JAMA dermatologyPub Date : 2025-04-01DOI: 10.1001/jamadermatol.2025.0055
Duc Binh Phan, Anthony P Bewley, Philip Laws, Teena Mackenzie, Catherine H Smith, Christopher E M Griffiths, Mark Lunt, Richard B Warren, Zenas Z N Yiu
{"title":"Effectiveness of Adalimumab Biosimilars and Originator for Psoriasis.","authors":"Duc Binh Phan, Anthony P Bewley, Philip Laws, Teena Mackenzie, Catherine H Smith, Christopher E M Griffiths, Mark Lunt, Richard B Warren, Zenas Z N Yiu","doi":"10.1001/jamadermatol.2025.0055","DOIUrl":"10.1001/jamadermatol.2025.0055","url":null,"abstract":"<p><strong>Importance: </strong>The uncertainties about the real-world effectiveness of adalimumab biosimilars limit their widespread adoption for psoriasis.</p><p><strong>Objective: </strong>To compare the effectiveness of adalimumab biosimilars Amjevita and Imraldi with Humira for psoriasis.</p><p><strong>Design, setting, and participants: </strong>An emulation of 2 targeted pragmatic clinical trials was conducted using data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), a prospective pharmacovigilance registry tracking individuals receiving biologic and conventional systemic treatments for psoriasis in the UK and the Republic of Ireland. Data from patients with psoriasis using adalimumab registered to BADBIR were included. Data were collected from September 2007 to January 2023, and data were analyzed from January to September 2023.</p><p><strong>Exposures: </strong>The effectiveness of initiating Amjevita and Imraldi were compared with initiating Humira among adalimumab-naive patients, and the effectiveness of switching from Humira to either Amjevita or Imraldi were compared with continuing Humira among patients who had been using Humira consistently for more than 2 years.</p><p><strong>Main outcomes and measures: </strong>The study outcomes were absolute Psoriasis Area and Severity Index (PASI) score of 2 or less and PASI score of 4 or less at 12 months after the index date. Inverse propensity treatment weighting was used to analyze receiving either biosimilars or Humira to account for confounding. Multiple imputations were used to account for missing PASI data at 12 months and inverse probability of censoring weighting to account for censorship due to deviation from the treatments under investigation. Logistic regression models were fitted to compare the outcomes between study cohorts.</p><p><strong>Results: </strong>Of 11 400 included patients, 6924 (60.7%) were male, and the mean (SD) age was 45.3 (12.5) years. A total of 6133 patients were identified in the new user analysis (5416 starting Humira, 382 starting Amjevita, and 335 starting Imraldi) and 5267 patients in the switcher analysis (3808 continuing Humira, 847 switching to Amjevita, and 612 switching to Imraldi). Amjevita and Imraldi new users had no significantly different probability of achieving a PASI score of 2 or less (Amjevita: adjusted odds ratio [aOR], 0.98; 95% CI, 0.78-1.25; Imraldi: aOR, 0.83; 95% CI, 0.64-1.07) and a PASI score of 4 or less (Amjevita: aOR, 1.07; 95% CI, 0.84-1.37; Imraldi: aOR, 0.91; 95% CI, 0.69-1.20) compared with Humira new users. Patients who switched to Amjevita and Imraldi also had no statistically significant differences in achieving a PASI score of 2 or less (Amjevita: aOR, 1.19; 95% CI, 0.94-1.51; Imraldi: aOR, 0.92; 95% CI, 0.72-1.18) and a PASI score of 4 or less (Amjevita: aOR, 1.32; 95% CI, 0.96-1.84; Imraldi: aOR, 1.00; 95% CI, 0.70-1.41) compared with those who continued Humira.</p><p><st","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"358-366"},"PeriodicalIF":11.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883583/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA dermatologyPub Date : 2025-04-01DOI: 10.1001/jamadermatol.2024.5416
Jenny Lai, John S Barbieri
{"title":"Acne Relapse and Isotretinoin Retrial in Patients With Acne.","authors":"Jenny Lai, John S Barbieri","doi":"10.1001/jamadermatol.2024.5416","DOIUrl":"10.1001/jamadermatol.2024.5416","url":null,"abstract":"<p><strong>Importance: </strong>Isotretinoin is the only medical acne treatment capable of inducing acne remission; however, some patients experience acne relapse and require retrials of isotretinoin. There is a need to understand who is most at risk and how daily dose and cumulative dosage can influence outcomes.</p><p><strong>Objective: </strong>To assess rates of acne relapse and isotretinoin retrial and to identify associated factors among patients with acne who received an isotretinoin treatment course.</p><p><strong>Design, setting, and participants: </strong>This cohort study used data from the MarketScan commercial claims database from January 1, 2017, to December 31, 2020, to identify patients with acne who were 12 years or older and had received isotretinoin for 4 months or longer, with at least 1 year of continuous enrollment after completion of isotretinoin. Data analyses were performed from June 30, 2024, to August 1, 2024.</p><p><strong>Main outcomes and measures: </strong>Multivariable Cox proportional hazards regression was used to quantify associations of patient demographic and treatment characteristics with acne relapse and isotretinoin retrial.</p><p><strong>Results: </strong>A total of 19 907 patients (mean [SD] age, 20.6 [7.8] years; 10 504 females [52.8%]) were included, among whom 4482 (22.5%) had acne relapse and 1639 (8.2%) had isotretinoin retrial. Female sex (hazard ratio [HR], 1.43; 95% CI, 1.35-1.52) was significantly associated with increased rates of acne relapse, and isotretinoin cumulative dosage (mg/kg) was associated with a decreased rate of acne relapse (HR, 0.996; 95% CI, 0.995-0.997). Furthermore, daily dose was not associated with decreased risk of acne relapse or isotretinoin retrial among those with conventional and high cumulative dosages. Female sex (HR, 0.68; 95% CI, 0.62-0.76) and isotretinoin cumulative dosage (HR, 0.99; 95% CI, 0.98-0.99) were associated with decreased rates of isotretinoin retrial. Stratification by cumulative dosage indicated that higher cumulative dosage was associated with decreased rates of retrial among patients with low (<120 mg/kg) and conventional (120-220 mg/kg), but not high (>220 mg/kg) cumulative dosage. Maximum daily dose (mg/kg/d) was not negatively associated with acne relapse or isotretinoin retrial in patients with cumulative dosage of 120 mg/kg or more.</p><p><strong>Conclusions and relevance: </strong>The findings of this cohort study suggest that higher cumulative dosage may potentially reduce risk of acne relapse and isotretinoin retrial. Furthermore, daily dose was not associated with decreased risk of the outcomes for conventional and high cumulative dosage; therefore, daily dosing could be individualized to patient goals and preferences.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"367-374"},"PeriodicalIF":11.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12004204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA dermatologyPub Date : 2025-04-01DOI: 10.1001/jamadermatol.2024.5697
Albert F Yang, Soham Patel, Keum San Chun, Dylan Richards, Jessica R Walter, Kazuaki Okamoto, Amy S Paller, Akihiko Ikoma, Shuai Xu
{"title":"Artificial Intelligence-Enabled Wearable Devices and Nocturnal Scratching in Mild Atopic Dermatitis.","authors":"Albert F Yang, Soham Patel, Keum San Chun, Dylan Richards, Jessica R Walter, Kazuaki Okamoto, Amy S Paller, Akihiko Ikoma, Shuai Xu","doi":"10.1001/jamadermatol.2024.5697","DOIUrl":"10.1001/jamadermatol.2024.5697","url":null,"abstract":"<p><strong>Importance: </strong>Although more than 1 in 10 people experience pruritus, there are limited medical technologies that can accurately and continuously quantify and simultaneously reduce scratching behaviors through nonpharmacological methods.</p><p><strong>Objective: </strong>To evaluate the accuracy and efficacy of an artificial intelligence-enabled wearable sensor with closed-loop haptic feedback to decrease nocturnal scratch in patients with mild atopic dermatitis who report a moderate to severe degree of scratching.</p><p><strong>Design, setting, and participants: </strong>This single-arm 2-stage cohort study with a within-participants design was conducted at a single center and carried out in an at-home environment. Adult patients with atopic dermatitis were recruited from the Northwestern University Department of Dermatology in Chicago, Illinois. Participants were fluent in English, 18 years old or older, had a diagnosis of atopic dermatitis, and self-reported moderate or severe scratching behaviors. Each participant's disease at time of recruitment was scored via the Validated Investigator Global Assessment for Atopic Dermatitis. Data were collected from April to July 2023.</p><p><strong>Exposures: </strong>Haptic feedback delivered by a wearable sensor mounted on the hand triggered whenever nocturnal scratch was detected by an artificial intelligence algorithm. Participants initially wore the sensor for sensing only for 7 nights to assess baseline nocturnal scratching and sleep parameters. This was followed by an additional 7 nights of wearing the sensor with haptic feedback activated.</p><p><strong>Main outcomes and measures: </strong>Retrospective analysis was performed for scratch events and scratch duration per night and per hour of sleep opportunity. Paired t tests were used to compare changes in patient scratching behaviors before and after use of the artificial intelligence-enabled haptic feedback devices.</p><p><strong>Results: </strong>Of 10 included patients, 6 were female, and the mean (SD) age was 36 (12) years. All patients had a Validated Investigator Global Assessment for Atopic Dermatitis score of 0 to 2 (clear to mild) who contributed a total of 104 sleep nights and 831 monitoring hours. No patients were lost to follow-up. There was a significant decrease in mean (SD) scratch events nightly (45.6 [24.0] vs 32.8 [13.0]; P = .03), a 28% difference, and mean (SD) scratch duration per hour of sleep opportunity (15.8 [10.7] seconds vs 7.9 [3.7] seconds; P = .01), a 50% difference, when haptic feedback was activated in the second week without a decrease in total sleep opportunity.</p><p><strong>Conclusions and relevance: </strong>This study found that haptic feedback may be used as a nonpharmacological intervention to reduce nocturnal scratching in patients with mild atopic dermatitis. Future randomized studies are needed to confirm.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"406-410"},"PeriodicalIF":11.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11800123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA dermatologyPub Date : 2025-04-01DOI: 10.1001/jamadermatol.2024.5881
Hsien-Yi Chiu, Ying-Ming Chiu
{"title":"Risk of Cardiovascular Morbidity and Mortality in Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Survivors.","authors":"Hsien-Yi Chiu, Ying-Ming Chiu","doi":"10.1001/jamadermatol.2024.5881","DOIUrl":"10.1001/jamadermatol.2024.5881","url":null,"abstract":"<p><strong>Importance: </strong>Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) cause diffuse epidermal detachment and necrosis. Patients who survive the initial SJS/TEN episodes are affected by various sequelae.</p><p><strong>Objective: </strong>To investigate the risks of cardiovascular morbidity and mortality in SJS/TEN survivors.</p><p><strong>Design, setting, and participants: </strong>This was a nationwide population-based cohort study using data from Taiwan's National Health Research Institute Database linked to the National Register of Death databases for 1998 to 2021. Survivors of SJS/TEN were identified and matched with non-SJS/TEN participants by age, sex, and Charlson Comorbidity Index. Data analysis was performed from November 2023 to June 2024.</p><p><strong>Exposure: </strong>Cerebrovascular accidents (CVA) or ischemic heart disease (IHD) after SJS/TEN survival.</p><p><strong>Main outcomes and measures: </strong>Cox proportional hazards models were used to estimate the hazard ratios (HRs) of CVA and IHD morbidity and mortality after SJS/TEN survival.</p><p><strong>Results: </strong>The CVA cohort included 10 571 SJS/TEN survivors (mean [SD] age, 56.1 [18.5] years; 5358 females [50.7%] and 5213 males [49.3%]). The IHD cohort included 11 084 SJS/TEN survivors (mean [SD] age, 56.6 [18.6] years; 5561 females [50.2%] and 5523 males [49.8%]). The Cox proportional hazards model and competing risk regression model showed that compared with non-SJS/TEN participants, patients with SJS/TEN had higher risks of cardiovascular morbidity (CVA: HR, 1.65 [95% CI, 1.57-1.72] and subdistribution HR [sHR], 1.40 [95% CI, 1.33-1.46]; IHD: HR, 1.58 [95% CI, 1.51-1.65] and sHR, 1.32 [95% CI, 1.26-1.38]) and death due to cardiovascular disease (CVA: HR, 1.69; 95% CI, 1.46-1.96; IHD: HR, 1.55; 95% CI, 1.32-1.82). The increased cardiovascular mortality risks peaked at 1 year after SJS/TEN and persisted for 4 to 7 years. Older survivors and survivors admitted to an intensive care unit at SJS/TEN diagnosis had significantly higher cardiovascular mortality risk.</p><p><strong>Conclusions and relevance: </strong>In this cohort study, SJS/TEN had a lasting association with cardiovascular function after the acute phase. This suggests a need to mitigate the elevated cardiovascular morbidity and mortality risks among survivors. Further research using databases or registries with more comprehensive clinical data are needed to validate these results.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"391-398"},"PeriodicalIF":11.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11840681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}