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Is Atopic Dermatitis Linked to Cognitive Impairment Symptoms in Children?
TOPLINE:
METHODOLOGY:
It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.
To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.
Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.
The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.
TAKEAWAY:
Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).
On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41).
When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).
Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions.
IN PRACTICE:
“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.
SOURCE:
Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.
LIMITATIONS:
The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep.
DISCLOSURES:
The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.
To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.
Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.
The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.
TAKEAWAY:
Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).
On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41).
When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).
Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions.
IN PRACTICE:
“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.
SOURCE:
Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.
LIMITATIONS:
The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep.
DISCLOSURES:
The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.
To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.
Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.
The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.
TAKEAWAY:
Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).
On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41).
When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).
Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions.
IN PRACTICE:
“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.
SOURCE:
Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.
LIMITATIONS:
The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep.
DISCLOSURES:
The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report.
A version of this article appeared on Medscape.com.
Study Finds No Increased Cancer Risk With Spironolactone
TOPLINE:
than that of unexposed women.
METHODOLOGY:
- Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
- The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
- Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.
TAKEAWAY:
- A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
- After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
- The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).
IN PRACTICE:
“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.
SOURCE:
The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.
A version of this article appeared on Medscape.com.
TOPLINE:
than that of unexposed women.
METHODOLOGY:
- Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
- The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
- Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.
TAKEAWAY:
- A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
- After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
- The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).
IN PRACTICE:
“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.
SOURCE:
The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.
A version of this article appeared on Medscape.com.
TOPLINE:
than that of unexposed women.
METHODOLOGY:
- Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
- The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
- Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.
TAKEAWAY:
- A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
- After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
- The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).
IN PRACTICE:
“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.
SOURCE:
The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.
A version of this article appeared on Medscape.com.
Another Neurotoxin for Frown Lines Enters the Market
The Food and Drug Administration (FDA) has approved letibotulinumtoxinA-wlbg, an injectable neurotoxin long used in South Korea for the treatment of moderate to severe glabellar (frown) lines in adults. Developed by Hugel, the product is being marketed under the brand name Letybo.
The FDA’s approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1000 individuals in the United States and Europe. According to information in the package insert, the most common adverse reaction reported in the trials was headache, which occurred in 2% of trial participants. Other adverse events reported by fewer than 1% of trial participants included brow ptosis, eyelid ptosis, and blepharospasm, while the most frequently reported injection site reactions included administrative site swelling, facial pain, folliculitis, and periorbital hematoma.
According to a press release from the company, letibotulinumtoxinA-wlbg has been the leading neurotoxin brand in South Korea for 7 consecutive years, and the product has been sold in more than 50 different countries. Hugel plans to launch Letybo for US-based aesthetic clinicians in the latter half of 2024.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved letibotulinumtoxinA-wlbg, an injectable neurotoxin long used in South Korea for the treatment of moderate to severe glabellar (frown) lines in adults. Developed by Hugel, the product is being marketed under the brand name Letybo.
The FDA’s approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1000 individuals in the United States and Europe. According to information in the package insert, the most common adverse reaction reported in the trials was headache, which occurred in 2% of trial participants. Other adverse events reported by fewer than 1% of trial participants included brow ptosis, eyelid ptosis, and blepharospasm, while the most frequently reported injection site reactions included administrative site swelling, facial pain, folliculitis, and periorbital hematoma.
According to a press release from the company, letibotulinumtoxinA-wlbg has been the leading neurotoxin brand in South Korea for 7 consecutive years, and the product has been sold in more than 50 different countries. Hugel plans to launch Letybo for US-based aesthetic clinicians in the latter half of 2024.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved letibotulinumtoxinA-wlbg, an injectable neurotoxin long used in South Korea for the treatment of moderate to severe glabellar (frown) lines in adults. Developed by Hugel, the product is being marketed under the brand name Letybo.
The FDA’s approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1000 individuals in the United States and Europe. According to information in the package insert, the most common adverse reaction reported in the trials was headache, which occurred in 2% of trial participants. Other adverse events reported by fewer than 1% of trial participants included brow ptosis, eyelid ptosis, and blepharospasm, while the most frequently reported injection site reactions included administrative site swelling, facial pain, folliculitis, and periorbital hematoma.
According to a press release from the company, letibotulinumtoxinA-wlbg has been the leading neurotoxin brand in South Korea for 7 consecutive years, and the product has been sold in more than 50 different countries. Hugel plans to launch Letybo for US-based aesthetic clinicians in the latter half of 2024.
A version of this article appeared on Medscape.com.
How Good are Tools to Screen for Spondyloarthritis in Patients With Psoriasis, Uveitis, IBD?
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Older Age Confers a Higher Risk for Second Primary Melanoma: Study
TOPLINE:
.
METHODOLOGY:
- Knowledge about one’s risk for a second primary invasive melanoma over time remains incomplete.
- Using data from the Cancer Registry of Norway, researchers performed a cohort study of 19,196 individuals diagnosed with invasive melanomas during 2008-2020; 51% were women. The mean age at the first primary melanoma diagnosis was 62 years.
- The main outcome of interest was the incidence rate of second primary invasive melanoma after the first diagnosis.
- The researchers used accelerated failure time models to examine potential associations with patient and tumor characteristics. They also calculated the median time between first and second melanomas and the likelihood of second primary melanomas on the same or different site as the first primary melanoma.
TAKEAWAY:
- The incidence rate of a second primary melanoma in the year following a first primary melanoma was 16.8 (95% CI, 14.9-18.7) per 1000 person-years. This decreased to 7.3 (95% CI, 6.0-8.6) per 1000 person-years during the second year and remained stable after that.
- Patient age influenced the median time between first and second primaries. The median interval was 37 months (95% CI, 8-49) in patients aged < 40 years, 18 months (95% CI, 13-24) in patients aged 50-59 years, and 11 months (95% CI, 7-18) in patients aged ≥ 80 years.
- The body site of the second primary melanoma was the same as the first primary in 47% of patients but was located on a different body site in the remaining 53% of patients.
- Among patients who developed a second primary melanoma on the same site as the first, the median interval was shorter for men compared with women: A median of 12 (95% CI, 7-19) months vs 22 (95% CI, 11-35) months, respectively.
IN PRACTICE:
“Our findings suggest that increased surveillance may be considered for older patients, especially men, for at least the first 3 years after their initial diagnosis, regardless of the characteristics of their first melanoma,” the authors wrote.
SOURCE:
Corresponding author Reza Ghiasvand, PhD, of the Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and colleagues conducted the research, published online on February 28, 2024, in JAMA Dermatology.
LIMITATIONS:
Information was lacking on phenotypic characteristics, personal ultraviolet radiation (UVR) exposure, genetic factors, and the number of follow-up skin examinations.
DISCLOSURES:
The study was supported by the South-Eastern Norway Regional Health Authority. The authors reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Knowledge about one’s risk for a second primary invasive melanoma over time remains incomplete.
- Using data from the Cancer Registry of Norway, researchers performed a cohort study of 19,196 individuals diagnosed with invasive melanomas during 2008-2020; 51% were women. The mean age at the first primary melanoma diagnosis was 62 years.
- The main outcome of interest was the incidence rate of second primary invasive melanoma after the first diagnosis.
- The researchers used accelerated failure time models to examine potential associations with patient and tumor characteristics. They also calculated the median time between first and second melanomas and the likelihood of second primary melanomas on the same or different site as the first primary melanoma.
TAKEAWAY:
- The incidence rate of a second primary melanoma in the year following a first primary melanoma was 16.8 (95% CI, 14.9-18.7) per 1000 person-years. This decreased to 7.3 (95% CI, 6.0-8.6) per 1000 person-years during the second year and remained stable after that.
- Patient age influenced the median time between first and second primaries. The median interval was 37 months (95% CI, 8-49) in patients aged < 40 years, 18 months (95% CI, 13-24) in patients aged 50-59 years, and 11 months (95% CI, 7-18) in patients aged ≥ 80 years.
- The body site of the second primary melanoma was the same as the first primary in 47% of patients but was located on a different body site in the remaining 53% of patients.
- Among patients who developed a second primary melanoma on the same site as the first, the median interval was shorter for men compared with women: A median of 12 (95% CI, 7-19) months vs 22 (95% CI, 11-35) months, respectively.
IN PRACTICE:
“Our findings suggest that increased surveillance may be considered for older patients, especially men, for at least the first 3 years after their initial diagnosis, regardless of the characteristics of their first melanoma,” the authors wrote.
SOURCE:
Corresponding author Reza Ghiasvand, PhD, of the Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and colleagues conducted the research, published online on February 28, 2024, in JAMA Dermatology.
LIMITATIONS:
Information was lacking on phenotypic characteristics, personal ultraviolet radiation (UVR) exposure, genetic factors, and the number of follow-up skin examinations.
DISCLOSURES:
The study was supported by the South-Eastern Norway Regional Health Authority. The authors reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Knowledge about one’s risk for a second primary invasive melanoma over time remains incomplete.
- Using data from the Cancer Registry of Norway, researchers performed a cohort study of 19,196 individuals diagnosed with invasive melanomas during 2008-2020; 51% were women. The mean age at the first primary melanoma diagnosis was 62 years.
- The main outcome of interest was the incidence rate of second primary invasive melanoma after the first diagnosis.
- The researchers used accelerated failure time models to examine potential associations with patient and tumor characteristics. They also calculated the median time between first and second melanomas and the likelihood of second primary melanomas on the same or different site as the first primary melanoma.
TAKEAWAY:
- The incidence rate of a second primary melanoma in the year following a first primary melanoma was 16.8 (95% CI, 14.9-18.7) per 1000 person-years. This decreased to 7.3 (95% CI, 6.0-8.6) per 1000 person-years during the second year and remained stable after that.
- Patient age influenced the median time between first and second primaries. The median interval was 37 months (95% CI, 8-49) in patients aged < 40 years, 18 months (95% CI, 13-24) in patients aged 50-59 years, and 11 months (95% CI, 7-18) in patients aged ≥ 80 years.
- The body site of the second primary melanoma was the same as the first primary in 47% of patients but was located on a different body site in the remaining 53% of patients.
- Among patients who developed a second primary melanoma on the same site as the first, the median interval was shorter for men compared with women: A median of 12 (95% CI, 7-19) months vs 22 (95% CI, 11-35) months, respectively.
IN PRACTICE:
“Our findings suggest that increased surveillance may be considered for older patients, especially men, for at least the first 3 years after their initial diagnosis, regardless of the characteristics of their first melanoma,” the authors wrote.
SOURCE:
Corresponding author Reza Ghiasvand, PhD, of the Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and colleagues conducted the research, published online on February 28, 2024, in JAMA Dermatology.
LIMITATIONS:
Information was lacking on phenotypic characteristics, personal ultraviolet radiation (UVR) exposure, genetic factors, and the number of follow-up skin examinations.
DISCLOSURES:
The study was supported by the South-Eastern Norway Regional Health Authority. The authors reported having no disclosures.
A version of this article appeared on Medscape.com.
Study Evaluates Factors Driving Fatigue in Patients With Psoriasis, PsA
TOPLINE:
Many factors may influence fatigue in patients with psoriasis and psoriatic arthritis (PsA), researchers report.
METHODOLOGY:
- The individual components of fatigue in psoriasis and PsA have not been examined thoroughly.
- Researchers drew from the nationwide prospective Danish Skin Cohort to identify 2741 adults with dermatologist-diagnosed psoriasis (of which 593 also had PsA) and 3788 controls in the general population.
- All adults in the analysis completed the multidimensional fatigue inventory (MIF-20), a validated 20-item tool that measures five dimensions of fatigue: General fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. A higher score indicates more severe fatigue.
- All adults were also asked about their current intensity of joint pain over the previous 7 days, severity of pruritus and skin pain over the previous 24 hours, and sleep problems over the previous 72 hours on a numerical rating scale (NRS). The researchers applied linear regression models to continuous outcomes and adjusted for age, sex, socioeconomic status, psoriasis severity, and joint pain intensity, and beta coefficients (β) for the slopes were estimated with 95% CIs.
TAKEAWAY:
- Compared with the general population, higher total MFI-20 scores were observed for psoriasis and PsA, respectively. However, on the adjusted analysis, the impact on total fatigue was greatest for those with PsA (β = 5.23; 95% CI, 3.55-6.90), followed by psoriasis (β = 2.10; 95% CI, 0.96-3.25) compared with the general population (P trend < .0001).
- Increasing age was associated with a lower impact on total fatigue in psoriasis (β = −0.13; 95% CI, −0.18 to −0.08) and in PsA (β = −0.10; 95% CI, −0.19 to −0.01).
- Among patients with psoriasis with or without PsA, increasing joint pain intensity was associated with overall fatigue (β = 2.23; 95% CI, 2.03-2.44) for each one-point increase in joint pain on the NRS.
- In other findings, greater intensity of itch was associated with higher fatigue scores for both psoriasis and PsA, while skin pain was significantly associated with fatigue in PsA (β = 0.65; 95% CI, 0.08-1.22) but not in psoriasis without PsA (P = .2043).
IN PRACTICE:
“The
when treating psoriasis, rather than focusing on objective severity measures alone,” the authors wrote.SOURCE:
Corresponding author Alexander Egeberg, MD, of the Department of Dermatology at Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark, and colleagues conducted the research, which was published in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The researchers were unable to assess whether the pain was inflammatory or noninflammatory or the number of affected joints. They also lacked information about the use of methotrexate, which commonly causes fatigue.
DISCLOSURES:
Dr. Egeberg is now an employee at LEO Pharma. He has received research funding from Pfizer, Eli Lilly, the Danish National Psoriasis Foundation, and the Royal Hofbundtmager Aage Bang Foundation, and honoraria as a consultant and/or speaker from AbbVie, Almirall, Bristol-Myers Squibb, Leo Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly, Novartis, UCB, Union Therapeutics, Horizon Therapeutics, Galderma, and Janssen Pharmaceuticals. Three of the coauthors reported being a consultant to, an adviser for, and/or having received research support from many pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
Many factors may influence fatigue in patients with psoriasis and psoriatic arthritis (PsA), researchers report.
METHODOLOGY:
- The individual components of fatigue in psoriasis and PsA have not been examined thoroughly.
- Researchers drew from the nationwide prospective Danish Skin Cohort to identify 2741 adults with dermatologist-diagnosed psoriasis (of which 593 also had PsA) and 3788 controls in the general population.
- All adults in the analysis completed the multidimensional fatigue inventory (MIF-20), a validated 20-item tool that measures five dimensions of fatigue: General fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. A higher score indicates more severe fatigue.
- All adults were also asked about their current intensity of joint pain over the previous 7 days, severity of pruritus and skin pain over the previous 24 hours, and sleep problems over the previous 72 hours on a numerical rating scale (NRS). The researchers applied linear regression models to continuous outcomes and adjusted for age, sex, socioeconomic status, psoriasis severity, and joint pain intensity, and beta coefficients (β) for the slopes were estimated with 95% CIs.
TAKEAWAY:
- Compared with the general population, higher total MFI-20 scores were observed for psoriasis and PsA, respectively. However, on the adjusted analysis, the impact on total fatigue was greatest for those with PsA (β = 5.23; 95% CI, 3.55-6.90), followed by psoriasis (β = 2.10; 95% CI, 0.96-3.25) compared with the general population (P trend < .0001).
- Increasing age was associated with a lower impact on total fatigue in psoriasis (β = −0.13; 95% CI, −0.18 to −0.08) and in PsA (β = −0.10; 95% CI, −0.19 to −0.01).
- Among patients with psoriasis with or without PsA, increasing joint pain intensity was associated with overall fatigue (β = 2.23; 95% CI, 2.03-2.44) for each one-point increase in joint pain on the NRS.
- In other findings, greater intensity of itch was associated with higher fatigue scores for both psoriasis and PsA, while skin pain was significantly associated with fatigue in PsA (β = 0.65; 95% CI, 0.08-1.22) but not in psoriasis without PsA (P = .2043).
IN PRACTICE:
“The
when treating psoriasis, rather than focusing on objective severity measures alone,” the authors wrote.SOURCE:
Corresponding author Alexander Egeberg, MD, of the Department of Dermatology at Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark, and colleagues conducted the research, which was published in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The researchers were unable to assess whether the pain was inflammatory or noninflammatory or the number of affected joints. They also lacked information about the use of methotrexate, which commonly causes fatigue.
DISCLOSURES:
Dr. Egeberg is now an employee at LEO Pharma. He has received research funding from Pfizer, Eli Lilly, the Danish National Psoriasis Foundation, and the Royal Hofbundtmager Aage Bang Foundation, and honoraria as a consultant and/or speaker from AbbVie, Almirall, Bristol-Myers Squibb, Leo Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly, Novartis, UCB, Union Therapeutics, Horizon Therapeutics, Galderma, and Janssen Pharmaceuticals. Three of the coauthors reported being a consultant to, an adviser for, and/or having received research support from many pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
Many factors may influence fatigue in patients with psoriasis and psoriatic arthritis (PsA), researchers report.
METHODOLOGY:
- The individual components of fatigue in psoriasis and PsA have not been examined thoroughly.
- Researchers drew from the nationwide prospective Danish Skin Cohort to identify 2741 adults with dermatologist-diagnosed psoriasis (of which 593 also had PsA) and 3788 controls in the general population.
- All adults in the analysis completed the multidimensional fatigue inventory (MIF-20), a validated 20-item tool that measures five dimensions of fatigue: General fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. A higher score indicates more severe fatigue.
- All adults were also asked about their current intensity of joint pain over the previous 7 days, severity of pruritus and skin pain over the previous 24 hours, and sleep problems over the previous 72 hours on a numerical rating scale (NRS). The researchers applied linear regression models to continuous outcomes and adjusted for age, sex, socioeconomic status, psoriasis severity, and joint pain intensity, and beta coefficients (β) for the slopes were estimated with 95% CIs.
TAKEAWAY:
- Compared with the general population, higher total MFI-20 scores were observed for psoriasis and PsA, respectively. However, on the adjusted analysis, the impact on total fatigue was greatest for those with PsA (β = 5.23; 95% CI, 3.55-6.90), followed by psoriasis (β = 2.10; 95% CI, 0.96-3.25) compared with the general population (P trend < .0001).
- Increasing age was associated with a lower impact on total fatigue in psoriasis (β = −0.13; 95% CI, −0.18 to −0.08) and in PsA (β = −0.10; 95% CI, −0.19 to −0.01).
- Among patients with psoriasis with or without PsA, increasing joint pain intensity was associated with overall fatigue (β = 2.23; 95% CI, 2.03-2.44) for each one-point increase in joint pain on the NRS.
- In other findings, greater intensity of itch was associated with higher fatigue scores for both psoriasis and PsA, while skin pain was significantly associated with fatigue in PsA (β = 0.65; 95% CI, 0.08-1.22) but not in psoriasis without PsA (P = .2043).
IN PRACTICE:
“The
when treating psoriasis, rather than focusing on objective severity measures alone,” the authors wrote.SOURCE:
Corresponding author Alexander Egeberg, MD, of the Department of Dermatology at Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark, and colleagues conducted the research, which was published in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The researchers were unable to assess whether the pain was inflammatory or noninflammatory or the number of affected joints. They also lacked information about the use of methotrexate, which commonly causes fatigue.
DISCLOSURES:
Dr. Egeberg is now an employee at LEO Pharma. He has received research funding from Pfizer, Eli Lilly, the Danish National Psoriasis Foundation, and the Royal Hofbundtmager Aage Bang Foundation, and honoraria as a consultant and/or speaker from AbbVie, Almirall, Bristol-Myers Squibb, Leo Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly, Novartis, UCB, Union Therapeutics, Horizon Therapeutics, Galderma, and Janssen Pharmaceuticals. Three of the coauthors reported being a consultant to, an adviser for, and/or having received research support from many pharmaceutical companies.
A version of this article appeared on Medscape.com.
Be Wary of TikTok Content on Infantile Hemangiomas: Study
TOPLINE:
.
METHODOLOGY:
- New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
- Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
- The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.
TAKEAWAY:
- Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
- Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
- Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
- In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.
IN PRACTICE:
“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.
SOURCE:
First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.
LIMITATIONS:
The authors noted no specific limitations to the study.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
- Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
- The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.
TAKEAWAY:
- Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
- Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
- Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
- In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.
IN PRACTICE:
“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.
SOURCE:
First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.
LIMITATIONS:
The authors noted no specific limitations to the study.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
- Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
- The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.
TAKEAWAY:
- Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
- Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
- Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
- In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.
IN PRACTICE:
“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.
SOURCE:
First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.
LIMITATIONS:
The authors noted no specific limitations to the study.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
Patient-Reported Outcomes Predict Mortality in Cutaneous Chronic GVHD
. Independent of potential confounders, these PROs moreover predicted non-relapse mortality for all three disease subtypes, making PROs potentially useful adjuncts for risk stratification and treatment decisions, the study authors said.
“These two findings highlight the importance of patient-reported outcomes in measuring this disease,” lead author Emily Baumrin, MD, MSCE, assistant professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, told this news organization. The study was published online February 28 in JAMA Dermatology.
Symptoms and QOL
The investigators monitored 436 patients from the Chronic GVHD Consortium until December 2020. The Lee Symptom Scale (LSS) skin subscale was used to evaluate symptom burden and the Functional Assessment of Cancer Therapy–Bone Marrow Transplantation (FACT-BMT) was used to measure quality of life.
Patients with sclerotic GVHD and combination disease at diagnosis had significantly worse median LSS scores than did those with epidermal disease (25, 35, and 20 points, respectively; P = .01). Patients with sclerotic disease had worse median FACT-BMT scores versus those with epidermal involvement (104 versus 109 points, respectively; P = .08).
Although these scores improved with all skin subtypes, LSS skin subscale and FACT-BMT scores remained significantly worse (by 9.0 points and 6.1 points, respectively) for patients with combination and sclerotic disease versus those with epidermal disease after adjusting for potential confounders.
Regarding mortality, every 7-point worsening (clinically meaningful difference) in FACT-BMT score at diagnosis of skin chronic GVHD conferred 9.1% increases in odds of both all-cause mortality and non-relapse mortality, after adjustment for factors such as age and sex. Likewise, for every 11 points worsening (clinically meaningful difference) in LSS skin subscale scores at diagnosis, researchers observed odds increases of 10% in all-cause mortality and 16.4% in non-relapse mortality.
Because patients with combination disease had only slightly more epidermal body surface area (BSA) involvement but significantly higher symptom burden than the other subtypes, the authors added, combination disease may represent a distinct phenotype. “Since we’ve also shown that the severity of patient-reported outcomes is associated with mortality,” Dr. Baumrin said in the interview, “perhaps these patients are at the highest risk of mortality as well.”
A growing population
Although many might think of chronic GVHD as rare, she noted, the number of allogeneic hematopoietic cell transplant (HCT) survivors living in the United States is growing. In a modeling study published in October of 2013 in Biology of Blood and Marrow Transplantation, authors predicted that by 2030, this figure will reach 502,000 — about half of whom will develop chronic GVHD, she said.
With more HCTs being performed each year and ongoing improvements in supportive care, patients are living longer post transplant. “Therefore, many transplant survivors are being taken care of in the community outside of transplant centers.”
Accordingly, Dr. Baumrin said, study findings are relevant to dermatologists in academic and transplant centers and the community who provide skin cancer screenings or other dermatologic care for transplant recipients. “Upon diagnosis of chronic GVHD, the evaluation of disease burden by patient-reported outcome measures may assist in assessing disease severity and response to treatments over time — and to stratify patients at higher risk for mortality and communicate that back to transplant physicians.”
Incorporating PROs into clinical practice might prove especially helpful for patients with sclerotic chronic cutaneous GVHD. Currently, clinicians assess cutaneous GVHD clinically, using parameters including skin thickness. The National Institutes of Health (NIH) Skin Score, used in clinical trials, also measures BSA.
“The issue with sclerosis is, it’s hard to determine clinical severity based on physical examination alone,” Dr. Baumrin said. It can be difficult to quantify skin thickness and changes over time. “So it’s hard to detect improvements, which are often slow. Patient-reported outcome measures may be a more sensitive way to detect response to treatment than our clinical assessments, which are often crude for sclerotic disease.”
In a secondary analysis of the phase 2 clinical trial of belumosudil, a treatment for chronic GVHD, published in October 2022 in Transplantation and Cellular Therapy, response rate was around 30% measured by NIH Skin Score and 77% by PROs. “Our clinical examination in sclerotic type disease falls short in terms of determining therapeutic benefit. PROs might complement those clinical measures,” she said.
Future research will involve determining and validating which PROs matter most clinically and to patients, added Dr. Baumrin. Although widely used in evaluating transplant patients, LSS skin subscale and FACT-BMT scores may not represent patients’ experience of living with cutaneous chronic GVHD as effectively as might other tools such as the Dermatology Life Quality Index (DLQI) or Patient-Reported Outcomes Measurement Information System (PROMIS) measures, she explained.
Study strengths included authors’ use of well-validated PROs rather than novel unvalidated measures, Sandra A. Mitchell, PhD, CRNP, of the National Cancer Institute, Rockville, Maryland, and Edward W. Cowen, MD, MHSc, of the Dermatology Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Bethesda, Maryland, wrote in an accompanying editorial in JAMA Dermatology. However, they added, incorporating causes of death might have revealed that the excess mortality associated with sclerotic disease stemmed at least partly from adverse effects of prolonged immunosuppression, particularly infection.
If future studies establish this to be the case, said Dr. Baumrin, reducing immunosuppression might be warranted for these patients. “And if death is primarily due to chronic GVHD itself, maybe we should treat more aggressively. PROs can help guide this decision.”
The study was supported by the NIH/NIAMS and the University of Pennsylvania. Dr. Baumrin and three coauthors report no relevant financial relationships; other authors had disclosures related to several pharmaceutical companies. Dr. Mitchell and Dr. Cowen had no disclosures.
. Independent of potential confounders, these PROs moreover predicted non-relapse mortality for all three disease subtypes, making PROs potentially useful adjuncts for risk stratification and treatment decisions, the study authors said.
“These two findings highlight the importance of patient-reported outcomes in measuring this disease,” lead author Emily Baumrin, MD, MSCE, assistant professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, told this news organization. The study was published online February 28 in JAMA Dermatology.
Symptoms and QOL
The investigators monitored 436 patients from the Chronic GVHD Consortium until December 2020. The Lee Symptom Scale (LSS) skin subscale was used to evaluate symptom burden and the Functional Assessment of Cancer Therapy–Bone Marrow Transplantation (FACT-BMT) was used to measure quality of life.
Patients with sclerotic GVHD and combination disease at diagnosis had significantly worse median LSS scores than did those with epidermal disease (25, 35, and 20 points, respectively; P = .01). Patients with sclerotic disease had worse median FACT-BMT scores versus those with epidermal involvement (104 versus 109 points, respectively; P = .08).
Although these scores improved with all skin subtypes, LSS skin subscale and FACT-BMT scores remained significantly worse (by 9.0 points and 6.1 points, respectively) for patients with combination and sclerotic disease versus those with epidermal disease after adjusting for potential confounders.
Regarding mortality, every 7-point worsening (clinically meaningful difference) in FACT-BMT score at diagnosis of skin chronic GVHD conferred 9.1% increases in odds of both all-cause mortality and non-relapse mortality, after adjustment for factors such as age and sex. Likewise, for every 11 points worsening (clinically meaningful difference) in LSS skin subscale scores at diagnosis, researchers observed odds increases of 10% in all-cause mortality and 16.4% in non-relapse mortality.
Because patients with combination disease had only slightly more epidermal body surface area (BSA) involvement but significantly higher symptom burden than the other subtypes, the authors added, combination disease may represent a distinct phenotype. “Since we’ve also shown that the severity of patient-reported outcomes is associated with mortality,” Dr. Baumrin said in the interview, “perhaps these patients are at the highest risk of mortality as well.”
A growing population
Although many might think of chronic GVHD as rare, she noted, the number of allogeneic hematopoietic cell transplant (HCT) survivors living in the United States is growing. In a modeling study published in October of 2013 in Biology of Blood and Marrow Transplantation, authors predicted that by 2030, this figure will reach 502,000 — about half of whom will develop chronic GVHD, she said.
With more HCTs being performed each year and ongoing improvements in supportive care, patients are living longer post transplant. “Therefore, many transplant survivors are being taken care of in the community outside of transplant centers.”
Accordingly, Dr. Baumrin said, study findings are relevant to dermatologists in academic and transplant centers and the community who provide skin cancer screenings or other dermatologic care for transplant recipients. “Upon diagnosis of chronic GVHD, the evaluation of disease burden by patient-reported outcome measures may assist in assessing disease severity and response to treatments over time — and to stratify patients at higher risk for mortality and communicate that back to transplant physicians.”
Incorporating PROs into clinical practice might prove especially helpful for patients with sclerotic chronic cutaneous GVHD. Currently, clinicians assess cutaneous GVHD clinically, using parameters including skin thickness. The National Institutes of Health (NIH) Skin Score, used in clinical trials, also measures BSA.
“The issue with sclerosis is, it’s hard to determine clinical severity based on physical examination alone,” Dr. Baumrin said. It can be difficult to quantify skin thickness and changes over time. “So it’s hard to detect improvements, which are often slow. Patient-reported outcome measures may be a more sensitive way to detect response to treatment than our clinical assessments, which are often crude for sclerotic disease.”
In a secondary analysis of the phase 2 clinical trial of belumosudil, a treatment for chronic GVHD, published in October 2022 in Transplantation and Cellular Therapy, response rate was around 30% measured by NIH Skin Score and 77% by PROs. “Our clinical examination in sclerotic type disease falls short in terms of determining therapeutic benefit. PROs might complement those clinical measures,” she said.
Future research will involve determining and validating which PROs matter most clinically and to patients, added Dr. Baumrin. Although widely used in evaluating transplant patients, LSS skin subscale and FACT-BMT scores may not represent patients’ experience of living with cutaneous chronic GVHD as effectively as might other tools such as the Dermatology Life Quality Index (DLQI) or Patient-Reported Outcomes Measurement Information System (PROMIS) measures, she explained.
Study strengths included authors’ use of well-validated PROs rather than novel unvalidated measures, Sandra A. Mitchell, PhD, CRNP, of the National Cancer Institute, Rockville, Maryland, and Edward W. Cowen, MD, MHSc, of the Dermatology Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Bethesda, Maryland, wrote in an accompanying editorial in JAMA Dermatology. However, they added, incorporating causes of death might have revealed that the excess mortality associated with sclerotic disease stemmed at least partly from adverse effects of prolonged immunosuppression, particularly infection.
If future studies establish this to be the case, said Dr. Baumrin, reducing immunosuppression might be warranted for these patients. “And if death is primarily due to chronic GVHD itself, maybe we should treat more aggressively. PROs can help guide this decision.”
The study was supported by the NIH/NIAMS and the University of Pennsylvania. Dr. Baumrin and three coauthors report no relevant financial relationships; other authors had disclosures related to several pharmaceutical companies. Dr. Mitchell and Dr. Cowen had no disclosures.
. Independent of potential confounders, these PROs moreover predicted non-relapse mortality for all three disease subtypes, making PROs potentially useful adjuncts for risk stratification and treatment decisions, the study authors said.
“These two findings highlight the importance of patient-reported outcomes in measuring this disease,” lead author Emily Baumrin, MD, MSCE, assistant professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, told this news organization. The study was published online February 28 in JAMA Dermatology.
Symptoms and QOL
The investigators monitored 436 patients from the Chronic GVHD Consortium until December 2020. The Lee Symptom Scale (LSS) skin subscale was used to evaluate symptom burden and the Functional Assessment of Cancer Therapy–Bone Marrow Transplantation (FACT-BMT) was used to measure quality of life.
Patients with sclerotic GVHD and combination disease at diagnosis had significantly worse median LSS scores than did those with epidermal disease (25, 35, and 20 points, respectively; P = .01). Patients with sclerotic disease had worse median FACT-BMT scores versus those with epidermal involvement (104 versus 109 points, respectively; P = .08).
Although these scores improved with all skin subtypes, LSS skin subscale and FACT-BMT scores remained significantly worse (by 9.0 points and 6.1 points, respectively) for patients with combination and sclerotic disease versus those with epidermal disease after adjusting for potential confounders.
Regarding mortality, every 7-point worsening (clinically meaningful difference) in FACT-BMT score at diagnosis of skin chronic GVHD conferred 9.1% increases in odds of both all-cause mortality and non-relapse mortality, after adjustment for factors such as age and sex. Likewise, for every 11 points worsening (clinically meaningful difference) in LSS skin subscale scores at diagnosis, researchers observed odds increases of 10% in all-cause mortality and 16.4% in non-relapse mortality.
Because patients with combination disease had only slightly more epidermal body surface area (BSA) involvement but significantly higher symptom burden than the other subtypes, the authors added, combination disease may represent a distinct phenotype. “Since we’ve also shown that the severity of patient-reported outcomes is associated with mortality,” Dr. Baumrin said in the interview, “perhaps these patients are at the highest risk of mortality as well.”
A growing population
Although many might think of chronic GVHD as rare, she noted, the number of allogeneic hematopoietic cell transplant (HCT) survivors living in the United States is growing. In a modeling study published in October of 2013 in Biology of Blood and Marrow Transplantation, authors predicted that by 2030, this figure will reach 502,000 — about half of whom will develop chronic GVHD, she said.
With more HCTs being performed each year and ongoing improvements in supportive care, patients are living longer post transplant. “Therefore, many transplant survivors are being taken care of in the community outside of transplant centers.”
Accordingly, Dr. Baumrin said, study findings are relevant to dermatologists in academic and transplant centers and the community who provide skin cancer screenings or other dermatologic care for transplant recipients. “Upon diagnosis of chronic GVHD, the evaluation of disease burden by patient-reported outcome measures may assist in assessing disease severity and response to treatments over time — and to stratify patients at higher risk for mortality and communicate that back to transplant physicians.”
Incorporating PROs into clinical practice might prove especially helpful for patients with sclerotic chronic cutaneous GVHD. Currently, clinicians assess cutaneous GVHD clinically, using parameters including skin thickness. The National Institutes of Health (NIH) Skin Score, used in clinical trials, also measures BSA.
“The issue with sclerosis is, it’s hard to determine clinical severity based on physical examination alone,” Dr. Baumrin said. It can be difficult to quantify skin thickness and changes over time. “So it’s hard to detect improvements, which are often slow. Patient-reported outcome measures may be a more sensitive way to detect response to treatment than our clinical assessments, which are often crude for sclerotic disease.”
In a secondary analysis of the phase 2 clinical trial of belumosudil, a treatment for chronic GVHD, published in October 2022 in Transplantation and Cellular Therapy, response rate was around 30% measured by NIH Skin Score and 77% by PROs. “Our clinical examination in sclerotic type disease falls short in terms of determining therapeutic benefit. PROs might complement those clinical measures,” she said.
Future research will involve determining and validating which PROs matter most clinically and to patients, added Dr. Baumrin. Although widely used in evaluating transplant patients, LSS skin subscale and FACT-BMT scores may not represent patients’ experience of living with cutaneous chronic GVHD as effectively as might other tools such as the Dermatology Life Quality Index (DLQI) or Patient-Reported Outcomes Measurement Information System (PROMIS) measures, she explained.
Study strengths included authors’ use of well-validated PROs rather than novel unvalidated measures, Sandra A. Mitchell, PhD, CRNP, of the National Cancer Institute, Rockville, Maryland, and Edward W. Cowen, MD, MHSc, of the Dermatology Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Bethesda, Maryland, wrote in an accompanying editorial in JAMA Dermatology. However, they added, incorporating causes of death might have revealed that the excess mortality associated with sclerotic disease stemmed at least partly from adverse effects of prolonged immunosuppression, particularly infection.
If future studies establish this to be the case, said Dr. Baumrin, reducing immunosuppression might be warranted for these patients. “And if death is primarily due to chronic GVHD itself, maybe we should treat more aggressively. PROs can help guide this decision.”
The study was supported by the NIH/NIAMS and the University of Pennsylvania. Dr. Baumrin and three coauthors report no relevant financial relationships; other authors had disclosures related to several pharmaceutical companies. Dr. Mitchell and Dr. Cowen had no disclosures.
FROM JAMA DERMATOLOGY
Climate Change and AD: New Review Shows Negative Impacts and Unknowns
A new
. But it also showed the extent to which research is lacking.“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.
“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”
Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology.
Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.
“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.
Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”
Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
Mixed Results, But Negative Impacts Overall
The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.
The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.
Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.
In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.
Studies From 10 Countries Reviewed
Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.
Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.
“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”
In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”
The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
The Need to Better Track AD, Anticipate Clinical Impact
“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.
More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.
There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”
She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.
The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.
The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.
More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.
Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.
A new
. But it also showed the extent to which research is lacking.“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.
“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”
Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology.
Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.
“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.
Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”
Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
Mixed Results, But Negative Impacts Overall
The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.
The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.
Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.
In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.
Studies From 10 Countries Reviewed
Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.
Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.
“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”
In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”
The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
The Need to Better Track AD, Anticipate Clinical Impact
“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.
More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.
There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”
She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.
The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.
The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.
More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.
Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.
A new
. But it also showed the extent to which research is lacking.“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.
“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”
Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology.
Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.
“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.
Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”
Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
Mixed Results, But Negative Impacts Overall
The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.
The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.
Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.
In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.
Studies From 10 Countries Reviewed
Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.
Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.
“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”
In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”
The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
The Need to Better Track AD, Anticipate Clinical Impact
“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.
More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.
There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”
She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.
The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.
The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.
More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.
Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.
FROM ALLERGY
FDA Approves 10th Humira Biosimilar, With Interchangeability
The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).
This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.
Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022.
Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.
Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot.
Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).
This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.
Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022.
Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.
Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot.
Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).
This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.
Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022.
Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.
Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot.
Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.
A version of this article appeared on Medscape.com.