Findings of a phase 3 clinical trial show that patients who take a 15 mg or 30 mg dose achieved higher ACR20, ACR50, and ACR70 scores than those who had a placebo.
Iain McInnis, FRCP, PhD
Adults with active psoriatic arthritis who took 15 mg or 30 mg doses of upadacitinib (RINVOQ) once daily saw more positive outcomes than those who had placebo, new findings of a phase 3 trial suggested.
Results from the Phase 3 SELECT-PsA 1 clinical trial conducted by global biopharmaceutical company, AbbVie, showed that upadacitinib, a selective and reversible JAK inhibitor, was beneficial for those who inadequately responded or were intolerant to 1 or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).
At week 12, 71% and 79% of patients who received 15 mg or 30 mg of upadacitinib achieved ACR20 compared to 36% of patients who received placebo (P <.0001).
In general, more patients who used upadacitinib achieved ACR20, ACR50, and ACR70 than those in the placebo group. The measure represented improvement by 20%-70% in the number of tender and swollen joints, and the same percentage improvement in 3 of the 5 criteria: patient global assessment; physician global assessment; functional ability measure; visual analog pain scale; and erythrocyte sedimentation rate or C-reactive protein.
The results were encouraging and added to the growing evidence that upadacitibin could improve outcomes for patients living with psoriatic arthritis, Iain McInnis, FRCP, PhD, a professor from the University Glasgow Institute of Infection, Immunity & Inflammation, said in a statement.
Investigators compared ACR20 response for upadacitinib at week 12 versus adalimumab (HUMIRA) and found that both doses of upadacitinib achieved non-inferiority and only the 30 mg dose showed superiority.
At week 12, ACR50 was achieved by 38% and 52% of patients who received 15 mg or 30 mg of upadacitinib, while it was achieved by 13% of patients who received placebo (nominal P <.0001). In terms of ACR70, 16% and 25% of patients who received 15 mg or 30 mg of upadacitinib achieved it at week 12, compared to 2% of the placebo group (nominal P <.0001).
Patients who received upadacitinib also had more improved physical function at 12 weeks, which investigators measured with the Health Assessment Questionnaire Disability Index. The adults in the 15 mg and 30 mg upadacitinib groups reported a -.42 and -.47 change from baseline in their assessment score, compared to -.14 for the placebo group (P <.0001).
There were no major adverse cardiovascular events reported by either upadacitinib group, while there was 1 in the placebo group and 2 in the adalimumab group. No deaths occurred in the upadacitinib or adalimumab groups, compared to 1 in the placebo group (.2%).
Upadacitinib improved skin symptoms at week 16, with 63% and 62% of those who received 15 mg or 30 mg of the drug reporting a 75% improvement in the Psoriasis Area Severity Index. Only 21% of those in the placebo group (P <.0001) achieved such an improvement.
Among the patients who used upadacitinib, 37% (15 mg) and 45% (30 mg) achieved minimal disease activity, while just 12% did in the placebo group (P <.0001).
SELECT-PsA 1 is a multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study and is ongoing. Extension remains blinded for the investigators to evaluate the long-term safety, tolerability, and efficacy of the 2 once-daily doses of upadacitinib in patients who completed the placebo-controlled period.