and we have limited information on the RA-ILD pattern.” He concluded that the study results “support the shared pathogenesis of IPF and RA-ILD. However, we found that this score has limited discriminative performance, compared to clinical risk factors alone.”
Drilling Down on ILD Subtypes
In a poster abstract presentation at the meeting, Gregory Campbell McDermott, MD, MPH, a rheumatologist at Brigham and Women’s Hospital, Boston, highlighted results from a study that investigated differences in demographic, serologic, and lifestyle factors for RA-ILD and the major subtypes of RA-ILD: usual interstitial pneumonia (UIP) and nonspecific interstitial pneumonia (NSIP). “Historically, RA-ILD has been studied as a single entity, even though we increasingly recognized that there are lots of different subtypes that fall under the umbrella of RA-ILD,” Dr. McDermott said in an interview. “We are also learning that the different subtypes probably have both prognostic and potentially therapeutic implications. For example, the UIP subtype, which is the most fibrotic subtype, has the worst prognosis but also may be a potential target for antifibrotic therapies. We’ve been trying to see if we can identify factors that are associated with specific subtypes, in particular the UIP subtype which has the worst prognosis.”
He and his colleagues examined 208 patients with RA-ILD with a mean age of 51 years and 547 patients with RA but no ILD with a mean age of 49 years from two RA cohorts comprising 3,328 patients: the Mass General Brigham Biobank RA Cohort and the Brigham RA Sequential Study (BRASS). Of the 208 RA-ILD cases, nearly half (48%) were RA-UIP, 18% were RA-NSIP, 8% were organizing pneumonia, 3% were respiratory bronchiolitis-ILD, and 23% were other/indeterminate. After conducting multivariable adjusted analyses, the researchers found that RA-ILD was associated with male sex (OR, 1.58; 95% CI, 1.09-2.23), seropositivity for RF and/or anti-CCP (OR, 2.22; 95% CI, 1.51-3.24) and being an ever smoker (OR, 1.70; 95% CI, 1.13-2.54). Having all three of these risk factors was strongly associated with RA-ILD (OR, 6.04; 95% CI, 2.92-12.47) and with RA-UIP in particular (OR, 7.1). “We found that a lot of the traditional RA-ILD risk factors like male sex, history of smoking, and seropositive status were most strongly associated with a UIP pattern,” Dr. McDermott said. “We think this is a first step in trying to understand how these different ILD subtypes may have different risk factors, pathogenesis, and potentially different treatments, prevention, and screening strategies.”
While clinicians wait for guidelines on systemic autoimmune rheumatic disease-associated ILD that are expected to be published by the ACR in 2024, he added that “we probably shouldn’t screen every single person with RA for ILD, but we need to identify people who have symptoms or findings on clinical exam. This study wasn’t designed to look specifically at who is at high risk, but I think we are moving toward that question: Who is high risk, and who’s asymptomatic [but] may need more screening?”
He pointed out limitations of the study, including its retrospective design and the fact that imaging was done for clinical purposes, “so it’s probably a higher risk group to begin with than the whole RA population,” he said. “We also didn’t have data on RA disease activity or erosions, some of these other measures that we think are important for understanding the full RA disease phenotype in these patients.”
Dr. Wheeler reported having no disclosures. Dr. Luedders reported that his study was supported by the VA, the Rheumatology Research Foundation, and the University of Nebraska Medical Center Mentored Scholars Program. Dr. McDermott reported that his study was supported by the Rheumatology Research Foundation.
FROM ACR 2023
Anti-Rheumatic Drugs Linked to Reduced Thyroid Disease Incidence
TOPLINE:
Patients with rheumatoid arthritis (RA) in a large Swedish population cohort show a reduced incidence of autoimmune thyroid diseases, such as hypothyroidism or hyperthyroidism, after being diagnosed with RA, with the effect being more pronounced among those treated with disease-modifying anti-rheumatic drugs (DMARDs), particularly TNF-inhibitors.
Although DMARDs are commonly used in the treatment of RA, the drugs are rarely used to treat autoimmune thyroid diseases. The new results support theories raised in previous smaller studies that DMARDs could have a protective effect against thyroid disease.
METHODOLOGY:
- The study involved 13,731 patients with new-onset RA who were listed in the Swedish Rheumatology Quality Register between 2006 and 2018.
- The patients were matched for sex, age, and residential area with up to five reference individuals in the general population of 63,201 comparators.
- Overall, patients with RA were 64.7% female, with a mean age of 59. They were followed up with their matched comparators until the development of autoimmune thyroid disease, death, emigration, or the end of the study period, December 2019.
- The relative risks of autoimmune thyroid disease following a diagnosis of RA and with treatment with DMARDs were compared with those risks in the general population.
- Participants with a non-autoimmune cause for thyroxine prescription were excluded, as were those with an autoimmune thyroid disease at the time of RA diagnosis.
TAKEAWAY:
- Following their RA diagnosis, 321 (2.3%) of patients developed an autoimmune thyroid disease, compared with 1838 (2.9%) in the general population comparators, representing an incidence of 3.7 vs 4.6 per 1000 person-years (hazard ratio [HR], 0.81).
- The lower incidence of autoimmune thyroid disease was more pronounced with longer RA duration. For instance, at 10-14 years after an RA diagnosis, the incidence was 2.9 vs. 4.5 autoimmune thyroid disease events per 1000 person-years, respectively (HR, 0.64).
- The decreased risk of incident autoimmune thyroid disease among RA patients compared with the general population was strongest among patients treated with biologic DMARDs (bDMARD), with an HR of 0.54.
- The reduced incidence of autoimmune thyroid disease with bDMARD use was most pronounced among users of TNF-inhibitors (HR, 0.67).
- The lower incidence of autoimmune thyroid disease following a diagnosis of RA contrasts with previous studies showing an increased risk for thyroid disease associated with RA.
- However, the decreased risk of thyroid disease following bDMARD treatment supports the theory that immunomodulatory treatment could also have an effect of blunting the inflammatory processes that can lead to overt clinical autoimmune thyroid disease.
IN PRACTICE:
“To our knowledge, no previous study has investigated whether the risk of new-onset autoimmune thyroid disease is affected by RA treatment in early RA,” the authors report.
“Our results demonstrate that compared to the general population, patients with RA treated with bDMARDs, TNF-inhibitors in particular, are at decreased risk of developing autoimmune thyroid disease, a finding that calls for replication and may open for drug-repurposing studies,” they note.
SOURCE:
The study was conducted by first author Kristin Waldenlind, PhD, of the Department of Medicine, Solna, Division of Clinical Epidemiology, Karolinska Institutet, Stockholm, Sweden, and colleagues. It was published online November 27 in the Journal of Internal Medicine.
LIMITATIONS:
The study lacked details on participants’ thyroid autoantibody and hormone levels.
The presence of autoimmune thyroid disease was determined based on prescriptions for thyroxine, hence the authors cannot exclude the possibility of a lower threshold for thyroxine prescription among patients treated with DMARDs.
Information was not available on potential risk factors for RA and autoimmune thyroid disease that might have introduced confounding, such as smoking or obesity.
DISCLOSURES:
The study received funding from the Swedish Research Council, the Swedish Heart Lung Foundation, Vinnova, and Region Stockholm/Karolinska Institutet (ALF). The authors’ disclosures are detailed in the published study.
A version of this article appeared on Medscape.com.
TOPLINE:
Patients with rheumatoid arthritis (RA) in a large Swedish population cohort show a reduced incidence of autoimmune thyroid diseases, such as hypothyroidism or hyperthyroidism, after being diagnosed with RA, with the effect being more pronounced among those treated with disease-modifying anti-rheumatic drugs (DMARDs), particularly TNF-inhibitors.
Although DMARDs are commonly used in the treatment of RA, the drugs are rarely used to treat autoimmune thyroid diseases. The new results support theories raised in previous smaller studies that DMARDs could have a protective effect against thyroid disease.
METHODOLOGY:
- The study involved 13,731 patients with new-onset RA who were listed in the Swedish Rheumatology Quality Register between 2006 and 2018.
- The patients were matched for sex, age, and residential area with up to five reference individuals in the general population of 63,201 comparators.
- Overall, patients with RA were 64.7% female, with a mean age of 59. They were followed up with their matched comparators until the development of autoimmune thyroid disease, death, emigration, or the end of the study period, December 2019.
- The relative risks of autoimmune thyroid disease following a diagnosis of RA and with treatment with DMARDs were compared with those risks in the general population.
- Participants with a non-autoimmune cause for thyroxine prescription were excluded, as were those with an autoimmune thyroid disease at the time of RA diagnosis.
TAKEAWAY:
- Following their RA diagnosis, 321 (2.3%) of patients developed an autoimmune thyroid disease, compared with 1838 (2.9%) in the general population comparators, representing an incidence of 3.7 vs 4.6 per 1000 person-years (hazard ratio [HR], 0.81).
- The lower incidence of autoimmune thyroid disease was more pronounced with longer RA duration. For instance, at 10-14 years after an RA diagnosis, the incidence was 2.9 vs. 4.5 autoimmune thyroid disease events per 1000 person-years, respectively (HR, 0.64).
- The decreased risk of incident autoimmune thyroid disease among RA patients compared with the general population was strongest among patients treated with biologic DMARDs (bDMARD), with an HR of 0.54.
- The reduced incidence of autoimmune thyroid disease with bDMARD use was most pronounced among users of TNF-inhibitors (HR, 0.67).
- The lower incidence of autoimmune thyroid disease following a diagnosis of RA contrasts with previous studies showing an increased risk for thyroid disease associated with RA.
- However, the decreased risk of thyroid disease following bDMARD treatment supports the theory that immunomodulatory treatment could also have an effect of blunting the inflammatory processes that can lead to overt clinical autoimmune thyroid disease.
IN PRACTICE:
“To our knowledge, no previous study has investigated whether the risk of new-onset autoimmune thyroid disease is affected by RA treatment in early RA,” the authors report.
“Our results demonstrate that compared to the general population, patients with RA treated with bDMARDs, TNF-inhibitors in particular, are at decreased risk of developing autoimmune thyroid disease, a finding that calls for replication and may open for drug-repurposing studies,” they note.
SOURCE:
The study was conducted by first author Kristin Waldenlind, PhD, of the Department of Medicine, Solna, Division of Clinical Epidemiology, Karolinska Institutet, Stockholm, Sweden, and colleagues. It was published online November 27 in the Journal of Internal Medicine.
LIMITATIONS:
The study lacked details on participants’ thyroid autoantibody and hormone levels.
The presence of autoimmune thyroid disease was determined based on prescriptions for thyroxine, hence the authors cannot exclude the possibility of a lower threshold for thyroxine prescription among patients treated with DMARDs.
Information was not available on potential risk factors for RA and autoimmune thyroid disease that might have introduced confounding, such as smoking or obesity.
DISCLOSURES:
The study received funding from the Swedish Research Council, the Swedish Heart Lung Foundation, Vinnova, and Region Stockholm/Karolinska Institutet (ALF). The authors’ disclosures are detailed in the published study.
A version of this article appeared on Medscape.com.
TOPLINE:
Patients with rheumatoid arthritis (RA) in a large Swedish population cohort show a reduced incidence of autoimmune thyroid diseases, such as hypothyroidism or hyperthyroidism, after being diagnosed with RA, with the effect being more pronounced among those treated with disease-modifying anti-rheumatic drugs (DMARDs), particularly TNF-inhibitors.
Although DMARDs are commonly used in the treatment of RA, the drugs are rarely used to treat autoimmune thyroid diseases. The new results support theories raised in previous smaller studies that DMARDs could have a protective effect against thyroid disease.
METHODOLOGY:
- The study involved 13,731 patients with new-onset RA who were listed in the Swedish Rheumatology Quality Register between 2006 and 2018.
- The patients were matched for sex, age, and residential area with up to five reference individuals in the general population of 63,201 comparators.
- Overall, patients with RA were 64.7% female, with a mean age of 59. They were followed up with their matched comparators until the development of autoimmune thyroid disease, death, emigration, or the end of the study period, December 2019.
- The relative risks of autoimmune thyroid disease following a diagnosis of RA and with treatment with DMARDs were compared with those risks in the general population.
- Participants with a non-autoimmune cause for thyroxine prescription were excluded, as were those with an autoimmune thyroid disease at the time of RA diagnosis.
TAKEAWAY:
- Following their RA diagnosis, 321 (2.3%) of patients developed an autoimmune thyroid disease, compared with 1838 (2.9%) in the general population comparators, representing an incidence of 3.7 vs 4.6 per 1000 person-years (hazard ratio [HR], 0.81).
- The lower incidence of autoimmune thyroid disease was more pronounced with longer RA duration. For instance, at 10-14 years after an RA diagnosis, the incidence was 2.9 vs. 4.5 autoimmune thyroid disease events per 1000 person-years, respectively (HR, 0.64).
- The decreased risk of incident autoimmune thyroid disease among RA patients compared with the general population was strongest among patients treated with biologic DMARDs (bDMARD), with an HR of 0.54.
- The reduced incidence of autoimmune thyroid disease with bDMARD use was most pronounced among users of TNF-inhibitors (HR, 0.67).
- The lower incidence of autoimmune thyroid disease following a diagnosis of RA contrasts with previous studies showing an increased risk for thyroid disease associated with RA.
- However, the decreased risk of thyroid disease following bDMARD treatment supports the theory that immunomodulatory treatment could also have an effect of blunting the inflammatory processes that can lead to overt clinical autoimmune thyroid disease.
IN PRACTICE:
“To our knowledge, no previous study has investigated whether the risk of new-onset autoimmune thyroid disease is affected by RA treatment in early RA,” the authors report.
“Our results demonstrate that compared to the general population, patients with RA treated with bDMARDs, TNF-inhibitors in particular, are at decreased risk of developing autoimmune thyroid disease, a finding that calls for replication and may open for drug-repurposing studies,” they note.
SOURCE:
The study was conducted by first author Kristin Waldenlind, PhD, of the Department of Medicine, Solna, Division of Clinical Epidemiology, Karolinska Institutet, Stockholm, Sweden, and colleagues. It was published online November 27 in the Journal of Internal Medicine.
LIMITATIONS:
The study lacked details on participants’ thyroid autoantibody and hormone levels.
The presence of autoimmune thyroid disease was determined based on prescriptions for thyroxine, hence the authors cannot exclude the possibility of a lower threshold for thyroxine prescription among patients treated with DMARDs.
Information was not available on potential risk factors for RA and autoimmune thyroid disease that might have introduced confounding, such as smoking or obesity.
DISCLOSURES:
The study received funding from the Swedish Research Council, the Swedish Heart Lung Foundation, Vinnova, and Region Stockholm/Karolinska Institutet (ALF). The authors’ disclosures are detailed in the published study.
A version of this article appeared on Medscape.com.
Sotatercept Endorsed for PAH by ICER
In a new report, the Midwest Institute for Clinical and Economic Review’s (ICER) Comparative Effectiveness Public Advisory Council concluded that the Merck drug sotatercept, currently under review by the US Food and Drug Administration (FDA), has a high certainty of at least a small net health benefit to patients with pulmonary arterial hypertension (PAH) when added to background therapy. The limited availability of evidence means that the benefit could range from minimal to substantial, according to the authors.
Sotatercept, administered by injection every 3 weeks, is a first-in-class activin signaling inhibitor. It counters cell proliferation and decreases inflammation in vessel walls, which may lead to improved pulmonary blood flow. The US FDA is considering it for approval through a biologics license application, with a decision expected by March 26, 2024.
There remains a great deal of uncertainty surrounding the long-term benefits of sotatercept. It’s possible that the drug is disease-modifying, but there isn’t yet any proof, according to Greg Curfman, MD, who attended a virtual ICER public meeting on December 1 that summarized the report and accepted public comments. “I’m still wondering the extent to which disease-modifying issue here is more aspirational at this point than really documented,” said Dr. Curfman, who is an associated professor of medicine at Harvard Medical School and executive editor of the Journal of the American Medical Association.
Current PAH treatment consists of vasodilators, including phosphodiesterase-5 inhibitors (PDE5i), guanylate cyclase stimulators, endothelin receptor antagonists (ERA), prostacyclin analogues (prostanoids), and a prostacyclin receptor agonist. The 2022 European Society of Cardiology and the European Respiratory Society clinical practice guideline recommends that low- and intermediate-risk patients should be started on ERA/PDE5i combination therapy, while high-risk patients should also be given an intravenous or subcutaneous prostacyclin analogue, referred to as triple therapy.
Sotatercept’s regulatory approval hinges on the phase 3 STELLAR trial, which included 323 patients with World Health Organization functional class (WHO-FC) II and III PAH who were randomized to 0.75 mg/kg sotatercept in addition to background double or triple therapy, or background therapy alone. The mean age was 48 years, and the mean time since diagnosis was 8.8 years. About 40% received infused prostacyclin therapy at baseline. At 24 weeks, the median change in 6-min walking distance (6mWD) was 40.8 m longer in the sotatercept group. More patients in the sotatercept group experienced WHO-FC improvement (29.4% vs 13.8%). Those in the sotatercept group also experienced an 84% reduction in risk for clinical worsening or death. PAH-specific quality of life scales did not show a difference between the two groups. Open-label extension trials have shown that benefits are maintained for up to 2 years. Adverse events likely related to sotatercept included telangiectasias, increased hemoglobin levels, and bleeding events.
Along with its benefits, the report authors suggest that the subcutaneous delivery of sotatercept may be less burdensome to patients than some other PAH treatments, especially inhaled and intravenous prostanoids. “However, uncertainty remains about sotatercept’s efficacy in sicker populations and in those with connective tissue disease, and about the durability of effect,” the authors wrote.
A lack of long-term data leaves open the question of its effect on mortality and unknown adverse effects.
Using a de novo decision analytic model, the authors estimated that sotatercept treatment would lead to a longer time without symptoms at rest and more quality-adjusted life years, life years, and equal value life years. They determined the health benefit price benchmark for sotatercept to be between $18,700 and $36,200 per year. “The long-term conventional cost-effectiveness of sotatercept is largely dependent on the long-term effect of sotatercept on improving functional class and slowing the worsening in functional class; however, controlled trial evidence for sotatercept is limited to 24 weeks. Long-term data are necessary to reduce the uncertainty in sotatercept’s long-term effect on improving functional class and slowing the worsening in functional class,” the authors wrote.
During the online meeting, Dr. Curfman took note of the fact that the STELLAR trial reported a median value of increase in 6mWD, rather than a mean, and the 40-m improvement is close to the value accepted as clinically meaningful. “So that tells us that half the patients had less than a clinically important improvement in the six-minute walk distance. We should be putting that in perspective,” said Dr. Curfman.
Another attendee pointed out that the open-label PULSAR extension trial showed that the proportion of patients in the sotatercept arm who were functional class I rose from 7.5% at the end of the trial to 20.6% at the end of the open-label period and wondered if that could be a sign of disease-modifying activity. “I think that’s a remarkable piece of data. I don’t recall seeing that in any other open label [trial of a PAH therapy] — that much of an improvement in getting to our best functional status,” said Marc Simon, MD, professor of medicine and director of the Pulmonary Hypertension Center at the University of California, San Francisco, who was a coauthor of the report.
Dr. Curfman has no relevant financial disclosures. Dr. Simon has consulted for Merck.
A version of this article appeared on Medscape.com.
In a new report, the Midwest Institute for Clinical and Economic Review’s (ICER) Comparative Effectiveness Public Advisory Council concluded that the Merck drug sotatercept, currently under review by the US Food and Drug Administration (FDA), has a high certainty of at least a small net health benefit to patients with pulmonary arterial hypertension (PAH) when added to background therapy. The limited availability of evidence means that the benefit could range from minimal to substantial, according to the authors.
Sotatercept, administered by injection every 3 weeks, is a first-in-class activin signaling inhibitor. It counters cell proliferation and decreases inflammation in vessel walls, which may lead to improved pulmonary blood flow. The US FDA is considering it for approval through a biologics license application, with a decision expected by March 26, 2024.
There remains a great deal of uncertainty surrounding the long-term benefits of sotatercept. It’s possible that the drug is disease-modifying, but there isn’t yet any proof, according to Greg Curfman, MD, who attended a virtual ICER public meeting on December 1 that summarized the report and accepted public comments. “I’m still wondering the extent to which disease-modifying issue here is more aspirational at this point than really documented,” said Dr. Curfman, who is an associated professor of medicine at Harvard Medical School and executive editor of the Journal of the American Medical Association.
Current PAH treatment consists of vasodilators, including phosphodiesterase-5 inhibitors (PDE5i), guanylate cyclase stimulators, endothelin receptor antagonists (ERA), prostacyclin analogues (prostanoids), and a prostacyclin receptor agonist. The 2022 European Society of Cardiology and the European Respiratory Society clinical practice guideline recommends that low- and intermediate-risk patients should be started on ERA/PDE5i combination therapy, while high-risk patients should also be given an intravenous or subcutaneous prostacyclin analogue, referred to as triple therapy.
Sotatercept’s regulatory approval hinges on the phase 3 STELLAR trial, which included 323 patients with World Health Organization functional class (WHO-FC) II and III PAH who were randomized to 0.75 mg/kg sotatercept in addition to background double or triple therapy, or background therapy alone. The mean age was 48 years, and the mean time since diagnosis was 8.8 years. About 40% received infused prostacyclin therapy at baseline. At 24 weeks, the median change in 6-min walking distance (6mWD) was 40.8 m longer in the sotatercept group. More patients in the sotatercept group experienced WHO-FC improvement (29.4% vs 13.8%). Those in the sotatercept group also experienced an 84% reduction in risk for clinical worsening or death. PAH-specific quality of life scales did not show a difference between the two groups. Open-label extension trials have shown that benefits are maintained for up to 2 years. Adverse events likely related to sotatercept included telangiectasias, increased hemoglobin levels, and bleeding events.
Along with its benefits, the report authors suggest that the subcutaneous delivery of sotatercept may be less burdensome to patients than some other PAH treatments, especially inhaled and intravenous prostanoids. “However, uncertainty remains about sotatercept’s efficacy in sicker populations and in those with connective tissue disease, and about the durability of effect,” the authors wrote.
A lack of long-term data leaves open the question of its effect on mortality and unknown adverse effects.
Using a de novo decision analytic model, the authors estimated that sotatercept treatment would lead to a longer time without symptoms at rest and more quality-adjusted life years, life years, and equal value life years. They determined the health benefit price benchmark for sotatercept to be between $18,700 and $36,200 per year. “The long-term conventional cost-effectiveness of sotatercept is largely dependent on the long-term effect of sotatercept on improving functional class and slowing the worsening in functional class; however, controlled trial evidence for sotatercept is limited to 24 weeks. Long-term data are necessary to reduce the uncertainty in sotatercept’s long-term effect on improving functional class and slowing the worsening in functional class,” the authors wrote.
During the online meeting, Dr. Curfman took note of the fact that the STELLAR trial reported a median value of increase in 6mWD, rather than a mean, and the 40-m improvement is close to the value accepted as clinically meaningful. “So that tells us that half the patients had less than a clinically important improvement in the six-minute walk distance. We should be putting that in perspective,” said Dr. Curfman.
Another attendee pointed out that the open-label PULSAR extension trial showed that the proportion of patients in the sotatercept arm who were functional class I rose from 7.5% at the end of the trial to 20.6% at the end of the open-label period and wondered if that could be a sign of disease-modifying activity. “I think that’s a remarkable piece of data. I don’t recall seeing that in any other open label [trial of a PAH therapy] — that much of an improvement in getting to our best functional status,” said Marc Simon, MD, professor of medicine and director of the Pulmonary Hypertension Center at the University of California, San Francisco, who was a coauthor of the report.
Dr. Curfman has no relevant financial disclosures. Dr. Simon has consulted for Merck.
A version of this article appeared on Medscape.com.
In a new report, the Midwest Institute for Clinical and Economic Review’s (ICER) Comparative Effectiveness Public Advisory Council concluded that the Merck drug sotatercept, currently under review by the US Food and Drug Administration (FDA), has a high certainty of at least a small net health benefit to patients with pulmonary arterial hypertension (PAH) when added to background therapy. The limited availability of evidence means that the benefit could range from minimal to substantial, according to the authors.
Sotatercept, administered by injection every 3 weeks, is a first-in-class activin signaling inhibitor. It counters cell proliferation and decreases inflammation in vessel walls, which may lead to improved pulmonary blood flow. The US FDA is considering it for approval through a biologics license application, with a decision expected by March 26, 2024.
There remains a great deal of uncertainty surrounding the long-term benefits of sotatercept. It’s possible that the drug is disease-modifying, but there isn’t yet any proof, according to Greg Curfman, MD, who attended a virtual ICER public meeting on December 1 that summarized the report and accepted public comments. “I’m still wondering the extent to which disease-modifying issue here is more aspirational at this point than really documented,” said Dr. Curfman, who is an associated professor of medicine at Harvard Medical School and executive editor of the Journal of the American Medical Association.
Current PAH treatment consists of vasodilators, including phosphodiesterase-5 inhibitors (PDE5i), guanylate cyclase stimulators, endothelin receptor antagonists (ERA), prostacyclin analogues (prostanoids), and a prostacyclin receptor agonist. The 2022 European Society of Cardiology and the European Respiratory Society clinical practice guideline recommends that low- and intermediate-risk patients should be started on ERA/PDE5i combination therapy, while high-risk patients should also be given an intravenous or subcutaneous prostacyclin analogue, referred to as triple therapy.
Sotatercept’s regulatory approval hinges on the phase 3 STELLAR trial, which included 323 patients with World Health Organization functional class (WHO-FC) II and III PAH who were randomized to 0.75 mg/kg sotatercept in addition to background double or triple therapy, or background therapy alone. The mean age was 48 years, and the mean time since diagnosis was 8.8 years. About 40% received infused prostacyclin therapy at baseline. At 24 weeks, the median change in 6-min walking distance (6mWD) was 40.8 m longer in the sotatercept group. More patients in the sotatercept group experienced WHO-FC improvement (29.4% vs 13.8%). Those in the sotatercept group also experienced an 84% reduction in risk for clinical worsening or death. PAH-specific quality of life scales did not show a difference between the two groups. Open-label extension trials have shown that benefits are maintained for up to 2 years. Adverse events likely related to sotatercept included telangiectasias, increased hemoglobin levels, and bleeding events.
Along with its benefits, the report authors suggest that the subcutaneous delivery of sotatercept may be less burdensome to patients than some other PAH treatments, especially inhaled and intravenous prostanoids. “However, uncertainty remains about sotatercept’s efficacy in sicker populations and in those with connective tissue disease, and about the durability of effect,” the authors wrote.
A lack of long-term data leaves open the question of its effect on mortality and unknown adverse effects.
Using a de novo decision analytic model, the authors estimated that sotatercept treatment would lead to a longer time without symptoms at rest and more quality-adjusted life years, life years, and equal value life years. They determined the health benefit price benchmark for sotatercept to be between $18,700 and $36,200 per year. “The long-term conventional cost-effectiveness of sotatercept is largely dependent on the long-term effect of sotatercept on improving functional class and slowing the worsening in functional class; however, controlled trial evidence for sotatercept is limited to 24 weeks. Long-term data are necessary to reduce the uncertainty in sotatercept’s long-term effect on improving functional class and slowing the worsening in functional class,” the authors wrote.
During the online meeting, Dr. Curfman took note of the fact that the STELLAR trial reported a median value of increase in 6mWD, rather than a mean, and the 40-m improvement is close to the value accepted as clinically meaningful. “So that tells us that half the patients had less than a clinically important improvement in the six-minute walk distance. We should be putting that in perspective,” said Dr. Curfman.
Another attendee pointed out that the open-label PULSAR extension trial showed that the proportion of patients in the sotatercept arm who were functional class I rose from 7.5% at the end of the trial to 20.6% at the end of the open-label period and wondered if that could be a sign of disease-modifying activity. “I think that’s a remarkable piece of data. I don’t recall seeing that in any other open label [trial of a PAH therapy] — that much of an improvement in getting to our best functional status,” said Marc Simon, MD, professor of medicine and director of the Pulmonary Hypertension Center at the University of California, San Francisco, who was a coauthor of the report.
Dr. Curfman has no relevant financial disclosures. Dr. Simon has consulted for Merck.
A version of this article appeared on Medscape.com.
ADA issues new screening, obesity management recommendations
for 2024.
“The Standards of Care are essentially the global guidelines for the care of individuals with diabetes and those at risk,” ADA chief scientific and medical officer Robert Gabbay, MD, PhD, said during a briefing announcing the new Standards.
The document was developed via a scientific literature review by the ADA’s Professional Practice Committee. The panel comprises 21 professionals, including physicians from many specialties, nurse practitioners, certified diabetes care and education specialists, dietitians, and pharmacists. The chair is Nuha A. El Sayed, MD, ADA’s senior vice president of healthcare improvement.
Specific sections of the 2024 document have been endorsed by the American College of Cardiology, the American Society of Bone and Mineral Research, and the Obesity Society. It was published on December 11, 2023, as a supplement in Diabetes Care.
An introductory section summarizing the changes for 2024 spans six pages. Those addressed during the briefing included the following:
Heart Failure Screening: Two new recommendations have been added to include screening of adults with diabetes for asymptomatic heart failure by measuring natriuretic peptide levels to facilitate the prevention or progression to symptomatic stages of heart failure.
“This is a really important and exciting area. We know that people with type 2 diabetes in particular are at high risk for heart failure,” Dr. Gabbay said, adding that these recommendations “are to really more aggressively screen those at high risk for heart failure with a simple blood test and, based on those values, then be able to move on to further evaluation and echocardiography, for example. The recommendations are really to screen a broad number of individuals with type 2 diabetes because many are at risk, [particularly] those without symptoms.”
PAD Screening: A new strong recommendation is to screen for PAD with ankle-brachial index testing in asymptomatic people with diabetes who are aged ≥ 50 years and have microvascular disease in any location, foot complications, or any end-organ damage from diabetes. The document also advises consideration of PAD screening for all individuals who have had diabetes for ≥ 10 years.
Dr. Gabbay commented, “We know that amputation rates are rising, unlike many other complications. We know that there are incredible health disparities. Blacks are two to four times more likely than Whites to have an amputation.”
Dr. El Sayed added, “Many patients don’t show the common symptoms of peripheral arterial disease. Screening is the most important way to find out if they have it or not because it can be a very devastating disease.”
Type 1 Diabetes Screening: This involves several new recommendations, including a framework for investigating suspected type 1 diabetes in newly diagnosed adults using islet autoantibody tests and diagnostic criteria for preclinical stages based on the recent approval of teplizumab for delaying the onset of type 1 diabetes.
“Screening and capturing disease earlier so that we can intervene is really an important consideration here. That includes screening for type 1 diabetes and thinking about therapeutic options to delay the development of frank type 1 diabetes,” Dr. Gabbay said.
Screening first-degree relatives of people with type 1 diabetes is a high priority because they’re at an elevated risk, he added.
Obesity Management: New recommendations here include the use of anthropomorphic measurements beyond body mass index to include waist circumference and waist:hip ratio and individual assessment of body fat mass and distribution.
Individualization of obesity management including behavioral, pharmacologic, and surgical approaches is encouraged. The use of a glucagon-like peptide-1 (GLP-1) receptor agonist or a dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist with greater weight loss efficacy is preferred for obesity management in people with diabetes.
“Obesity management is one of the biggest changes over this last year,” Dr. Gabbay commented.
Other New Recommendations: Among the many other revisions in the 2024 document are new recommendations about regular evaluation and treatment for bone health, assessment of disability and guidance for referral, and alignment of guidance for liver disease screening and management with those of other professional societies. Regarding the last item, Dr. Gabbay noted, “I don’t think it’s gotten the attention it deserves. Diabetes and obesity are becoming the leading causes of liver disease.”
Clinicians can also download the Standards of Care app on their smartphones. “That can be really helpful when questions come up since you can’t remember everything in there. Here you can look it up in a matter of seconds,” Dr. Gabbay said.
Dr. El Sayed added that asking patients about their priorities is also important. “If they aren’t brought up during the visit, it’s unlikely to be as fruitful as it should be.”
Dr. El Sayed has no disclosures. Dr. Gabbay serves as a consultant and/or advisor for HealthReveal, Lark Technologies, Onduo, StartUp Health, Sweetech, and Vida Health.
A version of this article appeared on Medscape.com.
for 2024.
“The Standards of Care are essentially the global guidelines for the care of individuals with diabetes and those at risk,” ADA chief scientific and medical officer Robert Gabbay, MD, PhD, said during a briefing announcing the new Standards.
The document was developed via a scientific literature review by the ADA’s Professional Practice Committee. The panel comprises 21 professionals, including physicians from many specialties, nurse practitioners, certified diabetes care and education specialists, dietitians, and pharmacists. The chair is Nuha A. El Sayed, MD, ADA’s senior vice president of healthcare improvement.
Specific sections of the 2024 document have been endorsed by the American College of Cardiology, the American Society of Bone and Mineral Research, and the Obesity Society. It was published on December 11, 2023, as a supplement in Diabetes Care.
An introductory section summarizing the changes for 2024 spans six pages. Those addressed during the briefing included the following:
Heart Failure Screening: Two new recommendations have been added to include screening of adults with diabetes for asymptomatic heart failure by measuring natriuretic peptide levels to facilitate the prevention or progression to symptomatic stages of heart failure.
“This is a really important and exciting area. We know that people with type 2 diabetes in particular are at high risk for heart failure,” Dr. Gabbay said, adding that these recommendations “are to really more aggressively screen those at high risk for heart failure with a simple blood test and, based on those values, then be able to move on to further evaluation and echocardiography, for example. The recommendations are really to screen a broad number of individuals with type 2 diabetes because many are at risk, [particularly] those without symptoms.”
PAD Screening: A new strong recommendation is to screen for PAD with ankle-brachial index testing in asymptomatic people with diabetes who are aged ≥ 50 years and have microvascular disease in any location, foot complications, or any end-organ damage from diabetes. The document also advises consideration of PAD screening for all individuals who have had diabetes for ≥ 10 years.
Dr. Gabbay commented, “We know that amputation rates are rising, unlike many other complications. We know that there are incredible health disparities. Blacks are two to four times more likely than Whites to have an amputation.”
Dr. El Sayed added, “Many patients don’t show the common symptoms of peripheral arterial disease. Screening is the most important way to find out if they have it or not because it can be a very devastating disease.”
Type 1 Diabetes Screening: This involves several new recommendations, including a framework for investigating suspected type 1 diabetes in newly diagnosed adults using islet autoantibody tests and diagnostic criteria for preclinical stages based on the recent approval of teplizumab for delaying the onset of type 1 diabetes.
“Screening and capturing disease earlier so that we can intervene is really an important consideration here. That includes screening for type 1 diabetes and thinking about therapeutic options to delay the development of frank type 1 diabetes,” Dr. Gabbay said.
Screening first-degree relatives of people with type 1 diabetes is a high priority because they’re at an elevated risk, he added.
Obesity Management: New recommendations here include the use of anthropomorphic measurements beyond body mass index to include waist circumference and waist:hip ratio and individual assessment of body fat mass and distribution.
Individualization of obesity management including behavioral, pharmacologic, and surgical approaches is encouraged. The use of a glucagon-like peptide-1 (GLP-1) receptor agonist or a dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist with greater weight loss efficacy is preferred for obesity management in people with diabetes.
“Obesity management is one of the biggest changes over this last year,” Dr. Gabbay commented.
Other New Recommendations: Among the many other revisions in the 2024 document are new recommendations about regular evaluation and treatment for bone health, assessment of disability and guidance for referral, and alignment of guidance for liver disease screening and management with those of other professional societies. Regarding the last item, Dr. Gabbay noted, “I don’t think it’s gotten the attention it deserves. Diabetes and obesity are becoming the leading causes of liver disease.”
Clinicians can also download the Standards of Care app on their smartphones. “That can be really helpful when questions come up since you can’t remember everything in there. Here you can look it up in a matter of seconds,” Dr. Gabbay said.
Dr. El Sayed added that asking patients about their priorities is also important. “If they aren’t brought up during the visit, it’s unlikely to be as fruitful as it should be.”
Dr. El Sayed has no disclosures. Dr. Gabbay serves as a consultant and/or advisor for HealthReveal, Lark Technologies, Onduo, StartUp Health, Sweetech, and Vida Health.
A version of this article appeared on Medscape.com.
for 2024.
“The Standards of Care are essentially the global guidelines for the care of individuals with diabetes and those at risk,” ADA chief scientific and medical officer Robert Gabbay, MD, PhD, said during a briefing announcing the new Standards.
The document was developed via a scientific literature review by the ADA’s Professional Practice Committee. The panel comprises 21 professionals, including physicians from many specialties, nurse practitioners, certified diabetes care and education specialists, dietitians, and pharmacists. The chair is Nuha A. El Sayed, MD, ADA’s senior vice president of healthcare improvement.
Specific sections of the 2024 document have been endorsed by the American College of Cardiology, the American Society of Bone and Mineral Research, and the Obesity Society. It was published on December 11, 2023, as a supplement in Diabetes Care.
An introductory section summarizing the changes for 2024 spans six pages. Those addressed during the briefing included the following:
Heart Failure Screening: Two new recommendations have been added to include screening of adults with diabetes for asymptomatic heart failure by measuring natriuretic peptide levels to facilitate the prevention or progression to symptomatic stages of heart failure.
“This is a really important and exciting area. We know that people with type 2 diabetes in particular are at high risk for heart failure,” Dr. Gabbay said, adding that these recommendations “are to really more aggressively screen those at high risk for heart failure with a simple blood test and, based on those values, then be able to move on to further evaluation and echocardiography, for example. The recommendations are really to screen a broad number of individuals with type 2 diabetes because many are at risk, [particularly] those without symptoms.”
PAD Screening: A new strong recommendation is to screen for PAD with ankle-brachial index testing in asymptomatic people with diabetes who are aged ≥ 50 years and have microvascular disease in any location, foot complications, or any end-organ damage from diabetes. The document also advises consideration of PAD screening for all individuals who have had diabetes for ≥ 10 years.
Dr. Gabbay commented, “We know that amputation rates are rising, unlike many other complications. We know that there are incredible health disparities. Blacks are two to four times more likely than Whites to have an amputation.”
Dr. El Sayed added, “Many patients don’t show the common symptoms of peripheral arterial disease. Screening is the most important way to find out if they have it or not because it can be a very devastating disease.”
Type 1 Diabetes Screening: This involves several new recommendations, including a framework for investigating suspected type 1 diabetes in newly diagnosed adults using islet autoantibody tests and diagnostic criteria for preclinical stages based on the recent approval of teplizumab for delaying the onset of type 1 diabetes.
“Screening and capturing disease earlier so that we can intervene is really an important consideration here. That includes screening for type 1 diabetes and thinking about therapeutic options to delay the development of frank type 1 diabetes,” Dr. Gabbay said.
Screening first-degree relatives of people with type 1 diabetes is a high priority because they’re at an elevated risk, he added.
Obesity Management: New recommendations here include the use of anthropomorphic measurements beyond body mass index to include waist circumference and waist:hip ratio and individual assessment of body fat mass and distribution.
Individualization of obesity management including behavioral, pharmacologic, and surgical approaches is encouraged. The use of a glucagon-like peptide-1 (GLP-1) receptor agonist or a dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist with greater weight loss efficacy is preferred for obesity management in people with diabetes.
“Obesity management is one of the biggest changes over this last year,” Dr. Gabbay commented.
Other New Recommendations: Among the many other revisions in the 2024 document are new recommendations about regular evaluation and treatment for bone health, assessment of disability and guidance for referral, and alignment of guidance for liver disease screening and management with those of other professional societies. Regarding the last item, Dr. Gabbay noted, “I don’t think it’s gotten the attention it deserves. Diabetes and obesity are becoming the leading causes of liver disease.”
Clinicians can also download the Standards of Care app on their smartphones. “That can be really helpful when questions come up since you can’t remember everything in there. Here you can look it up in a matter of seconds,” Dr. Gabbay said.
Dr. El Sayed added that asking patients about their priorities is also important. “If they aren’t brought up during the visit, it’s unlikely to be as fruitful as it should be.”
Dr. El Sayed has no disclosures. Dr. Gabbay serves as a consultant and/or advisor for HealthReveal, Lark Technologies, Onduo, StartUp Health, Sweetech, and Vida Health.
A version of this article appeared on Medscape.com.
Commentary: RA and Cancer, and Real-World Medication Studies, December 2023
The association of rheumatoid arthritis (RA) with increased cancer risk compared with the general population has long been known, though the balance between risk related to RA disease activity compared with risk related to immunosuppressive medication has not been clear. This increased risk is seen primarily with lymphoma and lung cancer, and prior research has suggested a risk with biological disease-modifying antirheumatic drugs (bDMARD), such as anti–tumor necrosis factor (TNF) agents. Beydon and colleagues performed a cohort study using a French national claims database; they looked at patients seen for at least 1 year with treatment for RA and compared the incidence of cancer by type. In over 257,000 patients, nearly 24,000 cancer cases were found. The most common cancers were breast, colon, lung, and prostate. All-cancer risk was > 1.2 (standardized incidence ratio) compared with those without cancer, higher in men compared with women, and the risk was increased in patients who received conventional synthetic (cs) DMARD, TNF inhibitors (TNFi), abatacept, and rituximab, but not interleukin (IL)-6 inhibitors or Janus kinase inhibitors (JAKi). Given that the risk was most highly associated with exposure to rituximab, this may show a type of bias rendering the study difficult to interpret, as rituximab is considered "safe" in cancer, and treatments such as csDMARD may have been given because they were not contraindicated in patients with cancer. This renders the study’s other results, such as lower risk with JAKi or higher risk with abatacept, hard to interpret.
Hayashi and colleagues performed a "real-world" comparative study using data from the Japanese observational ANSWER registry database to compare effectiveness of different JAKi over 6 months, a question of high interest given the availability of several JAKi currently. Within the database of over 11,000 participants, only 622 patients were exposed to tofacitinib, baricitinib, peficitinib, or upadacitinib, with 361 included in the final analysis due to missing baseline data (later missing data were imputed). Treatment retention rates were similar among all four JAKi, and discontinuation rates due to adverse events and due to lack of efficacy were similar as well. There was no significant difference in Health Assessment Questionnaire (HAQ), Clinical Disease Activity Index (CDAI), or C-reactive protein after 6 months between the four JAKi. Baricitinib had higher rates of CDAI low disease activity and remission at 6 months when used as a first-line biologic/targeted synthetic (b/ts) DMARD. However, this and other specific findings related to individual JAKi may be affected by the relatively small number of patients included and exposed to each JAKi, and the relatively short duration of follow-up (in terms of drug discontinuation), thus countering the initial premise for the study.
Finally, another important real-world study, by Tageldin and colleagues, looked at tapering therapy in the Rheumatoid Arthritis Medication Tapering (RHEUMTAP) cohort of patients with RA in sustained disease remission or low disease activity for at least 6 months on stable medications (infused bDMARD excluded). This 2-year prospective cohort included reducing frequency, reducing dose, and stopping medication according to predefined regimens. Of 131 patients, 40% underwent tapering, with more flares in the taper group over > 400 days of follow-up; flare rates were much higher in those tapering b/tsDMARD compared with csDMARD. Though limited by small numbers in examining the three different tapering groups, this real-world study provides an important counterpoint to the notion that medication can be tapered easily in RA patients doing well. A more stringent definition or longer duration of disease remission may also affect this finding.
The association of rheumatoid arthritis (RA) with increased cancer risk compared with the general population has long been known, though the balance between risk related to RA disease activity compared with risk related to immunosuppressive medication has not been clear. This increased risk is seen primarily with lymphoma and lung cancer, and prior research has suggested a risk with biological disease-modifying antirheumatic drugs (bDMARD), such as anti–tumor necrosis factor (TNF) agents. Beydon and colleagues performed a cohort study using a French national claims database; they looked at patients seen for at least 1 year with treatment for RA and compared the incidence of cancer by type. In over 257,000 patients, nearly 24,000 cancer cases were found. The most common cancers were breast, colon, lung, and prostate. All-cancer risk was > 1.2 (standardized incidence ratio) compared with those without cancer, higher in men compared with women, and the risk was increased in patients who received conventional synthetic (cs) DMARD, TNF inhibitors (TNFi), abatacept, and rituximab, but not interleukin (IL)-6 inhibitors or Janus kinase inhibitors (JAKi). Given that the risk was most highly associated with exposure to rituximab, this may show a type of bias rendering the study difficult to interpret, as rituximab is considered "safe" in cancer, and treatments such as csDMARD may have been given because they were not contraindicated in patients with cancer. This renders the study’s other results, such as lower risk with JAKi or higher risk with abatacept, hard to interpret.
Hayashi and colleagues performed a "real-world" comparative study using data from the Japanese observational ANSWER registry database to compare effectiveness of different JAKi over 6 months, a question of high interest given the availability of several JAKi currently. Within the database of over 11,000 participants, only 622 patients were exposed to tofacitinib, baricitinib, peficitinib, or upadacitinib, with 361 included in the final analysis due to missing baseline data (later missing data were imputed). Treatment retention rates were similar among all four JAKi, and discontinuation rates due to adverse events and due to lack of efficacy were similar as well. There was no significant difference in Health Assessment Questionnaire (HAQ), Clinical Disease Activity Index (CDAI), or C-reactive protein after 6 months between the four JAKi. Baricitinib had higher rates of CDAI low disease activity and remission at 6 months when used as a first-line biologic/targeted synthetic (b/ts) DMARD. However, this and other specific findings related to individual JAKi may be affected by the relatively small number of patients included and exposed to each JAKi, and the relatively short duration of follow-up (in terms of drug discontinuation), thus countering the initial premise for the study.
Finally, another important real-world study, by Tageldin and colleagues, looked at tapering therapy in the Rheumatoid Arthritis Medication Tapering (RHEUMTAP) cohort of patients with RA in sustained disease remission or low disease activity for at least 6 months on stable medications (infused bDMARD excluded). This 2-year prospective cohort included reducing frequency, reducing dose, and stopping medication according to predefined regimens. Of 131 patients, 40% underwent tapering, with more flares in the taper group over > 400 days of follow-up; flare rates were much higher in those tapering b/tsDMARD compared with csDMARD. Though limited by small numbers in examining the three different tapering groups, this real-world study provides an important counterpoint to the notion that medication can be tapered easily in RA patients doing well. A more stringent definition or longer duration of disease remission may also affect this finding.
The association of rheumatoid arthritis (RA) with increased cancer risk compared with the general population has long been known, though the balance between risk related to RA disease activity compared with risk related to immunosuppressive medication has not been clear. This increased risk is seen primarily with lymphoma and lung cancer, and prior research has suggested a risk with biological disease-modifying antirheumatic drugs (bDMARD), such as anti–tumor necrosis factor (TNF) agents. Beydon and colleagues performed a cohort study using a French national claims database; they looked at patients seen for at least 1 year with treatment for RA and compared the incidence of cancer by type. In over 257,000 patients, nearly 24,000 cancer cases were found. The most common cancers were breast, colon, lung, and prostate. All-cancer risk was > 1.2 (standardized incidence ratio) compared with those without cancer, higher in men compared with women, and the risk was increased in patients who received conventional synthetic (cs) DMARD, TNF inhibitors (TNFi), abatacept, and rituximab, but not interleukin (IL)-6 inhibitors or Janus kinase inhibitors (JAKi). Given that the risk was most highly associated with exposure to rituximab, this may show a type of bias rendering the study difficult to interpret, as rituximab is considered "safe" in cancer, and treatments such as csDMARD may have been given because they were not contraindicated in patients with cancer. This renders the study’s other results, such as lower risk with JAKi or higher risk with abatacept, hard to interpret.
Hayashi and colleagues performed a "real-world" comparative study using data from the Japanese observational ANSWER registry database to compare effectiveness of different JAKi over 6 months, a question of high interest given the availability of several JAKi currently. Within the database of over 11,000 participants, only 622 patients were exposed to tofacitinib, baricitinib, peficitinib, or upadacitinib, with 361 included in the final analysis due to missing baseline data (later missing data were imputed). Treatment retention rates were similar among all four JAKi, and discontinuation rates due to adverse events and due to lack of efficacy were similar as well. There was no significant difference in Health Assessment Questionnaire (HAQ), Clinical Disease Activity Index (CDAI), or C-reactive protein after 6 months between the four JAKi. Baricitinib had higher rates of CDAI low disease activity and remission at 6 months when used as a first-line biologic/targeted synthetic (b/ts) DMARD. However, this and other specific findings related to individual JAKi may be affected by the relatively small number of patients included and exposed to each JAKi, and the relatively short duration of follow-up (in terms of drug discontinuation), thus countering the initial premise for the study.
Finally, another important real-world study, by Tageldin and colleagues, looked at tapering therapy in the Rheumatoid Arthritis Medication Tapering (RHEUMTAP) cohort of patients with RA in sustained disease remission or low disease activity for at least 6 months on stable medications (infused bDMARD excluded). This 2-year prospective cohort included reducing frequency, reducing dose, and stopping medication according to predefined regimens. Of 131 patients, 40% underwent tapering, with more flares in the taper group over > 400 days of follow-up; flare rates were much higher in those tapering b/tsDMARD compared with csDMARD. Though limited by small numbers in examining the three different tapering groups, this real-world study provides an important counterpoint to the notion that medication can be tapered easily in RA patients doing well. A more stringent definition or longer duration of disease remission may also affect this finding.