Secukinumab is superior to fumaric acid esters in treating patients with moderate-to-severe plaque psoriasis who are naive to systemic treatments: results from the randomized controlled PRIME trial

Background Secukinumab is a fully human antibody that neutralizes interleukin-17A. It has significant efficacy and a favourable safety profile in moderate-to-severe plaque psoriasis and psoriatic arthritis. Objectives To compare secukinumab with fumaric acid esters (FAEs) in a randomized controlled trial. Methods In this 24-week, randomized, open-label, multicentre study with blinded assessment, patients with moderate-to-severe plaque psoriasis, naive to systemic treatments, were randomized to receive secukinumab 300 mg subcutaneously or oral FAEs. The primary end point was >= 75% improvement from baseline Psoriasis Area and Severity Index score (PASI 75 response) at week 24, and missing patients were considered responders if they were responders at the time of dropout. Results In total 202 patients were randomized and 200 were treated with at least one dose. Outcomes at week 24 were available for 147 and imputed for 53 patients. Discontinuations were mostly due to adverse events, which occurred more frequently in the FAE group (1.9% vs. 33.0%). At week 24, significantly more patients receiving secukinumab compared with FAEs achieved PASI 75 response (89.5% vs. 33.7%, P < 0.001), PASI 90 response (81.0% vs. 28.4%, P < 0.001) and Dermatology Life Quality Index 0 or 1 response (71.4% vs. 25.3%, P < 0.001). Conclusions Secukinumab demonstrated superior efficacy to FAEs in patients with psoriasis over a 24-week period.