- AbbVie (NYSE:ABBV) announces positive results from a Phase 3 clinical trial, SELECT-PsA 1, evaluating RINVOQ (upadacitinib) in adults with psoriatic arthritis (PA) who failed to respond adequately to or were intolerant of DMARD (disease modifying anti-rheumatic drug) therapy.
- The study met the primary endpoint demonstrating a statistically significant proportion of treated patients achieving ACR20 (20% improvement in PA) at week 12 versus placebo. Specifically, 71% and 79% of participants receiving 15 mg and 30 mg, respectively, of RINVOQ achieved ACR20 compared to 36% in the control arm (p<0.0001).
- Both doses of RINVOQ demonstrated non-inferiority to Humira (adalimumab) as measured by ACR20 at week 12 while the 30 mg dose also showed superiority.
- No new safety signals were observed.
- A sister Phase 3, SELECT-PsA 2, was also successful.
- Results will be submitted for presentation at a future medical conference and publication.
- The FDA approved the JAK inhibitor in August 2019 for rheumatoid arthritis.
- Shares up 1% premarket on light volume.