Upadacitinib Meets Endpoints for Phase 3 Study in RA
AbbVie announced positive mid-study results from its ongoing Phase 3 trials (SELECT-NEXT) of upadacitinib for the treatment of moderate to severe rheumatoid arthritis (RA) after inadequate response to stable doses of conventional synthetic disease-modifying antirheumatic drugs (csDMARD) therapy.
SELECT-NEXT, a double-blind, placebo-controlled multicenter study, is evaluating the efficacy of upadacitinib in achieving primary endpoints of ACR20 and low disease activity vs. placebo. Patients were randomized to receive once-daily upadacitinib 15mg (n=221), upadacitinib 30mg (n=219) or placebo (n=221). Other endpoints of the study include ACR50, ACR70 and clinical remission of RA.
The results from the 12-week period show that both arms of upadacitinib treatment were superior in achieving ACR 20 (64% in 15mg arm, 66% in 30mg arm) vs. placebo (36%). Forty-eight percent of patients in either treatment arm achieved low disease activity, compared to 17% with placebo. Clinical remission, defined by a Disease Activity Score with 28 joint counts (C-reactive protein) (DAS28 [CRP]) <2.6, was met in the 15mg and 30mg groups (31% and 28%, respectively) vs. 10% in placebo. Treatment also showed positive trends in ACR50 and ACR70 scores.
Adverse events monitored in SELECT-NEXT remain consistent with results from previous Phase 2 trials of upadacitinib, with no new safety signals reported. Serious adverse events occurred in 4% of the 15mg arm and 3% in the 30mg arm. Complete data on serious or common adverse events have not been published.
Upadacitinib is a novel oral JAK1 inhibitor aimed to prevent downstream processes involving cytokines, interleukins, and other proinflammatory mediators, which contribute to the pathophysiology of rheumatoid arthritis. Currently, upadacitinib is undergoing Phase 3 studies for its use in psoriatic arthritis. AbbVie is studying upadacitinib's potential in treatment of Crohn's disease, ulcerative colitis and atopic dermatitis as well.
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