AbbVie’s upadacitinib has hit primary and secondary targets in the first late-stage trial of the drug involving patients with moderate-to-severe rheumatoid arthritis (RA).
The Phase III SELECT-NEXT clinical trial evaluated the investigational oral JAK1-selective inhibitor in patients with the condition who did not adequately respond to treatment with conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs).
The firm said that top-line data showed that, after 12 weeks of treatment, both doses of upadacitinib (15mg and 30mg) met the study's primary endpoints of ACR20 and low disease activity, while key secondary endpoints - including ACR50, ACR70 and clinical remission - were also achieved.
Results at week 12 showed that of patients receiving a 15mg or 30mg oral, once-daily dose of upadacitinib, 64 percent and 66 percent achieved ACR20, respectively, compared to 36 percent of patients receiving placebo, while for ACR70 the numbers were 21 percent, 27 percent and 6 percent, respectively.
Low disease activity was achieved by 48 percent of patients receiving either dose of AbbVie’s drug, compared to 17 percent of patients receiving placebo, while clinical remission was achieved by 31 percent and 28 percent of patients receiving 15mg or 30mg of upadacitinib, respectively, compared to 10 percent receiving placebo.
“Selective inhibition of the JAK1 pathway may offer a novel treatment for rheumatoid arthritis patients who do not adequately respond to conventional therapies,” said Michael Severino, AbbVie’s executive vice president, R&D, and chief scientific officer.
“We are especially encouraged by the results on the more stringent measures of efficacy, such as ACR70, low disease activity and clinical remission,” he added.
Full results are to be presented at an upcoming medical meeting and published in a peer-reviewed publication, the firm noted.