Upadacitinib outperforms placebo in UC patients with inadequate response to biologics

Superiority of upadacitinib over placebo as induction therapy for patients with moderately to severely active ulcerative colitis (UC) was observed regardless of biological-inadequate responder status. In addition, efficacy of upadacitinib was consistent in patients for whom previous biologic therapies had failed and in patients who had a prior inadequate response to conventional therapies.

Upadacitinib is an oral selective and reversible JAK inhibitor. Two phase 3 induction trials (U-ACHIEVE [NCT02819635] and U-ACCOMPLISH [NCT03653026]) have demonstrated efficacy of upadacitinib over placebo in patients with moderately to severely active UC. Yet, in patients who have had an inadequate response (IR) to a biologic or conventional therapy, data on appropriate induction therapy is lacking. The post-hoc analysis presented by Prof. Séverine Vermeire (University Hospital Leuven, Belgium) aimed to assess the efficacy of upadacitinib (45 mg once daily) in patients who showed previous IR to biologics or conventional therapies [1]. The primary endpoint was the clinical remission per adapted Mayo score at week 8 (stool frequency score ≤1 and not greater than baseline, rectal bleeding score=0, Mayo endoscopic subscore ≤1).

Upadacitinib was superior to placebo in both biologic-IR patients and non-biologic-IR patients, in both the U-ACHIEVE trial and the U-ACCOMPLISH trial. In the biologic-IR patients of the U-ACHIEVE trial, clinical remission was achieved in 18% of the upadacitinib patients (n=168) versus 0% of the placebo patients (n=78). Among the non-biologic-IR participants, 35% of the upadacitinib receivers (n=151) reached clinical remission compared with 9.2% of the placebo patients (n=76). The U-ACCOMPLISH trial showed similar rates. Moreover, secondary endpoints demonstrated a superior efficacy of upadacitinib over placebo as well. No new safety issues emerged in this subgroup analysis.

1. Vermeire S, et al. Upadacitinib induction therapy in patients with moderately to severely active ulcerative colitis by biologic inadequate responder status: results from two randomized phase 3 studies. OP017, UEG Week 2021 Virtual Congress, 03–05 October.

 

Copyright ©2021 Medicom Medical Publishers



Posted on 27 October, 20218 April, 2024