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Is there a doctor on the plane? Tips for providing in-flight assistance
In most cases, passengers on an airline flight are representative of the general population, which means that anyone could have an emergency at any time.
as determined on the basis of in-flight medical emergencies that resulted in calls to a physician-directed medical communications center, said Amy Faith Ho, MD, MPH of Integrative Emergency Services, Dallas–Fort Worth, in a presentation at the annual meeting of the American College of Emergency Physicians.
The study authors reviewed records of 11,920 in-flight medical emergencies between Jan. 1, 2008, and Oct. 31, 2010. The data showed that physician passengers provided medical assistance in nearly half of in-flight emergencies (48.1%) and that flights were diverted because of the emergency in 7.3% of cases.
The majority of the in-flight emergencies involved syncope or presyncope (37.4% of cases), followed by respiratory symptoms (12.1%) and nausea or vomiting (9.5%), according to the study.
When a physician is faced with an in-flight emergency, the medical team includes the physician himself, medical ground control, and the flight attendants, said Dr. Ho. Requirements may vary among airlines, but all flight attendants will be trained in cardiopulmonary resuscitation (CPR) or basic life support, as well as use of automated external defibrillators (AEDs).
Physician call centers (medical ground control) can provide additional assistance remotely, she said.
The in-flight medical bag
Tools in a physician’s in-flight toolbox start with the first-aid kit. Airplanes also have an emergency medical kit (EMK), an oxygen tank, and an AED.
The minimum EMK contents are mandated by the Federal Aviation Administration, said Dr. Ho. The standard equipment includes a stethoscope, a sphygmomanometer, and three sizes of oropharyngeal airways. Other items include self-inflating manual resuscitation devices and CPR masks in thee sizes, alcohol sponges, gloves, adhesive tape, scissors, a tourniquet, as well as saline solution, needles, syringes, and an intravenous administration set consisting of tubing and two Y connectors.
An EMK also should contain the following medications: nonnarcotic analgesic tablets, antihistamine tablets, an injectable antihistamine, atropine, aspirin tablets, a bronchodilator, and epinephrine (both 1:1000; 1 injectable cc and 1:10,000; two injectable cc). Nitroglycerin tablets and 5 cc of 20 mg/mL injectable cardiac lidocaine are part of the mandated kit as well, according to Dr. Ho.
Some airlines carry additional supplies on all their flights, said Dr. Ho. Notably, American Airlines and British Airways carry EpiPens for adults and children, as well as opioid reversal medication (naloxone) and glucose for managing low blood sugar. American Airlines and Delta stock antiemetics, and Delta also carries naloxone. British Airways is unique in stocking additional cardiac medications, both oral and injectable.
How to handle an in-flight emergency
Physicians should always carry a copy of their medical license when traveling for documentation by the airline if they assist in a medical emergency during a flight, Dr. Ho emphasized. “Staff” personnel should be used. These include the flight attendants, medical ground control, and other passengers who might have useful skills, such as nursing, the ability to perform CPR, or therapy/counseling to calm a frightened patient. If needed, “crowdsource additional supplies from passengers,” such as a glucometer or pulse oximeter.
Legal lessons
Physicians are not obligated to assist during an in-flight medical emergency, said Dr. Ho. Legal jurisdiction can vary. In the United States, a bystander who assists in an emergency is generally protected by Good Samaritan laws; for international airlines, the laws may vary; those where the airline is based usually apply.
The Aviation Medical Assistance Act, passed in 1998, protects individuals from being sued for negligence while providing medical assistance, “unless the individual, while rendering such assistance, is guilty of gross negligence of willful misconduct,” Dr. Ho noted. The Aviation Medical Assistance Act also protects the airline itself “if the carrier in good faith believes that the passenger is a medically qualified individual.”
Dr. Ho disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In most cases, passengers on an airline flight are representative of the general population, which means that anyone could have an emergency at any time.
as determined on the basis of in-flight medical emergencies that resulted in calls to a physician-directed medical communications center, said Amy Faith Ho, MD, MPH of Integrative Emergency Services, Dallas–Fort Worth, in a presentation at the annual meeting of the American College of Emergency Physicians.
The study authors reviewed records of 11,920 in-flight medical emergencies between Jan. 1, 2008, and Oct. 31, 2010. The data showed that physician passengers provided medical assistance in nearly half of in-flight emergencies (48.1%) and that flights were diverted because of the emergency in 7.3% of cases.
The majority of the in-flight emergencies involved syncope or presyncope (37.4% of cases), followed by respiratory symptoms (12.1%) and nausea or vomiting (9.5%), according to the study.
When a physician is faced with an in-flight emergency, the medical team includes the physician himself, medical ground control, and the flight attendants, said Dr. Ho. Requirements may vary among airlines, but all flight attendants will be trained in cardiopulmonary resuscitation (CPR) or basic life support, as well as use of automated external defibrillators (AEDs).
Physician call centers (medical ground control) can provide additional assistance remotely, she said.
The in-flight medical bag
Tools in a physician’s in-flight toolbox start with the first-aid kit. Airplanes also have an emergency medical kit (EMK), an oxygen tank, and an AED.
The minimum EMK contents are mandated by the Federal Aviation Administration, said Dr. Ho. The standard equipment includes a stethoscope, a sphygmomanometer, and three sizes of oropharyngeal airways. Other items include self-inflating manual resuscitation devices and CPR masks in thee sizes, alcohol sponges, gloves, adhesive tape, scissors, a tourniquet, as well as saline solution, needles, syringes, and an intravenous administration set consisting of tubing and two Y connectors.
An EMK also should contain the following medications: nonnarcotic analgesic tablets, antihistamine tablets, an injectable antihistamine, atropine, aspirin tablets, a bronchodilator, and epinephrine (both 1:1000; 1 injectable cc and 1:10,000; two injectable cc). Nitroglycerin tablets and 5 cc of 20 mg/mL injectable cardiac lidocaine are part of the mandated kit as well, according to Dr. Ho.
Some airlines carry additional supplies on all their flights, said Dr. Ho. Notably, American Airlines and British Airways carry EpiPens for adults and children, as well as opioid reversal medication (naloxone) and glucose for managing low blood sugar. American Airlines and Delta stock antiemetics, and Delta also carries naloxone. British Airways is unique in stocking additional cardiac medications, both oral and injectable.
How to handle an in-flight emergency
Physicians should always carry a copy of their medical license when traveling for documentation by the airline if they assist in a medical emergency during a flight, Dr. Ho emphasized. “Staff” personnel should be used. These include the flight attendants, medical ground control, and other passengers who might have useful skills, such as nursing, the ability to perform CPR, or therapy/counseling to calm a frightened patient. If needed, “crowdsource additional supplies from passengers,” such as a glucometer or pulse oximeter.
Legal lessons
Physicians are not obligated to assist during an in-flight medical emergency, said Dr. Ho. Legal jurisdiction can vary. In the United States, a bystander who assists in an emergency is generally protected by Good Samaritan laws; for international airlines, the laws may vary; those where the airline is based usually apply.
The Aviation Medical Assistance Act, passed in 1998, protects individuals from being sued for negligence while providing medical assistance, “unless the individual, while rendering such assistance, is guilty of gross negligence of willful misconduct,” Dr. Ho noted. The Aviation Medical Assistance Act also protects the airline itself “if the carrier in good faith believes that the passenger is a medically qualified individual.”
Dr. Ho disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In most cases, passengers on an airline flight are representative of the general population, which means that anyone could have an emergency at any time.
as determined on the basis of in-flight medical emergencies that resulted in calls to a physician-directed medical communications center, said Amy Faith Ho, MD, MPH of Integrative Emergency Services, Dallas–Fort Worth, in a presentation at the annual meeting of the American College of Emergency Physicians.
The study authors reviewed records of 11,920 in-flight medical emergencies between Jan. 1, 2008, and Oct. 31, 2010. The data showed that physician passengers provided medical assistance in nearly half of in-flight emergencies (48.1%) and that flights were diverted because of the emergency in 7.3% of cases.
The majority of the in-flight emergencies involved syncope or presyncope (37.4% of cases), followed by respiratory symptoms (12.1%) and nausea or vomiting (9.5%), according to the study.
When a physician is faced with an in-flight emergency, the medical team includes the physician himself, medical ground control, and the flight attendants, said Dr. Ho. Requirements may vary among airlines, but all flight attendants will be trained in cardiopulmonary resuscitation (CPR) or basic life support, as well as use of automated external defibrillators (AEDs).
Physician call centers (medical ground control) can provide additional assistance remotely, she said.
The in-flight medical bag
Tools in a physician’s in-flight toolbox start with the first-aid kit. Airplanes also have an emergency medical kit (EMK), an oxygen tank, and an AED.
The minimum EMK contents are mandated by the Federal Aviation Administration, said Dr. Ho. The standard equipment includes a stethoscope, a sphygmomanometer, and three sizes of oropharyngeal airways. Other items include self-inflating manual resuscitation devices and CPR masks in thee sizes, alcohol sponges, gloves, adhesive tape, scissors, a tourniquet, as well as saline solution, needles, syringes, and an intravenous administration set consisting of tubing and two Y connectors.
An EMK also should contain the following medications: nonnarcotic analgesic tablets, antihistamine tablets, an injectable antihistamine, atropine, aspirin tablets, a bronchodilator, and epinephrine (both 1:1000; 1 injectable cc and 1:10,000; two injectable cc). Nitroglycerin tablets and 5 cc of 20 mg/mL injectable cardiac lidocaine are part of the mandated kit as well, according to Dr. Ho.
Some airlines carry additional supplies on all their flights, said Dr. Ho. Notably, American Airlines and British Airways carry EpiPens for adults and children, as well as opioid reversal medication (naloxone) and glucose for managing low blood sugar. American Airlines and Delta stock antiemetics, and Delta also carries naloxone. British Airways is unique in stocking additional cardiac medications, both oral and injectable.
How to handle an in-flight emergency
Physicians should always carry a copy of their medical license when traveling for documentation by the airline if they assist in a medical emergency during a flight, Dr. Ho emphasized. “Staff” personnel should be used. These include the flight attendants, medical ground control, and other passengers who might have useful skills, such as nursing, the ability to perform CPR, or therapy/counseling to calm a frightened patient. If needed, “crowdsource additional supplies from passengers,” such as a glucometer or pulse oximeter.
Legal lessons
Physicians are not obligated to assist during an in-flight medical emergency, said Dr. Ho. Legal jurisdiction can vary. In the United States, a bystander who assists in an emergency is generally protected by Good Samaritan laws; for international airlines, the laws may vary; those where the airline is based usually apply.
The Aviation Medical Assistance Act, passed in 1998, protects individuals from being sued for negligence while providing medical assistance, “unless the individual, while rendering such assistance, is guilty of gross negligence of willful misconduct,” Dr. Ho noted. The Aviation Medical Assistance Act also protects the airline itself “if the carrier in good faith believes that the passenger is a medically qualified individual.”
Dr. Ho disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ACEP 2022
OSA raises risk of atrial fibrillation and stroke
compared with controls, based on data from 303 individuals.
OSA has become a common chronic disease, and cardiovascular diseases including AFib also are known independent risk factors associated with OSA, Anna Hojager, MD, of Zealand University Hospital, Roskilde, Denmark, and colleagues wrote. Previous studies have shown a significant increase in AFib risk in OSA patients with severe disease, but the prevalence of undiagnosed AFib in OSA patients has not been explored.
In a study published in Sleep Medicine, the researchers enrolled 238 adults with severe OSA (based on apnea-hypopnea index of 15 or higher) and 65 with mild or no OSA (based on an AHI of less than 15). The mean AHI across all participants was 34.2, and ranged from 0.2 to 115.8.
Participants underwent heart rhythm monitoring using a home system or standard ECG for 7 days; they were instructed to carry the device at all times except when showering or sweating heavily. The primary outcome was the detection of AFib, defined as at least one period of 30 seconds or longer with an irregular heart rhythm but without detectable evidence of another diagnosis. Sleep was assessed for one night using a portable sleep monitoring device. All participants were examined at baseline and measured for blood pressure, body mass index, waist-to-hip ratio, and ECG.
Overall, AFib occurred in 21 patients with moderate to severe OSA and 1 patient with mild/no OSA (8.8% vs. 1.5%, P = .045). The majority of patients across both groups had hypertension (66%) and dyslipidemia (77.6%), but the severe OSA group was more likely to be dysregulated and to have unknown prediabetes. Participants who were deemed candidates for anticoagulation therapy were referred for additional treatment. None of the 22 total patients with AFib had heart failure with reduced ejection fraction, and 68.2% had normal ejection fraction and ventricle function.
The researchers noted that no guidelines currently exist for systematic opportunistic screening for comorbidities in OSA patients, although the American Academy of Sleep Medicine recommends patient education as part of a multidisciplinary chronic disease management strategy. The high prevalence of AFib in OSA patients, as seen in the current study, “might warrant a recommendation of screening for paroxysmal [AFib] and could be valuable in the management of modifiable cardiovascular risk factors in patients with OSA,” they wrote.
The study findings were limited by several factors including the observational design and absence of polysomnography to assess OSA, the researchers noted. However, the study has the highest known prevalence of silent AFib in patients with moderate to severe OSA, and supports the value of screening and management for known comorbidities of OSA.
The study received no outside funding. The researchers had no financial conflicts to disclose.
compared with controls, based on data from 303 individuals.
OSA has become a common chronic disease, and cardiovascular diseases including AFib also are known independent risk factors associated with OSA, Anna Hojager, MD, of Zealand University Hospital, Roskilde, Denmark, and colleagues wrote. Previous studies have shown a significant increase in AFib risk in OSA patients with severe disease, but the prevalence of undiagnosed AFib in OSA patients has not been explored.
In a study published in Sleep Medicine, the researchers enrolled 238 adults with severe OSA (based on apnea-hypopnea index of 15 or higher) and 65 with mild or no OSA (based on an AHI of less than 15). The mean AHI across all participants was 34.2, and ranged from 0.2 to 115.8.
Participants underwent heart rhythm monitoring using a home system or standard ECG for 7 days; they were instructed to carry the device at all times except when showering or sweating heavily. The primary outcome was the detection of AFib, defined as at least one period of 30 seconds or longer with an irregular heart rhythm but without detectable evidence of another diagnosis. Sleep was assessed for one night using a portable sleep monitoring device. All participants were examined at baseline and measured for blood pressure, body mass index, waist-to-hip ratio, and ECG.
Overall, AFib occurred in 21 patients with moderate to severe OSA and 1 patient with mild/no OSA (8.8% vs. 1.5%, P = .045). The majority of patients across both groups had hypertension (66%) and dyslipidemia (77.6%), but the severe OSA group was more likely to be dysregulated and to have unknown prediabetes. Participants who were deemed candidates for anticoagulation therapy were referred for additional treatment. None of the 22 total patients with AFib had heart failure with reduced ejection fraction, and 68.2% had normal ejection fraction and ventricle function.
The researchers noted that no guidelines currently exist for systematic opportunistic screening for comorbidities in OSA patients, although the American Academy of Sleep Medicine recommends patient education as part of a multidisciplinary chronic disease management strategy. The high prevalence of AFib in OSA patients, as seen in the current study, “might warrant a recommendation of screening for paroxysmal [AFib] and could be valuable in the management of modifiable cardiovascular risk factors in patients with OSA,” they wrote.
The study findings were limited by several factors including the observational design and absence of polysomnography to assess OSA, the researchers noted. However, the study has the highest known prevalence of silent AFib in patients with moderate to severe OSA, and supports the value of screening and management for known comorbidities of OSA.
The study received no outside funding. The researchers had no financial conflicts to disclose.
compared with controls, based on data from 303 individuals.
OSA has become a common chronic disease, and cardiovascular diseases including AFib also are known independent risk factors associated with OSA, Anna Hojager, MD, of Zealand University Hospital, Roskilde, Denmark, and colleagues wrote. Previous studies have shown a significant increase in AFib risk in OSA patients with severe disease, but the prevalence of undiagnosed AFib in OSA patients has not been explored.
In a study published in Sleep Medicine, the researchers enrolled 238 adults with severe OSA (based on apnea-hypopnea index of 15 or higher) and 65 with mild or no OSA (based on an AHI of less than 15). The mean AHI across all participants was 34.2, and ranged from 0.2 to 115.8.
Participants underwent heart rhythm monitoring using a home system or standard ECG for 7 days; they were instructed to carry the device at all times except when showering or sweating heavily. The primary outcome was the detection of AFib, defined as at least one period of 30 seconds or longer with an irregular heart rhythm but without detectable evidence of another diagnosis. Sleep was assessed for one night using a portable sleep monitoring device. All participants were examined at baseline and measured for blood pressure, body mass index, waist-to-hip ratio, and ECG.
Overall, AFib occurred in 21 patients with moderate to severe OSA and 1 patient with mild/no OSA (8.8% vs. 1.5%, P = .045). The majority of patients across both groups had hypertension (66%) and dyslipidemia (77.6%), but the severe OSA group was more likely to be dysregulated and to have unknown prediabetes. Participants who were deemed candidates for anticoagulation therapy were referred for additional treatment. None of the 22 total patients with AFib had heart failure with reduced ejection fraction, and 68.2% had normal ejection fraction and ventricle function.
The researchers noted that no guidelines currently exist for systematic opportunistic screening for comorbidities in OSA patients, although the American Academy of Sleep Medicine recommends patient education as part of a multidisciplinary chronic disease management strategy. The high prevalence of AFib in OSA patients, as seen in the current study, “might warrant a recommendation of screening for paroxysmal [AFib] and could be valuable in the management of modifiable cardiovascular risk factors in patients with OSA,” they wrote.
The study findings were limited by several factors including the observational design and absence of polysomnography to assess OSA, the researchers noted. However, the study has the highest known prevalence of silent AFib in patients with moderate to severe OSA, and supports the value of screening and management for known comorbidities of OSA.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM SLEEP MEDICINE
Total replacement and fusion yield similar outcomes for ankle osteoarthritis
Ankle osteoarthritis remains a cause of severe pain and disability. Patients are treated nonoperatively if possible, but surgery is often needed for individuals with end-stage disease, wrote Andrew Goldberg, MBBS, of University College London and colleagues in the Annals of Internal Medicine.
“Most patients with ankle arthritis respond to nonoperative treatments, such as weight loss, activity modification, support braces, and analgesia, [but] once the disease has progressed to end-stage osteoarthritis, the main surgical treatments are total ankle re-placement or ankle arthrodesis,” Dr. Goldberg said, in an interview.
In the new study, patients were randomized to receive either a total ankle replacement (TAR) or ankle fusion (AF).
“We showed that, in both treatment groups the clinical scores improved hugely, by more than three times the minimal clinically important difference,” Dr. Goldberg said in an interview.
“Although the ankle replacement arm improved, on average, by more than an extra 4 points over ankle fusion, this was not considered clinically or statistically significant,” he said.
The study is the first randomized trial to show high-quality and robust results, he noted, and findings support data from previous studies.
“Although both TAR and ankle fusion have been shown to be effective, they are very different treatments, with one fusing the bones so that there is no ankle joint movement, and the other replacing the joint with the aim of retaining ankle joint movement. It is difficult for a patient to know which treatment is more suitable for them, with most seeking guidance from their surgeon,” he said.
Generating high-quality evidence
The study, a randomized, multicenter, open-label trial known as TARVA (Total Ankle Replacement Versus Ankle Arthrodesis), aimed to compare the clinical effectiveness of the two existing publicly funded U.K. treatment options, the authors wrote.
Patients were recruited at 17 U.K. centers between March 6, 2015, and Jan. 10, 2019. The study enrolled 303 adults aged 50-85 years with end-stage ankle osteoarthritis. The mean age of the participants was 68 years; 71% were men. A total of 137 TAR patients and 144 ankle fusion patients completed their surgeries with clinical scores available for analysis. Baseline characteristics were mainly similar between the groups.
Blinding was not possible because of the nature of the procedures, but the surgeons who screened the patients were not aware of the randomization allocations, the researchers noted. A total of 33 surgeons participated in the trial, with a median number of seven patients per surgeon during the study period.
For TAR, U.K. surgeons use both two-component, fixed-bearing and three-component, mobile-bearing implants, the authors write. Ankle fusion was done using the surgeon’s usual technique of either arthroscopic-assisted or open ankle fusion.
The primary outcome was the change in the Manchester–Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores from baseline to 52 weeks after surgery. The MOXFQ-W/S uses a scale of 0-100, with lower scores representing better outcomes. Secondary outcomes included change in the MOXFQ-W/S scores at 26 weeks after surgery, as well as measures of patient quality of life.
No statistically significant difference
Overall, the mean MOXFQ-W/S scores improved significantly from baseline to 52 weeks for both groups, with average improvements of 49.9 in the TAR group and 44.4 points in the AF group. The average scores at 52 weeks were 31.4 in the TAR group and 36.8 in the AF group.
The adjusted difference in score change from baseline was –5.56, showing a slightly greater degree of improvement with TAR, but this difference was not clinically or statistically significant, the researchers noted.
Adverse event numbers were similar for both procedures, with 54% of TAR patients and 53% of AF patients experiencing at least 1 adverse event during the study period. Of those, 18% of TAR patients and 24% of AF patients experienced at least 1 serious adverse event.
However, the TAR patients experienced a higher rate of wound healing complications and nerve injuries, while thromboembolism was higher in the AF patients, the researchers noted.
A prespecified subgroup analysis of patients with osteoarthritis in adjacent joints suggested a greater improvement in TAR, compared with AF, a difference that increased when fixed-bearing TAR was compared with AF, the authors wrote.
“This reinforces previous reports that suggest that the presence of adjacent joint arthritis may be an indication for ankle replacement over AF,” the authors wrote in their discussion.
“Many of these patients did not have any symptoms in the adjacent joints,” they noted.
“The presence of adjacent joint arthritis, meaning the wear and tear of the joints around the ankle joint, seemed to favor ankle replacement,” Dr. Goldberg said. Approximately 30 joints in the foot continue to move after the ankle is fused, and if these adjacent joints are not healthy before surgery [as was the case in 42% of the study patients], the results of fusion were less successful, he explained.
A post hoc analysis between TAR subtypes showed that patients who had fixed-bearing TAR had significantly greater improvements, compared with AF patients, but this difference was not observed in patients who had mobile-bearing TAR, the researchers noted.
Dr. Goldberg said it was surprising “that, in a separate analysis, we found that the fixed-bearing ankle replacement patients [who accounted for half of the implants used] improved by a much greater difference when compared to ankle fusion.”
The study findings were limited by several factors including the short follow-up and study design that allowed surgeons to choose any implant and technique, the researchers noted.
Other limitations include a lack of data on cost-effectiveness and the impact of comorbidities on outcomes, they wrote. However, the study is the first completed multicenter randomized controlled trial to compare TAR and AF procedures for end-stage ankle osteoarthritis and shows that both yield similar clinical improvements, they concluded.
Data can inform treatment discussion
The take-home messages for clinicians are that both ankle replacement and ankle fusion are effective treatments that improve patients’ quality of life, and it is important to establish the health of adjacent joints before making treatment recommendations, Dr. Goldberg said.
“Careful counseling on the relative risks of each procedure should be part of the informed consent process,” he added. Ideally, all patients seeking surgical care for ankle arthritis should have a choice between ankle replacement and ankle fusion, but sometimes there is inequity of provision of the two treatments, he noted.
“We now encourage all surgeons to work in ankle arthritis networks so that every patient, no matter where they live, can have choice about the best treatment for them,” he said.
Researchers met the challenge of surgical RCT
Randomized trials of surgical interventions are challenging to conduct, and therefore limited, wrote Bruce Sangeorzan, MD, of the University of Washington, Seattle, and colleagues in an accompanying editorial. However, the new study was strengthened by the inclusion of 17 centers for heterogeneity of implant type and surgeon experience level, the editorialists said in the Annals of Internal Medicine.
The study is especially important, because ankle arthritis treatment is very understudied, compared with hip and knee arthritis, but it has a similar impact on activity, editorial coauthor Dr. Sangeorzan said in an interview.
“Randomized controlled trials are the gold standard for comparing medical therapies,” he said, “but they are very difficult to do in surgical treatments, particularly when the two treatments can be differentiated, in this case by movement of the ankle.”
In addition, there is a strong placebo effect attached to interventions, Dr. Sangeorzan noted. “Determining best-case treatment relies on prospective research, preferably randomized. Since both ankle fusion and ankle replacement are effective therapies, a prospective randomized trial is the best way to help make treatment decisions,” he said.
The current study findings are not surprising, but they are preliminary, and 1 year of follow-up is not enough to determine effectiveness, Dr. Sangeorzan emphasized. However, “the authors have done the hard work of randomizing the patients and collecting the data, and the patients can now be followed for a longer time,” he said.
“In addition, the trial was designed with multiple secondary outcome measures, so the data can be matched up with larger trials that were not randomized to identify key elements of success for each procedure,” he noted.
The key message for clinicians is that ankle arthritis has a significant impact on patients’ lives, but there are two effective treatments that can reduce the impact of the disease, said Dr. Sangeorzan. “The data suggest that there are differences in implant design and differences in comorbidities that should influence decision-making,” he added.
Additional research is needed in the form of a longer study duration with larger cohorts, said Dr. Sangeorzan. In particular, researchers need to determine what comorbidities might drive patients to one type of care vs. another, he said. “The suggestion that [patients receiving implants with two motion segments have better outcomes than those receiving implants with a one-motion segment] also deserves further study,” he added.
The research was supported by the UK National Institute for Health and Care Research Health Technology Assessment Programme. The trial was sponsored by University College London. Dr. Goldberg disclosed grant support from NIHR HTA, as well as financial relationships with companies including Stryker, Paragon 28, and stock options with Standing CT Company, Elstree Waterfront Outpatients, and X Bolt Orthopedics.
The editorialists had no financial conflicts to disclose.
Ankle osteoarthritis remains a cause of severe pain and disability. Patients are treated nonoperatively if possible, but surgery is often needed for individuals with end-stage disease, wrote Andrew Goldberg, MBBS, of University College London and colleagues in the Annals of Internal Medicine.
“Most patients with ankle arthritis respond to nonoperative treatments, such as weight loss, activity modification, support braces, and analgesia, [but] once the disease has progressed to end-stage osteoarthritis, the main surgical treatments are total ankle re-placement or ankle arthrodesis,” Dr. Goldberg said, in an interview.
In the new study, patients were randomized to receive either a total ankle replacement (TAR) or ankle fusion (AF).
“We showed that, in both treatment groups the clinical scores improved hugely, by more than three times the minimal clinically important difference,” Dr. Goldberg said in an interview.
“Although the ankle replacement arm improved, on average, by more than an extra 4 points over ankle fusion, this was not considered clinically or statistically significant,” he said.
The study is the first randomized trial to show high-quality and robust results, he noted, and findings support data from previous studies.
“Although both TAR and ankle fusion have been shown to be effective, they are very different treatments, with one fusing the bones so that there is no ankle joint movement, and the other replacing the joint with the aim of retaining ankle joint movement. It is difficult for a patient to know which treatment is more suitable for them, with most seeking guidance from their surgeon,” he said.
Generating high-quality evidence
The study, a randomized, multicenter, open-label trial known as TARVA (Total Ankle Replacement Versus Ankle Arthrodesis), aimed to compare the clinical effectiveness of the two existing publicly funded U.K. treatment options, the authors wrote.
Patients were recruited at 17 U.K. centers between March 6, 2015, and Jan. 10, 2019. The study enrolled 303 adults aged 50-85 years with end-stage ankle osteoarthritis. The mean age of the participants was 68 years; 71% were men. A total of 137 TAR patients and 144 ankle fusion patients completed their surgeries with clinical scores available for analysis. Baseline characteristics were mainly similar between the groups.
Blinding was not possible because of the nature of the procedures, but the surgeons who screened the patients were not aware of the randomization allocations, the researchers noted. A total of 33 surgeons participated in the trial, with a median number of seven patients per surgeon during the study period.
For TAR, U.K. surgeons use both two-component, fixed-bearing and three-component, mobile-bearing implants, the authors write. Ankle fusion was done using the surgeon’s usual technique of either arthroscopic-assisted or open ankle fusion.
The primary outcome was the change in the Manchester–Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores from baseline to 52 weeks after surgery. The MOXFQ-W/S uses a scale of 0-100, with lower scores representing better outcomes. Secondary outcomes included change in the MOXFQ-W/S scores at 26 weeks after surgery, as well as measures of patient quality of life.
No statistically significant difference
Overall, the mean MOXFQ-W/S scores improved significantly from baseline to 52 weeks for both groups, with average improvements of 49.9 in the TAR group and 44.4 points in the AF group. The average scores at 52 weeks were 31.4 in the TAR group and 36.8 in the AF group.
The adjusted difference in score change from baseline was –5.56, showing a slightly greater degree of improvement with TAR, but this difference was not clinically or statistically significant, the researchers noted.
Adverse event numbers were similar for both procedures, with 54% of TAR patients and 53% of AF patients experiencing at least 1 adverse event during the study period. Of those, 18% of TAR patients and 24% of AF patients experienced at least 1 serious adverse event.
However, the TAR patients experienced a higher rate of wound healing complications and nerve injuries, while thromboembolism was higher in the AF patients, the researchers noted.
A prespecified subgroup analysis of patients with osteoarthritis in adjacent joints suggested a greater improvement in TAR, compared with AF, a difference that increased when fixed-bearing TAR was compared with AF, the authors wrote.
“This reinforces previous reports that suggest that the presence of adjacent joint arthritis may be an indication for ankle replacement over AF,” the authors wrote in their discussion.
“Many of these patients did not have any symptoms in the adjacent joints,” they noted.
“The presence of adjacent joint arthritis, meaning the wear and tear of the joints around the ankle joint, seemed to favor ankle replacement,” Dr. Goldberg said. Approximately 30 joints in the foot continue to move after the ankle is fused, and if these adjacent joints are not healthy before surgery [as was the case in 42% of the study patients], the results of fusion were less successful, he explained.
A post hoc analysis between TAR subtypes showed that patients who had fixed-bearing TAR had significantly greater improvements, compared with AF patients, but this difference was not observed in patients who had mobile-bearing TAR, the researchers noted.
Dr. Goldberg said it was surprising “that, in a separate analysis, we found that the fixed-bearing ankle replacement patients [who accounted for half of the implants used] improved by a much greater difference when compared to ankle fusion.”
The study findings were limited by several factors including the short follow-up and study design that allowed surgeons to choose any implant and technique, the researchers noted.
Other limitations include a lack of data on cost-effectiveness and the impact of comorbidities on outcomes, they wrote. However, the study is the first completed multicenter randomized controlled trial to compare TAR and AF procedures for end-stage ankle osteoarthritis and shows that both yield similar clinical improvements, they concluded.
Data can inform treatment discussion
The take-home messages for clinicians are that both ankle replacement and ankle fusion are effective treatments that improve patients’ quality of life, and it is important to establish the health of adjacent joints before making treatment recommendations, Dr. Goldberg said.
“Careful counseling on the relative risks of each procedure should be part of the informed consent process,” he added. Ideally, all patients seeking surgical care for ankle arthritis should have a choice between ankle replacement and ankle fusion, but sometimes there is inequity of provision of the two treatments, he noted.
“We now encourage all surgeons to work in ankle arthritis networks so that every patient, no matter where they live, can have choice about the best treatment for them,” he said.
Researchers met the challenge of surgical RCT
Randomized trials of surgical interventions are challenging to conduct, and therefore limited, wrote Bruce Sangeorzan, MD, of the University of Washington, Seattle, and colleagues in an accompanying editorial. However, the new study was strengthened by the inclusion of 17 centers for heterogeneity of implant type and surgeon experience level, the editorialists said in the Annals of Internal Medicine.
The study is especially important, because ankle arthritis treatment is very understudied, compared with hip and knee arthritis, but it has a similar impact on activity, editorial coauthor Dr. Sangeorzan said in an interview.
“Randomized controlled trials are the gold standard for comparing medical therapies,” he said, “but they are very difficult to do in surgical treatments, particularly when the two treatments can be differentiated, in this case by movement of the ankle.”
In addition, there is a strong placebo effect attached to interventions, Dr. Sangeorzan noted. “Determining best-case treatment relies on prospective research, preferably randomized. Since both ankle fusion and ankle replacement are effective therapies, a prospective randomized trial is the best way to help make treatment decisions,” he said.
The current study findings are not surprising, but they are preliminary, and 1 year of follow-up is not enough to determine effectiveness, Dr. Sangeorzan emphasized. However, “the authors have done the hard work of randomizing the patients and collecting the data, and the patients can now be followed for a longer time,” he said.
“In addition, the trial was designed with multiple secondary outcome measures, so the data can be matched up with larger trials that were not randomized to identify key elements of success for each procedure,” he noted.
The key message for clinicians is that ankle arthritis has a significant impact on patients’ lives, but there are two effective treatments that can reduce the impact of the disease, said Dr. Sangeorzan. “The data suggest that there are differences in implant design and differences in comorbidities that should influence decision-making,” he added.
Additional research is needed in the form of a longer study duration with larger cohorts, said Dr. Sangeorzan. In particular, researchers need to determine what comorbidities might drive patients to one type of care vs. another, he said. “The suggestion that [patients receiving implants with two motion segments have better outcomes than those receiving implants with a one-motion segment] also deserves further study,” he added.
The research was supported by the UK National Institute for Health and Care Research Health Technology Assessment Programme. The trial was sponsored by University College London. Dr. Goldberg disclosed grant support from NIHR HTA, as well as financial relationships with companies including Stryker, Paragon 28, and stock options with Standing CT Company, Elstree Waterfront Outpatients, and X Bolt Orthopedics.
The editorialists had no financial conflicts to disclose.
Ankle osteoarthritis remains a cause of severe pain and disability. Patients are treated nonoperatively if possible, but surgery is often needed for individuals with end-stage disease, wrote Andrew Goldberg, MBBS, of University College London and colleagues in the Annals of Internal Medicine.
“Most patients with ankle arthritis respond to nonoperative treatments, such as weight loss, activity modification, support braces, and analgesia, [but] once the disease has progressed to end-stage osteoarthritis, the main surgical treatments are total ankle re-placement or ankle arthrodesis,” Dr. Goldberg said, in an interview.
In the new study, patients were randomized to receive either a total ankle replacement (TAR) or ankle fusion (AF).
“We showed that, in both treatment groups the clinical scores improved hugely, by more than three times the minimal clinically important difference,” Dr. Goldberg said in an interview.
“Although the ankle replacement arm improved, on average, by more than an extra 4 points over ankle fusion, this was not considered clinically or statistically significant,” he said.
The study is the first randomized trial to show high-quality and robust results, he noted, and findings support data from previous studies.
“Although both TAR and ankle fusion have been shown to be effective, they are very different treatments, with one fusing the bones so that there is no ankle joint movement, and the other replacing the joint with the aim of retaining ankle joint movement. It is difficult for a patient to know which treatment is more suitable for them, with most seeking guidance from their surgeon,” he said.
Generating high-quality evidence
The study, a randomized, multicenter, open-label trial known as TARVA (Total Ankle Replacement Versus Ankle Arthrodesis), aimed to compare the clinical effectiveness of the two existing publicly funded U.K. treatment options, the authors wrote.
Patients were recruited at 17 U.K. centers between March 6, 2015, and Jan. 10, 2019. The study enrolled 303 adults aged 50-85 years with end-stage ankle osteoarthritis. The mean age of the participants was 68 years; 71% were men. A total of 137 TAR patients and 144 ankle fusion patients completed their surgeries with clinical scores available for analysis. Baseline characteristics were mainly similar between the groups.
Blinding was not possible because of the nature of the procedures, but the surgeons who screened the patients were not aware of the randomization allocations, the researchers noted. A total of 33 surgeons participated in the trial, with a median number of seven patients per surgeon during the study period.
For TAR, U.K. surgeons use both two-component, fixed-bearing and three-component, mobile-bearing implants, the authors write. Ankle fusion was done using the surgeon’s usual technique of either arthroscopic-assisted or open ankle fusion.
The primary outcome was the change in the Manchester–Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores from baseline to 52 weeks after surgery. The MOXFQ-W/S uses a scale of 0-100, with lower scores representing better outcomes. Secondary outcomes included change in the MOXFQ-W/S scores at 26 weeks after surgery, as well as measures of patient quality of life.
No statistically significant difference
Overall, the mean MOXFQ-W/S scores improved significantly from baseline to 52 weeks for both groups, with average improvements of 49.9 in the TAR group and 44.4 points in the AF group. The average scores at 52 weeks were 31.4 in the TAR group and 36.8 in the AF group.
The adjusted difference in score change from baseline was –5.56, showing a slightly greater degree of improvement with TAR, but this difference was not clinically or statistically significant, the researchers noted.
Adverse event numbers were similar for both procedures, with 54% of TAR patients and 53% of AF patients experiencing at least 1 adverse event during the study period. Of those, 18% of TAR patients and 24% of AF patients experienced at least 1 serious adverse event.
However, the TAR patients experienced a higher rate of wound healing complications and nerve injuries, while thromboembolism was higher in the AF patients, the researchers noted.
A prespecified subgroup analysis of patients with osteoarthritis in adjacent joints suggested a greater improvement in TAR, compared with AF, a difference that increased when fixed-bearing TAR was compared with AF, the authors wrote.
“This reinforces previous reports that suggest that the presence of adjacent joint arthritis may be an indication for ankle replacement over AF,” the authors wrote in their discussion.
“Many of these patients did not have any symptoms in the adjacent joints,” they noted.
“The presence of adjacent joint arthritis, meaning the wear and tear of the joints around the ankle joint, seemed to favor ankle replacement,” Dr. Goldberg said. Approximately 30 joints in the foot continue to move after the ankle is fused, and if these adjacent joints are not healthy before surgery [as was the case in 42% of the study patients], the results of fusion were less successful, he explained.
A post hoc analysis between TAR subtypes showed that patients who had fixed-bearing TAR had significantly greater improvements, compared with AF patients, but this difference was not observed in patients who had mobile-bearing TAR, the researchers noted.
Dr. Goldberg said it was surprising “that, in a separate analysis, we found that the fixed-bearing ankle replacement patients [who accounted for half of the implants used] improved by a much greater difference when compared to ankle fusion.”
The study findings were limited by several factors including the short follow-up and study design that allowed surgeons to choose any implant and technique, the researchers noted.
Other limitations include a lack of data on cost-effectiveness and the impact of comorbidities on outcomes, they wrote. However, the study is the first completed multicenter randomized controlled trial to compare TAR and AF procedures for end-stage ankle osteoarthritis and shows that both yield similar clinical improvements, they concluded.
Data can inform treatment discussion
The take-home messages for clinicians are that both ankle replacement and ankle fusion are effective treatments that improve patients’ quality of life, and it is important to establish the health of adjacent joints before making treatment recommendations, Dr. Goldberg said.
“Careful counseling on the relative risks of each procedure should be part of the informed consent process,” he added. Ideally, all patients seeking surgical care for ankle arthritis should have a choice between ankle replacement and ankle fusion, but sometimes there is inequity of provision of the two treatments, he noted.
“We now encourage all surgeons to work in ankle arthritis networks so that every patient, no matter where they live, can have choice about the best treatment for them,” he said.
Researchers met the challenge of surgical RCT
Randomized trials of surgical interventions are challenging to conduct, and therefore limited, wrote Bruce Sangeorzan, MD, of the University of Washington, Seattle, and colleagues in an accompanying editorial. However, the new study was strengthened by the inclusion of 17 centers for heterogeneity of implant type and surgeon experience level, the editorialists said in the Annals of Internal Medicine.
The study is especially important, because ankle arthritis treatment is very understudied, compared with hip and knee arthritis, but it has a similar impact on activity, editorial coauthor Dr. Sangeorzan said in an interview.
“Randomized controlled trials are the gold standard for comparing medical therapies,” he said, “but they are very difficult to do in surgical treatments, particularly when the two treatments can be differentiated, in this case by movement of the ankle.”
In addition, there is a strong placebo effect attached to interventions, Dr. Sangeorzan noted. “Determining best-case treatment relies on prospective research, preferably randomized. Since both ankle fusion and ankle replacement are effective therapies, a prospective randomized trial is the best way to help make treatment decisions,” he said.
The current study findings are not surprising, but they are preliminary, and 1 year of follow-up is not enough to determine effectiveness, Dr. Sangeorzan emphasized. However, “the authors have done the hard work of randomizing the patients and collecting the data, and the patients can now be followed for a longer time,” he said.
“In addition, the trial was designed with multiple secondary outcome measures, so the data can be matched up with larger trials that were not randomized to identify key elements of success for each procedure,” he noted.
The key message for clinicians is that ankle arthritis has a significant impact on patients’ lives, but there are two effective treatments that can reduce the impact of the disease, said Dr. Sangeorzan. “The data suggest that there are differences in implant design and differences in comorbidities that should influence decision-making,” he added.
Additional research is needed in the form of a longer study duration with larger cohorts, said Dr. Sangeorzan. In particular, researchers need to determine what comorbidities might drive patients to one type of care vs. another, he said. “The suggestion that [patients receiving implants with two motion segments have better outcomes than those receiving implants with a one-motion segment] also deserves further study,” he added.
The research was supported by the UK National Institute for Health and Care Research Health Technology Assessment Programme. The trial was sponsored by University College London. Dr. Goldberg disclosed grant support from NIHR HTA, as well as financial relationships with companies including Stryker, Paragon 28, and stock options with Standing CT Company, Elstree Waterfront Outpatients, and X Bolt Orthopedics.
The editorialists had no financial conflicts to disclose.
Nitrogen test predicts lung function decline
The slope of the alveolar plateau on the single-breath nitrogen test (SBN2) was a significant predictor of lung function decline and of chronic obstructive pulmonary disease (COPD), based on data from 907 adults.
In recent years, interest in small airways disease (SAD) has renewed, with research suggesting a link between SAD pathology and COPD progression, wrote Francesco Pistelli, MD, of the University of Pisa (Italy) and colleagues.
The SBN2 has been used to detect early SAD, but few studies have examined the relationship between SBN2 measures and lung function decline over time, they said.
In a study published in Pulmonology , the researchers reviewed data from adults aged 20 years and older who were enrolled in the Po River Delta prospective study in Italy. The study population included 907 individuals, with a mean age of 37.4 years; 56% were male.
The primary outcome was a change in lung function and incidence of COPD during an 8-year follow-up period.
COPD was defined using either the Global Initiative for Chronic Obstructive Lung Disease (GOLD) or ATS European Respiratory Society (ATS-ERS) criteria.
In a multinomial regression model, one SBN2 index, the slope of alveolar plateau (N2-slope) was significantly associated with rates of forced expiratory volume in 1 second (FEV1) decline, with a decrease of 7.93 mL/year for each one-unit change in N2-slope.
, with a relative risk of 1.81 for mild obstruction and 2.78 for severe obstruction based on GOLD criteria. The association was similar for COPD based on the ATS-ERS criteria, with a relative risk of 1.62 for mild obstruction and 3.40 for moderate to severe obstruction.
Age was associated with an increased COPD risk using the GOLD criteria, but not the ATS-ERS criteria; neither sex nor current or former smoking were associated with increased COPD risk for either measure.
The results are consistent with some previous longitudinal studies, but not others, possibly because of differences in sampling procedures, test techniques, or statistical approaches, the researchers wrote in their discussion.
The study findings were limited by several factors including incomplete data on closing capacity and vital capacity, and by the lack of bronchodilator for performing baseline spirometry, since bronchodilator testing was not recommended at the time of the study, the researchers noted.
However, the results support the role of SAD as a contributor to COPD, and the potential value of the SBN2 test, they said. “Large prospective studies are needed to evaluate whether new proposed functional or imaging tests that measure small airways impairment may be useful in the early detection of COPD,” they noted. In the meantime, “pulmonologists could rediscover an ‘old’ test, which could provide important information on their patients at risk for developing COPD,” they concluded.
The study was supported in part by the National Research Council, Targeted Project and the Italian Electric Power Authority (ENEL). The researchers had no financial conflicts to disclose.
The slope of the alveolar plateau on the single-breath nitrogen test (SBN2) was a significant predictor of lung function decline and of chronic obstructive pulmonary disease (COPD), based on data from 907 adults.
In recent years, interest in small airways disease (SAD) has renewed, with research suggesting a link between SAD pathology and COPD progression, wrote Francesco Pistelli, MD, of the University of Pisa (Italy) and colleagues.
The SBN2 has been used to detect early SAD, but few studies have examined the relationship between SBN2 measures and lung function decline over time, they said.
In a study published in Pulmonology , the researchers reviewed data from adults aged 20 years and older who were enrolled in the Po River Delta prospective study in Italy. The study population included 907 individuals, with a mean age of 37.4 years; 56% were male.
The primary outcome was a change in lung function and incidence of COPD during an 8-year follow-up period.
COPD was defined using either the Global Initiative for Chronic Obstructive Lung Disease (GOLD) or ATS European Respiratory Society (ATS-ERS) criteria.
In a multinomial regression model, one SBN2 index, the slope of alveolar plateau (N2-slope) was significantly associated with rates of forced expiratory volume in 1 second (FEV1) decline, with a decrease of 7.93 mL/year for each one-unit change in N2-slope.
, with a relative risk of 1.81 for mild obstruction and 2.78 for severe obstruction based on GOLD criteria. The association was similar for COPD based on the ATS-ERS criteria, with a relative risk of 1.62 for mild obstruction and 3.40 for moderate to severe obstruction.
Age was associated with an increased COPD risk using the GOLD criteria, but not the ATS-ERS criteria; neither sex nor current or former smoking were associated with increased COPD risk for either measure.
The results are consistent with some previous longitudinal studies, but not others, possibly because of differences in sampling procedures, test techniques, or statistical approaches, the researchers wrote in their discussion.
The study findings were limited by several factors including incomplete data on closing capacity and vital capacity, and by the lack of bronchodilator for performing baseline spirometry, since bronchodilator testing was not recommended at the time of the study, the researchers noted.
However, the results support the role of SAD as a contributor to COPD, and the potential value of the SBN2 test, they said. “Large prospective studies are needed to evaluate whether new proposed functional or imaging tests that measure small airways impairment may be useful in the early detection of COPD,” they noted. In the meantime, “pulmonologists could rediscover an ‘old’ test, which could provide important information on their patients at risk for developing COPD,” they concluded.
The study was supported in part by the National Research Council, Targeted Project and the Italian Electric Power Authority (ENEL). The researchers had no financial conflicts to disclose.
The slope of the alveolar plateau on the single-breath nitrogen test (SBN2) was a significant predictor of lung function decline and of chronic obstructive pulmonary disease (COPD), based on data from 907 adults.
In recent years, interest in small airways disease (SAD) has renewed, with research suggesting a link between SAD pathology and COPD progression, wrote Francesco Pistelli, MD, of the University of Pisa (Italy) and colleagues.
The SBN2 has been used to detect early SAD, but few studies have examined the relationship between SBN2 measures and lung function decline over time, they said.
In a study published in Pulmonology , the researchers reviewed data from adults aged 20 years and older who were enrolled in the Po River Delta prospective study in Italy. The study population included 907 individuals, with a mean age of 37.4 years; 56% were male.
The primary outcome was a change in lung function and incidence of COPD during an 8-year follow-up period.
COPD was defined using either the Global Initiative for Chronic Obstructive Lung Disease (GOLD) or ATS European Respiratory Society (ATS-ERS) criteria.
In a multinomial regression model, one SBN2 index, the slope of alveolar plateau (N2-slope) was significantly associated with rates of forced expiratory volume in 1 second (FEV1) decline, with a decrease of 7.93 mL/year for each one-unit change in N2-slope.
, with a relative risk of 1.81 for mild obstruction and 2.78 for severe obstruction based on GOLD criteria. The association was similar for COPD based on the ATS-ERS criteria, with a relative risk of 1.62 for mild obstruction and 3.40 for moderate to severe obstruction.
Age was associated with an increased COPD risk using the GOLD criteria, but not the ATS-ERS criteria; neither sex nor current or former smoking were associated with increased COPD risk for either measure.
The results are consistent with some previous longitudinal studies, but not others, possibly because of differences in sampling procedures, test techniques, or statistical approaches, the researchers wrote in their discussion.
The study findings were limited by several factors including incomplete data on closing capacity and vital capacity, and by the lack of bronchodilator for performing baseline spirometry, since bronchodilator testing was not recommended at the time of the study, the researchers noted.
However, the results support the role of SAD as a contributor to COPD, and the potential value of the SBN2 test, they said. “Large prospective studies are needed to evaluate whether new proposed functional or imaging tests that measure small airways impairment may be useful in the early detection of COPD,” they noted. In the meantime, “pulmonologists could rediscover an ‘old’ test, which could provide important information on their patients at risk for developing COPD,” they concluded.
The study was supported in part by the National Research Council, Targeted Project and the Italian Electric Power Authority (ENEL). The researchers had no financial conflicts to disclose.
FROM PULMONOLOGY
Medicaid coverage of HPV vaccine in adults: Implications in dermatology
, according to the authors of a review of Medicaid policies across all 50 states.
The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.
A total of 33 states offered formal statewide Medicaid coverage policies that were accessible online or through the state’s Medicaid office. Another 11 states provided coverage through Medicaid managed care organizations, and 4 states had HPV vaccination as part of their formal Medicaid adult vaccination programs.
Overall, 43 states covered HPV vaccination through age 45 years with no need for prior authorization, and another 4 states (Ohio, Maine, Nebraska, and New York) provided coverage with prior authorization for adults older than 26 years.
The study findings were limited by the use of Medicaid coverage only, the researchers noted. Consequently, patients eligible for HPV vaccination who are uninsured or have other types of insurance may face additional barriers in the form of high costs, given that the current retail price is $250-$350 per shot for the three-shot series, the researchers noted.
However, the results suggest that Medicaid coverage for HPV vaccination may inform dermatologists’ recommendations for patients at increased risk, they said. More research is needed to “better identify dermatology patients at risk for new HPV infection and ways to improve vaccination rates in these vulnerable individuals,” they added.
Vaccine discussions are important in dermatology
“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.
“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted. 
However, “time may be a barrier for many dermatologists who have many important things to discuss with patients during their appointments,” she said. “We are currently working on developing educational information to help facilitate this conversation,” she added.
Looking ahead, she said that “additional research is necessary to create vaccine guidelines specific to dermatology patients and dermatology medications, so we can provide clear recommendations to our patients and ensure appropriate insurance coverage for all necessary vaccines.”
Vaccine discussions
“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”
Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.
The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”
The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.
, according to the authors of a review of Medicaid policies across all 50 states.
The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.
A total of 33 states offered formal statewide Medicaid coverage policies that were accessible online or through the state’s Medicaid office. Another 11 states provided coverage through Medicaid managed care organizations, and 4 states had HPV vaccination as part of their formal Medicaid adult vaccination programs.
Overall, 43 states covered HPV vaccination through age 45 years with no need for prior authorization, and another 4 states (Ohio, Maine, Nebraska, and New York) provided coverage with prior authorization for adults older than 26 years.
The study findings were limited by the use of Medicaid coverage only, the researchers noted. Consequently, patients eligible for HPV vaccination who are uninsured or have other types of insurance may face additional barriers in the form of high costs, given that the current retail price is $250-$350 per shot for the three-shot series, the researchers noted.
However, the results suggest that Medicaid coverage for HPV vaccination may inform dermatologists’ recommendations for patients at increased risk, they said. More research is needed to “better identify dermatology patients at risk for new HPV infection and ways to improve vaccination rates in these vulnerable individuals,” they added.
Vaccine discussions are important in dermatology
“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.
“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted.
However, “time may be a barrier for many dermatologists who have many important things to discuss with patients during their appointments,” she said. “We are currently working on developing educational information to help facilitate this conversation,” she added.
Looking ahead, she said that “additional research is necessary to create vaccine guidelines specific to dermatology patients and dermatology medications, so we can provide clear recommendations to our patients and ensure appropriate insurance coverage for all necessary vaccines.”
Vaccine discussions
“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”
Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.
The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”
The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.
, according to the authors of a review of Medicaid policies across all 50 states.
The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.
A total of 33 states offered formal statewide Medicaid coverage policies that were accessible online or through the state’s Medicaid office. Another 11 states provided coverage through Medicaid managed care organizations, and 4 states had HPV vaccination as part of their formal Medicaid adult vaccination programs.
Overall, 43 states covered HPV vaccination through age 45 years with no need for prior authorization, and another 4 states (Ohio, Maine, Nebraska, and New York) provided coverage with prior authorization for adults older than 26 years.
The study findings were limited by the use of Medicaid coverage only, the researchers noted. Consequently, patients eligible for HPV vaccination who are uninsured or have other types of insurance may face additional barriers in the form of high costs, given that the current retail price is $250-$350 per shot for the three-shot series, the researchers noted.
However, the results suggest that Medicaid coverage for HPV vaccination may inform dermatologists’ recommendations for patients at increased risk, they said. More research is needed to “better identify dermatology patients at risk for new HPV infection and ways to improve vaccination rates in these vulnerable individuals,” they added.
Vaccine discussions are important in dermatology
“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.
“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted.
However, “time may be a barrier for many dermatologists who have many important things to discuss with patients during their appointments,” she said. “We are currently working on developing educational information to help facilitate this conversation,” she added.
Looking ahead, she said that “additional research is necessary to create vaccine guidelines specific to dermatology patients and dermatology medications, so we can provide clear recommendations to our patients and ensure appropriate insurance coverage for all necessary vaccines.”
Vaccine discussions
“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”
Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.
The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”
The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.
FROM JAMA DERMATOLOGY
ACR introduces guideline for integrative interventions in RA
Exercise tops the list of 28 recommendations in a guideline for integrative interventions in patients with rheumatoid arthritis developed by the American College of Rheumatology.
The guideline is specific to RA and presents integrative interventions to accompany treatment with disease-modifying antirheumatic drugs (DMARDs), according to a summary statement issued by the ACR. The summary was approved by the ACR Board of Directors on Oct. 31, and the recommendations are part of a manuscript that will be submitted for publication in both Arthritis & Rheumatology and Arthritis Care & Research.
Consistent engagement in exercise earned the only strong recommendation; the other 27 were conditional. In the exercise category, the authors offered conditional recommendations for aerobic exercise, aquatic exercise, resistance exercise, and mind-body exercise.
Three recommendations focused on diet. Notably, the recommended diet is Mediterranean style. Two other recommendations were specifically against any other formal diet and against the use of dietary supplements. “The conditional recommendation for adhering to a Mediterranean-style diet, but not other formally defined diets, to improve RA-specific outcomes may be surprising to some clinicians,” said Bryant R. England, MD, PhD, of the University of Nebraska Medical Center, Omaha, and one of the guideline’s coprincipal investigators, in a press release. “The voting panel acknowledged, however, that other health indications may exist for alternative diet and dietary supplements, which makes it crucial for clinicians and patients to engage in shared decision-making,” Dr. England said.
Nearly half of the 28 recommendations (13) focused on rehabilitation, but all were conditional. These included comprehensive occupational and physical therapy and hand therapy, as well as the use of splinting, orthoses, compression, bracing, and taping of affected areas. Other conditional recommendations supported the use of joint protection techniques, assistive devices, adaptive equipment, and/or environmental adaptations. The authors also included a conditional recommendation for vocational rehabilitation and work-site evaluations and/or modifications.
A category of additional integrative interventions included recommendations against both electrotherapy and chiropractic care. However, conditional recommendations were positive for acupuncture, massage therapy, and thermal modalities. Conditional recommendations also supported cognitive-behavioral therapy and/or mind-body strategies, and a standardized self-management program.
The guideline was developed by an interprofessional voting panel of 20 individuals with expertise in epidemiology, exercise physiology, GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, integrative medicine, nursing, nutrition, occupational therapy, physical therapy, rheumatology, and social work, as well as three individuals who have RA. The panel developed questions, conducted a literature review, and used the GRADE approach to rate the certainty of evidence.
“These recommendations are specific to RA management, understanding that other medical indications and general health benefits may exist for many of these interventions,” the authors write in the summary statement.
The range of interventions shows both the importance of an interprofessional team–based approach to RA management and the need to engage patients in shared decision-making, they said.
A version of this article first appeared on Medscape.com.
Exercise tops the list of 28 recommendations in a guideline for integrative interventions in patients with rheumatoid arthritis developed by the American College of Rheumatology.
The guideline is specific to RA and presents integrative interventions to accompany treatment with disease-modifying antirheumatic drugs (DMARDs), according to a summary statement issued by the ACR. The summary was approved by the ACR Board of Directors on Oct. 31, and the recommendations are part of a manuscript that will be submitted for publication in both Arthritis & Rheumatology and Arthritis Care & Research.
Consistent engagement in exercise earned the only strong recommendation; the other 27 were conditional. In the exercise category, the authors offered conditional recommendations for aerobic exercise, aquatic exercise, resistance exercise, and mind-body exercise.
Three recommendations focused on diet. Notably, the recommended diet is Mediterranean style. Two other recommendations were specifically against any other formal diet and against the use of dietary supplements. “The conditional recommendation for adhering to a Mediterranean-style diet, but not other formally defined diets, to improve RA-specific outcomes may be surprising to some clinicians,” said Bryant R. England, MD, PhD, of the University of Nebraska Medical Center, Omaha, and one of the guideline’s coprincipal investigators, in a press release. “The voting panel acknowledged, however, that other health indications may exist for alternative diet and dietary supplements, which makes it crucial for clinicians and patients to engage in shared decision-making,” Dr. England said.
Nearly half of the 28 recommendations (13) focused on rehabilitation, but all were conditional. These included comprehensive occupational and physical therapy and hand therapy, as well as the use of splinting, orthoses, compression, bracing, and taping of affected areas. Other conditional recommendations supported the use of joint protection techniques, assistive devices, adaptive equipment, and/or environmental adaptations. The authors also included a conditional recommendation for vocational rehabilitation and work-site evaluations and/or modifications.
A category of additional integrative interventions included recommendations against both electrotherapy and chiropractic care. However, conditional recommendations were positive for acupuncture, massage therapy, and thermal modalities. Conditional recommendations also supported cognitive-behavioral therapy and/or mind-body strategies, and a standardized self-management program.
The guideline was developed by an interprofessional voting panel of 20 individuals with expertise in epidemiology, exercise physiology, GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, integrative medicine, nursing, nutrition, occupational therapy, physical therapy, rheumatology, and social work, as well as three individuals who have RA. The panel developed questions, conducted a literature review, and used the GRADE approach to rate the certainty of evidence.
“These recommendations are specific to RA management, understanding that other medical indications and general health benefits may exist for many of these interventions,” the authors write in the summary statement.
The range of interventions shows both the importance of an interprofessional team–based approach to RA management and the need to engage patients in shared decision-making, they said.
A version of this article first appeared on Medscape.com.
Exercise tops the list of 28 recommendations in a guideline for integrative interventions in patients with rheumatoid arthritis developed by the American College of Rheumatology.
The guideline is specific to RA and presents integrative interventions to accompany treatment with disease-modifying antirheumatic drugs (DMARDs), according to a summary statement issued by the ACR. The summary was approved by the ACR Board of Directors on Oct. 31, and the recommendations are part of a manuscript that will be submitted for publication in both Arthritis & Rheumatology and Arthritis Care & Research.
Consistent engagement in exercise earned the only strong recommendation; the other 27 were conditional. In the exercise category, the authors offered conditional recommendations for aerobic exercise, aquatic exercise, resistance exercise, and mind-body exercise.
Three recommendations focused on diet. Notably, the recommended diet is Mediterranean style. Two other recommendations were specifically against any other formal diet and against the use of dietary supplements. “The conditional recommendation for adhering to a Mediterranean-style diet, but not other formally defined diets, to improve RA-specific outcomes may be surprising to some clinicians,” said Bryant R. England, MD, PhD, of the University of Nebraska Medical Center, Omaha, and one of the guideline’s coprincipal investigators, in a press release. “The voting panel acknowledged, however, that other health indications may exist for alternative diet and dietary supplements, which makes it crucial for clinicians and patients to engage in shared decision-making,” Dr. England said.
Nearly half of the 28 recommendations (13) focused on rehabilitation, but all were conditional. These included comprehensive occupational and physical therapy and hand therapy, as well as the use of splinting, orthoses, compression, bracing, and taping of affected areas. Other conditional recommendations supported the use of joint protection techniques, assistive devices, adaptive equipment, and/or environmental adaptations. The authors also included a conditional recommendation for vocational rehabilitation and work-site evaluations and/or modifications.
A category of additional integrative interventions included recommendations against both electrotherapy and chiropractic care. However, conditional recommendations were positive for acupuncture, massage therapy, and thermal modalities. Conditional recommendations also supported cognitive-behavioral therapy and/or mind-body strategies, and a standardized self-management program.
The guideline was developed by an interprofessional voting panel of 20 individuals with expertise in epidemiology, exercise physiology, GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, integrative medicine, nursing, nutrition, occupational therapy, physical therapy, rheumatology, and social work, as well as three individuals who have RA. The panel developed questions, conducted a literature review, and used the GRADE approach to rate the certainty of evidence.
“These recommendations are specific to RA management, understanding that other medical indications and general health benefits may exist for many of these interventions,” the authors write in the summary statement.
The range of interventions shows both the importance of an interprofessional team–based approach to RA management and the need to engage patients in shared decision-making, they said.
A version of this article first appeared on Medscape.com.
Practical pearls guide treatment of psoriasis in tricky areas
LAS VEGAS – With the right regimen, a majority of patients with psoriasis can achieve at least a Psoriasis Area and Severity Index (PASI) 75 score, Jennifer Soung, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
The array of treatment options includes mainstay topicals, new nonsteroidals, traditional oral systemics, new oral systemics, biologics, and light therapy, said Dr. Soung, director of clinical research at Harbor-UCLA Medical Center, Santa Ana, Calif. However, she said.
For these areas, make sure the diagnosis of psoriasis is correct, to avoid wasting time on the wrong course of treatment, Dr. Soung emphasized.
Scalp strategies
The scalp is often the first area of the body affected by psoriasis, and patients with severe scalp psoriasis may have minimal plaques on the body, Dr. Soung said. However, a differential diagnosis should include seborrheic dermatitis, she noted.
For most cases of scalp psoriasis, “start with localized topical treatment,” such as vitamin D and corticosteroid combination therapy, or excimer laser, Dr. Soung advised.
Systemic treatments with demonstrated effectiveness on scalp psoriasis in post hoc analyses of patients with moderate to severe plaque psoriasis include adalimumab, etanercept, ixekizumab, and secukinumab. Studies specifically focused on treatment of scalp psoriasis have shown success with secukinumab and apremilast, she noted.
Roflumilast foam, 0.3%, is in development and is an emerging option for scalp psoriasis. (A cream formulation of roflumilast, a topical phosphodiesterase 4 inhibitor, was approved for treatment of plaque psoriasis in July 2022.) A phase 2b study of roflumilast foam showed that approximately one-third of patients with scalp psoriasis achieved a status of clear based on scalp-investigator global assessment, compared with approximately 3% of those on vehicle, and similar results were seen in a recently completed phase 3 trial for scalp and body psoriasis, she added.
Facial psoriasis
Patients with facial psoriasis tend to be younger, and they may have more severe disease overall, Dr. Soung said. Given the sensitivity of facial skin, “it is nice to have a nonsteroidal option,” she noted. Current novel nonsteroidal therapies include a cream formulation of tapinarof, an aryl hydrocarbon receptor agonist, which was approved earlier this year for plaque psoriasis in adults, and roflumilast cream. Vitamin D and topical calcineurin inhibitors are options as well, she said.
Intertriginous tricks
Intertriginous (inverse) psoriasis is distinct from other areas in that the plaques are usually smooth and well-demarcated, with little or no scaling, Dr. Soung said. Erosions or signs of maceration may be present. The prevalence of inverse psoriasis is approximately 30%, but the prevalence on external genitalia is 80%, she noted. For inverse psoriasis, topical corticosteroids can result in adverse events such as poor wound healing and skin fragility, and some patients resist the idea of a steroid and don’t adhere to the medication, she added. Dr. Soung recommended topical corticosteroids for the short term, and topical calcineurin inhibitors or calcipotriol for the long term.
New topical options for inverse psoriasis include tapinarof and roflumilast, Dr. Soung said. For tapinarof, the phase 3 PSOARING program included assessment of tolerability in sensitive skin areas and found little to no irritation. Similarly, treatment with roflumilast cream was effective and well tolerated by patients with intertriginous plaque psoriasis in the DERMIS-1 and DERMIS-2 studies, she said.
Genital psoriasis
Ask patients with psoriasis about genital psoriasis, because they often are too embarrassed to provide that information on their own, said Dr. Soung. In fact, 63% of patients with psoriasis report ever experiencing genital psoriasis, but it often goes undiagnosed and undertreated, which has a significant impact on patient quality of life and sexual health.
A differential diagnosis of genital psoriasis should include dermatitis, tinea or candidiasis, and even squamous cell carcinoma, she noted. Other considerations include fixed drug eruption, lichen nitidus, lichen sclerosus, and scabies.
Dr. Soung’s first line of treatment for genital psoriasis is low-potency topical corticosteroids for 2-4 weeks. If long-term topical therapy is needed, alternatives include calcineurin inhibitors and vitamin D analogs, she said. The new topicals roflumilast and tapinarof are options as well, she said.
For those patients with severe and extensive genital psoriasis, consider systemic therapy, possibly with ixekizumab or secukinumab, she added. Patients with moderate to severe genital psoriasis treated with apremilast have shown improvement at week 16, in an ongoing clinical trial, she noted.
Palmoplantar involvement
For patients with palmar plantar psoriasis, “don’t underestimate the impact on quality of life,” said Dr. Soung. Approximately 12%-16% of patients with psoriasis report palmoplantar involvement, she noted.
Palmoplantar psoriasis can be stubborn, and many patients will need combination therapy with topicals and systemics, she said. “I am very curious about how well our new topical nonsteroidals will work in these areas,” she added.
Dr. Soung starts patients with palmoplantar psoriasis with a “potent to super-potent” twice daily topical corticosteroid, with or without occlusion. Her first-line systemic therapy is acitretin, 10-50 mg daily. However, keep in mind that acitretin is contraindicated in pregnancy, and also may cause side effects including cheilitis, alopecia, and peeling skin, she cautioned.
During the question and answer session, Dr. Soung was asked whether she routinely biopsies patients with palmoplantar psoriasis. “Not always,” was her answer. Instead, she looks for clues elsewhere on the body to confirm the diagnosis.
Nail know-how
Approximately 23%-27% of patients with psoriasis experience nail involvement, said Dr. Soung. Nail psoriasis can appear on the nail plate as pitting, onycholysis, or subungual hyperkeratosis, or in the nail bed as splinter hemorrhages or oil spots, she said.
For patients with psoriasis of the nails only, Dr. Soung described the use of high-potency topical corticosteroids, with or without calcipotriol. In her experience, she said that intralesional steroids for nail psoriasis are torturous to patients. For patients who have failed topical therapy or have psoriasis in other areas, with or without psoriatic arthritis, she advised the use of either IL-17 antagonists (secukinumab, ixekizumab, brodalumab) or IL-23 antagonists (risankizumab, guselkumab).
Dr. Soung disclosed serving as a consultant or advisor for Arcutis, Bristol Myers Squibb Company, Dermavant, and Novartis. She also disclosed serving as a speaker or member of the speakers’ bureau for AbbVie, Amgen, Arcutis, Bristol Myers Squibb Company, Celgene, Leo Pharma, Eli Lilly, Novartis, Ortho Dermatologics, Pfizer, Regeneron, and Sanofi, as well as research funding from AbbVie, Amgen, Arcutis, Castle Biosciences, Dermavant, KoBio, Kyowa Kirin, Leo Pharma, Eli Lilly, Novartis, Pfizer, and UCB.
MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – With the right regimen, a majority of patients with psoriasis can achieve at least a Psoriasis Area and Severity Index (PASI) 75 score, Jennifer Soung, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
The array of treatment options includes mainstay topicals, new nonsteroidals, traditional oral systemics, new oral systemics, biologics, and light therapy, said Dr. Soung, director of clinical research at Harbor-UCLA Medical Center, Santa Ana, Calif. However, she said.
For these areas, make sure the diagnosis of psoriasis is correct, to avoid wasting time on the wrong course of treatment, Dr. Soung emphasized.
Scalp strategies
The scalp is often the first area of the body affected by psoriasis, and patients with severe scalp psoriasis may have minimal plaques on the body, Dr. Soung said. However, a differential diagnosis should include seborrheic dermatitis, she noted.
For most cases of scalp psoriasis, “start with localized topical treatment,” such as vitamin D and corticosteroid combination therapy, or excimer laser, Dr. Soung advised.
Systemic treatments with demonstrated effectiveness on scalp psoriasis in post hoc analyses of patients with moderate to severe plaque psoriasis include adalimumab, etanercept, ixekizumab, and secukinumab. Studies specifically focused on treatment of scalp psoriasis have shown success with secukinumab and apremilast, she noted.
Roflumilast foam, 0.3%, is in development and is an emerging option for scalp psoriasis. (A cream formulation of roflumilast, a topical phosphodiesterase 4 inhibitor, was approved for treatment of plaque psoriasis in July 2022.) A phase 2b study of roflumilast foam showed that approximately one-third of patients with scalp psoriasis achieved a status of clear based on scalp-investigator global assessment, compared with approximately 3% of those on vehicle, and similar results were seen in a recently completed phase 3 trial for scalp and body psoriasis, she added.
Facial psoriasis
Patients with facial psoriasis tend to be younger, and they may have more severe disease overall, Dr. Soung said. Given the sensitivity of facial skin, “it is nice to have a nonsteroidal option,” she noted. Current novel nonsteroidal therapies include a cream formulation of tapinarof, an aryl hydrocarbon receptor agonist, which was approved earlier this year for plaque psoriasis in adults, and roflumilast cream. Vitamin D and topical calcineurin inhibitors are options as well, she said.
Intertriginous tricks
Intertriginous (inverse) psoriasis is distinct from other areas in that the plaques are usually smooth and well-demarcated, with little or no scaling, Dr. Soung said. Erosions or signs of maceration may be present. The prevalence of inverse psoriasis is approximately 30%, but the prevalence on external genitalia is 80%, she noted. For inverse psoriasis, topical corticosteroids can result in adverse events such as poor wound healing and skin fragility, and some patients resist the idea of a steroid and don’t adhere to the medication, she added. Dr. Soung recommended topical corticosteroids for the short term, and topical calcineurin inhibitors or calcipotriol for the long term.
New topical options for inverse psoriasis include tapinarof and roflumilast, Dr. Soung said. For tapinarof, the phase 3 PSOARING program included assessment of tolerability in sensitive skin areas and found little to no irritation. Similarly, treatment with roflumilast cream was effective and well tolerated by patients with intertriginous plaque psoriasis in the DERMIS-1 and DERMIS-2 studies, she said.
Genital psoriasis
Ask patients with psoriasis about genital psoriasis, because they often are too embarrassed to provide that information on their own, said Dr. Soung. In fact, 63% of patients with psoriasis report ever experiencing genital psoriasis, but it often goes undiagnosed and undertreated, which has a significant impact on patient quality of life and sexual health.
A differential diagnosis of genital psoriasis should include dermatitis, tinea or candidiasis, and even squamous cell carcinoma, she noted. Other considerations include fixed drug eruption, lichen nitidus, lichen sclerosus, and scabies.
Dr. Soung’s first line of treatment for genital psoriasis is low-potency topical corticosteroids for 2-4 weeks. If long-term topical therapy is needed, alternatives include calcineurin inhibitors and vitamin D analogs, she said. The new topicals roflumilast and tapinarof are options as well, she said.
For those patients with severe and extensive genital psoriasis, consider systemic therapy, possibly with ixekizumab or secukinumab, she added. Patients with moderate to severe genital psoriasis treated with apremilast have shown improvement at week 16, in an ongoing clinical trial, she noted.
Palmoplantar involvement
For patients with palmar plantar psoriasis, “don’t underestimate the impact on quality of life,” said Dr. Soung. Approximately 12%-16% of patients with psoriasis report palmoplantar involvement, she noted.
Palmoplantar psoriasis can be stubborn, and many patients will need combination therapy with topicals and systemics, she said. “I am very curious about how well our new topical nonsteroidals will work in these areas,” she added.
Dr. Soung starts patients with palmoplantar psoriasis with a “potent to super-potent” twice daily topical corticosteroid, with or without occlusion. Her first-line systemic therapy is acitretin, 10-50 mg daily. However, keep in mind that acitretin is contraindicated in pregnancy, and also may cause side effects including cheilitis, alopecia, and peeling skin, she cautioned.
During the question and answer session, Dr. Soung was asked whether she routinely biopsies patients with palmoplantar psoriasis. “Not always,” was her answer. Instead, she looks for clues elsewhere on the body to confirm the diagnosis.
Nail know-how
Approximately 23%-27% of patients with psoriasis experience nail involvement, said Dr. Soung. Nail psoriasis can appear on the nail plate as pitting, onycholysis, or subungual hyperkeratosis, or in the nail bed as splinter hemorrhages or oil spots, she said.
For patients with psoriasis of the nails only, Dr. Soung described the use of high-potency topical corticosteroids, with or without calcipotriol. In her experience, she said that intralesional steroids for nail psoriasis are torturous to patients. For patients who have failed topical therapy or have psoriasis in other areas, with or without psoriatic arthritis, she advised the use of either IL-17 antagonists (secukinumab, ixekizumab, brodalumab) or IL-23 antagonists (risankizumab, guselkumab).
Dr. Soung disclosed serving as a consultant or advisor for Arcutis, Bristol Myers Squibb Company, Dermavant, and Novartis. She also disclosed serving as a speaker or member of the speakers’ bureau for AbbVie, Amgen, Arcutis, Bristol Myers Squibb Company, Celgene, Leo Pharma, Eli Lilly, Novartis, Ortho Dermatologics, Pfizer, Regeneron, and Sanofi, as well as research funding from AbbVie, Amgen, Arcutis, Castle Biosciences, Dermavant, KoBio, Kyowa Kirin, Leo Pharma, Eli Lilly, Novartis, Pfizer, and UCB.
MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – With the right regimen, a majority of patients with psoriasis can achieve at least a Psoriasis Area and Severity Index (PASI) 75 score, Jennifer Soung, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
The array of treatment options includes mainstay topicals, new nonsteroidals, traditional oral systemics, new oral systemics, biologics, and light therapy, said Dr. Soung, director of clinical research at Harbor-UCLA Medical Center, Santa Ana, Calif. However, she said.
For these areas, make sure the diagnosis of psoriasis is correct, to avoid wasting time on the wrong course of treatment, Dr. Soung emphasized.
Scalp strategies
The scalp is often the first area of the body affected by psoriasis, and patients with severe scalp psoriasis may have minimal plaques on the body, Dr. Soung said. However, a differential diagnosis should include seborrheic dermatitis, she noted.
For most cases of scalp psoriasis, “start with localized topical treatment,” such as vitamin D and corticosteroid combination therapy, or excimer laser, Dr. Soung advised.
Systemic treatments with demonstrated effectiveness on scalp psoriasis in post hoc analyses of patients with moderate to severe plaque psoriasis include adalimumab, etanercept, ixekizumab, and secukinumab. Studies specifically focused on treatment of scalp psoriasis have shown success with secukinumab and apremilast, she noted.
Roflumilast foam, 0.3%, is in development and is an emerging option for scalp psoriasis. (A cream formulation of roflumilast, a topical phosphodiesterase 4 inhibitor, was approved for treatment of plaque psoriasis in July 2022.) A phase 2b study of roflumilast foam showed that approximately one-third of patients with scalp psoriasis achieved a status of clear based on scalp-investigator global assessment, compared with approximately 3% of those on vehicle, and similar results were seen in a recently completed phase 3 trial for scalp and body psoriasis, she added.
Facial psoriasis
Patients with facial psoriasis tend to be younger, and they may have more severe disease overall, Dr. Soung said. Given the sensitivity of facial skin, “it is nice to have a nonsteroidal option,” she noted. Current novel nonsteroidal therapies include a cream formulation of tapinarof, an aryl hydrocarbon receptor agonist, which was approved earlier this year for plaque psoriasis in adults, and roflumilast cream. Vitamin D and topical calcineurin inhibitors are options as well, she said.
Intertriginous tricks
Intertriginous (inverse) psoriasis is distinct from other areas in that the plaques are usually smooth and well-demarcated, with little or no scaling, Dr. Soung said. Erosions or signs of maceration may be present. The prevalence of inverse psoriasis is approximately 30%, but the prevalence on external genitalia is 80%, she noted. For inverse psoriasis, topical corticosteroids can result in adverse events such as poor wound healing and skin fragility, and some patients resist the idea of a steroid and don’t adhere to the medication, she added. Dr. Soung recommended topical corticosteroids for the short term, and topical calcineurin inhibitors or calcipotriol for the long term.
New topical options for inverse psoriasis include tapinarof and roflumilast, Dr. Soung said. For tapinarof, the phase 3 PSOARING program included assessment of tolerability in sensitive skin areas and found little to no irritation. Similarly, treatment with roflumilast cream was effective and well tolerated by patients with intertriginous plaque psoriasis in the DERMIS-1 and DERMIS-2 studies, she said.
Genital psoriasis
Ask patients with psoriasis about genital psoriasis, because they often are too embarrassed to provide that information on their own, said Dr. Soung. In fact, 63% of patients with psoriasis report ever experiencing genital psoriasis, but it often goes undiagnosed and undertreated, which has a significant impact on patient quality of life and sexual health.
A differential diagnosis of genital psoriasis should include dermatitis, tinea or candidiasis, and even squamous cell carcinoma, she noted. Other considerations include fixed drug eruption, lichen nitidus, lichen sclerosus, and scabies.
Dr. Soung’s first line of treatment for genital psoriasis is low-potency topical corticosteroids for 2-4 weeks. If long-term topical therapy is needed, alternatives include calcineurin inhibitors and vitamin D analogs, she said. The new topicals roflumilast and tapinarof are options as well, she said.
For those patients with severe and extensive genital psoriasis, consider systemic therapy, possibly with ixekizumab or secukinumab, she added. Patients with moderate to severe genital psoriasis treated with apremilast have shown improvement at week 16, in an ongoing clinical trial, she noted.
Palmoplantar involvement
For patients with palmar plantar psoriasis, “don’t underestimate the impact on quality of life,” said Dr. Soung. Approximately 12%-16% of patients with psoriasis report palmoplantar involvement, she noted.
Palmoplantar psoriasis can be stubborn, and many patients will need combination therapy with topicals and systemics, she said. “I am very curious about how well our new topical nonsteroidals will work in these areas,” she added.
Dr. Soung starts patients with palmoplantar psoriasis with a “potent to super-potent” twice daily topical corticosteroid, with or without occlusion. Her first-line systemic therapy is acitretin, 10-50 mg daily. However, keep in mind that acitretin is contraindicated in pregnancy, and also may cause side effects including cheilitis, alopecia, and peeling skin, she cautioned.
During the question and answer session, Dr. Soung was asked whether she routinely biopsies patients with palmoplantar psoriasis. “Not always,” was her answer. Instead, she looks for clues elsewhere on the body to confirm the diagnosis.
Nail know-how
Approximately 23%-27% of patients with psoriasis experience nail involvement, said Dr. Soung. Nail psoriasis can appear on the nail plate as pitting, onycholysis, or subungual hyperkeratosis, or in the nail bed as splinter hemorrhages or oil spots, she said.
For patients with psoriasis of the nails only, Dr. Soung described the use of high-potency topical corticosteroids, with or without calcipotriol. In her experience, she said that intralesional steroids for nail psoriasis are torturous to patients. For patients who have failed topical therapy or have psoriasis in other areas, with or without psoriatic arthritis, she advised the use of either IL-17 antagonists (secukinumab, ixekizumab, brodalumab) or IL-23 antagonists (risankizumab, guselkumab).
Dr. Soung disclosed serving as a consultant or advisor for Arcutis, Bristol Myers Squibb Company, Dermavant, and Novartis. She also disclosed serving as a speaker or member of the speakers’ bureau for AbbVie, Amgen, Arcutis, Bristol Myers Squibb Company, Celgene, Leo Pharma, Eli Lilly, Novartis, Ortho Dermatologics, Pfizer, Regeneron, and Sanofi, as well as research funding from AbbVie, Amgen, Arcutis, Castle Biosciences, Dermavant, KoBio, Kyowa Kirin, Leo Pharma, Eli Lilly, Novartis, Pfizer, and UCB.
MedscapeLive and this news organization are owned by the same parent company.
AT INNOVATIONS IN DERMATOLOGY
Daily aspirin fails to reduce risk of fractures in older adults
Previous research suggests that aspirin may reduce the risk of fragility fractures by delaying bone loss, but the direct effects of aspirin on bone microarchitecture and the association between aspirin use and fracture risk in humans has not been explored, corresponding author Anna L. Barker, PhD, and colleagues wrote in their paper published in JAMA Internal Medicine.
Dr. Barker, who is executive director of research and innovation for Silverchain (a senior care program), said, in an interview, that she and her coauthors hypothesized “that aspirin could reduce both falls and fractures by reducing cardiovascular-associated physical and cognitive impairments and the anti-inflammatory properties mediating bone remodeling.”
Study methods and results
In the ASPREE-FRACTURE substudy, the authors examined the impact of daily low-dose aspirin (100 mg) on incidence of any fracture in more than 16,000 community-dwelling adults aged 70 years and older. A secondary endpoint was the incidence of serious falls, defined as falls requiring a hospital visit. Individuals with chronic illness and cardiovascular or cerebrovascular disease were excluded, as were those with dementia or other cognitive impairment, or a physical disability.
The study population included 16,703 participants enrolled in the larger Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial between 2010 and 2014. Of these, 8,322 were randomized to aspirin and 8,381 to a placebo. The median age was 74 years, and 55% of the participants were women.
Over a median follow-up of 4.6 years (76,219 total person-years), the risk of first fracture was similar between the aspirin and placebo groups (hazard ratio, 0.97), but the risk of serious falls was significantly higher in the aspirin group (884 falls vs. 804 falls, P = .01).
The incidence of first fracture was similar between the aspirin and placebo groups (813 vs. 718), as was the incidence of all fractures (1,394 and 1,471, respectively).
The results for both fractures and falls were essentially unchanged in a multivariate analysis controlling for variables known to affect fracture and fall risk and remained similar for different types of fractures (hip, trauma-related, nonpathological) as well, the researchers noted.
In their discussion, the researchers wrote that the clinical significance of the study is the inability of aspirin to reduce the risk of fractures in otherwise healthy older adults. They expressed surprise at the increase in serious falls, citing their hypothesis that the antiplatelet effects of aspirin may reduce cardiovascular and cerebrovascular events, thereby slowing physical decline and decreasing fall risk.
The increased risk of serious falls was not accompanied by an increase in fractures, and the increased fall risk was similar across subgroups of aspirin users, the researchers said.
Low-dose aspirin’s failure to reduce the risk of fractures but increasing the risk of serious falls adds to evidence that this agent provides little favorable benefit in a healthy, White older adult population.
The study findings were limited by several factors including the relatively homogeneous older and healthy population, and possible insufficient study duration to allow for changes in fracture and fall risk, the researchers noted. Other potential limitations include that the dose of aspirin used in the study was too low to affect bone remodeling and the lack of data on bone density, rheumatoid arthritis, and osteoporosis, they said.
However, the results were strengthened by the large sample size and high participant retention rate, and represent the first known examination of data from a randomized, controlled trial of the effect of aspirin on fractures, they added.
Setting the stage for more research
Overall, “This study adds to the growing body of evidence from other studies that the use of aspirin in people who do not have a risk of cardiovascular disease or stroke provides little benefit,” said Dr. Barker, who is also a professor at Monash University, Melbourne, Australia. However, “Older adults with a medical reason to take aspirin should continue to do so,” she emphasized.
“The most important thing the study showed is the primary endpoint, which was that aspirin use does not have an effect on fracture risk,” said Neil Skolnik, MD, of Sidney Kimmel Medical College, Philadelphia, in an interview.
“The increase in serious falls, as defined by a fall resulting in a visit to a hospital, is likely due to an increased risk of bleeding after a fall on aspirin,” said Dr. Skolnik, who was not involved in the study. Dr. Skolnik added that the current study findings support the current recommendations of the United States Preventive Services Task Force, which he quoted as follows, “The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older.”
The study was supported by the National Institute on Aging and the National Cancer Institute at the National Institutes of Health; the National Health and Medical Research Council (Australia); Monash University; and the Victorian Cancer Agency. Lead author Dr. Barker was supported in part by the NHMRC and also disclosed grants from the NHMRC outside the current study. The ASPREE substudy also was supported by the University of Pittsburgh Claude D. Pepper Older American Independence Center and the Wake Forest University Claude D. Pepper Older Americans Independence Center. Bayer AG provided the aspirin used in the study but had no other role. Dr. Skolnik had no financial conflicts to disclose, but he serves on the editorial advisory board of Family Practice News.
Previous research suggests that aspirin may reduce the risk of fragility fractures by delaying bone loss, but the direct effects of aspirin on bone microarchitecture and the association between aspirin use and fracture risk in humans has not been explored, corresponding author Anna L. Barker, PhD, and colleagues wrote in their paper published in JAMA Internal Medicine.
Dr. Barker, who is executive director of research and innovation for Silverchain (a senior care program), said, in an interview, that she and her coauthors hypothesized “that aspirin could reduce both falls and fractures by reducing cardiovascular-associated physical and cognitive impairments and the anti-inflammatory properties mediating bone remodeling.”
Study methods and results
In the ASPREE-FRACTURE substudy, the authors examined the impact of daily low-dose aspirin (100 mg) on incidence of any fracture in more than 16,000 community-dwelling adults aged 70 years and older. A secondary endpoint was the incidence of serious falls, defined as falls requiring a hospital visit. Individuals with chronic illness and cardiovascular or cerebrovascular disease were excluded, as were those with dementia or other cognitive impairment, or a physical disability.
The study population included 16,703 participants enrolled in the larger Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial between 2010 and 2014. Of these, 8,322 were randomized to aspirin and 8,381 to a placebo. The median age was 74 years, and 55% of the participants were women.
Over a median follow-up of 4.6 years (76,219 total person-years), the risk of first fracture was similar between the aspirin and placebo groups (hazard ratio, 0.97), but the risk of serious falls was significantly higher in the aspirin group (884 falls vs. 804 falls, P = .01).
The incidence of first fracture was similar between the aspirin and placebo groups (813 vs. 718), as was the incidence of all fractures (1,394 and 1,471, respectively).
The results for both fractures and falls were essentially unchanged in a multivariate analysis controlling for variables known to affect fracture and fall risk and remained similar for different types of fractures (hip, trauma-related, nonpathological) as well, the researchers noted.
In their discussion, the researchers wrote that the clinical significance of the study is the inability of aspirin to reduce the risk of fractures in otherwise healthy older adults. They expressed surprise at the increase in serious falls, citing their hypothesis that the antiplatelet effects of aspirin may reduce cardiovascular and cerebrovascular events, thereby slowing physical decline and decreasing fall risk.
The increased risk of serious falls was not accompanied by an increase in fractures, and the increased fall risk was similar across subgroups of aspirin users, the researchers said.
Low-dose aspirin’s failure to reduce the risk of fractures but increasing the risk of serious falls adds to evidence that this agent provides little favorable benefit in a healthy, White older adult population.
The study findings were limited by several factors including the relatively homogeneous older and healthy population, and possible insufficient study duration to allow for changes in fracture and fall risk, the researchers noted. Other potential limitations include that the dose of aspirin used in the study was too low to affect bone remodeling and the lack of data on bone density, rheumatoid arthritis, and osteoporosis, they said.
However, the results were strengthened by the large sample size and high participant retention rate, and represent the first known examination of data from a randomized, controlled trial of the effect of aspirin on fractures, they added.
Setting the stage for more research
Overall, “This study adds to the growing body of evidence from other studies that the use of aspirin in people who do not have a risk of cardiovascular disease or stroke provides little benefit,” said Dr. Barker, who is also a professor at Monash University, Melbourne, Australia. However, “Older adults with a medical reason to take aspirin should continue to do so,” she emphasized.
“The most important thing the study showed is the primary endpoint, which was that aspirin use does not have an effect on fracture risk,” said Neil Skolnik, MD, of Sidney Kimmel Medical College, Philadelphia, in an interview.
“The increase in serious falls, as defined by a fall resulting in a visit to a hospital, is likely due to an increased risk of bleeding after a fall on aspirin,” said Dr. Skolnik, who was not involved in the study. Dr. Skolnik added that the current study findings support the current recommendations of the United States Preventive Services Task Force, which he quoted as follows, “The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older.”
The study was supported by the National Institute on Aging and the National Cancer Institute at the National Institutes of Health; the National Health and Medical Research Council (Australia); Monash University; and the Victorian Cancer Agency. Lead author Dr. Barker was supported in part by the NHMRC and also disclosed grants from the NHMRC outside the current study. The ASPREE substudy also was supported by the University of Pittsburgh Claude D. Pepper Older American Independence Center and the Wake Forest University Claude D. Pepper Older Americans Independence Center. Bayer AG provided the aspirin used in the study but had no other role. Dr. Skolnik had no financial conflicts to disclose, but he serves on the editorial advisory board of Family Practice News.
Previous research suggests that aspirin may reduce the risk of fragility fractures by delaying bone loss, but the direct effects of aspirin on bone microarchitecture and the association between aspirin use and fracture risk in humans has not been explored, corresponding author Anna L. Barker, PhD, and colleagues wrote in their paper published in JAMA Internal Medicine.
Dr. Barker, who is executive director of research and innovation for Silverchain (a senior care program), said, in an interview, that she and her coauthors hypothesized “that aspirin could reduce both falls and fractures by reducing cardiovascular-associated physical and cognitive impairments and the anti-inflammatory properties mediating bone remodeling.”
Study methods and results
In the ASPREE-FRACTURE substudy, the authors examined the impact of daily low-dose aspirin (100 mg) on incidence of any fracture in more than 16,000 community-dwelling adults aged 70 years and older. A secondary endpoint was the incidence of serious falls, defined as falls requiring a hospital visit. Individuals with chronic illness and cardiovascular or cerebrovascular disease were excluded, as were those with dementia or other cognitive impairment, or a physical disability.
The study population included 16,703 participants enrolled in the larger Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial between 2010 and 2014. Of these, 8,322 were randomized to aspirin and 8,381 to a placebo. The median age was 74 years, and 55% of the participants were women.
Over a median follow-up of 4.6 years (76,219 total person-years), the risk of first fracture was similar between the aspirin and placebo groups (hazard ratio, 0.97), but the risk of serious falls was significantly higher in the aspirin group (884 falls vs. 804 falls, P = .01).
The incidence of first fracture was similar between the aspirin and placebo groups (813 vs. 718), as was the incidence of all fractures (1,394 and 1,471, respectively).
The results for both fractures and falls were essentially unchanged in a multivariate analysis controlling for variables known to affect fracture and fall risk and remained similar for different types of fractures (hip, trauma-related, nonpathological) as well, the researchers noted.
In their discussion, the researchers wrote that the clinical significance of the study is the inability of aspirin to reduce the risk of fractures in otherwise healthy older adults. They expressed surprise at the increase in serious falls, citing their hypothesis that the antiplatelet effects of aspirin may reduce cardiovascular and cerebrovascular events, thereby slowing physical decline and decreasing fall risk.
The increased risk of serious falls was not accompanied by an increase in fractures, and the increased fall risk was similar across subgroups of aspirin users, the researchers said.
Low-dose aspirin’s failure to reduce the risk of fractures but increasing the risk of serious falls adds to evidence that this agent provides little favorable benefit in a healthy, White older adult population.
The study findings were limited by several factors including the relatively homogeneous older and healthy population, and possible insufficient study duration to allow for changes in fracture and fall risk, the researchers noted. Other potential limitations include that the dose of aspirin used in the study was too low to affect bone remodeling and the lack of data on bone density, rheumatoid arthritis, and osteoporosis, they said.
However, the results were strengthened by the large sample size and high participant retention rate, and represent the first known examination of data from a randomized, controlled trial of the effect of aspirin on fractures, they added.
Setting the stage for more research
Overall, “This study adds to the growing body of evidence from other studies that the use of aspirin in people who do not have a risk of cardiovascular disease or stroke provides little benefit,” said Dr. Barker, who is also a professor at Monash University, Melbourne, Australia. However, “Older adults with a medical reason to take aspirin should continue to do so,” she emphasized.
“The most important thing the study showed is the primary endpoint, which was that aspirin use does not have an effect on fracture risk,” said Neil Skolnik, MD, of Sidney Kimmel Medical College, Philadelphia, in an interview.
“The increase in serious falls, as defined by a fall resulting in a visit to a hospital, is likely due to an increased risk of bleeding after a fall on aspirin,” said Dr. Skolnik, who was not involved in the study. Dr. Skolnik added that the current study findings support the current recommendations of the United States Preventive Services Task Force, which he quoted as follows, “The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older.”
The study was supported by the National Institute on Aging and the National Cancer Institute at the National Institutes of Health; the National Health and Medical Research Council (Australia); Monash University; and the Victorian Cancer Agency. Lead author Dr. Barker was supported in part by the NHMRC and also disclosed grants from the NHMRC outside the current study. The ASPREE substudy also was supported by the University of Pittsburgh Claude D. Pepper Older American Independence Center and the Wake Forest University Claude D. Pepper Older Americans Independence Center. Bayer AG provided the aspirin used in the study but had no other role. Dr. Skolnik had no financial conflicts to disclose, but he serves on the editorial advisory board of Family Practice News.
FROM JAMA INTERNAL MEDICINE
Therapeutic drug monitoring pays off for arthritis patients
Therapeutic drug monitoring allowed patients with rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis to reduce their dosage of tumor necrosis factor–alpha (TNF) inhibitors, based on data from 239 individuals.
Use of TNF-alpha inhibitors improves treatment response for many arthritis patients but dosage is rarely adjusted on an individual level, which may lead to unnecessary overdosing in some patients, Mogens Pfeiffer-Jensen, MD, of Aarhus (Denmark) University Hospital, and colleagues wrote.
Data from previous studies suggest that therapeutic drug monitoring (TDM) based on serum trough levels may allow for dose optimization and dose reduction in inflammatory bowel disease patients, but data in patients with arthritis are lacking, they wrote.
In a study published in the Scandinavian Journal of Rheumatology, the researchers recruited 99 patients with RA, 48 with psoriatic arthritis (PsA), and 92 with spondyloarthritis (SpA). The participants were randomized to standard care or standard care plus TDM. Serum trough levels were assessed at baseline and at every 4 months, and prescription changes or drug switches were implemented based on these levels. At baseline, 81 patients were being treated with infliximab (Remicade and biosimilars), 79 with etanercept (Enbrel), and 79 with adalimumab (Humira).
The primary endpoint was reduced drug prescription after 48 weeks.
Overall, TDM significantly reduced prescription of infliximab by 12% (P = .001) and prescription of etanercept by 15% (P = .01), compared with standard care. TDM also prolonged the interdosing intervals of etanercept by 235% (P = .02) and of adalimumab by 28% (P = .04), compared with standard care.
TDM patients taking infliximab had more frequent dose reduction and less frequent dose increases during and after the study when compared with patients who stayed with standard care; similar trends were seen with adalimumab. TDM also accelerated the switch to other biologics for patients on all three medications.
No significant differences occurred in adverse events or hospitalizations between the TDM and standard care patients.
Clinical composite scores (Disease Activity Score based on 28 joints with C-reactive protein) were reduced in patients with RA and PsA who were taking adalimumab and randomized to TDM, but no other clinical outcome differences were noted. Scores on the Health Assessment Questionnaire and global Visual Analog Scale for pain were significantly lower in patients in the TDM group who were taking infliximab and adalimumab, “indicating equally or superior sustained remission across diagnoses,” the researchers emphasized.
The findings were limited by several factors, including the variations in pathophysiology and open-label design. “However, since the TDM was based on an objective serum value and decision procedures were clear, we do not consider the potential of unconscious bias to outweigh the benefits of dose-changing abilities,” they wrote.
The researchers expressed surprise that the reduced use of TNF-alpha inhibitors did not significantly reduce adverse events or serious adverse events, compared with standard care, but they proposed that standard of care may have taken adverse events into account, because all patients had received prescriptions at least 3 months before the study.
As for clinical implications, the current costs of the biochemical assays necessary for TDM may be a barrier to implementing TDM as a standard part of daily clinical practice, the researchers added. However, the study was strengthened by the inclusion of patients with RA, PsA, and SpA, and is the first known to include patients receiving etanercept or adalimumab in an examination of TDM.
“Our data support TDM based solely on serum trough levels in [TNF-alpha inhibitors] with different pharmacokinetics as a future key player in personalized medicine for chronic rheumatoid diseases treated with biologics,” they concluded.
The study was supported by Spydspidspuljen, Region Midt, Denmark, and Department of Rheumatology, Aarhus University Hospital. The researchers had no financial conflicts to disclose.
Therapeutic drug monitoring allowed patients with rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis to reduce their dosage of tumor necrosis factor–alpha (TNF) inhibitors, based on data from 239 individuals.
Use of TNF-alpha inhibitors improves treatment response for many arthritis patients but dosage is rarely adjusted on an individual level, which may lead to unnecessary overdosing in some patients, Mogens Pfeiffer-Jensen, MD, of Aarhus (Denmark) University Hospital, and colleagues wrote.
Data from previous studies suggest that therapeutic drug monitoring (TDM) based on serum trough levels may allow for dose optimization and dose reduction in inflammatory bowel disease patients, but data in patients with arthritis are lacking, they wrote.
In a study published in the Scandinavian Journal of Rheumatology, the researchers recruited 99 patients with RA, 48 with psoriatic arthritis (PsA), and 92 with spondyloarthritis (SpA). The participants were randomized to standard care or standard care plus TDM. Serum trough levels were assessed at baseline and at every 4 months, and prescription changes or drug switches were implemented based on these levels. At baseline, 81 patients were being treated with infliximab (Remicade and biosimilars), 79 with etanercept (Enbrel), and 79 with adalimumab (Humira).
The primary endpoint was reduced drug prescription after 48 weeks.
Overall, TDM significantly reduced prescription of infliximab by 12% (P = .001) and prescription of etanercept by 15% (P = .01), compared with standard care. TDM also prolonged the interdosing intervals of etanercept by 235% (P = .02) and of adalimumab by 28% (P = .04), compared with standard care.
TDM patients taking infliximab had more frequent dose reduction and less frequent dose increases during and after the study when compared with patients who stayed with standard care; similar trends were seen with adalimumab. TDM also accelerated the switch to other biologics for patients on all three medications.
No significant differences occurred in adverse events or hospitalizations between the TDM and standard care patients.
Clinical composite scores (Disease Activity Score based on 28 joints with C-reactive protein) were reduced in patients with RA and PsA who were taking adalimumab and randomized to TDM, but no other clinical outcome differences were noted. Scores on the Health Assessment Questionnaire and global Visual Analog Scale for pain were significantly lower in patients in the TDM group who were taking infliximab and adalimumab, “indicating equally or superior sustained remission across diagnoses,” the researchers emphasized.
The findings were limited by several factors, including the variations in pathophysiology and open-label design. “However, since the TDM was based on an objective serum value and decision procedures were clear, we do not consider the potential of unconscious bias to outweigh the benefits of dose-changing abilities,” they wrote.
The researchers expressed surprise that the reduced use of TNF-alpha inhibitors did not significantly reduce adverse events or serious adverse events, compared with standard care, but they proposed that standard of care may have taken adverse events into account, because all patients had received prescriptions at least 3 months before the study.
As for clinical implications, the current costs of the biochemical assays necessary for TDM may be a barrier to implementing TDM as a standard part of daily clinical practice, the researchers added. However, the study was strengthened by the inclusion of patients with RA, PsA, and SpA, and is the first known to include patients receiving etanercept or adalimumab in an examination of TDM.
“Our data support TDM based solely on serum trough levels in [TNF-alpha inhibitors] with different pharmacokinetics as a future key player in personalized medicine for chronic rheumatoid diseases treated with biologics,” they concluded.
The study was supported by Spydspidspuljen, Region Midt, Denmark, and Department of Rheumatology, Aarhus University Hospital. The researchers had no financial conflicts to disclose.
Therapeutic drug monitoring allowed patients with rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis to reduce their dosage of tumor necrosis factor–alpha (TNF) inhibitors, based on data from 239 individuals.
Use of TNF-alpha inhibitors improves treatment response for many arthritis patients but dosage is rarely adjusted on an individual level, which may lead to unnecessary overdosing in some patients, Mogens Pfeiffer-Jensen, MD, of Aarhus (Denmark) University Hospital, and colleagues wrote.
Data from previous studies suggest that therapeutic drug monitoring (TDM) based on serum trough levels may allow for dose optimization and dose reduction in inflammatory bowel disease patients, but data in patients with arthritis are lacking, they wrote.
In a study published in the Scandinavian Journal of Rheumatology, the researchers recruited 99 patients with RA, 48 with psoriatic arthritis (PsA), and 92 with spondyloarthritis (SpA). The participants were randomized to standard care or standard care plus TDM. Serum trough levels were assessed at baseline and at every 4 months, and prescription changes or drug switches were implemented based on these levels. At baseline, 81 patients were being treated with infliximab (Remicade and biosimilars), 79 with etanercept (Enbrel), and 79 with adalimumab (Humira).
The primary endpoint was reduced drug prescription after 48 weeks.
Overall, TDM significantly reduced prescription of infliximab by 12% (P = .001) and prescription of etanercept by 15% (P = .01), compared with standard care. TDM also prolonged the interdosing intervals of etanercept by 235% (P = .02) and of adalimumab by 28% (P = .04), compared with standard care.
TDM patients taking infliximab had more frequent dose reduction and less frequent dose increases during and after the study when compared with patients who stayed with standard care; similar trends were seen with adalimumab. TDM also accelerated the switch to other biologics for patients on all three medications.
No significant differences occurred in adverse events or hospitalizations between the TDM and standard care patients.
Clinical composite scores (Disease Activity Score based on 28 joints with C-reactive protein) were reduced in patients with RA and PsA who were taking adalimumab and randomized to TDM, but no other clinical outcome differences were noted. Scores on the Health Assessment Questionnaire and global Visual Analog Scale for pain were significantly lower in patients in the TDM group who were taking infliximab and adalimumab, “indicating equally or superior sustained remission across diagnoses,” the researchers emphasized.
The findings were limited by several factors, including the variations in pathophysiology and open-label design. “However, since the TDM was based on an objective serum value and decision procedures were clear, we do not consider the potential of unconscious bias to outweigh the benefits of dose-changing abilities,” they wrote.
The researchers expressed surprise that the reduced use of TNF-alpha inhibitors did not significantly reduce adverse events or serious adverse events, compared with standard care, but they proposed that standard of care may have taken adverse events into account, because all patients had received prescriptions at least 3 months before the study.
As for clinical implications, the current costs of the biochemical assays necessary for TDM may be a barrier to implementing TDM as a standard part of daily clinical practice, the researchers added. However, the study was strengthened by the inclusion of patients with RA, PsA, and SpA, and is the first known to include patients receiving etanercept or adalimumab in an examination of TDM.
“Our data support TDM based solely on serum trough levels in [TNF-alpha inhibitors] with different pharmacokinetics as a future key player in personalized medicine for chronic rheumatoid diseases treated with biologics,” they concluded.
The study was supported by Spydspidspuljen, Region Midt, Denmark, and Department of Rheumatology, Aarhus University Hospital. The researchers had no financial conflicts to disclose.
FROM THE SCANDINAVIAN JOURNAL OF RHEUMATOLOGY
Education about OTC tools key for patients with acne and rosacea
LAS VEGAS – , Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.
In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.
However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.
Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.
Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.
Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.
Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.
Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.
The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.
“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.
For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.
Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.
OTC products for rosacea
Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.
Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.
No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.
Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – , Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.
In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.
However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.
Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.
Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.
Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.
Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.
Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.
The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.
“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.
For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.
Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.
OTC products for rosacea
Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.
Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.
No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.
Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – , Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.
In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.
However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.
Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.
Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.
Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.
Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.
Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.
The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.
“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.
For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.
Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.
OTC products for rosacea
Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.
Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.
No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.
Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.
AT INNOVATIONS IN DERMATOLOGY