Upadacitinib Meets Endpoints for Phase 3 Study in RA

Over 600 patients were enrolled in the trial which evaluated upadacitinib for achieving low disease activity
Over 600 patients were enrolled in the trial which evaluated upadacitinib for achieving low disease activity

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. 

Related Articles

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.

For more information visit AbbVie.com.