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Slight weight gain, no blood pressure increase with low-dose steroids for RA
Patients taking long-term, low-dose glucocorticoids for rheumatoid arthritis over 2 years had a very modest relative weight gain but no relative increase in blood pressure when compared with patients who did not take the drugs, according to findings from a combined study of randomized, controlled trials (RCTs).
“This pooled analysis of five RCTs in RA found that 2 years of low-dose glucocorticoid treatment [at 7.5 mg/day or less] leads to a modest weight gain of about 1 kg but has no effect on blood pressure,” lead study author Andriko Palmowski, MD, a physician and researcher in rheumatology and clinical immunology at Charité-Universitätsmedizin Berlin, and colleagues wrote in the study, published in Annals of Internal Medicine.
“Many clinicians fear using even low-dose glucocorticoids because of the adverse effects associated with their long-term use at higher doses,” noted Leslie J. Crofford, MD, professor of medicine, pathology, microbiology, and immunology, and director of the division of rheumatology and immunology at Vanderbilt University, Nashville, Tenn.
“Indeed, long-term use of even these low doses increases risk for many significant adverse effects, including osteoporosis and cataracts in observational cohorts,” added Dr. Crofford, who was not involved in the study.
Studies were combined for stronger results
Observational studies are prone to confounding, and the RCTs in the literature have been small, resulting in low statistical power, the authors explained.
To overcome these limitations, Dr. Palmowski and associates combined individual participant data from five RCTs of glucocorticoid treatment for RA in 12 countries in Europe. The 1,112 participants had early and established RA, averaged 61.4 years of age, and 68% were women. The GLORIA trial, an RCT that contributed about 40% of the overall study population, “explicitly included elderly patients and patients with multimorbidity who are often excluded from RA trials,” the authors wrote.
Participants in the intervention group took low-dose glucocorticoids (prednisone equivalent, ≤ 7.5 mg/day; three trials used a dose of 5 mg prednisone equivalent per day); and patients in the control groups took placebo, disease-modifying antirheumatic drugs, or both. The researchers compared change over 2 years in body weight and mean arterial pressure between the groups.
At 2 years, both groups gained weight, but participants who took glucocorticoids gained an average of 1.1 kg (P < .001) more than the controls. Mean arterial pressure increased by around 2 mm Hg in both groups, with a –0.4 mm Hg between-group difference (P = .187).
Daniel G. Arkfeld MD, DDS, professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, found this “a fascinating analysis” and called the lack of change in blood pressure important.
“Steroids are used less in RA due to perceived side effects. Yet many patients have ongoing synovitis and need steroids to enable them to work and perform other activities,” said Dr. Arkfeld, who also was not involved in the study. “NSAIDs are more of an issue, with up to 10% raising blood pressure. Should we be using more steroids and less NSAIDs?”
Dr. Arkfeld also was concerned that the small 2-year weight gain may become significant over time.
Kim Marie Huffman, MD, PhD, associate professor of medicine at Duke University, Durham, N.C., agreed.
“More investigations and longer (or shorter) time periods may have yielded additional findings,” said Dr. Huffman, who also was not involved in the study. “Efforts should be made to minimize long-term prednisone use to minimize impact on weight gain and resulting consequences.”
Are these results applicable to U.S. patients?
“Low-dose prednisone is commonly used in the U.S.,” Dr. Huffman said. “Extrapolating the results to a U.S. population is probably fine.”
Dr. Arkfeld agreed that the results can be used to treat U.S. patients because of the large number of study participants.
According to Rebecca B. Blank, MD, PhD, rheumatologist and instructor of medicine at NYU Langone Health, New York, this is an important study. But she cautioned that the literature does not contain good data for other potential harmful effects of long-term, low-dose glucocorticoid use. “Therefore, as per both ACR [American College of Rheumatology] and EULAR [European Alliance of Associations for Rheumatology] recommendations, we should still try to limit glucocorticoids to the lowest dose and shortest duration possible in our RA patients,” advised Dr. Blank, who was not an author in the study.
Strengths, weaknesses, and thoughts on further research
“Pooling trials can be tricky, but these investigators used individual-level data, which increases the rigor of the analyses,” Dr. Crofford noted. “There were differences in patient populations and with the glucocorticoid doses and routes of administration. The fact that the patients in each of the studies were randomized is very important in determining if the outcomes can be attributed to the drugs or could be the results of other exposures.”
Dr. Arkfeld would like to know whether early versus late RA patients may have different results because they may have different pathophysiologies.
Dr. Huffman is interested in low-dose glucocorticoids’ impacts on glucose homeostasis, bone density, infection, and other common adverse effects.
In an accompanying editorial, David Fernandez, MD, PhD, of Hospital for Special Surgery, New York, wrote: “These findings provide a more quantifiable assessment of the potential adverse effects of steroid therapy than had existed previously and will be helpful to providers and patients as they decide on the relative risks and benefits of glucocorticoids as part of their therapy plan in rheumatoid arthritis.”
The study received no specific funding. Four of the study’s 13 authors reported financial relationships with pharmaceutical companies. Dr. Fernandez and all outside experts who commented on the study reported no relevant financial relationships.
Patients taking long-term, low-dose glucocorticoids for rheumatoid arthritis over 2 years had a very modest relative weight gain but no relative increase in blood pressure when compared with patients who did not take the drugs, according to findings from a combined study of randomized, controlled trials (RCTs).
“This pooled analysis of five RCTs in RA found that 2 years of low-dose glucocorticoid treatment [at 7.5 mg/day or less] leads to a modest weight gain of about 1 kg but has no effect on blood pressure,” lead study author Andriko Palmowski, MD, a physician and researcher in rheumatology and clinical immunology at Charité-Universitätsmedizin Berlin, and colleagues wrote in the study, published in Annals of Internal Medicine.
“Many clinicians fear using even low-dose glucocorticoids because of the adverse effects associated with their long-term use at higher doses,” noted Leslie J. Crofford, MD, professor of medicine, pathology, microbiology, and immunology, and director of the division of rheumatology and immunology at Vanderbilt University, Nashville, Tenn.
“Indeed, long-term use of even these low doses increases risk for many significant adverse effects, including osteoporosis and cataracts in observational cohorts,” added Dr. Crofford, who was not involved in the study.
Studies were combined for stronger results
Observational studies are prone to confounding, and the RCTs in the literature have been small, resulting in low statistical power, the authors explained.
To overcome these limitations, Dr. Palmowski and associates combined individual participant data from five RCTs of glucocorticoid treatment for RA in 12 countries in Europe. The 1,112 participants had early and established RA, averaged 61.4 years of age, and 68% were women. The GLORIA trial, an RCT that contributed about 40% of the overall study population, “explicitly included elderly patients and patients with multimorbidity who are often excluded from RA trials,” the authors wrote.
Participants in the intervention group took low-dose glucocorticoids (prednisone equivalent, ≤ 7.5 mg/day; three trials used a dose of 5 mg prednisone equivalent per day); and patients in the control groups took placebo, disease-modifying antirheumatic drugs, or both. The researchers compared change over 2 years in body weight and mean arterial pressure between the groups.
At 2 years, both groups gained weight, but participants who took glucocorticoids gained an average of 1.1 kg (P < .001) more than the controls. Mean arterial pressure increased by around 2 mm Hg in both groups, with a –0.4 mm Hg between-group difference (P = .187).
Daniel G. Arkfeld MD, DDS, professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, found this “a fascinating analysis” and called the lack of change in blood pressure important.
“Steroids are used less in RA due to perceived side effects. Yet many patients have ongoing synovitis and need steroids to enable them to work and perform other activities,” said Dr. Arkfeld, who also was not involved in the study. “NSAIDs are more of an issue, with up to 10% raising blood pressure. Should we be using more steroids and less NSAIDs?”
Dr. Arkfeld also was concerned that the small 2-year weight gain may become significant over time.
Kim Marie Huffman, MD, PhD, associate professor of medicine at Duke University, Durham, N.C., agreed.
“More investigations and longer (or shorter) time periods may have yielded additional findings,” said Dr. Huffman, who also was not involved in the study. “Efforts should be made to minimize long-term prednisone use to minimize impact on weight gain and resulting consequences.”
Are these results applicable to U.S. patients?
“Low-dose prednisone is commonly used in the U.S.,” Dr. Huffman said. “Extrapolating the results to a U.S. population is probably fine.”
Dr. Arkfeld agreed that the results can be used to treat U.S. patients because of the large number of study participants.
According to Rebecca B. Blank, MD, PhD, rheumatologist and instructor of medicine at NYU Langone Health, New York, this is an important study. But she cautioned that the literature does not contain good data for other potential harmful effects of long-term, low-dose glucocorticoid use. “Therefore, as per both ACR [American College of Rheumatology] and EULAR [European Alliance of Associations for Rheumatology] recommendations, we should still try to limit glucocorticoids to the lowest dose and shortest duration possible in our RA patients,” advised Dr. Blank, who was not an author in the study.
Strengths, weaknesses, and thoughts on further research
“Pooling trials can be tricky, but these investigators used individual-level data, which increases the rigor of the analyses,” Dr. Crofford noted. “There were differences in patient populations and with the glucocorticoid doses and routes of administration. The fact that the patients in each of the studies were randomized is very important in determining if the outcomes can be attributed to the drugs or could be the results of other exposures.”
Dr. Arkfeld would like to know whether early versus late RA patients may have different results because they may have different pathophysiologies.
Dr. Huffman is interested in low-dose glucocorticoids’ impacts on glucose homeostasis, bone density, infection, and other common adverse effects.
In an accompanying editorial, David Fernandez, MD, PhD, of Hospital for Special Surgery, New York, wrote: “These findings provide a more quantifiable assessment of the potential adverse effects of steroid therapy than had existed previously and will be helpful to providers and patients as they decide on the relative risks and benefits of glucocorticoids as part of their therapy plan in rheumatoid arthritis.”
The study received no specific funding. Four of the study’s 13 authors reported financial relationships with pharmaceutical companies. Dr. Fernandez and all outside experts who commented on the study reported no relevant financial relationships.
Patients taking long-term, low-dose glucocorticoids for rheumatoid arthritis over 2 years had a very modest relative weight gain but no relative increase in blood pressure when compared with patients who did not take the drugs, according to findings from a combined study of randomized, controlled trials (RCTs).
“This pooled analysis of five RCTs in RA found that 2 years of low-dose glucocorticoid treatment [at 7.5 mg/day or less] leads to a modest weight gain of about 1 kg but has no effect on blood pressure,” lead study author Andriko Palmowski, MD, a physician and researcher in rheumatology and clinical immunology at Charité-Universitätsmedizin Berlin, and colleagues wrote in the study, published in Annals of Internal Medicine.
“Many clinicians fear using even low-dose glucocorticoids because of the adverse effects associated with their long-term use at higher doses,” noted Leslie J. Crofford, MD, professor of medicine, pathology, microbiology, and immunology, and director of the division of rheumatology and immunology at Vanderbilt University, Nashville, Tenn.
“Indeed, long-term use of even these low doses increases risk for many significant adverse effects, including osteoporosis and cataracts in observational cohorts,” added Dr. Crofford, who was not involved in the study.
Studies were combined for stronger results
Observational studies are prone to confounding, and the RCTs in the literature have been small, resulting in low statistical power, the authors explained.
To overcome these limitations, Dr. Palmowski and associates combined individual participant data from five RCTs of glucocorticoid treatment for RA in 12 countries in Europe. The 1,112 participants had early and established RA, averaged 61.4 years of age, and 68% were women. The GLORIA trial, an RCT that contributed about 40% of the overall study population, “explicitly included elderly patients and patients with multimorbidity who are often excluded from RA trials,” the authors wrote.
Participants in the intervention group took low-dose glucocorticoids (prednisone equivalent, ≤ 7.5 mg/day; three trials used a dose of 5 mg prednisone equivalent per day); and patients in the control groups took placebo, disease-modifying antirheumatic drugs, or both. The researchers compared change over 2 years in body weight and mean arterial pressure between the groups.
At 2 years, both groups gained weight, but participants who took glucocorticoids gained an average of 1.1 kg (P < .001) more than the controls. Mean arterial pressure increased by around 2 mm Hg in both groups, with a –0.4 mm Hg between-group difference (P = .187).
Daniel G. Arkfeld MD, DDS, professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, found this “a fascinating analysis” and called the lack of change in blood pressure important.
“Steroids are used less in RA due to perceived side effects. Yet many patients have ongoing synovitis and need steroids to enable them to work and perform other activities,” said Dr. Arkfeld, who also was not involved in the study. “NSAIDs are more of an issue, with up to 10% raising blood pressure. Should we be using more steroids and less NSAIDs?”
Dr. Arkfeld also was concerned that the small 2-year weight gain may become significant over time.
Kim Marie Huffman, MD, PhD, associate professor of medicine at Duke University, Durham, N.C., agreed.
“More investigations and longer (or shorter) time periods may have yielded additional findings,” said Dr. Huffman, who also was not involved in the study. “Efforts should be made to minimize long-term prednisone use to minimize impact on weight gain and resulting consequences.”
Are these results applicable to U.S. patients?
“Low-dose prednisone is commonly used in the U.S.,” Dr. Huffman said. “Extrapolating the results to a U.S. population is probably fine.”
Dr. Arkfeld agreed that the results can be used to treat U.S. patients because of the large number of study participants.
According to Rebecca B. Blank, MD, PhD, rheumatologist and instructor of medicine at NYU Langone Health, New York, this is an important study. But she cautioned that the literature does not contain good data for other potential harmful effects of long-term, low-dose glucocorticoid use. “Therefore, as per both ACR [American College of Rheumatology] and EULAR [European Alliance of Associations for Rheumatology] recommendations, we should still try to limit glucocorticoids to the lowest dose and shortest duration possible in our RA patients,” advised Dr. Blank, who was not an author in the study.
Strengths, weaknesses, and thoughts on further research
“Pooling trials can be tricky, but these investigators used individual-level data, which increases the rigor of the analyses,” Dr. Crofford noted. “There were differences in patient populations and with the glucocorticoid doses and routes of administration. The fact that the patients in each of the studies were randomized is very important in determining if the outcomes can be attributed to the drugs or could be the results of other exposures.”
Dr. Arkfeld would like to know whether early versus late RA patients may have different results because they may have different pathophysiologies.
Dr. Huffman is interested in low-dose glucocorticoids’ impacts on glucose homeostasis, bone density, infection, and other common adverse effects.
In an accompanying editorial, David Fernandez, MD, PhD, of Hospital for Special Surgery, New York, wrote: “These findings provide a more quantifiable assessment of the potential adverse effects of steroid therapy than had existed previously and will be helpful to providers and patients as they decide on the relative risks and benefits of glucocorticoids as part of their therapy plan in rheumatoid arthritis.”
The study received no specific funding. Four of the study’s 13 authors reported financial relationships with pharmaceutical companies. Dr. Fernandez and all outside experts who commented on the study reported no relevant financial relationships.
FROM ANNALS OF INTERNAL MEDICINE
Dupilumab gains off-label uses as clinicians turn to drug for more indications
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
We asked doctors using AI scribes: Just how good are they?
Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.
The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.
All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.
“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”
You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).
Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.
These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.
The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.
But do these tools fulfill that promise?
According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
A tech solution for a tech problem
“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.
Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.
Enter AI scribes.
“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”
While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.
But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”
Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.
“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.
The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
What’s it like to use an AI medical scribe?
The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.
In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.
Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.
At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.
The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.
Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
How accurate are AI notes?
The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.
“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”
Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.
Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
Should you let patients know they’re being recorded?
The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.
But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.
All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
How much do AI scribes cost?
As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.
Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.
Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.
In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”
A version of this article appeared on Medscape.com.
Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.
The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.
All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.
“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”
You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).
Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.
These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.
The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.
But do these tools fulfill that promise?
According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
A tech solution for a tech problem
“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.
Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.
Enter AI scribes.
“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”
While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.
But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”
Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.
“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.
The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
What’s it like to use an AI medical scribe?
The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.
In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.
Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.
At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.
The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.
Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
How accurate are AI notes?
The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.
“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”
Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.
Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
Should you let patients know they’re being recorded?
The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.
But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.
All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
How much do AI scribes cost?
As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.
Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.
Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.
In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”
A version of this article appeared on Medscape.com.
Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.
The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.
All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.
“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”
You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).
Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.
These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.
The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.
But do these tools fulfill that promise?
According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
A tech solution for a tech problem
“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.
Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.
Enter AI scribes.
“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”
While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.
But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”
Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.
“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.
The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
What’s it like to use an AI medical scribe?
The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.
In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.
Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.
At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.
The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.
Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
How accurate are AI notes?
The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.
“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”
Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.
Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
Should you let patients know they’re being recorded?
The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.
But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.
All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
How much do AI scribes cost?
As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.
Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.
Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.
In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”
A version of this article appeared on Medscape.com.
Many users of skin-lightening product unaware of risks
, a recent cross-sectional survey suggests.
Skin lightening – which uses chemicals to lighten dark areas of skin or to generally lighten skin tone – poses a health risk from potentially unsafe formulations, the authors write in the International Journal of Women’s Dermatology.
Skin lightening is “influenced by colorism, the system of inequality that affords opportunities and privileges to lighter-skinned individuals across racial/ethnic groups,” they add. “Women, in particular, are vulnerable as media and popular culture propagate beauty standards that lighter skin can elevate physical appearance and social acceptance.”
“It is important to recognize that the primary motivator for skin lightening is most often dermatological disease but that, less frequently, it can be colorism,” senior study author Roopal V. Kundu, MD, professor of dermatology and founding director of the Northwestern Center for Ethnic Skin and Hair at Northwestern University, Chicago, said in an email interview.
Skin lightening is a growing, multibillion-dollar, largely unregulated, global industry. Rates have been estimated at 27% in South Africa, 40% in China and South Korea, 77% in Nigeria, but U.S. rates are unknown.
To investigate skin-lightening habits and the role colorism plays in skin-lightening practices in the United States, Dr. Kundu and her colleagues sent an online survey to 578 adults with darker skin who participated in ResearchMatch, a national health registry supported by the National Institutes of Health that connects volunteers with research studies they choose to take part in.
Of the 455 people who completed the 19-item anonymous questionnaire, 238 (52.3%) identified as Black or African American, 83 (18.2%) as Asian, 84 (18.5%) as multiracial, 31 (6.8%) as Hispanic, 14 (3.1%) as American Indian or Alaska Native, and 5 (1.1%) as other. Overall, 364 (80.0%) were women.
The survey asked about demographics, colorism attitudes, skin tone satisfaction, and skin-lightening product use. To assess colorism attitudes, the researchers asked respondents to rate six colorism statements on a Likert scale of 1 (strongly disagree) to 5 (strongly agree). The statements included “Lighter skin tone increases one’s self-esteem,” and “Lighter skin tone increases one’s chance of having a romantic relationship or getting married.” The researchers also asked them to rate their skin satisfaction levels on a Likert scale from 1 (very unsatisfied) to 5 (very satisfied).
Used mostly to treat skin conditions
Despite a lack of medical input, about three-quarters of people who used skin-lightening products reported using them for medical conditions, and around one-quarter used them for general lightening, the researchers report.
Of all respondents, 97 (21.3%) reported using skin-lightening agents. Of them, 71 (73.2%) used them to treat a skin condition such as acne, melasma, or postinflammatory hyperpigmentation, and 26 (26.8% of skin-lightening product users; 5.7% of all respondents) used them for generalized skin lightening.
The 97 users mostly obtained skin-lightening products from chain pharmacy and grocery stores, and also from community beauty stores, abroad, online, and medical providers, while two made them at home.
Skin-lightening product use did not differ with age, gender, race or ethnicity, education level, or immigration status.
Only 22 (22.7%) of the product users consulted a medical provider before using the products, and only 14 (14.4%) received skin-lightening products from medical providers.
In addition, 44 respondents (45.4%) could not identify the active ingredient in their skin-lightening products, but 34 (35.1%) reported using hydroquinone-based products. Other reported active ingredients included ascorbic acid, glycolic acid, salicylic acid, niacinamide, steroids, and mercury.
The face (86 people or 88.7%) and neck (37 or 38.1%) were the most common application sites.
Skin-lightening users were more likely to report that lighter skin was more beautiful and that it increased self-esteem and romantic prospects (P < .001 for all).
Elma Baron, MD, professor of dermatology at Case Western Reserve University, Cleveland, advised doctors to remind patients to consult a dermatologist before they use skin-lightening agents. “A dermatologist can evaluate whether there is a true indication for skin-lightening agents and explain the benefits, risks, and limitations of common skin-lightening formulations.
“When dealing with hyperpigmentation, clinicians should remember that ultraviolet light is a potent stimulus for melanogenesis,” added Dr. Baron by email. She was not involved in the study. “Wearing hats and other sun-protective clothing, using sunscreen, and avoiding sunlight during peak hours must always be emphasized.”
Amy J. McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., often sees patients who try products based on persuasive advertising, not scientific benefit, she said by email.
“The findings are important, because many primary care providers and dermatologists do not realize that patients will use skin-lightening agents simply to provide a glow and in an attempt to attain complexion blending,” added Dr. McMichael, also not involved in the study.
She encouraged doctors to understand what motivates their patients to use skin-lightening agents, so they can effectively communicate what works and what does not work for their condition, as well as inform them about potential risks.
Strengths of the study, Dr. McMichael said, are the number of people surveyed and the inclusion of colorism data not typically gathered in studies of skin-lightening product use. Limitations include whether the reported conditions were what people actually had, and that, with over 50% of respondents being Black, the results may not be generalizable to other groups.
“Colorism is complex,” Dr. Kundu noted. “Dermatologists need to recognize how colorism impacts their patients, so they can provide them with culturally mindful care and deter them from using potentially harmful products.”
Illegal products may still be available
Dr. McMichael would like to know how many of these patients used products containing > 4%-strength hydroquinone, because they “can be dangerous, and patients don’t understand how these higher-strength medications can damage the skin.”
“Following the Coronavirus Aid, Relief, and Economic Security [CARES] Act of 2020, over-the-counter hydroquinone sales were prohibited in the U.S.,” the authors write. In 2022, the Food and Drug Administration issued warning letters to 12 companies that sold products containing unsafe concentrations of hydroquinone, because of concerns about swelling, rashes, and discoloration. Hydroquinone has also been linked with skin cancer.
“However, this study demonstrates that consumers in the U.S. may still have access to hydroquinone formulations,” the authors caution.
At its Skin Facts! Resources website, the FDA warns about potentially harmful over-the-counter skin-lightening products containing hydroquinone or mercury and recommends using only prescribed products. The information site was created by the FDA Office of Minority Health and Health Equity.
The study authors, Dr. Baron, and Dr. McMichael report no relevant financial relationships. The study did not receive external funding. All experts commented by email.
, a recent cross-sectional survey suggests.
Skin lightening – which uses chemicals to lighten dark areas of skin or to generally lighten skin tone – poses a health risk from potentially unsafe formulations, the authors write in the International Journal of Women’s Dermatology.
Skin lightening is “influenced by colorism, the system of inequality that affords opportunities and privileges to lighter-skinned individuals across racial/ethnic groups,” they add. “Women, in particular, are vulnerable as media and popular culture propagate beauty standards that lighter skin can elevate physical appearance and social acceptance.”
“It is important to recognize that the primary motivator for skin lightening is most often dermatological disease but that, less frequently, it can be colorism,” senior study author Roopal V. Kundu, MD, professor of dermatology and founding director of the Northwestern Center for Ethnic Skin and Hair at Northwestern University, Chicago, said in an email interview.
Skin lightening is a growing, multibillion-dollar, largely unregulated, global industry. Rates have been estimated at 27% in South Africa, 40% in China and South Korea, 77% in Nigeria, but U.S. rates are unknown.
To investigate skin-lightening habits and the role colorism plays in skin-lightening practices in the United States, Dr. Kundu and her colleagues sent an online survey to 578 adults with darker skin who participated in ResearchMatch, a national health registry supported by the National Institutes of Health that connects volunteers with research studies they choose to take part in.
Of the 455 people who completed the 19-item anonymous questionnaire, 238 (52.3%) identified as Black or African American, 83 (18.2%) as Asian, 84 (18.5%) as multiracial, 31 (6.8%) as Hispanic, 14 (3.1%) as American Indian or Alaska Native, and 5 (1.1%) as other. Overall, 364 (80.0%) were women.
The survey asked about demographics, colorism attitudes, skin tone satisfaction, and skin-lightening product use. To assess colorism attitudes, the researchers asked respondents to rate six colorism statements on a Likert scale of 1 (strongly disagree) to 5 (strongly agree). The statements included “Lighter skin tone increases one’s self-esteem,” and “Lighter skin tone increases one’s chance of having a romantic relationship or getting married.” The researchers also asked them to rate their skin satisfaction levels on a Likert scale from 1 (very unsatisfied) to 5 (very satisfied).
Used mostly to treat skin conditions
Despite a lack of medical input, about three-quarters of people who used skin-lightening products reported using them for medical conditions, and around one-quarter used them for general lightening, the researchers report.
Of all respondents, 97 (21.3%) reported using skin-lightening agents. Of them, 71 (73.2%) used them to treat a skin condition such as acne, melasma, or postinflammatory hyperpigmentation, and 26 (26.8% of skin-lightening product users; 5.7% of all respondents) used them for generalized skin lightening.
The 97 users mostly obtained skin-lightening products from chain pharmacy and grocery stores, and also from community beauty stores, abroad, online, and medical providers, while two made them at home.
Skin-lightening product use did not differ with age, gender, race or ethnicity, education level, or immigration status.
Only 22 (22.7%) of the product users consulted a medical provider before using the products, and only 14 (14.4%) received skin-lightening products from medical providers.
In addition, 44 respondents (45.4%) could not identify the active ingredient in their skin-lightening products, but 34 (35.1%) reported using hydroquinone-based products. Other reported active ingredients included ascorbic acid, glycolic acid, salicylic acid, niacinamide, steroids, and mercury.
The face (86 people or 88.7%) and neck (37 or 38.1%) were the most common application sites.
Skin-lightening users were more likely to report that lighter skin was more beautiful and that it increased self-esteem and romantic prospects (P < .001 for all).
Elma Baron, MD, professor of dermatology at Case Western Reserve University, Cleveland, advised doctors to remind patients to consult a dermatologist before they use skin-lightening agents. “A dermatologist can evaluate whether there is a true indication for skin-lightening agents and explain the benefits, risks, and limitations of common skin-lightening formulations.
“When dealing with hyperpigmentation, clinicians should remember that ultraviolet light is a potent stimulus for melanogenesis,” added Dr. Baron by email. She was not involved in the study. “Wearing hats and other sun-protective clothing, using sunscreen, and avoiding sunlight during peak hours must always be emphasized.”
Amy J. McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., often sees patients who try products based on persuasive advertising, not scientific benefit, she said by email.
“The findings are important, because many primary care providers and dermatologists do not realize that patients will use skin-lightening agents simply to provide a glow and in an attempt to attain complexion blending,” added Dr. McMichael, also not involved in the study.
She encouraged doctors to understand what motivates their patients to use skin-lightening agents, so they can effectively communicate what works and what does not work for their condition, as well as inform them about potential risks.
Strengths of the study, Dr. McMichael said, are the number of people surveyed and the inclusion of colorism data not typically gathered in studies of skin-lightening product use. Limitations include whether the reported conditions were what people actually had, and that, with over 50% of respondents being Black, the results may not be generalizable to other groups.
“Colorism is complex,” Dr. Kundu noted. “Dermatologists need to recognize how colorism impacts their patients, so they can provide them with culturally mindful care and deter them from using potentially harmful products.”
Illegal products may still be available
Dr. McMichael would like to know how many of these patients used products containing > 4%-strength hydroquinone, because they “can be dangerous, and patients don’t understand how these higher-strength medications can damage the skin.”
“Following the Coronavirus Aid, Relief, and Economic Security [CARES] Act of 2020, over-the-counter hydroquinone sales were prohibited in the U.S.,” the authors write. In 2022, the Food and Drug Administration issued warning letters to 12 companies that sold products containing unsafe concentrations of hydroquinone, because of concerns about swelling, rashes, and discoloration. Hydroquinone has also been linked with skin cancer.
“However, this study demonstrates that consumers in the U.S. may still have access to hydroquinone formulations,” the authors caution.
At its Skin Facts! Resources website, the FDA warns about potentially harmful over-the-counter skin-lightening products containing hydroquinone or mercury and recommends using only prescribed products. The information site was created by the FDA Office of Minority Health and Health Equity.
The study authors, Dr. Baron, and Dr. McMichael report no relevant financial relationships. The study did not receive external funding. All experts commented by email.
, a recent cross-sectional survey suggests.
Skin lightening – which uses chemicals to lighten dark areas of skin or to generally lighten skin tone – poses a health risk from potentially unsafe formulations, the authors write in the International Journal of Women’s Dermatology.
Skin lightening is “influenced by colorism, the system of inequality that affords opportunities and privileges to lighter-skinned individuals across racial/ethnic groups,” they add. “Women, in particular, are vulnerable as media and popular culture propagate beauty standards that lighter skin can elevate physical appearance and social acceptance.”
“It is important to recognize that the primary motivator for skin lightening is most often dermatological disease but that, less frequently, it can be colorism,” senior study author Roopal V. Kundu, MD, professor of dermatology and founding director of the Northwestern Center for Ethnic Skin and Hair at Northwestern University, Chicago, said in an email interview.
Skin lightening is a growing, multibillion-dollar, largely unregulated, global industry. Rates have been estimated at 27% in South Africa, 40% in China and South Korea, 77% in Nigeria, but U.S. rates are unknown.
To investigate skin-lightening habits and the role colorism plays in skin-lightening practices in the United States, Dr. Kundu and her colleagues sent an online survey to 578 adults with darker skin who participated in ResearchMatch, a national health registry supported by the National Institutes of Health that connects volunteers with research studies they choose to take part in.
Of the 455 people who completed the 19-item anonymous questionnaire, 238 (52.3%) identified as Black or African American, 83 (18.2%) as Asian, 84 (18.5%) as multiracial, 31 (6.8%) as Hispanic, 14 (3.1%) as American Indian or Alaska Native, and 5 (1.1%) as other. Overall, 364 (80.0%) were women.
The survey asked about demographics, colorism attitudes, skin tone satisfaction, and skin-lightening product use. To assess colorism attitudes, the researchers asked respondents to rate six colorism statements on a Likert scale of 1 (strongly disagree) to 5 (strongly agree). The statements included “Lighter skin tone increases one’s self-esteem,” and “Lighter skin tone increases one’s chance of having a romantic relationship or getting married.” The researchers also asked them to rate their skin satisfaction levels on a Likert scale from 1 (very unsatisfied) to 5 (very satisfied).
Used mostly to treat skin conditions
Despite a lack of medical input, about three-quarters of people who used skin-lightening products reported using them for medical conditions, and around one-quarter used them for general lightening, the researchers report.
Of all respondents, 97 (21.3%) reported using skin-lightening agents. Of them, 71 (73.2%) used them to treat a skin condition such as acne, melasma, or postinflammatory hyperpigmentation, and 26 (26.8% of skin-lightening product users; 5.7% of all respondents) used them for generalized skin lightening.
The 97 users mostly obtained skin-lightening products from chain pharmacy and grocery stores, and also from community beauty stores, abroad, online, and medical providers, while two made them at home.
Skin-lightening product use did not differ with age, gender, race or ethnicity, education level, or immigration status.
Only 22 (22.7%) of the product users consulted a medical provider before using the products, and only 14 (14.4%) received skin-lightening products from medical providers.
In addition, 44 respondents (45.4%) could not identify the active ingredient in their skin-lightening products, but 34 (35.1%) reported using hydroquinone-based products. Other reported active ingredients included ascorbic acid, glycolic acid, salicylic acid, niacinamide, steroids, and mercury.
The face (86 people or 88.7%) and neck (37 or 38.1%) were the most common application sites.
Skin-lightening users were more likely to report that lighter skin was more beautiful and that it increased self-esteem and romantic prospects (P < .001 for all).
Elma Baron, MD, professor of dermatology at Case Western Reserve University, Cleveland, advised doctors to remind patients to consult a dermatologist before they use skin-lightening agents. “A dermatologist can evaluate whether there is a true indication for skin-lightening agents and explain the benefits, risks, and limitations of common skin-lightening formulations.
“When dealing with hyperpigmentation, clinicians should remember that ultraviolet light is a potent stimulus for melanogenesis,” added Dr. Baron by email. She was not involved in the study. “Wearing hats and other sun-protective clothing, using sunscreen, and avoiding sunlight during peak hours must always be emphasized.”
Amy J. McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., often sees patients who try products based on persuasive advertising, not scientific benefit, she said by email.
“The findings are important, because many primary care providers and dermatologists do not realize that patients will use skin-lightening agents simply to provide a glow and in an attempt to attain complexion blending,” added Dr. McMichael, also not involved in the study.
She encouraged doctors to understand what motivates their patients to use skin-lightening agents, so they can effectively communicate what works and what does not work for their condition, as well as inform them about potential risks.
Strengths of the study, Dr. McMichael said, are the number of people surveyed and the inclusion of colorism data not typically gathered in studies of skin-lightening product use. Limitations include whether the reported conditions were what people actually had, and that, with over 50% of respondents being Black, the results may not be generalizable to other groups.
“Colorism is complex,” Dr. Kundu noted. “Dermatologists need to recognize how colorism impacts their patients, so they can provide them with culturally mindful care and deter them from using potentially harmful products.”
Illegal products may still be available
Dr. McMichael would like to know how many of these patients used products containing > 4%-strength hydroquinone, because they “can be dangerous, and patients don’t understand how these higher-strength medications can damage the skin.”
“Following the Coronavirus Aid, Relief, and Economic Security [CARES] Act of 2020, over-the-counter hydroquinone sales were prohibited in the U.S.,” the authors write. In 2022, the Food and Drug Administration issued warning letters to 12 companies that sold products containing unsafe concentrations of hydroquinone, because of concerns about swelling, rashes, and discoloration. Hydroquinone has also been linked with skin cancer.
“However, this study demonstrates that consumers in the U.S. may still have access to hydroquinone formulations,” the authors caution.
At its Skin Facts! Resources website, the FDA warns about potentially harmful over-the-counter skin-lightening products containing hydroquinone or mercury and recommends using only prescribed products. The information site was created by the FDA Office of Minority Health and Health Equity.
The study authors, Dr. Baron, and Dr. McMichael report no relevant financial relationships. The study did not receive external funding. All experts commented by email.
FROM THE INTERNATIONAL JOURNAL OF WOMEN’S DERMATOLOGY
Does screening kids with acute sinusitis symptoms for bacterial infection cut unnecessary antibiotic use?
Testing children with acute sinusitis symptoms for specific bacteria may dramatically decrease unnecessary antibiotic use, new research suggests.
The study, published in JAMA, found that children with positive nasopharyngeal tests for one or more of Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis had better resolution of symptoms with antibiotics than those without these bacteria.
If antibiotic use was limited to children with H. influenzae or S. pneumoniae in their nasopharynx at the time of diagnosis, antibiotic use would decrease by 53%, according to the study authors.
Sinusitis is common in children, and symptoms are similar with uncomplicated viral upper respiratory infections.
“We have not had a good way to predict which children will benefit from antibiotics,” said Nader Shaikh, MD, MPH, professor of pediatrics and clinical and translational science at the University of Pittsburgh, and the lead study author. “When a child comes in with a sore throat, we test for strep. If the test is positive, we prescribe antibiotics.”
Dr. Shaikh and his colleagues found that the same approach – swabbing the nose and testing for various bacteria – worked for children with sinusitis.
“Children who tested negative for bacteria did not benefit from antibiotics,” Dr. Shaikh said.
In the double-blind clinical trial, Dr. Shaikh and his colleagues randomized 510 children between ages 2 and 11 with acute sinusitis at six academic primary care offices over a 6-year period. Almost two-thirds of participants were between ages 2 and 5, around half were male, and around half were White. All participants had an initial score of nine or higher on the validated Pediatric Rhinosinusitis Symptom Scale (PRSS).
For 10 days, 254 children received oral amoxicillin (90 mg/kg/day) and clavulanate (6.4mg/kg/day) and 256 received placebo.
In children receiving antibiotics, symptoms resolved over a median of 7 days, compared with 9 days for those given placebo (P = .003).
Children without detected nasopharyngeal pathogens did not benefit from antibiotics as much as those with the pathogens, the researchers found. Among those with pathogens, the mean symptom burden score was 1.95 points lower in the group that received antibiotics, compared with the group that received placebo. For those without pathogens, there was a 0.88-point difference between the antibiotic and placebo groups (P = .02).
The researchers also took nasal swabs at the first and final study visits and tested for S. pneumoniae, H. influenzae, and M. catarrhalis. During that time, parents or caregivers used the PRSS to assess their child’s symptoms, and they recorded the nasal discharge color. Nasal discharge color, Dr. Shaikh and colleagues found, was not linked with antibiotic effect.
Welcome findings
Pediatricians and primary care providers face a significant clinical dilemma when they consider using antibiotics with upper respiratory tract infections (URTIs), according to John H. Greinwald Jr., MD, professor in the department of pediatrics at Cincinnati Children’s Hospital Medical Center.
“These findings certainly make sense because most respiratory infections in children are viral,” Dr. Greinwald said. “The investigators follow the appropriate clinical guidelines for considering antibiotic use in patients with URTIs, which include URTI symptoms lasting longer than 10 days or symptoms initially getting better, then worsening again day 6 through 10.”
Not only is antibiotic resistance a major public health concern, but the drugs can have side effects such as diarrhea, and their long-term effects on the microbiome are unknown.
“Differentiating who has acute sinusitis from who has a viral infection is difficult for primary care providers,” said Eelam A. Adil, MD, MBA, assistant professor of otolaryngology at Harvard Medical School in Boston.
The findings may help clinicians be more selective with antibiotic prescriptions, according to Jacob G. Eide, MD, a head and neck surgeon at Henry Ford Health in Detroit.
“However, we do not want to deny antibiotics when they are beneficial,” Dr. Eide said. “And the difficulty and costs involved in developing the tests need to be considered.”
Dr. Shaikh and his team are studying ways to bring nasal testing into clinical practice, potentially utilizing commercially available molecular testing and rapid antigen tests that work like COVID-19 at-home tests. They are also exploring if other biomarkers in nasal discharge may indicate the presence of bacteria.
All study authors as well as outside experts reported no relevant financial relationships. The study was supported by the National Institute of Allergy and Infectious Diseases.
A version of this article first appeared on Medscape.com.
Testing children with acute sinusitis symptoms for specific bacteria may dramatically decrease unnecessary antibiotic use, new research suggests.
The study, published in JAMA, found that children with positive nasopharyngeal tests for one or more of Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis had better resolution of symptoms with antibiotics than those without these bacteria.
If antibiotic use was limited to children with H. influenzae or S. pneumoniae in their nasopharynx at the time of diagnosis, antibiotic use would decrease by 53%, according to the study authors.
Sinusitis is common in children, and symptoms are similar with uncomplicated viral upper respiratory infections.
“We have not had a good way to predict which children will benefit from antibiotics,” said Nader Shaikh, MD, MPH, professor of pediatrics and clinical and translational science at the University of Pittsburgh, and the lead study author. “When a child comes in with a sore throat, we test for strep. If the test is positive, we prescribe antibiotics.”
Dr. Shaikh and his colleagues found that the same approach – swabbing the nose and testing for various bacteria – worked for children with sinusitis.
“Children who tested negative for bacteria did not benefit from antibiotics,” Dr. Shaikh said.
In the double-blind clinical trial, Dr. Shaikh and his colleagues randomized 510 children between ages 2 and 11 with acute sinusitis at six academic primary care offices over a 6-year period. Almost two-thirds of participants were between ages 2 and 5, around half were male, and around half were White. All participants had an initial score of nine or higher on the validated Pediatric Rhinosinusitis Symptom Scale (PRSS).
For 10 days, 254 children received oral amoxicillin (90 mg/kg/day) and clavulanate (6.4mg/kg/day) and 256 received placebo.
In children receiving antibiotics, symptoms resolved over a median of 7 days, compared with 9 days for those given placebo (P = .003).
Children without detected nasopharyngeal pathogens did not benefit from antibiotics as much as those with the pathogens, the researchers found. Among those with pathogens, the mean symptom burden score was 1.95 points lower in the group that received antibiotics, compared with the group that received placebo. For those without pathogens, there was a 0.88-point difference between the antibiotic and placebo groups (P = .02).
The researchers also took nasal swabs at the first and final study visits and tested for S. pneumoniae, H. influenzae, and M. catarrhalis. During that time, parents or caregivers used the PRSS to assess their child’s symptoms, and they recorded the nasal discharge color. Nasal discharge color, Dr. Shaikh and colleagues found, was not linked with antibiotic effect.
Welcome findings
Pediatricians and primary care providers face a significant clinical dilemma when they consider using antibiotics with upper respiratory tract infections (URTIs), according to John H. Greinwald Jr., MD, professor in the department of pediatrics at Cincinnati Children’s Hospital Medical Center.
“These findings certainly make sense because most respiratory infections in children are viral,” Dr. Greinwald said. “The investigators follow the appropriate clinical guidelines for considering antibiotic use in patients with URTIs, which include URTI symptoms lasting longer than 10 days or symptoms initially getting better, then worsening again day 6 through 10.”
Not only is antibiotic resistance a major public health concern, but the drugs can have side effects such as diarrhea, and their long-term effects on the microbiome are unknown.
“Differentiating who has acute sinusitis from who has a viral infection is difficult for primary care providers,” said Eelam A. Adil, MD, MBA, assistant professor of otolaryngology at Harvard Medical School in Boston.
The findings may help clinicians be more selective with antibiotic prescriptions, according to Jacob G. Eide, MD, a head and neck surgeon at Henry Ford Health in Detroit.
“However, we do not want to deny antibiotics when they are beneficial,” Dr. Eide said. “And the difficulty and costs involved in developing the tests need to be considered.”
Dr. Shaikh and his team are studying ways to bring nasal testing into clinical practice, potentially utilizing commercially available molecular testing and rapid antigen tests that work like COVID-19 at-home tests. They are also exploring if other biomarkers in nasal discharge may indicate the presence of bacteria.
All study authors as well as outside experts reported no relevant financial relationships. The study was supported by the National Institute of Allergy and Infectious Diseases.
A version of this article first appeared on Medscape.com.
Testing children with acute sinusitis symptoms for specific bacteria may dramatically decrease unnecessary antibiotic use, new research suggests.
The study, published in JAMA, found that children with positive nasopharyngeal tests for one or more of Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis had better resolution of symptoms with antibiotics than those without these bacteria.
If antibiotic use was limited to children with H. influenzae or S. pneumoniae in their nasopharynx at the time of diagnosis, antibiotic use would decrease by 53%, according to the study authors.
Sinusitis is common in children, and symptoms are similar with uncomplicated viral upper respiratory infections.
“We have not had a good way to predict which children will benefit from antibiotics,” said Nader Shaikh, MD, MPH, professor of pediatrics and clinical and translational science at the University of Pittsburgh, and the lead study author. “When a child comes in with a sore throat, we test for strep. If the test is positive, we prescribe antibiotics.”
Dr. Shaikh and his colleagues found that the same approach – swabbing the nose and testing for various bacteria – worked for children with sinusitis.
“Children who tested negative for bacteria did not benefit from antibiotics,” Dr. Shaikh said.
In the double-blind clinical trial, Dr. Shaikh and his colleagues randomized 510 children between ages 2 and 11 with acute sinusitis at six academic primary care offices over a 6-year period. Almost two-thirds of participants were between ages 2 and 5, around half were male, and around half were White. All participants had an initial score of nine or higher on the validated Pediatric Rhinosinusitis Symptom Scale (PRSS).
For 10 days, 254 children received oral amoxicillin (90 mg/kg/day) and clavulanate (6.4mg/kg/day) and 256 received placebo.
In children receiving antibiotics, symptoms resolved over a median of 7 days, compared with 9 days for those given placebo (P = .003).
Children without detected nasopharyngeal pathogens did not benefit from antibiotics as much as those with the pathogens, the researchers found. Among those with pathogens, the mean symptom burden score was 1.95 points lower in the group that received antibiotics, compared with the group that received placebo. For those without pathogens, there was a 0.88-point difference between the antibiotic and placebo groups (P = .02).
The researchers also took nasal swabs at the first and final study visits and tested for S. pneumoniae, H. influenzae, and M. catarrhalis. During that time, parents or caregivers used the PRSS to assess their child’s symptoms, and they recorded the nasal discharge color. Nasal discharge color, Dr. Shaikh and colleagues found, was not linked with antibiotic effect.
Welcome findings
Pediatricians and primary care providers face a significant clinical dilemma when they consider using antibiotics with upper respiratory tract infections (URTIs), according to John H. Greinwald Jr., MD, professor in the department of pediatrics at Cincinnati Children’s Hospital Medical Center.
“These findings certainly make sense because most respiratory infections in children are viral,” Dr. Greinwald said. “The investigators follow the appropriate clinical guidelines for considering antibiotic use in patients with URTIs, which include URTI symptoms lasting longer than 10 days or symptoms initially getting better, then worsening again day 6 through 10.”
Not only is antibiotic resistance a major public health concern, but the drugs can have side effects such as diarrhea, and their long-term effects on the microbiome are unknown.
“Differentiating who has acute sinusitis from who has a viral infection is difficult for primary care providers,” said Eelam A. Adil, MD, MBA, assistant professor of otolaryngology at Harvard Medical School in Boston.
The findings may help clinicians be more selective with antibiotic prescriptions, according to Jacob G. Eide, MD, a head and neck surgeon at Henry Ford Health in Detroit.
“However, we do not want to deny antibiotics when they are beneficial,” Dr. Eide said. “And the difficulty and costs involved in developing the tests need to be considered.”
Dr. Shaikh and his team are studying ways to bring nasal testing into clinical practice, potentially utilizing commercially available molecular testing and rapid antigen tests that work like COVID-19 at-home tests. They are also exploring if other biomarkers in nasal discharge may indicate the presence of bacteria.
All study authors as well as outside experts reported no relevant financial relationships. The study was supported by the National Institute of Allergy and Infectious Diseases.
A version of this article first appeared on Medscape.com.
FROM JAMA
For psoriasis, review finds several biosimilars as safe and effective as biologics
The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.
“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”
Biologics versus biosimilars
In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.
Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”
Systematic review
Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.
Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.
The researchers found the following:
At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.
At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.
In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.
At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.
At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).
Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.
Experts weigh in
Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.
However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.
“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”
Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.
“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.
Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.
“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”
Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.
Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.
The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.
“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”
Biologics versus biosimilars
In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.
Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”
Systematic review
Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.
Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.
The researchers found the following:
At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.
At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.
In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.
At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.
At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).
Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.
Experts weigh in
Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.
However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.
“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”
Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.
“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.
Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.
“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”
Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.
Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.
The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.
“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”
Biologics versus biosimilars
In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.
Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”
Systematic review
Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.
Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.
The researchers found the following:
At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.
At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.
In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.
At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.
At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).
Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.
Experts weigh in
Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.
However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.
“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”
Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.
“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.
Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.
“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”
Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.
Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.
FROM JAMA DERMATOLOGY
Gout linked to smaller brain volume, higher likelihood of neurodegenerative diseases
Patients with gout may have smaller brain volumes and higher brain iron markers than people without gout, and also be more likely to develop Parkinson’s disease, probable essential tremor, and dementia, researchers in the United Kingdom report.
“We were surprised about the regions of the brain affected by gout, several of which are important for motor function. The other intriguing finding was that the risk of dementia amongst gout patients was strongly time-dependent: highest in the first 3 years after their gout diagnosis,” lead study author Anya Topiwala, BMBCh, DPhil, said in an interview.
“Our combination of traditional and genetic approaches increases the confidence that gout is causing the brain findings,” said Dr. Topiwala, a clinical research fellow and consultant psychiatrist in the Nuffield Department of Population Health at the University of Oxford, England.
“We suggest that clinicians be vigilant for cognitive and motor problems after gout diagnosis, particularly in the early stages,” she added.
Links between gout and neurodegenerative diseases debated in earlier studies
Gout, the most common inflammatory arthritis, affects around 1%-4% of people, the authors wrote, with monosodium urate crystal deposits causing acute flares of pain and swelling in joints and periarticular tissues.
Whether and how gout may affect the brain has been debated in the literature. Gout and hyperuricemia have been linked with elevated stroke risk; and although observational studies have linked hyperuricemia with lower dementia risk, especially Alzheimer’s disease, Mendelian randomization studies have had conflicting results in Alzheimer’s disease.
A novel approach that analyzes brain structure and genetics
In a study published in Nature Communications, Dr. Topiwala and her colleagues combined observational and Mendelian randomization techniques to explore relationships between gout and neurodegenerative diseases. They analyzed data from over 303,000 volunteer participants between 40 and 69 years of age recruited between 2006 and 2010 to contribute their detailed genetic and health information to the U.K. Biobank, a large-scale biomedical database and research resource.
Patients with gout tended to be older and male. At baseline, all participants’ serum urate levels were measured, and 30.8% of patients with gout reported that they currently used urate-lowering therapy.
MRI shows brain changes in patients with gout
In what the authors said is the first investigation of neuroimaging markers in patients with gout, they compared differences in gray matter volumes found in the 1,165 participants with gout and the 32,202 controls without gout who had MRI data.
They found no marked sex differences in associations. Urate was inversely linked with global brain volume and with gray and white matter volumes, and gout appeared to age global gray matter by 2 years.
Patients with gout and higher urate showed significant differences in regional gray matter volumes, especially in the cerebellum, pons, and midbrain, as well as subcortical differences in the nucleus accumbens, putamen, and caudate. They also showed significant differences in white matter tract microstructure in the fornix.
Patients with gout were more likely to develop dementia (average hazard ratio [HR] over study = 1.60), especially in the first 3 years after gout diagnosis (HR = 7.40). They were also at higher risk for vascular dementia (average HR = 2.41), compared with all-cause dementia, but not for Alzheimer’s disease (average HR = 1.62).
In asymptomatic participants though, urate and dementia were inversely linked (HR = 0.85), with no time dependence.
Gout was linked with higher incidence of Parkinson’s disease (HR = 1.43) and probable essential tremor (HR = 6.75). In asymptomatic participants, urate and Parkinson’s disease (HR = 0.89), but not probable essential tremor, were inversely linked.
Genetic analyses reinforce MRI results
Using Mendelian randomization estimates, the authors found that genetic links generally reflected their observational findings. Both genetically predicted gout and serum urate were significantly linked with regional gray matter volumes, including cerebellar, midbrain, pons, and brainstem.
They also found significant links with higher magnetic susceptibility in the putamen and caudate, markers of higher iron. But while genetically predicted gout was significantly linked with global gray matter volume, urate was not.
In males, but not in females, urate was positively linked with alcohol intake and lower socioeconomic status.
Dr. Topiwala acknowledged several limitations to the study, writing that “the results from the volunteer participants may not apply to other populations; the cross-sectional serum urate measurements may not reflect chronic exposure; and Parkinson’s disease and essential tremor may have been diagnostically confounded.”
A novel approach that suggests further related research
Asked to comment on the study, Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor, called its novel use of neuroimaging interesting.
Dr. Khanna, who was not involved in the study, said she would like to know more about the role that horizontal pleiotropy – one genetic variant having independent effects on multiple traits – plays in this disease process, and about the impact of the antioxidative properties of urate in maintaining neuroprotection.
“[The] U.K. Biobank is an excellent database to look at questions of association,” John D. FitzGerald, MD, PhD, MPH, MBA, professor and clinical chief of rheumatology at the University of California, Los Angeles, said in an interview.
“This is a fairly rigorous study,” added Dr. FitzGerald, also not involved in the study. “While it has lots of strengths,” including its large sample size and Mendelian randomization, it also has “abundant weaknesses,” he added. “It is largely cross-sectional, with single urate measurement and single brain MRI.”
“Causation is the big question,” Dr. FitzGerald noted. “Does treating gout (or urate) help prevent dementia or neurodegenerative decline?”
Early diagnosis benefits patients
Dr. Khanna and Dr. FitzGerald joined the authors in advising doctors to monitor their gout patients for cognitive and motor symptoms of neurodegenerative disease.
“It is clearly important to pay close attention to the neurologic exam and history in gout, especially because it is a disease of the aging population,” Dr. Khanna advised. “Addressing dementia when gout is diagnosed can lead to prompt mitigation strategies that can hugely impact patients.”
Dr. Topiwala and her colleagues would like to investigate why the dementia risk was time-dependent. “Is this because of the acute inflammatory response in gout, or could it just be that patients with gout visit their doctors more frequently, so any cognitive problems are picked up sooner?” she asked.
The authors, and Dr. Khanna and Dr. FitzGerald, report no relevant financial relationships. The Wellcome Trust; the U.K. Medical Research Council; the European Commission Horizon 2020 research and innovation program; the British Heart Foundation; the U.S. National Institutes of Health; the Engineering and Physical Sciences Research Council; and the National Institute for Health and Care Research funded the study.
Patients with gout may have smaller brain volumes and higher brain iron markers than people without gout, and also be more likely to develop Parkinson’s disease, probable essential tremor, and dementia, researchers in the United Kingdom report.
“We were surprised about the regions of the brain affected by gout, several of which are important for motor function. The other intriguing finding was that the risk of dementia amongst gout patients was strongly time-dependent: highest in the first 3 years after their gout diagnosis,” lead study author Anya Topiwala, BMBCh, DPhil, said in an interview.
“Our combination of traditional and genetic approaches increases the confidence that gout is causing the brain findings,” said Dr. Topiwala, a clinical research fellow and consultant psychiatrist in the Nuffield Department of Population Health at the University of Oxford, England.
“We suggest that clinicians be vigilant for cognitive and motor problems after gout diagnosis, particularly in the early stages,” she added.
Links between gout and neurodegenerative diseases debated in earlier studies
Gout, the most common inflammatory arthritis, affects around 1%-4% of people, the authors wrote, with monosodium urate crystal deposits causing acute flares of pain and swelling in joints and periarticular tissues.
Whether and how gout may affect the brain has been debated in the literature. Gout and hyperuricemia have been linked with elevated stroke risk; and although observational studies have linked hyperuricemia with lower dementia risk, especially Alzheimer’s disease, Mendelian randomization studies have had conflicting results in Alzheimer’s disease.
A novel approach that analyzes brain structure and genetics
In a study published in Nature Communications, Dr. Topiwala and her colleagues combined observational and Mendelian randomization techniques to explore relationships between gout and neurodegenerative diseases. They analyzed data from over 303,000 volunteer participants between 40 and 69 years of age recruited between 2006 and 2010 to contribute their detailed genetic and health information to the U.K. Biobank, a large-scale biomedical database and research resource.
Patients with gout tended to be older and male. At baseline, all participants’ serum urate levels were measured, and 30.8% of patients with gout reported that they currently used urate-lowering therapy.
MRI shows brain changes in patients with gout
In what the authors said is the first investigation of neuroimaging markers in patients with gout, they compared differences in gray matter volumes found in the 1,165 participants with gout and the 32,202 controls without gout who had MRI data.
They found no marked sex differences in associations. Urate was inversely linked with global brain volume and with gray and white matter volumes, and gout appeared to age global gray matter by 2 years.
Patients with gout and higher urate showed significant differences in regional gray matter volumes, especially in the cerebellum, pons, and midbrain, as well as subcortical differences in the nucleus accumbens, putamen, and caudate. They also showed significant differences in white matter tract microstructure in the fornix.
Patients with gout were more likely to develop dementia (average hazard ratio [HR] over study = 1.60), especially in the first 3 years after gout diagnosis (HR = 7.40). They were also at higher risk for vascular dementia (average HR = 2.41), compared with all-cause dementia, but not for Alzheimer’s disease (average HR = 1.62).
In asymptomatic participants though, urate and dementia were inversely linked (HR = 0.85), with no time dependence.
Gout was linked with higher incidence of Parkinson’s disease (HR = 1.43) and probable essential tremor (HR = 6.75). In asymptomatic participants, urate and Parkinson’s disease (HR = 0.89), but not probable essential tremor, were inversely linked.
Genetic analyses reinforce MRI results
Using Mendelian randomization estimates, the authors found that genetic links generally reflected their observational findings. Both genetically predicted gout and serum urate were significantly linked with regional gray matter volumes, including cerebellar, midbrain, pons, and brainstem.
They also found significant links with higher magnetic susceptibility in the putamen and caudate, markers of higher iron. But while genetically predicted gout was significantly linked with global gray matter volume, urate was not.
In males, but not in females, urate was positively linked with alcohol intake and lower socioeconomic status.
Dr. Topiwala acknowledged several limitations to the study, writing that “the results from the volunteer participants may not apply to other populations; the cross-sectional serum urate measurements may not reflect chronic exposure; and Parkinson’s disease and essential tremor may have been diagnostically confounded.”
A novel approach that suggests further related research
Asked to comment on the study, Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor, called its novel use of neuroimaging interesting.
Dr. Khanna, who was not involved in the study, said she would like to know more about the role that horizontal pleiotropy – one genetic variant having independent effects on multiple traits – plays in this disease process, and about the impact of the antioxidative properties of urate in maintaining neuroprotection.
“[The] U.K. Biobank is an excellent database to look at questions of association,” John D. FitzGerald, MD, PhD, MPH, MBA, professor and clinical chief of rheumatology at the University of California, Los Angeles, said in an interview.
“This is a fairly rigorous study,” added Dr. FitzGerald, also not involved in the study. “While it has lots of strengths,” including its large sample size and Mendelian randomization, it also has “abundant weaknesses,” he added. “It is largely cross-sectional, with single urate measurement and single brain MRI.”
“Causation is the big question,” Dr. FitzGerald noted. “Does treating gout (or urate) help prevent dementia or neurodegenerative decline?”
Early diagnosis benefits patients
Dr. Khanna and Dr. FitzGerald joined the authors in advising doctors to monitor their gout patients for cognitive and motor symptoms of neurodegenerative disease.
“It is clearly important to pay close attention to the neurologic exam and history in gout, especially because it is a disease of the aging population,” Dr. Khanna advised. “Addressing dementia when gout is diagnosed can lead to prompt mitigation strategies that can hugely impact patients.”
Dr. Topiwala and her colleagues would like to investigate why the dementia risk was time-dependent. “Is this because of the acute inflammatory response in gout, or could it just be that patients with gout visit their doctors more frequently, so any cognitive problems are picked up sooner?” she asked.
The authors, and Dr. Khanna and Dr. FitzGerald, report no relevant financial relationships. The Wellcome Trust; the U.K. Medical Research Council; the European Commission Horizon 2020 research and innovation program; the British Heart Foundation; the U.S. National Institutes of Health; the Engineering and Physical Sciences Research Council; and the National Institute for Health and Care Research funded the study.
Patients with gout may have smaller brain volumes and higher brain iron markers than people without gout, and also be more likely to develop Parkinson’s disease, probable essential tremor, and dementia, researchers in the United Kingdom report.
“We were surprised about the regions of the brain affected by gout, several of which are important for motor function. The other intriguing finding was that the risk of dementia amongst gout patients was strongly time-dependent: highest in the first 3 years after their gout diagnosis,” lead study author Anya Topiwala, BMBCh, DPhil, said in an interview.
“Our combination of traditional and genetic approaches increases the confidence that gout is causing the brain findings,” said Dr. Topiwala, a clinical research fellow and consultant psychiatrist in the Nuffield Department of Population Health at the University of Oxford, England.
“We suggest that clinicians be vigilant for cognitive and motor problems after gout diagnosis, particularly in the early stages,” she added.
Links between gout and neurodegenerative diseases debated in earlier studies
Gout, the most common inflammatory arthritis, affects around 1%-4% of people, the authors wrote, with monosodium urate crystal deposits causing acute flares of pain and swelling in joints and periarticular tissues.
Whether and how gout may affect the brain has been debated in the literature. Gout and hyperuricemia have been linked with elevated stroke risk; and although observational studies have linked hyperuricemia with lower dementia risk, especially Alzheimer’s disease, Mendelian randomization studies have had conflicting results in Alzheimer’s disease.
A novel approach that analyzes brain structure and genetics
In a study published in Nature Communications, Dr. Topiwala and her colleagues combined observational and Mendelian randomization techniques to explore relationships between gout and neurodegenerative diseases. They analyzed data from over 303,000 volunteer participants between 40 and 69 years of age recruited between 2006 and 2010 to contribute their detailed genetic and health information to the U.K. Biobank, a large-scale biomedical database and research resource.
Patients with gout tended to be older and male. At baseline, all participants’ serum urate levels were measured, and 30.8% of patients with gout reported that they currently used urate-lowering therapy.
MRI shows brain changes in patients with gout
In what the authors said is the first investigation of neuroimaging markers in patients with gout, they compared differences in gray matter volumes found in the 1,165 participants with gout and the 32,202 controls without gout who had MRI data.
They found no marked sex differences in associations. Urate was inversely linked with global brain volume and with gray and white matter volumes, and gout appeared to age global gray matter by 2 years.
Patients with gout and higher urate showed significant differences in regional gray matter volumes, especially in the cerebellum, pons, and midbrain, as well as subcortical differences in the nucleus accumbens, putamen, and caudate. They also showed significant differences in white matter tract microstructure in the fornix.
Patients with gout were more likely to develop dementia (average hazard ratio [HR] over study = 1.60), especially in the first 3 years after gout diagnosis (HR = 7.40). They were also at higher risk for vascular dementia (average HR = 2.41), compared with all-cause dementia, but not for Alzheimer’s disease (average HR = 1.62).
In asymptomatic participants though, urate and dementia were inversely linked (HR = 0.85), with no time dependence.
Gout was linked with higher incidence of Parkinson’s disease (HR = 1.43) and probable essential tremor (HR = 6.75). In asymptomatic participants, urate and Parkinson’s disease (HR = 0.89), but not probable essential tremor, were inversely linked.
Genetic analyses reinforce MRI results
Using Mendelian randomization estimates, the authors found that genetic links generally reflected their observational findings. Both genetically predicted gout and serum urate were significantly linked with regional gray matter volumes, including cerebellar, midbrain, pons, and brainstem.
They also found significant links with higher magnetic susceptibility in the putamen and caudate, markers of higher iron. But while genetically predicted gout was significantly linked with global gray matter volume, urate was not.
In males, but not in females, urate was positively linked with alcohol intake and lower socioeconomic status.
Dr. Topiwala acknowledged several limitations to the study, writing that “the results from the volunteer participants may not apply to other populations; the cross-sectional serum urate measurements may not reflect chronic exposure; and Parkinson’s disease and essential tremor may have been diagnostically confounded.”
A novel approach that suggests further related research
Asked to comment on the study, Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor, called its novel use of neuroimaging interesting.
Dr. Khanna, who was not involved in the study, said she would like to know more about the role that horizontal pleiotropy – one genetic variant having independent effects on multiple traits – plays in this disease process, and about the impact of the antioxidative properties of urate in maintaining neuroprotection.
“[The] U.K. Biobank is an excellent database to look at questions of association,” John D. FitzGerald, MD, PhD, MPH, MBA, professor and clinical chief of rheumatology at the University of California, Los Angeles, said in an interview.
“This is a fairly rigorous study,” added Dr. FitzGerald, also not involved in the study. “While it has lots of strengths,” including its large sample size and Mendelian randomization, it also has “abundant weaknesses,” he added. “It is largely cross-sectional, with single urate measurement and single brain MRI.”
“Causation is the big question,” Dr. FitzGerald noted. “Does treating gout (or urate) help prevent dementia or neurodegenerative decline?”
Early diagnosis benefits patients
Dr. Khanna and Dr. FitzGerald joined the authors in advising doctors to monitor their gout patients for cognitive and motor symptoms of neurodegenerative disease.
“It is clearly important to pay close attention to the neurologic exam and history in gout, especially because it is a disease of the aging population,” Dr. Khanna advised. “Addressing dementia when gout is diagnosed can lead to prompt mitigation strategies that can hugely impact patients.”
Dr. Topiwala and her colleagues would like to investigate why the dementia risk was time-dependent. “Is this because of the acute inflammatory response in gout, or could it just be that patients with gout visit their doctors more frequently, so any cognitive problems are picked up sooner?” she asked.
The authors, and Dr. Khanna and Dr. FitzGerald, report no relevant financial relationships. The Wellcome Trust; the U.K. Medical Research Council; the European Commission Horizon 2020 research and innovation program; the British Heart Foundation; the U.S. National Institutes of Health; the Engineering and Physical Sciences Research Council; and the National Institute for Health and Care Research funded the study.
FROM NATURE COMMUNICATIONS
Can online mindfulness and self-compassion training improve quality of life for patients with atopic dermatitis?
, according to results of a small randomized controlled trial in Japan.
“We found that skin disease–specific QOL improved over time with a large effect size,” lead study author Sanae Kishimoto, MHS, MPH, of the School of Public Health, Graduate School of Medicine at Kyoto University and colleagues write in JAMA Dermatology. “These findings suggest that mindfulness and self-compassion training is an effective treatment option for adults with AD.”
A bothersome disease that worsens quality of life
AD, a chronic, relapsing, inflammatory, multifactorial skin disease involving intense itching, affects an estimated 15%-30% of children and 2%-10% of adults, with the incidence increasing in industrialized countries, the authors state.
Measured by disability-adjusted life years, AD has the highest disease burden among skin diseases, and people with AD commonly have anxiety, depression, and sleep problems. Treatments include medications, other skin care, and lifestyle changes. New biologics appear to be effective but are expensive and need to be studied for their long-term safety, the authors add.
“Stress can make the skin worse, but at the same time the skin disease and symptoms cause stress,” Peter A. Lio, MD, who was not involved in the study, told this news organization by email. “This vicious cycle contributes greatly to impairing quality of life.”
A program focused on wise, kind self-care
In the SMiLE study, the authors recruited adults with moderate to severe AD and Dermatology Life Quality Index (DLQI) score above 6 from dermatology clinics and through online announcements over 1 year beginning in July 2019.
Participants averaged 36.3 years of age, 80% were women, and their mean AD duration was 26.6 years. Everyone was allowed to receive usual care during the study, except for dupilumab (a newly marketed drug when the study started), psychotherapy, or other mindfulness training.
The researchers randomly assigned 56 adults to receive mindfulness training in addition to their usual care and 51 to the wait list plus usual care. Those in the training group received eight weekly 90-minute online mindfulness and self-compassion sessions. Each group-based session was conducted at the same time and day of the week and included meditation, informal psychoeducation, inquiry, and a short lecture, along with an optional 1-day silent meditation retreat at week 7 and an optional 2-hour videoconferencing booster session at week 13.
The intervention encouraged a nonjudgmental relationship with stress using mindfulness-based stress reduction (MBSR) and emphasized a compassionate relationship with oneself during suffering using mindful self-compassion (MSC). The program was developed and taught by lead author Dr. Kishimoto, a Japanese licensed clinical psychologist who has a history of AD, the paper notes.
At 13 weeks, after completing electronic assessments, patients in the training group showed greater improvement in the DLQI score than those on the wait list (between-group difference estimate, –6.34; 95% confidence interval, –8.27 to –4.41; P < .001). The standardized effect size (Cohen’s d) at 13 weeks was –1.06 (95% CI, –1.39 to –0.74).
Patients in the training group also improved more in all secondary outcomes: severity, itch- and scratch-related visual analog scales, self-compassion, mindfulness, psychological symptoms, and adherence to dermatologist-advised treatments.
They were also more likely to follow their dermatologist’s medical treatment plans, including moisturizer and topical steroid use.
One serious adverse event, endometrial cancer in one patient, was judged to be unrelated to the intervention.
Online format may give more patients access to treatment
“With relatively limited data in the literature, this particularly well-done, important study is likely to positively shape thinking around this topic,” said Dr. Lio, of the departments of dermatology and pediatrics at Northwestern University, Chicago. “This study nicely demonstrates that an online approach can be effective.
“In theory, these methods or techniques could democratize treatments like this, and open them up to many more patients,” he added. He would like to see partially or entirely automated apps (free of cost), similar to meditation “apps,” to treat patients more cost-effectively.
Dr. Lio explained that excluding participants on dupilumab (Dupixent) makes the results slightly less generalizable to patients with moderate to severe AD, who may have the most serious QOL challenges and who are often candidates for dupilumab.
“However, given that we almost never have all the known variables for a study, we are generally comfortable extrapolating that the intervention would likely be helpful for patients taking dupilumab as well, despite it not being specifically evaluated in that group,” he said.
Susan Massick, MD, of the department of dermatology at the Ohio State University Wexner Medical Center in Columbus, advises clinicians to take a multipronged approach to treating the physical and behavioral components of AD and to embrace therapies beyond prescription medications.
“Self-compassion training is another tool in our toolbox toward finding the right fix for our patients,” Dr. Massick said by email. She was not involved with this research.
“I applaud the focus of this study on behavioral health training as a means toward wellness and improved mindfulness,” she added. “I was impressed by the extent to which these simple measures helped improve the quality of life for patients who used the training.”
U.S. patients can benefit from these findings
“My sense is that AD patients the world over have many similar characteristics and concerns, so I would anticipate that the results would be comparable in a U.S. population,” Dr. Lio said. “Other studies performed in the U.S. also support this line of thinking.”
Although the study involved highly motivated patients in Japan, the suffering that patients with AD experience is universal regardless of race or ethnicity, Dr. Massick said. “Americans may be even more willing to embrace mindfulness and self-compassion training as a path toward better health and wellness.”
The study was funded by the Japan Agency for Medical Research and Development and the Mental Health Okamoto Memorial Foundation, the KDDI Foundation, the Pfizer Health Research Foundation, and the Japan Society for the Promotion of Science.
Dr. Kishimoto and several coauthors report relevant financial relationships with pharmaceutical companies. Dr. Lio reports financial relationships with Sanofi and Regeneron, the joint developers of dupilumab. Dr. Massick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to results of a small randomized controlled trial in Japan.
“We found that skin disease–specific QOL improved over time with a large effect size,” lead study author Sanae Kishimoto, MHS, MPH, of the School of Public Health, Graduate School of Medicine at Kyoto University and colleagues write in JAMA Dermatology. “These findings suggest that mindfulness and self-compassion training is an effective treatment option for adults with AD.”
A bothersome disease that worsens quality of life
AD, a chronic, relapsing, inflammatory, multifactorial skin disease involving intense itching, affects an estimated 15%-30% of children and 2%-10% of adults, with the incidence increasing in industrialized countries, the authors state.
Measured by disability-adjusted life years, AD has the highest disease burden among skin diseases, and people with AD commonly have anxiety, depression, and sleep problems. Treatments include medications, other skin care, and lifestyle changes. New biologics appear to be effective but are expensive and need to be studied for their long-term safety, the authors add.
“Stress can make the skin worse, but at the same time the skin disease and symptoms cause stress,” Peter A. Lio, MD, who was not involved in the study, told this news organization by email. “This vicious cycle contributes greatly to impairing quality of life.”
A program focused on wise, kind self-care
In the SMiLE study, the authors recruited adults with moderate to severe AD and Dermatology Life Quality Index (DLQI) score above 6 from dermatology clinics and through online announcements over 1 year beginning in July 2019.
Participants averaged 36.3 years of age, 80% were women, and their mean AD duration was 26.6 years. Everyone was allowed to receive usual care during the study, except for dupilumab (a newly marketed drug when the study started), psychotherapy, or other mindfulness training.
The researchers randomly assigned 56 adults to receive mindfulness training in addition to their usual care and 51 to the wait list plus usual care. Those in the training group received eight weekly 90-minute online mindfulness and self-compassion sessions. Each group-based session was conducted at the same time and day of the week and included meditation, informal psychoeducation, inquiry, and a short lecture, along with an optional 1-day silent meditation retreat at week 7 and an optional 2-hour videoconferencing booster session at week 13.
The intervention encouraged a nonjudgmental relationship with stress using mindfulness-based stress reduction (MBSR) and emphasized a compassionate relationship with oneself during suffering using mindful self-compassion (MSC). The program was developed and taught by lead author Dr. Kishimoto, a Japanese licensed clinical psychologist who has a history of AD, the paper notes.
At 13 weeks, after completing electronic assessments, patients in the training group showed greater improvement in the DLQI score than those on the wait list (between-group difference estimate, –6.34; 95% confidence interval, –8.27 to –4.41; P < .001). The standardized effect size (Cohen’s d) at 13 weeks was –1.06 (95% CI, –1.39 to –0.74).
Patients in the training group also improved more in all secondary outcomes: severity, itch- and scratch-related visual analog scales, self-compassion, mindfulness, psychological symptoms, and adherence to dermatologist-advised treatments.
They were also more likely to follow their dermatologist’s medical treatment plans, including moisturizer and topical steroid use.
One serious adverse event, endometrial cancer in one patient, was judged to be unrelated to the intervention.
Online format may give more patients access to treatment
“With relatively limited data in the literature, this particularly well-done, important study is likely to positively shape thinking around this topic,” said Dr. Lio, of the departments of dermatology and pediatrics at Northwestern University, Chicago. “This study nicely demonstrates that an online approach can be effective.
“In theory, these methods or techniques could democratize treatments like this, and open them up to many more patients,” he added. He would like to see partially or entirely automated apps (free of cost), similar to meditation “apps,” to treat patients more cost-effectively.
Dr. Lio explained that excluding participants on dupilumab (Dupixent) makes the results slightly less generalizable to patients with moderate to severe AD, who may have the most serious QOL challenges and who are often candidates for dupilumab.
“However, given that we almost never have all the known variables for a study, we are generally comfortable extrapolating that the intervention would likely be helpful for patients taking dupilumab as well, despite it not being specifically evaluated in that group,” he said.
Susan Massick, MD, of the department of dermatology at the Ohio State University Wexner Medical Center in Columbus, advises clinicians to take a multipronged approach to treating the physical and behavioral components of AD and to embrace therapies beyond prescription medications.
“Self-compassion training is another tool in our toolbox toward finding the right fix for our patients,” Dr. Massick said by email. She was not involved with this research.
“I applaud the focus of this study on behavioral health training as a means toward wellness and improved mindfulness,” she added. “I was impressed by the extent to which these simple measures helped improve the quality of life for patients who used the training.”
U.S. patients can benefit from these findings
“My sense is that AD patients the world over have many similar characteristics and concerns, so I would anticipate that the results would be comparable in a U.S. population,” Dr. Lio said. “Other studies performed in the U.S. also support this line of thinking.”
Although the study involved highly motivated patients in Japan, the suffering that patients with AD experience is universal regardless of race or ethnicity, Dr. Massick said. “Americans may be even more willing to embrace mindfulness and self-compassion training as a path toward better health and wellness.”
The study was funded by the Japan Agency for Medical Research and Development and the Mental Health Okamoto Memorial Foundation, the KDDI Foundation, the Pfizer Health Research Foundation, and the Japan Society for the Promotion of Science.
Dr. Kishimoto and several coauthors report relevant financial relationships with pharmaceutical companies. Dr. Lio reports financial relationships with Sanofi and Regeneron, the joint developers of dupilumab. Dr. Massick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to results of a small randomized controlled trial in Japan.
“We found that skin disease–specific QOL improved over time with a large effect size,” lead study author Sanae Kishimoto, MHS, MPH, of the School of Public Health, Graduate School of Medicine at Kyoto University and colleagues write in JAMA Dermatology. “These findings suggest that mindfulness and self-compassion training is an effective treatment option for adults with AD.”
A bothersome disease that worsens quality of life
AD, a chronic, relapsing, inflammatory, multifactorial skin disease involving intense itching, affects an estimated 15%-30% of children and 2%-10% of adults, with the incidence increasing in industrialized countries, the authors state.
Measured by disability-adjusted life years, AD has the highest disease burden among skin diseases, and people with AD commonly have anxiety, depression, and sleep problems. Treatments include medications, other skin care, and lifestyle changes. New biologics appear to be effective but are expensive and need to be studied for their long-term safety, the authors add.
“Stress can make the skin worse, but at the same time the skin disease and symptoms cause stress,” Peter A. Lio, MD, who was not involved in the study, told this news organization by email. “This vicious cycle contributes greatly to impairing quality of life.”
A program focused on wise, kind self-care
In the SMiLE study, the authors recruited adults with moderate to severe AD and Dermatology Life Quality Index (DLQI) score above 6 from dermatology clinics and through online announcements over 1 year beginning in July 2019.
Participants averaged 36.3 years of age, 80% were women, and their mean AD duration was 26.6 years. Everyone was allowed to receive usual care during the study, except for dupilumab (a newly marketed drug when the study started), psychotherapy, or other mindfulness training.
The researchers randomly assigned 56 adults to receive mindfulness training in addition to their usual care and 51 to the wait list plus usual care. Those in the training group received eight weekly 90-minute online mindfulness and self-compassion sessions. Each group-based session was conducted at the same time and day of the week and included meditation, informal psychoeducation, inquiry, and a short lecture, along with an optional 1-day silent meditation retreat at week 7 and an optional 2-hour videoconferencing booster session at week 13.
The intervention encouraged a nonjudgmental relationship with stress using mindfulness-based stress reduction (MBSR) and emphasized a compassionate relationship with oneself during suffering using mindful self-compassion (MSC). The program was developed and taught by lead author Dr. Kishimoto, a Japanese licensed clinical psychologist who has a history of AD, the paper notes.
At 13 weeks, after completing electronic assessments, patients in the training group showed greater improvement in the DLQI score than those on the wait list (between-group difference estimate, –6.34; 95% confidence interval, –8.27 to –4.41; P < .001). The standardized effect size (Cohen’s d) at 13 weeks was –1.06 (95% CI, –1.39 to –0.74).
Patients in the training group also improved more in all secondary outcomes: severity, itch- and scratch-related visual analog scales, self-compassion, mindfulness, psychological symptoms, and adherence to dermatologist-advised treatments.
They were also more likely to follow their dermatologist’s medical treatment plans, including moisturizer and topical steroid use.
One serious adverse event, endometrial cancer in one patient, was judged to be unrelated to the intervention.
Online format may give more patients access to treatment
“With relatively limited data in the literature, this particularly well-done, important study is likely to positively shape thinking around this topic,” said Dr. Lio, of the departments of dermatology and pediatrics at Northwestern University, Chicago. “This study nicely demonstrates that an online approach can be effective.
“In theory, these methods or techniques could democratize treatments like this, and open them up to many more patients,” he added. He would like to see partially or entirely automated apps (free of cost), similar to meditation “apps,” to treat patients more cost-effectively.
Dr. Lio explained that excluding participants on dupilumab (Dupixent) makes the results slightly less generalizable to patients with moderate to severe AD, who may have the most serious QOL challenges and who are often candidates for dupilumab.
“However, given that we almost never have all the known variables for a study, we are generally comfortable extrapolating that the intervention would likely be helpful for patients taking dupilumab as well, despite it not being specifically evaluated in that group,” he said.
Susan Massick, MD, of the department of dermatology at the Ohio State University Wexner Medical Center in Columbus, advises clinicians to take a multipronged approach to treating the physical and behavioral components of AD and to embrace therapies beyond prescription medications.
“Self-compassion training is another tool in our toolbox toward finding the right fix for our patients,” Dr. Massick said by email. She was not involved with this research.
“I applaud the focus of this study on behavioral health training as a means toward wellness and improved mindfulness,” she added. “I was impressed by the extent to which these simple measures helped improve the quality of life for patients who used the training.”
U.S. patients can benefit from these findings
“My sense is that AD patients the world over have many similar characteristics and concerns, so I would anticipate that the results would be comparable in a U.S. population,” Dr. Lio said. “Other studies performed in the U.S. also support this line of thinking.”
Although the study involved highly motivated patients in Japan, the suffering that patients with AD experience is universal regardless of race or ethnicity, Dr. Massick said. “Americans may be even more willing to embrace mindfulness and self-compassion training as a path toward better health and wellness.”
The study was funded by the Japan Agency for Medical Research and Development and the Mental Health Okamoto Memorial Foundation, the KDDI Foundation, the Pfizer Health Research Foundation, and the Japan Society for the Promotion of Science.
Dr. Kishimoto and several coauthors report relevant financial relationships with pharmaceutical companies. Dr. Lio reports financial relationships with Sanofi and Regeneron, the joint developers of dupilumab. Dr. Massick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA DERMATOLOGY
Study focuses on adolescent data in upadacitinib AD trials
(AD), an analysis of three clinical trials reports.
Upadacitinib (Rinvoq) was approved by the Food and Drug Administration for treating adults and pediatric patients 12 years of age and older with refractory, moderate to severe AD, in January 2022. This study analyzed the adolescent data in three double-blind, placebo-controlled phase 3 randomized clinical trials, which included adults and 552 adolescents between 12 and 17 years of age with moderate to severe AD in more than 20 countries in Europe, North and South America, the Middle East, Oceania, and the Asia-Pacific region from July 2018 through December 2020.
In the studies, “treatment of moderate to severe AD in adolescents with upadacitinib was effective and generally well tolerated, with an overall efficacy and safety profile similar to that observed in adults, and patient-reported outcomes indicated an overall better health-related quality of life compared with placebo,” lead study author Amy S. Paller, MD, chair of the department of dermatology and professor of dermatology and pediatrics, at Northwestern University, Chicago, and her colleagues write in JAMA Dermatology.
Adolescents in the three studies – Measure Up 1, Measure Up 2, and AD Up – received once-daily oral upadacitinib 15 mg, 30 mg, or placebo. All participants in AD Up used topical corticosteroids.
At 16 weeks, in Measure Up 1, Measure Up 2, and AD Up, respectively, a greater proportion of adolescents improved by at least 75% in the Eczema Area and Severity Index (EASI 75) with upadacitinib 15 mg (73%, 69%, 63%); and with upadacitinib 30 mg (78%, 73%, 84%), compared with placebo (12%, 13%, 30%), (P < .001 for all comparisons vs. placebo).
Upadacitinib was generally well tolerated among the adolescents, with mild or moderate acne being the most common adverse event, reported in 10%-13% of those on 15 mg and 15%-16% of those on 30 mg vs. 2%-3% of those on placebo.
Asked to comment on the study, Peck Ong, MD, a pediatric allergist and immunologist at Children’s Hospital Los Angeles, said that he was not surprised by the drug’s effectiveness because JAK inhibitors are potent immunosuppressants. Strengths of the studies include the many pediatric participants, its international reach, and its use of standardized and validated measures, said Dr. Ong, who was not involved in the study.
“The effect of JAK inhibitors is more specific than traditional immunosuppressants such as cyclosporine and methotrexate but not as specific as biologics; therefore, long-term safety data are needed,” he advised. “16 weeks is a very short time to study a chronic disease like atopic dermatitis. We need safety data longer than 1 year.”
Given the disease’s potential impact on self-esteem, sleep, and other important areas of life, Sean Reynolds, MBBCH, a pediatric dermatologist at Children’s Mercy Kansas City (Mo.), welcomed the data on the newer pharmacologic agents.
“FDA-approved systemic treatment options for adolescents with AD are currently limited, which necessitates studies such as this that explore additional treatment options,” said Dr. Reynolds, who also was not involved in the study, told this news organization.
He added that oral upadacitinib may especially help patients who have not found relief with other topical or systemic treatments or who are needle phobic. While the overall efficacy and relatively mild side effects for most patients taking upadacitinib in the trials are encouraging, “the long-term efficacy and side effects in this population require further study, especially considering the limited systemic AD treatment options available in this age group,” he added.
“Given the reported use of other JAK inhibitors to treat myriad inflammatory skin conditions beyond atopic dermatitis, the potential use of upadacitinib and other JAK inhibitors to treat these skin diseases in children and adolescents represents an exciting area for future study in the field of pediatric dermatology,” Dr. Reynolds noted.
The study was funded by AbbVie, the developer and manufacturer of upadacitinib. Dr. Paller and almost all other authors reported relevant financial relationships with AbbVie and other pharmaceutical companies. Dr. Ong reported serving on an AbbVie advisory board, and Dr. Reynolds reported no conflict of interest with the study.
(AD), an analysis of three clinical trials reports.
Upadacitinib (Rinvoq) was approved by the Food and Drug Administration for treating adults and pediatric patients 12 years of age and older with refractory, moderate to severe AD, in January 2022. This study analyzed the adolescent data in three double-blind, placebo-controlled phase 3 randomized clinical trials, which included adults and 552 adolescents between 12 and 17 years of age with moderate to severe AD in more than 20 countries in Europe, North and South America, the Middle East, Oceania, and the Asia-Pacific region from July 2018 through December 2020.
In the studies, “treatment of moderate to severe AD in adolescents with upadacitinib was effective and generally well tolerated, with an overall efficacy and safety profile similar to that observed in adults, and patient-reported outcomes indicated an overall better health-related quality of life compared with placebo,” lead study author Amy S. Paller, MD, chair of the department of dermatology and professor of dermatology and pediatrics, at Northwestern University, Chicago, and her colleagues write in JAMA Dermatology.
Adolescents in the three studies – Measure Up 1, Measure Up 2, and AD Up – received once-daily oral upadacitinib 15 mg, 30 mg, or placebo. All participants in AD Up used topical corticosteroids.
At 16 weeks, in Measure Up 1, Measure Up 2, and AD Up, respectively, a greater proportion of adolescents improved by at least 75% in the Eczema Area and Severity Index (EASI 75) with upadacitinib 15 mg (73%, 69%, 63%); and with upadacitinib 30 mg (78%, 73%, 84%), compared with placebo (12%, 13%, 30%), (P < .001 for all comparisons vs. placebo).
Upadacitinib was generally well tolerated among the adolescents, with mild or moderate acne being the most common adverse event, reported in 10%-13% of those on 15 mg and 15%-16% of those on 30 mg vs. 2%-3% of those on placebo.
Asked to comment on the study, Peck Ong, MD, a pediatric allergist and immunologist at Children’s Hospital Los Angeles, said that he was not surprised by the drug’s effectiveness because JAK inhibitors are potent immunosuppressants. Strengths of the studies include the many pediatric participants, its international reach, and its use of standardized and validated measures, said Dr. Ong, who was not involved in the study.
“The effect of JAK inhibitors is more specific than traditional immunosuppressants such as cyclosporine and methotrexate but not as specific as biologics; therefore, long-term safety data are needed,” he advised. “16 weeks is a very short time to study a chronic disease like atopic dermatitis. We need safety data longer than 1 year.”
Given the disease’s potential impact on self-esteem, sleep, and other important areas of life, Sean Reynolds, MBBCH, a pediatric dermatologist at Children’s Mercy Kansas City (Mo.), welcomed the data on the newer pharmacologic agents.
“FDA-approved systemic treatment options for adolescents with AD are currently limited, which necessitates studies such as this that explore additional treatment options,” said Dr. Reynolds, who also was not involved in the study, told this news organization.
He added that oral upadacitinib may especially help patients who have not found relief with other topical or systemic treatments or who are needle phobic. While the overall efficacy and relatively mild side effects for most patients taking upadacitinib in the trials are encouraging, “the long-term efficacy and side effects in this population require further study, especially considering the limited systemic AD treatment options available in this age group,” he added.
“Given the reported use of other JAK inhibitors to treat myriad inflammatory skin conditions beyond atopic dermatitis, the potential use of upadacitinib and other JAK inhibitors to treat these skin diseases in children and adolescents represents an exciting area for future study in the field of pediatric dermatology,” Dr. Reynolds noted.
The study was funded by AbbVie, the developer and manufacturer of upadacitinib. Dr. Paller and almost all other authors reported relevant financial relationships with AbbVie and other pharmaceutical companies. Dr. Ong reported serving on an AbbVie advisory board, and Dr. Reynolds reported no conflict of interest with the study.
(AD), an analysis of three clinical trials reports.
Upadacitinib (Rinvoq) was approved by the Food and Drug Administration for treating adults and pediatric patients 12 years of age and older with refractory, moderate to severe AD, in January 2022. This study analyzed the adolescent data in three double-blind, placebo-controlled phase 3 randomized clinical trials, which included adults and 552 adolescents between 12 and 17 years of age with moderate to severe AD in more than 20 countries in Europe, North and South America, the Middle East, Oceania, and the Asia-Pacific region from July 2018 through December 2020.
In the studies, “treatment of moderate to severe AD in adolescents with upadacitinib was effective and generally well tolerated, with an overall efficacy and safety profile similar to that observed in adults, and patient-reported outcomes indicated an overall better health-related quality of life compared with placebo,” lead study author Amy S. Paller, MD, chair of the department of dermatology and professor of dermatology and pediatrics, at Northwestern University, Chicago, and her colleagues write in JAMA Dermatology.
Adolescents in the three studies – Measure Up 1, Measure Up 2, and AD Up – received once-daily oral upadacitinib 15 mg, 30 mg, or placebo. All participants in AD Up used topical corticosteroids.
At 16 weeks, in Measure Up 1, Measure Up 2, and AD Up, respectively, a greater proportion of adolescents improved by at least 75% in the Eczema Area and Severity Index (EASI 75) with upadacitinib 15 mg (73%, 69%, 63%); and with upadacitinib 30 mg (78%, 73%, 84%), compared with placebo (12%, 13%, 30%), (P < .001 for all comparisons vs. placebo).
Upadacitinib was generally well tolerated among the adolescents, with mild or moderate acne being the most common adverse event, reported in 10%-13% of those on 15 mg and 15%-16% of those on 30 mg vs. 2%-3% of those on placebo.
Asked to comment on the study, Peck Ong, MD, a pediatric allergist and immunologist at Children’s Hospital Los Angeles, said that he was not surprised by the drug’s effectiveness because JAK inhibitors are potent immunosuppressants. Strengths of the studies include the many pediatric participants, its international reach, and its use of standardized and validated measures, said Dr. Ong, who was not involved in the study.
“The effect of JAK inhibitors is more specific than traditional immunosuppressants such as cyclosporine and methotrexate but not as specific as biologics; therefore, long-term safety data are needed,” he advised. “16 weeks is a very short time to study a chronic disease like atopic dermatitis. We need safety data longer than 1 year.”
Given the disease’s potential impact on self-esteem, sleep, and other important areas of life, Sean Reynolds, MBBCH, a pediatric dermatologist at Children’s Mercy Kansas City (Mo.), welcomed the data on the newer pharmacologic agents.
“FDA-approved systemic treatment options for adolescents with AD are currently limited, which necessitates studies such as this that explore additional treatment options,” said Dr. Reynolds, who also was not involved in the study, told this news organization.
He added that oral upadacitinib may especially help patients who have not found relief with other topical or systemic treatments or who are needle phobic. While the overall efficacy and relatively mild side effects for most patients taking upadacitinib in the trials are encouraging, “the long-term efficacy and side effects in this population require further study, especially considering the limited systemic AD treatment options available in this age group,” he added.
“Given the reported use of other JAK inhibitors to treat myriad inflammatory skin conditions beyond atopic dermatitis, the potential use of upadacitinib and other JAK inhibitors to treat these skin diseases in children and adolescents represents an exciting area for future study in the field of pediatric dermatology,” Dr. Reynolds noted.
The study was funded by AbbVie, the developer and manufacturer of upadacitinib. Dr. Paller and almost all other authors reported relevant financial relationships with AbbVie and other pharmaceutical companies. Dr. Ong reported serving on an AbbVie advisory board, and Dr. Reynolds reported no conflict of interest with the study.
FROM JAMA DERMATOLOGY
Anifrolumab shows promise in refractory discoid lupus erythematosus
a small retrospective study reports.
DLE, the most common form of chronic cutaneous lupus erythematosus, can permanently scar and disfigure patients, and traditional treatments such as antimalarials, steroid-sparing immunosuppressive agents, thalidomide, retinoids, and lenalidomide don’t consistently improve refractory DLE, the authors noted.
“All patients demonstrated significant improvement in symptomatology and disease activity within 2 months of initiating anifrolumab,” lead study author Katharina Shaw, MD, of the department of dermatology of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues wrote in a research letter published in JAMA Dermatology. “These early results highlight the potential for anifrolumab to be a viable therapeutic option for patients with DLE, particularly those with severe or recalcitrant disease.”
The Food and Drug Administration approved anifrolumab (Saphnelo), a human monoclonal antibody targeting type 1 interferon receptor subunit 1, in 2021 for adults with moderate to severe systemic lupus erythematosus, but it has not been approved for the treatment of DLE.
Dr. Shaw and colleagues queried the medical records from Brigham and Women’s Hospital and Massachusetts General Hospital, Boston, to find all cases of DLE based on biopsy, expert opinion, or both from January 2000 to October 2022.
The researchers identified eight female patients who had received anifrolumab for at least 8 weeks. The women were aged between 19 and 75 years (median, 42.5 years), and all had DLE recalcitrant to standard therapies and had been treated with hydroxychloroquine and between 1 and 10 other drugs, most commonly methotrexate and mycophenolate mofetil (MMF).
The authors looked for improvements in patient-reported symptoms and Cutaneous Lupus Erythematosus Disease Area and Severity Index scores, including CLASI A (activity) score 0-70, and CLASI-D (damage) score 0-56.
All patients showed significantly improved symptoms and disease activity within 2 months of their first infusion of the treatment. The mean decrease and mean percentage decrease in CLASI-A scores were 17.1 and 65.1%, respectively. The mean decrease and mean percentage decrease in CLASI-D scores were 0.5 and 2.9%, respectively.
The rapid clinical improvements with anifrolumab, compared with improvements with traditional medications, were striking, the authors wrote. “Given the risk for permanent scarring, dyspigmentation, and alopecia with poorly controlled DLE, the importance of rapidly mitigating disease activity cannot be overemphasized.”
They acknowledged that the results are limited by the study’s small sample size and retrospective design, and they recommend larger related prospective studies.
Asked to comment on the results, Kaveh Ardalan, MD, MS, assistant professor of pediatrics in the division of pediatric rheumatology at Duke University, Durham, N.C., said that finding new DLE therapeutics is important because of the huge impact of uncontrolled DLE on patients’ quality of life, body image, and social roles.
Dr. Ardalan noted that he sees DLE in his pediatric patients, “either as an isolated finding or in the context of systemic lupus erythematosus. Anifrolumab is not approved by the FDA to treat DLE or children.
“Randomized controlled trials, including the TULIP-1 and TULIP-2 studies of anifrolumab in systemic lupus, have indicated that lupus skin manifestations can improve in patients who receive anifrolumab,” said Dr. Ardalan, who was not involved in the study. “And we know that type I interferons are major drivers of cutaneous disease activity in patients with lupus, so targeting that mechanism with anifrolumab makes biological sense.”
The authors’ use of the validated CLASI classification system to quantify disease activity and damage over time, and their determination of the length of time for the drug to take effect are strengths of the study, he added.
Funding information was not provided. Two authors reported financial relationships with Pfizer, which does not manufacture anifrolumab. Dr. Ardalan reported no conflicts of interest with the study.
a small retrospective study reports.
DLE, the most common form of chronic cutaneous lupus erythematosus, can permanently scar and disfigure patients, and traditional treatments such as antimalarials, steroid-sparing immunosuppressive agents, thalidomide, retinoids, and lenalidomide don’t consistently improve refractory DLE, the authors noted.
“All patients demonstrated significant improvement in symptomatology and disease activity within 2 months of initiating anifrolumab,” lead study author Katharina Shaw, MD, of the department of dermatology of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues wrote in a research letter published in JAMA Dermatology. “These early results highlight the potential for anifrolumab to be a viable therapeutic option for patients with DLE, particularly those with severe or recalcitrant disease.”
The Food and Drug Administration approved anifrolumab (Saphnelo), a human monoclonal antibody targeting type 1 interferon receptor subunit 1, in 2021 for adults with moderate to severe systemic lupus erythematosus, but it has not been approved for the treatment of DLE.
Dr. Shaw and colleagues queried the medical records from Brigham and Women’s Hospital and Massachusetts General Hospital, Boston, to find all cases of DLE based on biopsy, expert opinion, or both from January 2000 to October 2022.
The researchers identified eight female patients who had received anifrolumab for at least 8 weeks. The women were aged between 19 and 75 years (median, 42.5 years), and all had DLE recalcitrant to standard therapies and had been treated with hydroxychloroquine and between 1 and 10 other drugs, most commonly methotrexate and mycophenolate mofetil (MMF).
The authors looked for improvements in patient-reported symptoms and Cutaneous Lupus Erythematosus Disease Area and Severity Index scores, including CLASI A (activity) score 0-70, and CLASI-D (damage) score 0-56.
All patients showed significantly improved symptoms and disease activity within 2 months of their first infusion of the treatment. The mean decrease and mean percentage decrease in CLASI-A scores were 17.1 and 65.1%, respectively. The mean decrease and mean percentage decrease in CLASI-D scores were 0.5 and 2.9%, respectively.
The rapid clinical improvements with anifrolumab, compared with improvements with traditional medications, were striking, the authors wrote. “Given the risk for permanent scarring, dyspigmentation, and alopecia with poorly controlled DLE, the importance of rapidly mitigating disease activity cannot be overemphasized.”
They acknowledged that the results are limited by the study’s small sample size and retrospective design, and they recommend larger related prospective studies.
Asked to comment on the results, Kaveh Ardalan, MD, MS, assistant professor of pediatrics in the division of pediatric rheumatology at Duke University, Durham, N.C., said that finding new DLE therapeutics is important because of the huge impact of uncontrolled DLE on patients’ quality of life, body image, and social roles.
Dr. Ardalan noted that he sees DLE in his pediatric patients, “either as an isolated finding or in the context of systemic lupus erythematosus. Anifrolumab is not approved by the FDA to treat DLE or children.
“Randomized controlled trials, including the TULIP-1 and TULIP-2 studies of anifrolumab in systemic lupus, have indicated that lupus skin manifestations can improve in patients who receive anifrolumab,” said Dr. Ardalan, who was not involved in the study. “And we know that type I interferons are major drivers of cutaneous disease activity in patients with lupus, so targeting that mechanism with anifrolumab makes biological sense.”
The authors’ use of the validated CLASI classification system to quantify disease activity and damage over time, and their determination of the length of time for the drug to take effect are strengths of the study, he added.
Funding information was not provided. Two authors reported financial relationships with Pfizer, which does not manufacture anifrolumab. Dr. Ardalan reported no conflicts of interest with the study.
a small retrospective study reports.
DLE, the most common form of chronic cutaneous lupus erythematosus, can permanently scar and disfigure patients, and traditional treatments such as antimalarials, steroid-sparing immunosuppressive agents, thalidomide, retinoids, and lenalidomide don’t consistently improve refractory DLE, the authors noted.
“All patients demonstrated significant improvement in symptomatology and disease activity within 2 months of initiating anifrolumab,” lead study author Katharina Shaw, MD, of the department of dermatology of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues wrote in a research letter published in JAMA Dermatology. “These early results highlight the potential for anifrolumab to be a viable therapeutic option for patients with DLE, particularly those with severe or recalcitrant disease.”
The Food and Drug Administration approved anifrolumab (Saphnelo), a human monoclonal antibody targeting type 1 interferon receptor subunit 1, in 2021 for adults with moderate to severe systemic lupus erythematosus, but it has not been approved for the treatment of DLE.
Dr. Shaw and colleagues queried the medical records from Brigham and Women’s Hospital and Massachusetts General Hospital, Boston, to find all cases of DLE based on biopsy, expert opinion, or both from January 2000 to October 2022.
The researchers identified eight female patients who had received anifrolumab for at least 8 weeks. The women were aged between 19 and 75 years (median, 42.5 years), and all had DLE recalcitrant to standard therapies and had been treated with hydroxychloroquine and between 1 and 10 other drugs, most commonly methotrexate and mycophenolate mofetil (MMF).
The authors looked for improvements in patient-reported symptoms and Cutaneous Lupus Erythematosus Disease Area and Severity Index scores, including CLASI A (activity) score 0-70, and CLASI-D (damage) score 0-56.
All patients showed significantly improved symptoms and disease activity within 2 months of their first infusion of the treatment. The mean decrease and mean percentage decrease in CLASI-A scores were 17.1 and 65.1%, respectively. The mean decrease and mean percentage decrease in CLASI-D scores were 0.5 and 2.9%, respectively.
The rapid clinical improvements with anifrolumab, compared with improvements with traditional medications, were striking, the authors wrote. “Given the risk for permanent scarring, dyspigmentation, and alopecia with poorly controlled DLE, the importance of rapidly mitigating disease activity cannot be overemphasized.”
They acknowledged that the results are limited by the study’s small sample size and retrospective design, and they recommend larger related prospective studies.
Asked to comment on the results, Kaveh Ardalan, MD, MS, assistant professor of pediatrics in the division of pediatric rheumatology at Duke University, Durham, N.C., said that finding new DLE therapeutics is important because of the huge impact of uncontrolled DLE on patients’ quality of life, body image, and social roles.
Dr. Ardalan noted that he sees DLE in his pediatric patients, “either as an isolated finding or in the context of systemic lupus erythematosus. Anifrolumab is not approved by the FDA to treat DLE or children.
“Randomized controlled trials, including the TULIP-1 and TULIP-2 studies of anifrolumab in systemic lupus, have indicated that lupus skin manifestations can improve in patients who receive anifrolumab,” said Dr. Ardalan, who was not involved in the study. “And we know that type I interferons are major drivers of cutaneous disease activity in patients with lupus, so targeting that mechanism with anifrolumab makes biological sense.”
The authors’ use of the validated CLASI classification system to quantify disease activity and damage over time, and their determination of the length of time for the drug to take effect are strengths of the study, he added.
Funding information was not provided. Two authors reported financial relationships with Pfizer, which does not manufacture anifrolumab. Dr. Ardalan reported no conflicts of interest with the study.
FROM JAMA DERMATOLOGY