Efficacy and safety of ixekizumab after switching from fumaric acid esters or methotrexate in patients with moderate‐to‐severe plaque psoriasis naïve to systemic treatment

Abstract

DEAR EDITOR, Psoriasis is a chronic inflammatory skin disorder, which, in cases of moderate-to-severe disease, requires longterm systemic therapy. 1 For patients with an inadequate response or intolerance to a specific systemic therapy, switching psoriasis treatments is a common practice that may improve outcomes. Switching from conventional to biological therapies is of particular interest, but few head-to-head trials have been performed. 2 The first head-to-head, prospective, randomized trial comparing fumaric acid esters (FAEs) and methotrexate (MTX)two commonly used first-line conventional systemic agentsand an interleukin-17A antagonist, ixekizumab, was published recently. 3 Here we present efficacy and safety results from the extension period of this head-tohead study, in which patients treated with ixekizumab for the first 24 weeks continued with this treatment for up to 60 weeks, and patients treated with FAE or methotrexate up to week 24 were allowed to switch to ixekizumab for a further 36 weeks.This was a phase IIIb, open-label, parallel-group, raterblinded study extension. Patients with moderate-to-severe plaque psoriasis (n = 162) were randomized (1: 1: 1) to FAE, MTX or ixekizumab. 3 Week 24 was reached by 23, 49 and 49 patients on FAE, MTX and ixekizumab, respectively. At week 24, 19 (83%) patients receiving FAE and 31 (63%) patients receiving MTX switched to ixekizumab, while 48 (98%) patients receiving ixekizumab continued treatment. Of these, 18 (95%), 29 (94%) and 45 (94%), respectively, remained in the study to week 60. Missing values were imputed using nonresponder imputation. The efficacy of ixekizumab at week 60 was evaluated for each group as the percentage of patients achieving absolute Psoriasis Area and Severity Index (PASI) 0, ≤ 1, ≤ 2 and ≤ 3. Improvement in quality of life was measured with the Dermatology Life Quality Index (DLQI) (0,1). Safety was assessed throughout the study by the monitoring of adverse events (AEs).Patient baseline demographic and clinical data have been published elsewhere. 3 The most common reason for switching to ixekizumab at week 24 was an inadequate response to FAE