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Efficacy, Safety, and Pharmacokinetics of Upadacitinib Among Patients in East Asia With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Subanalysis of Randomized Phase 3 Studies.

Shu Chen Wei·Hiroshi Nakase·Byong Duk Ye·Kang Chao·Hsin-Yun Wu·Jason Eccleston·Xuan Yao·Hannah Palac·Mohamed-Eslam F Mohamed·Ana Victoria Ponce-Bobadilla·Smitha Suravaram·Elena Marced Barrachina·Tadakazu Hisamatsu·Xiang Gao
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Abstract

BACKGROUND AND AIM: Upadacitinib, a selective Janus kinase 1 inhibitor, is approved to treat moderately to severely active ulcerative colitis (UC). This post hoc subanalysis evaluated the efficacy, safety, and pharmacokinetics of upadacitinib in patients in East Asia. METHODS: U-ACHIEVE (UC1; NCT02819635) and U-ACCOMPLISH (UC2; NCT03653026) were Phase 3, multicenter, randomized, double-blind, induction studies evaluating upadacitinib 45 mg or placebo daily in adults with moderately to severely active UC. Clinical responders to 8 weeks of upadacitinib induction were eligible to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo daily in the 52-week U-ACHIEVE maintenance study (UC3; NCT02819635). Efficacy outcomes, safety, and pharmacokinetics were evaluated among East Asian patients. RESULTS: A higher proportion of East Asian patients achieved clinical remission with upadacitinib than placebo at induction Week 8 (UC1: n = 127, 31.4% vs. 7.3%; UC2: n = 114, 31.2% vs. 2.7%) and maintenance Week 52 (UC3: n = 184, upadacitinib 15 mg, 52.4%; upadacitinib 30 mg, 53.8%; placebo, 10.7%). Rates of endoscopic outcomes were higher with upadacitinib than with placebo across studies. No new safety signals were identified. Herpes zoster occurrences were low (UC1 and UC2: upadacitinib 45 mg, two events [in one patient]; placebo, zero events; UC3: upadacitinib 15 mg, five events; upadacitinib 30 mg, eight events; placebo, zero events). Pharmacokinetics and trends in the relationship between upadacitinib exposure and efficacy were consistent in the East Asian and global populations. CONCLUSION: Upadacitinib was generally well tolerated and effective for treating moderately to severely active UC in patients in East Asia, with a favorable benefit-risk profile consistent with the global population. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02819635, NCT03653026.

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HumansColitis, UlcerativeHeterocyclic Compounds, 3-RingMaleAdultTreatment OutcomeDouble-Blind MethodFemaleSeverity of Illness IndexMiddle AgedAsia, EasternJanus Kinase 1Remission InductionJanus Kinase InhibitorsEast Asian peopleJanus kinase inhibitorspharmacokineticstreatment outcomeulcerative colitisJournal ArticleMulticenter StudyClinical Trial, Phase IIIRandomized Controlled Trial

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Shu Chen Wei, Hiroshi Nakase, Byong Duk Ye, Kang Chao, Hsin-Yun Wu, Jason Eccleston, Xuan Yao, Hannah Palac, Mohamed-Eslam F Mohamed, Ana Victoria Ponce-Bobadilla, Smitha Suravaram, Elena Marced Barrachina, Tadakazu Hisamatsu, Xiang Gao. 2026-08-19. Efficacy, Safety, and Pharmacokinetics of Upadacitinib Among Patients in East Asia With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Subanalysis of Randomized Phase 3 Studies.. https://doi.org/10.1111/jgh.70634

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Adult subjectClinical Trial, Phase III subjectDouble-Blind Method subjectEast Asian People subjectFemale subjectHeterocyclic Compounds, 3-Ring subjectHumans subjectJanus Kinase Inhibitors subjectJournal Article subjectMale subjectMiddle Aged subjectMulticenter Study subjectRandomized controlled trials studypharmacokinetics subject

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