Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials

Abstract

Introduction Low disease activity (LDA)/remission is the target of treatment in patients with psoriatic arthritis (PsA). We assessed the proportions of patients with PsA receiving upadacitinib who achieved LDA/remission over 1 year. Methods This was a post hoc analysis of the double-blind, placebo-controlled SELECT-PsA 1 (also adalimumab-controlled) and SELECT-PsA 2 trials. Treatment targets assessed included LDA/remission defined by Disease Activity in Psoriatic Arthritis (≤ 14/ ≤ 4) and Psoriatic Arthritis Disease Activity Scores (≤ 3.2/ ≤ 1.9), as well as minimal disease activity (MDA)/very low disease activity (VLDA) states (5/7 and 7/7 components, respectively, of MDA criteria). Targets were assessed at 24 and 56 weeks. For binary outcomes, non-responder imputation was used for missing data. Data from patients receiving upadacitinib 30 mg was not included in the analysis. Results Overall, 1386 patients were analyzed. Disease control (i.e., LDA/MDA) was achieved at 24 weeks in upadacitinib 15 mg-treated patients across both studies: LDA/MDA was achieved by 25–48% of patients receiving upadacitinib 15 mg versus 2–16% of patients receiving placebo, and remission/VLDA rates were 7–14% with upadacitinib 15 mg versus 0–4% with placebo. The proportions of patients achieving treatment targets were numerically similar to upadacitinib 15 mg and adalimumab. All responses were sustained at 56 weeks. Conclusions Remission and LDA are feasible targets with upadacitinib treatment in patients with PsA. Trial Registration ClinicalTrial.gov identifiers NCT03104400 (SELECT-PsA 1) and NCT03104374 (SELECT-PsA 2). Supplementary Information The online version contains supplementary material available at 10.1007/s40744-022-00449-6.

JAK Inhibitors in Psoriatic Disease

“…At week 56, the efficacy of upadacitinib, in terms of PASI75/90/100, PROs and MDA, was maintained over time. [96][97][98][99] At week 56, the proportions of patients achieving PASI75/90/100 using non-responder imputation (NRI) were 52/41/ 27% with upadacitinib 15mg, and 59/47/35% with upadacitinib 30mg. In both placebo to upadacitinib groups, PASI75/ 90/100 responses at week 56 were similar to those for patients who received upadacitinib from baseline, with the exception of PASI100 in the placebo to upadacitinib 15mg group.…”