M Augustin1, S Abeysinghe2, U Mallya3, A Qureshi4, N Roskell5, D McBride2, C Papavassillis6, J Gelfand7. 1. Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 2. RTI Health Solutions, Didsbury, UK. 3. Novartis Pharmaceuticals Corp., East Hanover, NJ, USA. 4. Department of Dermatology, Brigham and Women's Hospital, Boston, MA, USA. 5. CROS NT Ltd., Milton Keynes, UK. 6. Novartis Pharma AG, Basel, Switzerland. 7. Department of Dermatology and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
Abstract
BACKGROUND: The social stigma and chronicity of psoriasis significantly affect health-related quality of life (HRQoL). OBJECTIVE: We examined the effect of three regimens of secukinumab on HRQoL in moderate to severe psoriasis patients. METHODS: Twelve-week data from a phase II, randomized, double-blind, placebo-controlled, regimen-finding study evaluated HRQoL, measured by the Dermatology Life Quality Index (DLQI). Secukinumab or placebo was administered subcutaneously in three treatment regimens: single (baseline only), monthly (baseline, weeks 4, 8) and early (baseline, weeks 1, 2, 4). Differences among regimens were assessed with logistic regression models and Fisher's exact test. RESULTS:Patients (n = 404) were randomized to single (baseline) treatment regimen, n = 66; monthly, (baseline, weeks 4 and 8), n = 138; early, (baseline, weeks 1, 2, 4), n = 133; and placebo, n = 67. DLQI response was significantly higher in early, monthly and single regimens than in placebo regimen (40.8%, 33.6% and 13.1% vs. 1.6%, respectively; P < 0.001 for all). CONCLUSION:Moderate to severe psoriasis patients receiving monthly and early treatment with secukinumab demonstrated improved HRQoL compared with placebo.
RCT Entities:
BACKGROUND: The social stigma and chronicity of psoriasis significantly affect health-related quality of life (HRQoL). OBJECTIVE: We examined the effect of three regimens of secukinumab on HRQoL in moderate to severe psoriasispatients. METHODS: Twelve-week data from a phase II, randomized, double-blind, placebo-controlled, regimen-finding study evaluated HRQoL, measured by the Dermatology Life Quality Index (DLQI). Secukinumab or placebo was administered subcutaneously in three treatment regimens: single (baseline only), monthly (baseline, weeks 4, 8) and early (baseline, weeks 1, 2, 4). Differences among regimens were assessed with logistic regression models and Fisher's exact test. RESULTS:Patients (n = 404) were randomized to single (baseline) treatment regimen, n = 66; monthly, (baseline, weeks 4 and 8), n = 138; early, (baseline, weeks 1, 2, 4), n = 133; and placebo, n = 67. DLQI response was significantly higher in early, monthly and single regimens than in placebo regimen (40.8%, 33.6% and 13.1% vs. 1.6%, respectively; P < 0.001 for all). CONCLUSION: Moderate to severe psoriasispatients receiving monthly and early treatment with secukinumab demonstrated improved HRQoL compared with placebo.
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