Trial reportJournal of gastroenterology and hepatology2025
Guselkumab in East Asians With Moderate-to-Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies.
Trial report in Journal of gastroenterology and hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04033445 (CNTO1959UCO3001), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
CNTO1959UCO3001: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines on the Use of Small Molecules and IL-23 p19 Inhibitors in Ulcerative Colitis and Crohn's Disease.Journal of gastroenterology and hepatology · 2026Guideline
- Guselkumab in East Asians With Moderate-to-Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies.Journal of gastroenterology and hepatology · 2025Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
BACKGROUND AND
aimThe global QUASAR (NCT04033445) clinical program demonstrated the efficacy and safety of guselkumab, a dual-acting interleukin-23 p19 subunit inhibitor, as induction and maintenance therapy in participants with moderate to severely active ulcerative colitis (UC). We report a subgroup analysis in East Asian participants.
methodsThe QUASAR program included two randomized, placebo-controlled, 12-week induction studies of guselkumab 200 mg (and 400 mg, Phase 2b) IV every 4 weeks (q4w) in adults with baseline modified Mayo scores of 5-9 and inadequate response/intolerance to conventional and/or advanced UC therapy. Clinical responders to guselkumab induction were re-randomized (1:1:1) at maintenance study baseline to SC guselkumab 200 mg q4w, 100 mg q8w, or placebo. Primary endpoints were clinical response (Phase 2b) or clinical remission (Phase 3) at induction Week 12 (I-12) and clinical remission at maintenance Week 44 (M-44). Subgroup analyses included participants from sites in China, Japan, Korea, and Taiwan region.
resultsData were from 71 (Phase 2b) and 135 (Phase 3) East Asians in the induction studies and 106 in the maintenance study. At Week I-12, 45.5%-58.8% of guselkumab versus 25.5%-29.2% of placebo participants achieved clinical response and 16.0%-23.8% versus 4.2%-5.5%, respectively, achieved clinical remission. At Week M-44, 37.1%-46.3% of guselkumab versus 13.3% of placebo participants achieved clinical remission. The adverse event profile was generally consistent with the global QUASAR population.
conclusionsResults support the efficacy and safety of guselkumab induction and maintenance in East Asians with moderately to severely active UC, consistent with findings from the global QUASAR studies.
trial registrationClinicalTrials.gov, NCT04033445; EudraCT, 2018-004002-25.
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