Favorable Safety and Efficacy Profile of Guselkumab in Patients With PsA With Inadequate TNFi Response

Among patients with psoriatic arthritis (PsA) with an inadequate response to tumor necrosis factor inhibitors (TNFis), guselkumab vs placebo was found to have a significantly higher American College of Rheumatology 20% improvement criteria (ACR20) response rate, according to study results presented European Alliance of Associations for Rheumatology (EULAR) 2021 Virtual Congress, held from June 2 to 5, 2021.

A total of 285 patients with active PsA with an inadequate or intolerant response to 1 to 2 TNFis were enrolled in the randomized, double-blind, placebo-controlled trial. Patients were randomly assigned to receive 100 mg subcutaneous guselkumab (n=189) or placebo (n=96) at baseline and week 4, then every 8 weeks up to week 44. Crossover from placebo to guselkumab occurred at week 24.

The primary study endpoint was ACR20 response at week 24.

Although baseline characteristics were similar between the groups, a higher percentage of patients in the guselkumab vs placebo group were women (54% vs 46%, respectively) and had more severe joint symptoms. At week 24, the percentage of patients achieving ACR20 was 44.4% and 19.8% in the guselkumab and placebo groups, respectively (P <.001). Efficacy and safety were consistent across subgroups, based on demographics, disease characteristics, and medication use at baseline. The occurrence of adverse events was also similar between groups.

Researchers concluded, “In this [phase] 3b, placebo-controlled study of [patients with] PsA with [inadequate response] to 1 [to] 2 TNFi, [guselkumab] 100 mg Q8W elicited a significantly higher ACR20 response rate vs [placebo] at [week] 24; results of prespecified sensitivity and subgroup analyses were consistent. [Guselkumab] safety in [patients with PsA with inadequate response to TNFi] through [week] 24 is consistent with the favorable [guselkumab] safety profile in psoriasis and biologic-naive [patients with] PsA.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Coates LC, Gossec L, Theander E, 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. Presented at: EULAR 2021 Virtual Congress; June 2-5, 2021. Poster #OP0230.