Phase 3 study of upadacitinib yielded promising results in patients with rheumatoid arthritis
AbbVie Inc. announced positive results from a phase 3 clinical trial that evaluated upadacitinib, an oral Janus kinese-1 selective inhibitor, for patients with moderate or severe rheumatoid arthritis with intolerant or inadequate response to biologic disease-modifying antirheumatic drugs, according to company release.
According to the release, the 15-mg and 30-mg once-daily doses of upadacitinib (ABT-494) both met the primary endpoints of ACR20 and low disease activity at 12 weeks. Secondary endpoints for both doses were also achieved. Upadacitinib is not yet approved by regulatory authorities, and its safety and efficacy have not been established.
“We are pleased with the positive results for upadacitinib in the SELECT-BEYOND trial,” Michael Severino, MD, executive vice president for research and development and chief scientific officer of AbbVie, said in the release. “Particularly exciting is the proportion of patients who achieved clinical remission by week 12 and 24, despite having inadequate responses with previous biologic therapies. Together with previously reported results from SELECT-NEXT, these data further support the potential for upadacitinib to be a meaningful treatment option for rheumatoid arthritis patients. We continue to build upon our leadership in immunology as we advance the development program for upadacitinib across a broad range of immune-mediated diseases.”
At 12 weeks, ACR20 and ACR50 results were statistically significant for patients who received oral once-daily 15-mg or 30-mg upadacitinib compared with patients who received placebo. However, there was no statistically significant difference between the placebo and 15-mg dose group for ACR70. More patients who received either dose of upadacitinib achieved low disease activity and clinical remission targets compared with patients who received placebo.
At 24 weeks, the results continued to be promising, according to the release. Two deaths were reported in the study. In addition, no deep vein thrombosis and two cases of pulmonary embolism were reported during the placebo-controlled period.