Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2

Annals of the rheumatic diseases. 2021 Mar 1;80(3):312-20.

In this trial of patients with active PsA who had inadequate response or intolerance to at least one biologic DMARD, upadacitinib 15 mg and 30 mg was more effective than placebo over 24 weeks in improving signs and symptoms of PsA. Despite the availability of bDMARDs in PsA, only a small proportion of patients achieve the recommended target of minimal disease activity; as such, additional treatment options are needed. Upadacitinib is under evaluation for PsA. This paper reports the 24-week data from SELECT-PsA 2, a randomised, placebo-controlled, double-blind, Phase 3 trial. SELECT-PsA 2 evaluated upadacitinib in 641 patients with PsA and prior inadequate response or intolerance to at least one bDMARD. Patients were randomised to receive once-daily upadacitinib 15 or 30 mg, or placebo. At Week 24, placebo patients were switched to upadacitinib. Efficacy was observed as early as Week 2 and demonstrated in all measures of the various core clinical domains of PsA. More patients in the upadacitinib arms versus placebo achieved the primary endpoint of ACR20 at Week 12, and more upadacitinib-treated patients achieved minimal disease activity as assessed at Week 24. Through Week 24, the rate of overall treatment-emergent adverse events was higher in the upadacitinib 30 mg arm, but overall the safety findings were consistent with the known safety profile of upadacitinib observed in RA, and no new risks were identified. In conclusion upadacitinib was more effective than placebo at improving the signs and symptoms of active PsA in patients with an inadequate response or intolerance to bDMARDs.