M Sticherling1, U Mrowietz2, M Augustin3, D Thaçi4, N Melzer5, C Hentschke5, J Kneidl5, C Sieder5, K Reich6. 1. Universitätsklinikum Erlangen, Hautklinik, Ulmenweg 18, Erlangen, D-91054, Germany. 2. Department of Dermatology, Psoriasis-Center, University Medical Center Schleswig-Holstein, Campus Kiel Schittenhelmstraße 7, Kiel, 24105, Germany. 3. Institute for Health Services Research in Dermatology & Nursing, Medical Centre Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany. 4. Department of Dermatology, Institut für Entzündungsmedizin, University Hospitals Schleswig-Holstein, Ratzeburger Str. 160, Lübeck, 23538, Germany. 5. Novartis Pharma GmbH, Roonstrasse 25, Nürnberg, 90429, Germany. 6. Dermatologikum Hamburg and SCIderm Research Institute, Stephansplatz 5, Hamburg, 20354, Germany.
Abstract
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, and occurred more frequently in the FAE group (1·9% vs. 40·0%). 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 (75·2% vs. 18·9%, 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.
RCT Entities:
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, and occurred more frequently in the FAE group (1·9% vs. 40·0%). 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 (75·2% vs. 18·9%, 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.
Authors: Johan Burisch; Wolfgang Eigner; Stefan Schreiber; Daniel Aletaha; Wolfgang Weninger; Michael Trauner; Walter Reinisch; Neeraj Narula Journal: PLoS One Date: 2020-05-27 Impact factor: 3.240