AbbVie (NYSE:ABBV) announces positive results from a Phase 3 clinical trial, SELECT-PsA 2, evaluating Rinvoq (upadacitinib) in adult patients with active psoriatic arthritis (PA) who have failed to respond adequately to one or more biologic disease-modifying anti-rheumatic drugs (bDMARDs).
The study met the primary endpoint of a statistically significant proportion of patients achieving ACR20 (20% improvement in number of swollen joints and 20% improvement in three of five other criteria) at week 12 compared to placebo. Specifically, 89% (n=57/64) of treated patients achieved ACR20 versus 24% for control.
Key secondary endpoints were also met, including the proportion of participants achieving PASI 75 (75% improvement in PA) at week 16 and the proportion achieving minimal disease activity.
No new safety signals were observed.
Complete results will be submitted for presentation at a future medical conference.
The FDA approved the JAK inhibitor in August for rheumatoid arthritis.
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