{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T21:59:41Z","timestamp":1791410381815,"version":"4.3.3"},"reference-count":12,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2023,9,1]]},"abstract":"Importance<\/jats:title>Baricitinib is an oral selective Janus kinase 1\/2 inhibitor that has achieved clinically meaningful outcomes for scalp, eyebrow, and eyelash hair regrowth in patients with severe alopecia areata (AA) at week 36 of treatment. Treatment with baricitinib, 4 mg, has resulted in higher response rates than baricitinib, 2 mg, at weeks 36 and 52.<\/jats:p><\/jats:sec>Objective<\/jats:title>To determine the efficacy of uptitration to baricitinib, 4 mg, for 24 weeks in patients who had previously not responded to baricitinib, 2 mg (Severity of Alopecia Tool [SALT] score of &amp;gt;20).<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>BRAVE-AA1 and BRAVE-AA2 are multicenter, placebo-controlled, phase 3 randomized clinical trials that were initiated on September 24, 2018, and July 8, 2019, respectively, with follow-up to 200 weeks (data cutoffs of November 11, 2021, and November 5, 2021, respectively). This pooled analysis reports long-term extension data up to week 76. At baseline, 1200 adult patients with severe AA (SALT score \u226550) were randomly assigned in a 3:2:2 ratio to receive baricitinib, 4 mg; baricitinib, 2 mg; or placebo. Patients treated with baricitinib remained on the same treatment dose until week 52. Patients were considered nonresponders to baricitinib, 2 mg, if they had a SALT score greater than 20 after 52 weeks of therapy.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The proportions of patients achieving a SALT score of 20 or lower and clinician-reported outcome for eyebrow hair loss and eyelash hair loss scores of 0 or 1 (full coverage or minimal gaps) with 2-point or higher improvements from baseline (among those with baseline scores \u22652 [significant gaps to no notable hair]) were analyzed through week 76.<\/jats:p><\/jats:sec>Results<\/jats:title>At week 52, of the 340 patients (mean [SD] age, 38.4 [12.9] years; 212 [62.4%] female) treated with baricitinib, 2 mg, 212 (62.4%) had a SALT score higher than 20 and were uptitrated to baricitinib, 4 mg. Two-thirds of these patients (142 of 212 [67.0%]) had a baseline SALT score of 95 to 100, indicating very severe AA. At week 76, 55 of the 212 patients (25.9%) had achieved a SALT score of 20 or lower. During the same period, response rates for clinician-reported outcome scores of 0 or 1 increased from 19.3% (31 of 161 patients) to 37.9% (61 of 161 patients) for eyebrows and from 24.1% (33 of 137 patients) to 40.9% (56 of 137 patients) for eyelashes.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this pooled analysis of the BRAVE-AA1 and BRAVE-AA2 trials, uptitration of baricitinib, 2 mg, to baricitinib, 4 mg, in those who did not respond to the 2-mg dose resulted in meaningful improvement of response rates over the subsequent 24 weeks for scalp, eyebrow, and eyelash hair loss.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifiers: NCT03570749<\/jats:ext-link> and NCT03899259<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamadermatol.2023.2581","type":"journal-article","created":{"date-parts":[[2023,8,9]],"date-time":"2023-08-09T15:01:13Z","timestamp":1691593273000},"page":"970","source":"Crossref","is-referenced-by-count":22,"title":["Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata"],"prefix":"10.1001","volume":"159","author":[{"given":"Justin M.","family":"Ko","sequence":"first","affiliation":[{"name":"Department of Dermatology, Stanford University School of Medicine, Stanford, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiffany T.","family":"Mayo","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Heersink School of Medicine, University of Alabama at Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilma F.","family":"Bergfeld","sequence":"additional","affiliation":[{"name":"Departments of Dermatology and Histopathology, Cleveland Clinic Foundation, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Dutronc","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guanglei","family":"Yu","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan G.","family":"Ball","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Najwa","family":"Somani","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brittany G.","family":"Craiglow","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Yale School of Medicine, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"key":"doi230033r1","doi-asserted-by":"publisher","first-page":"17011","DOI":"10.1038\/nrdp.2017.11","article-title":"Alopecia areata.","volume":"3","author":"Pratt","year":"2017","journal-title":"Nat Rev Dis Primers"},{"issue":"4","key":"doi230033r2","doi-asserted-by":"publisher","first-page":"806","DOI":"10.1016\/j.jaad.2016.04.035","article-title":"Health-related quality of life (HRQoL) among patients with alopecia areata (AA): a systematic review.","volume":"75","author":"Liu","year":"2016","journal-title":"J Am Acad Dermatol"},{"issue":"3","key":"doi230033r3","doi-asserted-by":"publisher","first-page":"556","DOI":"10.1016\/j.jaad.2018.01.048","article-title":"Alopecia areata is associated with impaired health-related quality of life: a survey of affected adults and children and their families.","volume":"79","author":"Liu","year":"2018","journal-title":"J Am Acad Dermatol"},{"issue":"1","key":"doi230033r4","doi-asserted-by":"publisher","first-page":"76","DOI":"10.1186\/s41687-020-00240-7","article-title":"\u201c\u2018You lose your hair, what\u2019s the big deal?\u2019 I was so embarrassed, I was so self-conscious, I was so depressed:\u201d a qualitative interview study to understand the psychosocial burden of alopecia areata.","volume":"4","author":"Aldhouse","year":"2020","journal-title":"J Patient Rep Outcomes"},{"issue":"4","key":"doi230033r5","doi-asserted-by":"publisher","first-page":"709","DOI":"10.1111\/jdv.v34.4","article-title":"Alopecia totalis and universalis long-term outcomes: a review.","volume":"34","author":"Burroway","year":"2020","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"18","key":"doi230033r6","doi-asserted-by":"publisher","first-page":"1687","DOI":"10.1056\/NEJMoa2110343","article-title":"Two phase 3 trials of baricitinib for alopecia areata.","volume":"386","author":"King","year":"2022","journal-title":"N Engl J Med"},{"issue":"3","key":"doi230033r7","doi-asserted-by":"publisher","first-page":"AB52","DOI":"10.1016\/j.jaad.2022.06.243","article-title":"33766 Efficacy of baricitinib in patients with various degrees of alopecia areata severity: results from BRAVE-AA1 and BRAVE-AA2.","volume":"87","author":"Taylor","year":"2022","journal-title":"J Am Acad Dermatol"},{"issue":"3","key":"doi230033r8","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1007\/s40257-023-00764-w","article-title":"Efficacy and safety of baricitinib in patients with severe alopecia areata over 52 weeks of continuous therapy in two phase III trials (BRAVE-AA1 and BRAVE-AA2).","volume":"24","author":"Kwon","year":"2023","journal-title":"Am J Clin Dermatol"},{"issue":"2","key":"doi230033r12","doi-asserted-by":"publisher","first-page":"218","DOI":"10.1093\/bjd\/ljac059","article-title":"Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials.","volume":"188","author":"King","year":"2023","journal-title":"Br J Dermatol"},{"key":"doi230033r9","author":"Mayo","year":"2023"},{"key":"doi230033r10","unstructured":"A study of baricitinib (LY3009104) in participants with severe or very severe alopecia areata (BRAVE-AA1). 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Accessed July 4, 2023. https:\/\/clinicaltrials.gov\/study\/NCT03899259?term=NCT03899259&rank=1"}],"container-title":["JAMA Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamadermatology\/articlepdf\/2808309\/jamadermatology_ko_2023_oi_230033_1695075688.79609.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,20]],"date-time":"2023-09-20T15:13:43Z","timestamp":1695222823000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamadermatology\/fullarticle\/2808309"}},"subtitle":["A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials"],"short-title":[],"issued":{"date-parts":[[2023,9,1]]},"references-count":12,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2023,9,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamadermatol.2023.2581","relation":{},"ISSN":["2168-6068"],"issn-type":[{"value":"2168-6068","type":"print"}],"subject":[],"published":{"date-parts":[[2023,9,1]]}}}