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.

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. 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. 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. Remission and LDA are feasible targets with upadacitinib treatment in patients with PsA. ClinicalTrial.gov identifiers NCT03104400 (SELECT-PsA 1) and NCT03104374 (SELECT-PsA 2). Psoriatic arthritis is a disease that causes inflammation of the skin and joints. Doctors measure how bad a patient’s disease is by measuring signs and symptoms of the disease, and using these to make a “score.” The aim of treatment is to reduce the score to low levels (known as “low disease activity”) or very low levels (“remission”). This study looked at results from two clinical trials that compared upadacitinib, a medicine used to treat psoriatic arthritis, with no medicine (placebo) to see how many patients had low disease activity or were in remission after 1 year of treatment. The results showed that more patients who were taking upadacitinib had low disease activity or were in remission after the first 6 months of treatment compared with those who took placebo. This difference between upadacitinib and placebo could still be seen after 1 year of treatment. These results show that treatment with upadacitinib is effective enough for some patients with psoriatic arthritis to achieve low disease activity or remission and to stay at this level, even after more than 1 year of treatment.

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