P1638 - Upadacitinib Is Effective at Inducing Clinical Remission and Response in Ulcerative Colitis Patients Regardless of Baseline Corticosteroid Use: Results From Two Phase 3 Studies

David T. Rubin, MD, FACG¹, Tim Raine, MD², Tricia Finney-Hayward, PhD³, Edward V. Loftus, MD, FACG⁴, Laura Targownik, MD⁵, Dapo Ilo, MD⁶, Charles Phillips, MD⁶, Xuan Yao, PhD⁶, Severine Vermeire, MD, PhD⁷, Silvio Danese, MD, PhD^8
1University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; ²Cambridge University Hospitals, Cambridge, England, United Kingdom; ³AbbVie Ltd., Maidenhead, England, United Kingdom; ⁴Mayo Clinic, Rochester, MN; ⁵Mount Sinai Hospital, Toronto, ON, Canada; ⁶AbbVie, Inc., North Chicago, IL; ⁷University Hospitals Leuven, Leuven, Brussels Hoofdstedelijk Gewest, Belgium; ⁸Inflammatory Bowel Diseases Center, Humanitas Clinical and Research Center IRCCS and Hunimed, Milan, Lombardia, Italy

Introduction: Corticosteroid (CS) therapy is often used to treat ulcerative colitis (UC) relapses. It is efficient at reducing inflammation and clinical symptoms but is not effective nor is it recommended in the management of maintenance phases due to associated adverse events. The need for an effective, targeted induction therapy in the absence of CS is of key interest. Upadacitinib (UPA) is an oral selective and reversible JAK inhibitor that demonstrated significantly greater efficacy as an induction therapy compared with placebo (PBO) in patients with moderately to severely active UC during two phase 3 trials (U-ACHIEVE [NCT02819635] and U-ACCOMPLISH [NCT03653026]). This subgroup analysis evaluated the impact of baseline CS use on UPA efficacy in UC patients from these trials.



Methods: U-ACHIEVE and U-ACCOMPLISH were multicentre, double-blind, PBO-controlled trials that enrolled patients who have had moderately to severely UC with an Adapted Mayo Score of 5 to 9 points and a baseline endoscopy subscore of 2 to 3. Patients (n=988 in both studies) were randomized to receive UPA 45mg once daily (QD) or PBO for 8 weeks (wks). Endpoints presented here are the percentage of patients in clinical remission at wk 8, per Adapted Mayo score, and the percentage of patients with a clinical response at wk 2, per partial Adapted Mayo score (both defined in Table footnotes), respectively, in patients who were on concomitant CS at baseline, at a dose maintained to the end of induction and in those treated with UPA without concomitant CS.

Results: UPA was superior to PBO, with a higher percentage of UPA-treated patients achieving clinical remission at wk 8 and clinical response at wk 2 regardless of baseline CS use. No significant differences were observed in the wk 8 clinical remission rate between UPA-treated patients receiving baseline CS (U-ACHIEVE: 24.3%; U-ACCOMPLISH: 28.8%) and those who received UPA without CS (U-ACHIEVE: 27.3%; U-ACCOMPLISH: 35.9%). Similar results were found with the clinical response rate at wk 2, with no difference between UPA-treated patients who received baseline CS (U-ACHIEVE: 58.1%; U-ACCOMPLISH: 55.1%) and those that received UPA without CS (U-ACHIEVE: 61.4%; U-ACCOMPLISH: 67.7%).

Discussion: In patients with moderately to severely active UC, UPA is superior to PBO in conferring clinical remission and response, with similar rates in patients on CS at baseline and those without CS use.



Disclosures:


David T. Rubin, MD, FACG¹, Tim Raine, MD², Tricia Finney-Hayward, PhD³, Edward V. Loftus, MD, FACG⁴, Laura Targownik, MD⁵, Dapo Ilo, MD⁶, Charles Phillips, MD⁶, Xuan Yao, PhD⁶, Severine Vermeire, MD, PhD⁷, Silvio Danese, MD, PhD⁸. P1638 - Upadacitinib Is Effective at Inducing Clinical Remission and Response in Ulcerative Colitis Patients Regardless of Baseline Corticosteroid Use: Results From Two Phase 3 Studies, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.