A phase 4, randomised, head-to-head trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate-to-severe plaque psoriasis (CHANGE)

A Pinter, M Hoffmann, K Reich, M Augustin, K Kaplan, S D Gudjónsdóttir, T Delvin, U Mrowietz
Journal of the European Academy of Dermatology and Venereology: JEADV 2020 September 16

BACKGROUND: Brodalumab is a fully human monoclonal immunoglobulin IgG2 antibody that binds to the human IL-17 receptor subunit A and by that inhibits the biologic action of IL-17A, 17F, 17C, and 17E. Therapy with fumaric acid esters (FAE) is a well-established and widely used first-line systemic treatment for subjects with moderate-to-severe plaque psoriasis OBJECTIVES: To compare brodalumab to FAE in terms of clinical efficacy, patient-reported outcomes, and safety in subjects with moderate to severe plaque psoriasis who were naïve to systemic treatment.

METHODS: Eligible subjects were randomised 1:1 to 210 mg brodalumab injections or oral FAE according to product label in this 24-week, open-label, assessor-blinded, multi-centre, head-to-head phase 4 trial. The primary endpoints were having PASI75 and having sPGA score of 0 or 1 (sPGA 0/1). Subjects with missing values for the primary endpoints were considered non-responders.

RESULTS: A total of 210 subjects were randomised. 91/105 subjects completed brodalumab treatment and 58/105 subjects completed FAE treatment. At Week 24, significantly more subjects in the brodalumab group compared to the FAE group had PASI75 (81.0% vs. 38.1%, p<0.001) and sPGA 0/1 (64.8% vs. 20.0%, p<0.001). In the brodalumab group, the median time to both PASI75 and to PASI90 was significantly shorter than in the FAE group (4.1 weeks vs. 16.4 weeks, and 7.4 weeks vs. 24.4 weeks, respectively, p<0.0001 for both). The rate of adverse events was lower in subjects treated with brodalumab compared to subjects treated with FAE (616.4 vs. 1195.8 events per 100 exposure years). No new safety signals were detected for brodalumab.

CONCLUSIONS: Brodalumab was associated with rapid and significant improvements in signs and symptoms of moderate-to-severe plaque psoriasis, with a superior efficacy profile to what was observed with FAE in systemic-naïve subjects over 24 weeks.

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