AbbVie has announced positive top-line results from their Phase 3 clinical trial of upadacitinib for the treatment of patients with moderate-to-severe rheumatoid arthritis.
Upadacitinib is an investigational oral agent that selectively inhibits JAK1. The safety and efficacy of upadacitinib was evaluated in the randomized, double-blind, SELECT-COMPARE Phase 3 trial. Study patients with moderate to severe rheumatoid arthritis who were on a stable background of methotrexate and had an inadequate response were randomized to either upadacitinib (15mg once-daily; n=651), adalimumab (40mg subcutaneous injections every other week; n=327), or placebo (n=651).
The primary endpoints were the achievement of the American College of Rheumatology 20% (ACR20), defined as an improvement in both tender and swollen joint counts, plus 3 of the following: patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant (high sensitivity c-reactive protein). Also clinical remission was a co-primary endpoint.
At week 12, the results showed that 71% of the upadacitinib group achieved American College of Rheumatology 20% (ACR20; primary endpoint), compared to 63% and 36% in the adalimumab and placebo groups, respectively. Clinical remission – based on Disease Activity Score with 28 joint counts (C-reactive protein) (DAS28 [CRP]) ≤2.6 – was achieved by 29%, 18% and 6% of the upadacitinib, adalimumab and placebo groups, respectively. ACR 50% and 70% was achieved by 45% and 25% of the upadacitinib group compared with 29% and 13% in the adalimumab group and 15% and 5% in the placebo group, respectively.
In addition, upadacitinib significantly inhibited radiographic progression following 26 weeks of treatment, as measured by the change in modified total Sharp score from baseline compared with placebo (0.24 vs 0.92, P<0.001).
Serious adverse events occurred in 3.7%, 4.3%, and 2.9% of upadacitinib-treated, adalimumab-treated, and placebo-treated patients, respectively. The safety profile of upadacitinib was consistent with previous studies; no new safety signals were detected.
The SELECT-COMPARE trial is the fourth of 6 planned Phase 3 trials in the SELECT rheumatoid arthritis clinical trial program. The Company plans to submit a new drug application for upadacitinib in rheumatoid arthritis in the second half of 2018.
For more information visit AbbVie.com.