Secukinumab is Superior to Fumaric Acid Esters in Treating Subjects with Moderate to Severe Plaque Psoriasis who are Naïve to Systemic Treatments: Results from the Randomized Controlled PRIME Trial

Abstract

Background

Secukinumab is a fully human antibody that neutralizes IL-17A and has significant efficacy and a favorable safety profile in moderate to severe plaque psoriasis and psoriatic arthritis.

Methods

In this 24-week, randomized, open-label, multicenter study with blinded assessment, subjects with moderate to severe plaque psoriasis, naïve to systemic treatments, were randomized to receive secukinumab 300 mg subcutaneously or oral fumaric acid esters (FAE). The primary objective was ≥75% improvement from Baseline Psoriasis Area and Severity Index (PASI) score (PASI 75 response) at Week 24 and missing subjects were considered responders if they were responders at the time of drop-out.

Results

202 subjects were randomized and 200 were treated with at least one dose. Outcomes at week 24 were available for 147 and imputed for 53 subjects. Discontinuations were mostly due to Adverse Events (AE) which occurred more frequently in the FAE group (1.9% vs. 33.0%). At week 24, significantly more subjects receiving secukinumab compared to FAE 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 (DLQI) 0/1 response (71.4% vs. 25.3%, P<0.001).

Conclusions

Secukinumab demonstrates superior efficacy to FAE in psoriasis subjects over a 24-week period.

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