Upadacitinib (ABT-494) is an oral, once-daily JAK1 inhibitor in Phase 3 clinical trials for treating rheumatoid arthritis (RA).1 The SELECT Phase 3 trial by the manufacturer AbbVie is evaluating the treatment in more than 4,000 patients with moderate to severe RA in six different studies.
A recent clinical trial, SELECT-NEXT, evaluated upadacitinib in patients with moderate to severe RA who do not adequately respond to treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).2 After Week 12, the study met its primary and secondary endpoints. The primary endpoints included ACR20 and low disease activity. Key secondary endpoints included ACR50, ACR70 and clinical remission. These results were achieved by patients taking 15 or 30 mg upadacitinib once daily.
For patients receiving 15 or 30 mg upadacitinib, the Week 12 results showed a 64% and 66% ACR20 response rate, respectively, compared with a 36% achievement in ACR20 for placebo-treated patients. The ACR50 response rates for upadacitinib-treated patients were 38% and 43%, respectively, vs. 15% for placebo-treated patients. And the ACR70 responses for upadacitinib-treated patients were achieved in 21% of patients treated with 15 mg and 27% of patients treated with 30 mg vs. 6% of placebo-treated patients. Overall, low disease activity was achieved in 48% of upadacitinib-treated patients receiving either dose compared with 17% of placebo-treated patients. Clinical remission was achieved by 31% of 15 mg upadacitinib-treated patients and 28% of 30 mg upadacitinib-treated patients. Only 10% of placebo-treated patients achieved clinical remission. All study endpoints were considered statistically significant (P<0.001) compared with placebo.
The safety of upadacitinib is still being evaluated. The treatment is also in Phase 3 trials for psoriatic arthritis and is being investigated to treat Crohn’s disease, ulcerative colitis and atopic dermatitis.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- AbbVie Inc. News release: AbbVie’s upadacitinib (ABT-494) meets all primary and ranked secondary endpoints in phase 3 study in rheumatoid arthritis. PR Newswire. 2017 Jun 7.
- U.S. National Institutes of Health. A study comparing ABT-494 to placebo in subjects with rheumatoid arthritis on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) who have an inadequate response to csDMARDs alone (SELECT-NEXT). ClincalTrials.gov. 2017 Jun 29.