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

Abstract

SummaryBackground Secukinumab is a fully human antibody that neutralizes interleukin-17A. It has significant efficacy and a favourable safety profile in moderate-tosevere 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 (1Á9% vs. 33Á0%). At week 24, significantly more patients receiving secukinumab compared with FAEs achieved PASI 75 response (89Á5% vs. 33Á7%, P < 0Á001), PASI 90 response (81Á0% vs. 28Á4%, P < 0Á001) and Dermatology Life Quality Index 0 or 1 response (71Á4% vs. 25Á3%, P < 0Á001). Conclusions Secukinumab demonstrated superior efficacy to FAEs in patients with psoriasis over a 24-week period.

A 24‐week multicentre, randomized, open‐label, parallel‐group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate‐to‐severe plaque psoriasis naive to systemic treatment

“…These results are consistent with data from previous trials . The data from this study lend further support to the rapidly growing body of evidence implicating IL‐17A as a cytokine essential to the pathogenesis of psoriasis …”

Long‐term real‐life safety profile and effectiveness of fumaric acid esters in psoriasis patients: a single‐centre, retrospective, observational study

“…18,46,79,80 However, it is worth noting that for all three treatment options, achieving a satisfactory and sustained clinical response requires a long treatment duration. 14 Despite the introduction of novel fast-acting and highly efficacious biologics, 81,82 it is our opinion that the use of FAEs in the first-line therapy of psoriasis remains fully justified, given (i) the possibility of timely and individualized dosage adjustments, 83 (ii) a very low drug-drug interaction potential 23,24,30 and (iii) a reasonable cost-benefit-risk ratio over long-term treatment, 5,30 especially for patients moderately affected with psoriasis.…”

IL-17A in Psoriasis and Beyond: Cardiovascular and Metabolic Implications

“…Recently, high sustained efficacy and safety of 300 mg secukinumab treatment through 5 years in moderate to severe psoriasis was published (43). Direct comparison with firstline conventional treatment in Germany with fumaric acid esters showed clinically meaningful and statistically highly significant differences in patients naïve to any previous systemic treatment (44). Early treatment with secukinumab even as a first-line systemic treatment became possible, not only according to label but also in daily practice.…”