Secukinumab treatment of plaque psoriasis shows early improvement in DLQI response – results of a phase II regimen‐finding trial

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 12-week data from a phase 2, 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), 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.

Raising Standards for the Evaluation of Future Psoriasis Therapeutics: A Critical Checklist

“…Subgroup analyses and/or secondary analyses are frequently reported in RCTs for psoriasis biologic therapies. For example, there were 11 different reports from subgroup analyses, some pooled from several RCTs to increase power, for secukinumab on PubMed (search term: secukinumab AND psoriasis) . It is important that reporting of such analyses is transparent, with the intention to perform these analyses specified a priori in trial registries and the power to detect differences in a particular subgroup also reported.…”

The Role of IL-17 in the Pathogenesis of Psoriasis and Update on IL-17 Inhibitors for the Treatment of Plaque Psoriasis

“…Secukinumab treatment of plaque psoriasis also led to improvements in health-related quality of life as demonstrated by improvement by the Dermatology Life and Quality Index. 42…”

“…Secukinumab treatment of plaque psoriasis also led to improvements in health-related quality of life as demonstrated by improvement by the Dermatology Life and Quality Index. 42 Secukinumab has also demonstrated efficacy in the treatment of psoriatic arthritis (PsA). 43,44 Hence, secukinumab received approval from the Food and Drug Administration in January 2016 for PsA and ankylosing spondylitis.…”

Polymorphism of Cytokine Genes (Il17a and Il17f) in Psoriasis and Psoriatic Arthritis

“…Среди семейства IL-17 эти два цитокина имеют сходные функции и самую высокую гомологию последовательности белка (приблизительно 50 %) и общий рецептор (IL-17 рецептор A/ IL-17 рецептор С комплекс). Ген, кодирующий продукцию IL-17A и IL-17F, расположен на хромосоме 6p12 [21] Выделение ДНК проведено с использованием набора DIAtomDNAPrep («Изоген», Россия). Молекулярно-генетическое определение аллельных вариантов генов IL17A (rs2275913), IL17F (rs763780) осуществляли методом рестрикционного анализа продуктов амплификации (ПДРФ -анализ) специфических участков генома.…”

“…Полиморфизм rs2275913 локализован в промоторном регионе гена IL17A, и оказывает влияние на уровень экспрессии, тогда как полиморфизм rs763780 расположен в 3 экзоне гена IL17F и обусловливает замену аминокислоты гистидина (CAT) на аргинин (CGT). Амплификацию фрагмента ДНК генов IL17A (rs2275913), IL17F (rs763780) проводили с помощью полимеразной цепной реакции (ПЦР) со специфическими олигонуклеотидными праймерами [21]. Температура отжига для IL17A составляла 53С, для IL17F -60C.…”