{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T02:10:39Z","timestamp":1769566239824,"version":"3.49.0"},"reference-count":11,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2025,9,18]],"date-time":"2025-09-18T00:00:00Z","timestamp":1758153600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006190","name":"research and development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006190","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,27]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We conducted a phase IIb clinical trial of pumecitinib 3% gel (PG-011), a novel selective Janus kinase (JAK)1\/2 inhibitor, applied topically to treat mild-to-moderate atopic dermatitis (AD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess pumecitinib 3% gel for its efficacy and safety in treating adult patients with mild-to-moderate AD, and to determine the optimal treatment regimen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this study, 139 participants with mild-to-moderate AD were randomized 1 : 1 : 1 to pumecitinib 3% gel twice daily (n = 47), pumecitinib 3% gel once daily (n = 46) and placebo (n = 46) for 8 weeks of treatment. Percentage change in Eczema Area and Severity Index (EASI) score from baseline to week 8 was the primary efficacy endpoint. The percentage of participants with an Investigator\u2019s Global Assessment score of 0 or 1 (\u2265 2-point improvement from baseline) at week 8, the proportion of participants attaining \u2265 50% improvement in EASI (EASI 50), \u2265 75% improvement in EASI (EASI 75) and \u2265 90% improvement in EASI (EASI 90) at week 8, and improvement in quality of life were also evaluated. Safety, local tolerability and some pharmacokinetics were monitored.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At week 8, the percentage change from baseline in EASI score in the pumecitinib 3% gel twice daily, pumecitinib 3% gel once daily and placebo groups was \u201383.6%, \u201344.0% and \u201322.0%, respectively. Both pumecitinib treatment regimens showed a significantly greater effect compared with placebo (P &amp;lt; 0.006) and the pumecitinib 3% gel twice-daily regimen had a greater effect than once-daily treatment (P &amp;lt; 0.001). Other efficacy endpoints were also improved in participants in the pumecitinib groups vs. those in the placebo group, and pumecitinib 3% gel twice daily consistently exhibited better efficacy than the once-daily treatment. With regard to safety, the rate of adverse events in the pumecitinib and placebo groups was 48% and 48%, respectively. Safety profiles were generally similar between the pumecitinib and placebo groups, and treatment was well tolerated. Mean plasma drug concentrations were low (range 38\u2013104 pg mL\u20131) over the 8-week treatment period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Pumecitinib 3% gel showed good efficacy and safety profiles in the treatment of adults with mild-to-moderate AD. The pumecitinib 3% twice-daily treatment regimen showed greater efficacy than the once-daily regimen in treating mild-to-moderate AD. Pumecitinib 3% gel was well tolerated and generated low systemic drug exposure when used topically. It may be a new choice of topical JAK inhibitor to treat mild-to-moderate AD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljaf363","type":"journal-article","created":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T12:14:29Z","timestamp":1758111269000},"page":"236-243","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of pumecitinib 3% gel in treating mild-to-moderate atopic dermatitis: a multicentre randomized double-blind parallel placebo-controlled phase IIb clinical trial"],"prefix":"10.1093","volume":"194","author":[{"given":"Li","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Dermatology, The First Hospital of China Medical University , Shenyang ,","place":["China"]},{"name":"Key Laboratory of Immunodermatology, Ministry of Education, and National Health Commission; National Joint Engineering Research Center for Theranostics of Immunological Skin Diseases , Shenyang ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mingyue","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, The First Hospital of China Medical University , Shenyang ,","place":["China"]},{"name":"Key Laboratory of Immunodermatology, Ministry of Education, and National Health Commission; National Joint Engineering Research Center for Theranostics of Immunological Skin Diseases , Shenyang ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Litao","family":"Zhang","sequence":"additional","affiliation":[{"name":"Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital , Tianjin ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunsheng","family":"Liang","sequence":"additional","affiliation":[{"name":"Dermatology Hospital of Southern Medical University , Guangzhou, Guangdong ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenlin","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, The Second Affiliated Hospital of Guangzhou Medical University , Guangzhou, Guangdong ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liming","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Affiliated Hangzhou First People's Hospital, School of Medicine, West Lake University , Hangzhou ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lei","family":"Cao","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Wuxi No.2 People\u2019s Hospital , Wuxi ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanyan","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Chengdu Second People\u2019s Hospital , Chengdu ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zudong","family":"Meng","sequence":"additional","affiliation":[{"name":"Shiyan Renmin Hospital , Shiyan, Hubei ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rixin","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Nanyang First People\u2019s Hospital , Nanyang ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yingxia","family":"He","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Genertec Liaoyougem Flower Hospital , Panjin ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linfeng","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Beijing Friendship Hospital, Capital Medical University , Beijing ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenli","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Dermatovenereology, Second Hospital of Shanxi Medical University , Taiyuan ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bingjiang","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Dermatology, The First Affiliated Hospital of Ningbo University , Ningbo ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aie","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hangzhou Third People\u2019s Hospital , Hangzhou ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meiying","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, The Second Affiliated Hospital of Nanchang University , Nanchang 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