Guselkumab efficacious in PsA patients with inadequate response to TNF inhibition

Guselkumab was more efficacious than placebo in patients with psoriatic arthritis (PsA) who had an inadequate response or showed intolerance to 1 or 2 TNF inhibitors. Furthermore, the observed safety profile of guselkumab was reassuring [1]. The phase 3, double-blind, randomised, placebo-controlled COSMOS trial is the first study to assess an IL-23 inhibitor specifically in patients with PsA who failed prior TNF inhibitor treatment.

Guselkumab is a selective, monoclonal antibody targeting the IL-23p19 subunit. It has previously been shown to be effective in patients with PsA in the phase 3 DISCOVER-1 and -2 trials [2,3]. In the COSMOS trial (NCT03796858), patients with active PsA who had failed TNF inhibitor treatment were randomised 2:1 to guselkumab (n=189) or placebo (n=96). Patients in the treatment arm received subcutaneous doses of 100 mg guselkumab at week 0 and week 4, and subsequently every 8 weeks. The primary efficacy endpoint was American College of Rheumatology (ACR)20 response at week 24. Dr Laura Coates (University of Oxford, UK) presented the findings of the study.

Baseline characteristics between the groups were similar. An ACR20 response was achieved in 44.4% of the patients in the guselkumab arm and in 19.8% of patients in the placebo arm (P<0.001). Subgroup analyses demonstrated that the efficacy of guselkumab was consistent across patients who had failed prior TNF inhibitor treatment due to a lack of efficacy and patients who had shown intolerance to TNF inhibitor treatment.

Adverse events were reported in 37% of the patients in the guselkumab arm and in 48% of the patients who received placebo. Serious adverse events were observed in 3% of the patients in both arms of the trial. No new safety issues were reported.

1. Coates LC, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who demonstrated inadequate response to tumor necrosis factor inhibition: week 24 results of a phase 3b randomized, controlled study. OP0230, EULAR 2021 Virtual Congress, 2–5 June.
2. Deodhar A, et al.Lancet 2020;395(10230): 1115–25.
3. Mease PJ, et al.Lancet 2020;395: 1126–36.

 

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Posted on 2 August, 202116 February, 2024