AbbVie said its Phase III SELECT-NEXT clinical trial of upadacitinib (ABT-494) in patients with moderate to severe rheumatoid arthritis (RA) achieved positive results.
The trial, involving patients who had not responded to conventional synthetic DMARDs (csDMARDs) treatments, evaluated upadacitinib in 15 milligram and 30 milligram doses versus a placebo. At week 12, 64 percent and 66 percent, respectively, reached American College of Rheumatology criteria 20 percent (ACR20) improvement versus 36 percent of the patients who received the placebo, AbbVie said in a release. The best response, ACR70, was reached by 21 percent and 27 percent of the 15 mg and 30 mg groups, respectively. Only 6 percent of the placebo group reached ACR70.
In addition, 31 percent and 28 percent of the participants receiving the 15 mg and 30 mg dosages reached clinical remission. Ten percent of the patients who received the placebo reached clinical remission, the release said.
"We are excited by these promising results for upadacitinib," Michael Severino, AbbVie executive vice president of research and development and chief scientific officer, said in the release. "Selective inhibition of the JAK1 pathway may offer a novel treatment for rheumatoid arthritis patients who do not adequately respond to conventional therapies. We are especially encouraged by the results on the more stringent measures of efficacy, such as ACR70, low disease activity and clinical remission. We look forward to seeing the full results from our Phase 3 program. AbbVie's longstanding leadership in the treatment of immune-mediated diseases provides an opportunity to build upon our understanding and develop innovative therapies to address unmet patient needs."