Rheumatoid Arthritis Treatment Achieves All Primary Endpoints in Phase 3 Trial

Upadacitinib (AbbVie), a potential new treatment for rheumatoid arthritis (RA), met all primary endpoints in a phase 3 clinical trial, according to a press release.

Upadacitinib, an oral agent engineered to selectively inhibit JAK1, is being studied as a once-daily therapy in RA in the SELECT-COMPARE clinical trial and across multiple immune-mediated diseases.

In the phase 3 SELECT-COMPARE trial, researchers evaluated the safety and efficacy of upadacitinib compared with placebo and adalimumab in adult patients with moderate-to-severe RA who are on a stable background of methotrexate and who have an inadequate response. Patients received either upadacitinib (15 mg once-daily), placebo, or adalimumab (given as a subcutaneous injection of 40 mg every other week).

At week 12 of the study, 71% of patients administered an oral once-daily dose of upadacitinib 15 mg achieved an ACR20 response, compared with 36% of patients administered placebo. Additionally, patients receiving upadacitinib achieved ACR50/70 responses of 45/25% compared with 15/5% of patients receiving placebo at week 12. Low disease activity based on DAS28(CRP) was seen in 45% of patients receiving upadacitinib compared with 29% receiving adalimumab and 14% receiving placebo at week 12, respectively.

The researchers also determined superiority of upadacitinib over adalimumab, on ranked secondary endpoints that compared both groups. Forty-five percent of a upadacitinib patients achieved ACR50 compared with 29% of adalimumab patients at week 12, according to the findings. Upadacitinib was also superior in reduction of pain.

“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,” Michael Severino, MD, executive vice president, research and development and chief scientific officer at AbbVie, said in the 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,” he added.

In the study, upadacitinib’s safety profile was consistent with previously reported results, AbbVie noted.

Currently, phase 3 trials of upadacitinib as a treatment for RA, psoriatic arthritis, and Crohn disease are ongoing, and it is also being investigated to treat ulcerative colitis, ankylosing spondylitis, atopic dermatitis, and giant cell arteritis, according to the press release.

Reference

Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis [news release]. AbbVie’s website. https://news.abbvie.com/news/upadacitinib-meets-all-primary-and-ranked-secondary-endpoints-including-superiority-versus-adalimumab-in-phase-3-study-in-rheumatoid-arthritis.htm. Accessed April 11, 2018.