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Efficacy of Upadacitinib Dose Escalation in a Phase 3 Long-Term Extension Ulcerative Colitis Study
The American Journal of Gastroenterology ; 117(10S):e574-e575, 2022.
Article in English | ProQuest Central | ID: covidwho-2111057
ABSTRACT

Introduction:

Upadacitinib (UPA), an oral selective and reversible JAK inhibitor, recently demonstrated significantly greater therapeutic efficacy compared to placebo (PBO) in patients with moderate to severe ulcerative colitis (UC) during a Phase 3 program.1,2,3 We evaluated the efficacy of dose escalation to UPA 30 mg QD (UPA30) among patients who demonstrated an inadequate response to UPA 15 mg QD (UPA15) during the long-term extension (LTE) study U-ACTIVATE. Results were based on non-responder imputation (NRI-NC) with 95% confidence intervals (CI) calculated by normal approximation to binomial distribution. F020For patients enrolled from U-ACHIEVE Maintenance due to loss of response, inadequate response was defined as SFS + RBS value that remains unchanged or has increased from wk 0 on two consecutive visits at least 7 days apart. a Non-responder imputation with no special data handling for missing due to COVID-19 was applied. 95% CI calculated by normal approximation to binomial distribution. b Clinical remission per Adapted Mayo score SFS≤1 and not greater than baseline (of induction), RBS=0, and endoscopic subscore (ES) ≤ 1. c Clinical remission per Adapted Mayo score and CS-free clinical remission (clinical remission at wk 48 and CS-free for ≥90 days prior to wk 48 among patients with clinical remission at the end of the induction therapy). d Endoscopic improvement ES ≤ 1 e Endoscopic remission ES= 0.
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Full text: Available Collection: Databases of international organizations Database: ProQuest Central Language: English Journal: The American Journal of Gastroenterology Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: ProQuest Central Language: English Journal: The American Journal of Gastroenterology Year: 2022 Document Type: Article