Guselkumab for Moderate-to-severe Plaque Psoriasis in Systemic Treatment-naïve Patients

In a new study, researchers compared the safety and efficacy of guselkumab, a fully human interleukin-23 antibody indicated for the systemic treatment of moderate-to-severe plaque psoriasis, to that of fumaric acid esters in patients with moderate-to-severe plaque who are naïve to systemic treatment.

The study design was that of a randomized, multicenter, open-label, assessor-blinded, active comparator-controlled phase 3b study. Patients were randomized to receive either 100 mg guselkumab by subcutaneous injection (n = 60) or oral fumaric acid esters (n = 59) based on local label guidelines. A total of 56/60 guselkumab patients and 36/59 fumaric acid esters patients completed 24 weeks of treatment. The primary outcome measure was the proportion of patients with at least a 90% improvement from baseline Psoriasis Area and Severity Index (PASI 90 response). Other outcome measures included PASI 75 response, Dermatology Life Quality Index (DLQI) response of 0/1 (no effect at all on the patient’s life), PASI 100 response, and adverse events (AEs) incidence.

After 24 weeks of treatment, a significantly larger portion of guselkumab patients achieved PASI 90 response compared to fumaric acid esters patients (81.7% vs. 13.6%; P<0.001). The guselkumab group also had a higher proportion of patients achieve PASI 75 response (90.0% vs. 27.1%; P<0.001) as well as a DLQI response of 0/1 (61.7% vs. 16.9%; P<0.001). More patients achieved completely clear skin as measured by a PASI 100 response in the guselkumab group (31.7%) compared to the fumaric acid esters group (3.4%) (P<0.001). Guselkumab patients were less likely to sustain an AE (73.3%) than fumaric acid esters patients (98.3%). There were no discontinuations or new safety findings reported for guselkumab; 27.6% of fumaric acid esters patients discontinued treatment.

The researchers concluded that in systemic treatment-naïve moderate-to-severe plaque psoriasis patients, guselkumab was superior to fumaric acid esters.