{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T04:48:35Z","timestamp":1790916515747,"version":"4.1.0"},"reference-count":39,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T00:00:00Z","timestamp":1737590400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>ALLEGRO\u2010LT is an ongoing, long\u2010term, open\u2010label, multicentre, phase 3 study of ritlecitinib in adults and adolescents with alopecia areata (AA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate ritlecitinib safety and efficacy through Month 24 in patients with AA and \u226525% scalp hair loss.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ALLEGRO\u2010LT enrolled rollover patients who previously received study intervention in either ALLEGRO phase 2a or 2b\/3 studies and de novo patients who had not received treatment in either study. The de novo cohort results are reported here. Patients aged \u226512\u2009years with AA and \u226525% scalp hair loss received a daily, 4\u2010week 200\u2010mg ritlecitinib loading dose, followed by daily 50\u2010mg ritlecitinib. Analyses are based on data up to the cut\u2010off (December 2022). Efficacy outcomes included proportions of patients achieving Severity of Alopecia Tool (SALT) scores \u226420 and \u226410, Patient Global Impression of Change (PGI\u2010C) score of \u2018moderately improved\u2019 or \u2018greatly improved\u2019 and eyebrow assessment (EBA) and eyelash assessment (ELA) response (\u22652\u2010grade improvement from baseline or normal score in patients with abnormal baseline EBA\/ELA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Mean (SD) ritlecitinib exposure among the 449 de novo patients enrolled was 728.7 (273.81) days. At Month 24 (as observed), 73.5% and 66.4% of patients achieved SALT score \u226420 and \u226410; 82.4% had PGI\u2010C response; 60.8% and 65.7% had EBA and ELA response. 86.1% of patients reported treatment\u2010emergent adverse events (AEs); most were mild or moderate in severity, with the most frequent being positive SARS\u2010CoV\u20102 test (24.2%), headache (20.8%) and pyrexia (13.0%). Rates of serious AEs, severe AEs and treatment discontinuations were 4.9%, 6.0% and 6.5%, respectively. Herpes zoster infection occurred in six patients, serious infections in four, malignancies (excluding nonmelanoma skin cancer) in three and major adverse cardiovascular events in three.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In patients with AA and \u226525% scalp hair loss, ritlecitinib demonstrated clinical efficacy and had an acceptable safety profile with long\u2010term treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT04006457.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jdv.20526","type":"journal-article","created":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T06:55:51Z","timestamp":1737615351000},"page":"1152-1162","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Long\u2010term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata and at least 25% scalp hair loss: Results from the\n                    <scp>ALLEGRO<\/scp>\n                    \u2010\n                    <scp>LT<\/scp>\n                    phase 3, open\u2010label study"],"prefix":"10.1111","volume":"39","author":[{"given":"C.","family":"Tziotzios","sequence":"first","affiliation":[{"name":"St John's Institute of Dermatology King's College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6751-1428","authenticated-orcid":false,"given":"R.","family":"Sinclair","sequence":"additional","affiliation":[{"name":"Sinclair Dermatology  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Lesiak","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Pediatric Dermatology and Oncology Medical University of Lodz  Lodz Poland"},{"name":"Laboratory of Autoinflammatory Genetic and Rare Skin Disorders, Department of Dermatology, Pediatric Dermatology and Oncology Medical University of Lodz  Lodz Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Mehlis","sequence":"additional","affiliation":[{"name":"Division of Dermatology, Department of Medicine NorthShore University HealthSystem  Evanston Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Kinoshita\u2010Ise","sequence":"additional","affiliation":[{"name":"Department of Dermatology Kyorin University Faculty of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Tsianakas","sequence":"additional","affiliation":[{"name":"Department of Dermatology Fachklinik Bad Bentheim  Bad Bentheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"X.","family":"Luo","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6111-8008","authenticated-orcid":false,"given":"E. H.","family":"Law","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Ishowo\u2010Adejumo","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Wolk","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Sadrarhami","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Lejeune","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,1,23]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2014.10.014"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2019.08.032"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2022.6085"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2018.01.048"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jisp.2020.05.007"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555\u2010021\u201000512\u20100"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.2147\/ccid.S10182"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2009.10.031"},{"key":"e_1_2_14_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555\u2010023\u201000997\u2010x"},{"key":"e_1_2_14_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555\u2010023\u201001033\u20108"},{"key":"e_1_2_14_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.09.007"},{"key":"e_1_2_14_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/bjd\/ljad253"},{"key":"e_1_2_14_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/exd.14155"},{"key":"e_1_2_14_15_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1087\u20100024.2003.00807.x"},{"key":"e_1_2_14_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2016.04.004"},{"key":"e_1_2_14_17_1","doi-asserted-by":"publisher","DOI":"10.2147\/dddt.s172638"},{"key":"e_1_2_14_18_1","doi-asserted-by":"publisher","DOI":"10.1172\/jci31942"},{"key":"e_1_2_14_19_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.02342"},{"key":"e_1_2_14_20_1","doi-asserted-by":"publisher","DOI":"10.1126\/scisignal.aad7279"},{"key":"e_1_2_14_21_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.02847"},{"key":"e_1_2_14_22_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2023.1243556"},{"key":"e_1_2_14_23_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2110343"},{"key":"e_1_2_14_24_1","unstructured":"Sun Pharmaceutical Industries Ltd.U.S. FDA Approves LEQSELVI\u2122 (deuruxolitinib) an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata. Accessed August 2024. Available from:https:\/\/sunpharma.com\/wp\u2010content\/uploads\/2024\/07\/Sunpharma\u2010LEQSELVI\u2010Approval\u2010Scenario\u2010Press\u2010Release.pdf"},{"key":"e_1_2_14_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(23)00222\u20102"},{"key":"e_1_2_14_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555\u2010022\u201000711\u20103"},{"key":"e_1_2_14_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2003.09.032"},{"key":"e_1_2_14_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2017.10.048"},{"key":"e_1_2_14_29_1","unstructured":"United States Food and Drug Administration.Patient\u2010focused drug development public meeting for alopecia areata. September 11 2017. 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