Upadacitinib Effective in Biologic Refractory Psoriatic Arthritis Save
The SELECT-PsA 2 trial was presented at the ACR meeting and recently published in Annals of Rheumatic Disease, shows that psoriatic arthritis (PsA) patients who have failed at least one biologic DMARD, did respond well to upadacitinib.
The trial evaluated upadacitinib in patients with PsA and prior inadequate response or intolerance to at least one biologic disease-modifying antirheumatic drug (DMARD). This phase 3 trial, randomized 642 PsA patients to receive either placebo or upadacitinib (15 mg or 30 mg) daily , placebo followed by upadacitinib 15 mg or placebo for 24 weeks. The primary endpoint was the ACR 20 response at week 12. Other secondary endpoints, including minimal disease activity (MDA), were assessed at week 24. Roughly 35% of patients entered the trial while on background methotrexate.
By week 12, patients on upadacitinib (15 mg or 30 mg qd) showed significantly higher ACR20 responses (56.9% and 63.8%) vs. placebo (24.1%) (p<0.001 for both comparisons).
At week 24, MDA was moreso achieved by upadacitinib 15 mg (25.1%) and 30 mg-treated patients (28.9%) versus placebo (2.8%; p<0.001 for both comparisons).
Skin outcomes were improved by week 12 (and through week 24) such that the PASI75 was significantly higher with upadacitinib (52% and 56%) compared to placebo (16%) at week 16 (p<0.001).
The safety findings are consistent with the known safety profile of upadacitinib observed in rheumatoid arthritis; no new safety risks have been identified. Serious infections were 0.5%, 0.5% and 2.8% with placebo, upadacitinib 15 mg and upadacitinib 30 mg, respectively. There was only case each of non-fatal myocardial infarction and pulmonary embolism reported in the upadacitinib 15 mg arm
In this trial, PsA patients who have failed one (60-64%), two (17-21%) and tree or more (11-16%) biologic DMARDs, were able to achieve a near 60/40/20 (ACR20/50/70) response by switching to upadacitinib daily.