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Abbvie has announced top line results of their SELECT-PSA trial of upadacitinib (UPA), wherein both the 15 and 30 mg doses met the primary endpoint of ACR20 response at week 12 and demonstrated radiographic inhibition at week 24.
SELECT-PsA 1 was a Phase 3, double-blind, randomized study with 1705 active psoriatic arthritis (PsA) patients, unresponsive to at least one non-biologic DMARD, who were randomized to received daily placebo, or upadacitinib (15 or 30 mg) for 24 weeks. The primary endpoint was the ACR20 response at 12 weeks.
Week 12 results:
UPA vs placebo (p<0.0001).
Significantly more patients receiving either dose of UPA achieved PASI 75 at week 16 compared to placebo.
Radiographic outcomes were assessed; and after 24 weeks, both the 15 mg and 30 mg dose of UPA significantly inhibited radiographic progression compared to placebo (p<0.01).
The safety profile of UPA was consistent with previously reported results across indications, with no new safety risks detected. Serious infections occurred in 1.2 percent and 2.6 percent of patients in the 15 mg and 30 mg UPA groups, respectively, compared to 0.9 percent in the placebo group and 0.7 percent in the adalimumab group.
There was one case of adjudicated venous thromboembolic events (VTE) in the UPA 30 mg group (0.2 percent), no cases in the UPA 15 mg group, two cases in the adalimumab group (0.5 percent) and one case in the placebo group (0.2 percent).