AbbVie's JAK Inhibitor Upadacitinib Meets Primary and Key Secondary Endpoints in Phase 3 Trial for Ulcerative Colitis

AbbVie Inc. announced today that its JAK inhibitor upadacitinib met the primary endpoint of clinical remission, as well as all key secondary endpoints, in a Phase 3 clinical trial for adult patients with moderately to severely active ulcerative colitis. At Week 8 of treatment, 26% of patients in the upadacitinib group achieved clinical remission, compared with 5% in the placebo group (p<0.001).

Ulcerative colitis is a chronic, systemic inflammatory disease caused by inflammation of the large intestine, leading to abdominal pain, bloody diarrhea, severe urgency to defecate, weight loss, and fatigue. The severity of symptoms and the unpredictability of disease relapse impose a significant burden on patients and often result in disability.

Upadacitinib, discovered and developed by AbbVie scientists, is a selective and reversible JAK inhibitor administered orally once daily. In August 2019, it received approval from the U.S. FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The JAK protein family mediates the signaling of multiple inflammatory cytokines. Consequently, upadacitinib is currently being evaluated in numerous clinical trials for the treatment of various inflammatory diseases, including atopic dermatitis, Crohn's disease, and psoriatic arthritis.

The trial results showed that, in addition to meeting the primary endpoint, a greater proportion of patients in the upadacitinib group achieved endoscopic improvement at Week 8 compared with the placebo group (36% vs. 7%; p<0.001). Furthermore, a higher proportion of patients receiving upadacitinib achieved clinical response at Week 8 (73% vs. 27%; p<0.001).

▲Efficacy Results from Phase 3 Clinical Trials of Upadacitinib (Image source: Reference [1])

References:

[1] Upadacitinib (RINVOQ™) Meets Primary and All Ranked Secondary Endpoints in First Phase 3 Induction Study in Ulcerative Colitis. Retrieved December 9, 2020, from https://news.abbvie.com/news/press-releases/upadacitinib-rinvoq-meets-primary-and-all-ranked-secondary-endpoints-in-first-phase-3-induction-study-in-ulcerative-colitis.htm?view_id=3438

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