Phase 3 of Rheumatoid Arthritis Drug Meets Primary and Secondary Endpoints

This morning, AbbVie revealed positive top-line results from the Phase 3 SELECT-COMPARE clinical trial evaluating upadacitinib in rheumatoid arthritis.

SELECT-COMPARE is the fourth of 6 Phase 3 studies in the SELECT rheumatoid arthritis clinical trial program. Upadacitinib is an investigational oral agent being developed to selectively inhibit JAK1, which plays an important role in the pathophysiology of immune-mediated disorders.

Results from the multicenter, randomized, double-blind, study showed that at 12 weeks, 71% of patients with moderate to severe rheumatoid arthritis receiving upadacitinib once-daily at 15 mg met the primary endpoints of ACR20, meaning that a person’s rheumatoid arthritis has improved by 20%, and clinical remission versus patients receiving placebo (36%). All enrolled patients were on a stable background of methotrexate and who have an inadequate response.

"These results show a significant impact on both signs and symptoms and radiographic progression compared to placebo, as well as improvements in important measures such as ACR response and low disease activity compared to adalimumab," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie in a press release. "We are excited by these strong results which add to the body of evidence that support the potential of upadacitinib to be an important treatment option for patients with rheumatoid arthritis."

A meaningfully higher proportion of patients receiving upadacitinib achieved clinical remission (29%) compared with placebo at week 12 (6%). Patients receiving upadacitinib achieved ACR50/70 responses of 45/25 percent compared to 15/5 percent of patients receiving placebo at week 12. Additionally, low disease activity (LDA) was observed in 45% of patients receiving upadacitinib compared to 29% receiving adalimumab (given as a subcutaneous injection of 40 mg every other week) and 14% receiving placebo at week 12, respectively.

Additionally, on ranked secondary endpoints that compared both groups, the study findings showed superiority of upadacitinib over adalimumab.

At week 12, 45% of upadacitinib patients achieved ACR50 compared with 29% of adalimumab patients. Upadacitinib was also superior to adalimumab in reduction of pain and improvements in physical function. Following 26 weeks of treatment, upadacitinib significantly inhibited radiographic progression compared to placebo. The inhibition of joint damage is important for rheumatoid arthritis patients as this can lead to permanent loss of function and consequent disability.

The safety profile of upadacitinib in the study was consistent with historical data, and no new safety signals were detected.

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