Upadacitinib improves PsA signs, symptoms in DMARD-refractory patients
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Upadacitinib, in doses of either 15 or 30 mg, is superior to placebo in improving signs and symptoms of active psoriatic arthritis among patients who are intolerant, or had an inadequate response, to a biologic DMARD, according to data.
“Current treatment guidelines for PsA vary, recommending conventional synthetic DMARDs such as methotrexate as initial therapy, followed by biologic DMARDs (tumor necrosis factor inhibitors (TNFi), interleukin-12/23 or interleukin-17 inhibitors) or targeted synthetic DMARDs, such as apremilast or tofacitinib, or TNFi initially, followed by other approved therapies,” Philip J. Mease, MD, of the Swedish Medical Center, in Seattle, and colleagues wrote in the Annals of the Rheumatic Diseases.
“While multiple therapeutic choices are now available, additional options are needed as under one-third achieving minimal disease activity (MDA) in most placebo-controlled trials,” they added. “Upadacitinib is an oral, reversible janus kinase inhibitor with selectivity for JAK1 over JAK2, JAK3 and tyrosine kinase approved for the treatment of rheumatoid arthritis based on five phase 3 studies.”
To examine upadacitinib (Rinvoq, AbbVie) among patients with active PsA who had prior inadequate response or intolerance to at least one biologic DMARD, Mease and colleagues conducted the SELECT-PsA 2 trial. In this 24-week, placebo-controlled, double-blind, phase 3 study, the researchers randomized 642 participants 2:2:1:1 to receive either 15 mg or 30 mg of upadacitinib once per day, placebo followed by 15 mg upadacitinib at week 24, or placebo followed by 30 mg upadacitinib at week 24.
The primary endpoint was the proportion of patients who achieved the ACR20 response at week 12. The researchers assessed minimal disease activity at week 24. Treatment-related adverse events were reported for all 641 participants who received at least one upadacitinib dose. In all, 543 participants completed week 24 on the trial drug.
According to the researchers, 63.8% of participants who received 30 mg of upadacitinib, and 56.9% of those in the 15 mg group, achieved the ACR20 response at week 12, compared with 24.1% of those who received a placebo (P < .001). By week 24, 28.9% of those treated with upadacitinib 30 mg had achieved minimal disease activity, compared with 25.1% in the 15 mg group and 2.8% for placebo (P < .001).
Rates of treatment-related adverse events at week 24 were generally similar between the placebo and 15 mg upadacitinib 15 groups, but higher in the 30 mg group. Rates of serious infections were 0.5%, 0.5% and 2.8% in the placebo, upadacitinib 15 mg and upadacitinib 30 mg groups, respectively.
“In a PsA population refractory or intolerant to prior biologic DMARD therapy, upadacitinib 15 mg and 30 mg once per day, with or without concomitant nonbiologic DMARD therapy, showed rapid improvements versus placebo as measured by ACR20 response and efficacy across all clinical domains of PsA, including rigorous levels of efficacy in musculoskeletal and psoriatic skin disease measures as well as of comprehensive disease control,” Mease and colleagues wrote. “No new safety signals were identified compared with what has been observed with upadacitinib in rheumatoid arthritis.”
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