Updated results from the extension portion of a Phase 2 clinical trial, CELEST, evaluating AbbVie's (ABBV +3%) JAK1 inhibitor upadacitinib in adult Crohn's disease patients who had not responded adequately to prior immunomodulator or tumor necrosis factor alpha antagonist therapy showed a sustained treatment benefit. The data are being presented at ECCO in Vienna, Austria.
CELEST is a 52-week randomized, double-blind trial consisting of a 16-week dose-ranging induction and a 36-week extension phase. All participants who completed the 16-week portion were re-randomized 1:1:1 to receive one of the following upadacitinib dosing regimens: 3 mg twice daily, 12 mg twice daily or 24 mg once daily for 36 weeks. The 24 mg arm was later stopped and replaced with a 6 mg twice-daily arm.
The co-primary endpoints were the proportion of patients achieving clinical remission and endoscopic remission up to week 16.
In patients who responded clinically by week 16, 41% of those receiving the 12 mg twice-daily dose achieved clinical remission at week 52. For the 3 mg, 6 mg and 24 mg arms, the rates of clinical remission were 25%, 29% and 32%, respectively.
The proportions who achieved endoscopic remission at week 52 in the 3 mg, 6 mg, 12 mg and 24 mg arms were 16%, 21%, 24% and 26%, respectively.
Upadacitinib (formerly ABT-494) is in Phase 3 development for ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, Crohn's disease and atopic dermatitis.
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