In a double-blind, randomised controlled phase 3 trial, patients with psoriatic arthritis who have an inadequate response to ≥1 non-biologic disease-modifying anti-rheumatic drug (non-bDMARD) showed improvement in musculoskeletal symptoms, psoriasis, physical function, pain, and fatigue and inhibited radiographic progression when treated with upadacitinib. These improvements were seen by week 2; no new safety signals emerged .
Upadacitinib –an oral, reversible, Janus kinase (JAK) inhibitor approved for the treatment of rheumatoid arthritis– is currently under evaluation for treatment of psoriatic arthritis. The SELECT-PsA-1 study, presented by Prof. Iain McInnes (University of Glasgow, Scotland), assessed the efficacy and safety of upadacitinib compared with placebo and adalimumab in patients with psoriatic arthritis and prior inadequate response or intolerance to ≥1 non-bDMARD. Participants (n=1,704) were randomized to 15 mg upadacitinib once daily, 30 mg upadacitinib once daily, 40 mg adalimumab every other week, or placebo. The primary endpoint of the study was the proportion of patients achieving ACR20 for upadacitinib versus placebo at week 12. The mean age of the participants was 50.8 years, 53.2% were female, the mean duration of their psoriatic arthritis diagnosis was 6.1 years, and 82% were on ≥1 concomitant non-bDMARD (84% received methotrexate +/- another non-bDMARD).
At week 12, ACR20 rates were 70.6% in the 15 mg upadacitinib arm and 78.5% in the 30 mg upadacitinib arm, compared with 36.2% in the placebo group and 65.0% with 40 mg adalimumab. A greater proportion of patients achieved ACR50/70 with 15 mg or 30 mg upadacitinib compared with placebo, and with 30 mg upadacitinib vs adalimumab. At week 24, change in modified Sharp/van der Heijde Score (mTSS) was 0.25 for placebo, -0.04 for 15 mg upadacitinib 15 mg, 0.03 for upadacitinib 30 mg, and 0.01 for adalimumab. Rates of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs) were similar in the groups receiving placebo, 15 mg upadacitinib, and adalimumab; they were higher in patients receiving 30 mg upadacitinib. However, the safety profile was in line with what was already known from studies of upadacitinib in rheumatoid arthritis.
1. McInnes I, et al. Efficacy and safety of upadacitinib versus placebo and adalimumab in patients with active psoriatic arthritis and inadequate response to non-biologic disease-modifying anti-rheumatic drugs (SELECT-PsA-1): a double-blind, randomized controlled phase 3 trial. Abstract LB0001. EULAR E-Congress, 3-6 June 2020.