{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T15:47:27Z","timestamp":1792597647035,"version":"4.5.0"},"reference-count":23,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2026,10,1]]},"abstract":"\n Importance<\/jats:title>\n Brepocitinib, a first-in-class oral, selective TYK2 and JAK1 inhibitor, demonstrated broad efficacy in a phase 3 randomized clinical trial in dermatomyositis.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the effects of brepocitinib on cutaneous disease activity, itch, skin-related quality of life (QOL), and achievement of remission-level end points in adults with dermatomyositis over 52 weeks of treatment.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This prespecified secondary analysis of the 52-week, phase 3, double-blind, placebo-controlled, randomized VALOR clinical trial, conducted from October 2022 to July 2025 at 90 sites in 20 countries, included adults with dermatomyositis and active skin and muscle disease.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Once-daily brepocitinib, 30 mg; brepocitinib, 15 mg; or placebo.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Key secondary outcomes in VALOR included change in the Cutaneous Dermatomyositis Disease Area and Severity Index\u2013Activity (CDASI-A) score and achievement of clinically meaningful CDASI-A response (\u226540% relative and \u22654-point absolute improvement). Exploratory outcomes included itch (Peak Pruritus Numeric Rating Scale [PP-NRS]); skin-related QOL (Skindex-16); achievement of Cutaneous Dermatomyositis Activity\u2013Investigator\u2019s Global Assessment (CDA-IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement; and functional skin remission (CDASI-A \u22645). Between-group differences were analyzed using ANCOVA or Cochran-Mantel-Haenszel methods.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The VALOR trial enrolled 241 participants (mean [SD] age, 50.6 [13.3] years; 187 [77.6%] female; 54 [22.4%] male). Beginning at week 4, brepocitinib, 30 mg, demonstrated superiority over placebo in mean (SD) change from baseline in CDASI-A score (\u22126.4 [5.8] vs \u22123.5 [6.0], respectively; difference, \u22123.0; 95% CI, \u22124.6 to \u22121.4;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) and resulted in greater achievement of clinically meaningful CDASI-A response (27 participants [33.3%] vs 14 participants [17.7%], respectively; difference, 15.1 percentage points [pp]; 95% CI, 1.7-28.6 pp), itch remission (PP-NRS \u22641: 31 participants [38.3%] vs 15 participants [19.0%], respectively; difference, 18.9 pp; 95% CI, 5.0-32.9 pp) and improvement in skin-related QOL (Skindex-16 score: \u221212.9 [21.6] vs \u22120.9 [22.4], respectively; difference, \u221211.9; 95% CI, \u221217.9 to \u22126.0). Benefits on these measures were observed at all time points from week 4 through week 52. Among the 155 participants (64.3%) with moderate to severe skin disease at baseline, brepocitinib, 30 mg, was also associated with higher rates of achievement of a CDA-IGA score of clear or almost clear compared with placebo (21 participants [45.7%] vs 12 participants [21.8%], respectively; difference, 21.1 pp at week 52; 95% CI, 2.5-39.7 pp) and functional skin remission (20 participants [43.5%] vs 11 participants [20.8%], respectively; difference at week 52, 26.6 pp; 95% CI, 7.6-45.5 pp). Brepocitinib exhibited a safety profile consistent with approved JAK and TYK2 inhibitors.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this secondary analysis of a randomized clinical trial in dermatomyositis, once-daily brepocitinib, 30 mg, resulted in rapid, durable, and remission-level control of skin disease with an acceptable safety profile.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05437263<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamadermatol.2026.3199","type":"journal-article","created":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T15:30:45Z","timestamp":1787758245000},"page":"1026","source":"Crossref","is-referenced-by-count":1,"title":["Skin-Specific Outcomes of Brepocitinib in Patients With Dermatomyositis"],"prefix":"10.1001","volume":"162","author":[{"given":"Aaron R.","family":"Mangold","sequence":"first","affiliation":[{"name":"Department of Dermatology, Mayo Clinic, Scottsdale, Arizona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Haemel","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of California, San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neda","family":"Shahriari","sequence":"additional","affiliation":[{"name":"Mass General Brigham Department of Dermatology, Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Chong","sequence":"additional","affiliation":[{"name":"Department of Dermatology, UT Southwestern, Dallas, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony P.","family":"Fernandez","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Pathology, Cleveland Clinic, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Fiorentino","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Stanford University School of Medicine, Stanford, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Pearson","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Minnesota, Minneapolis"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Sluzevich","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Mayo Clinic, Jacksonville, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oluwakemi","family":"Onajin","sequence":"additional","affiliation":[{"name":"Section of Dermatology, Department of Medicine, University of Chicago, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pranita V.","family":"Rambhatla","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Henry Ford Health, Detroit, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehdi","family":"Rashighi","sequence":"additional","affiliation":[{"name":"Department of Dermatology, UMass Chan Medical School, Worcester, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Hurabielle","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of California, San Francisco"},{"name":"Division of Rheumatology, Department of Medicine, University of California, San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Fivenson","sequence":"additional","affiliation":[{"name":"Fivenson Dermatology, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Boh","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Tulane University School of Medicine, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taraneh","family":"Paravar","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of California, San Diego"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley","family":"Crew","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Keck Medicine of University of Southern California, Los Angeles"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. 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