Secukinumab Self-Administration by Prefilled Syringe Maintains Reduction of Plaque Psoriasis Severity Over 52 Weeks: Results of the FEATURE Trial

October 2016 | Volume 15 | Issue 10 | Original Article | 1226 | Copyright © 2016

Alice B. Gottlieb MD PhD,a Andrew Blauvelt MD MBA,b Jörg C. Prinz MD,c Philemon Papanastasiou PhD,d Rashidkhan Pathan MS,e Judit Nyirady MD MBA,f Todd Fox PharmD ACPR,d Charis Papavassilis MD PhDd

aDepartment of Dermatology, New York Medical College, Valhalla, NY bOregon Medical Research Center, Portland, OR cDepartment of Dermatology and Allergology, Ludwig-Maximilians-University, Munich, Germany dNovartis Pharma AG, Basel, Switzerland eNovartis Healthcare Private Limited, Hyderabad, India fNovartis Pharmaceuticals Corporation, East Hanover, NJ

Abstract

BACKGROUND: Secukinumab, a human monoclonal antibody that selectively targets interleukin-17A, is highly efficacious in the treatment of moderate-to-severe psoriasis, starting at early time points, with a sustained effect and a favorable safety profile. METHODS: Patients with moderate-to-severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg, or placebo self-administered by prefilled syringe at baseline, weeks 1, 2, and 3, and then every four weeks from week 4 to 48. Efficacy responses (≥ 75/90/100% improvement in Psoriasis Area and Severity Index [PASI 75/90/100] and clear/almost clear skin by Investigator’s Global Assessment 2011 modified version [IGA mod 2011 0/1]) were measured to week 52. Patient-reported usability of the prefilled syringe was evaluated by the Self-Injection Assessment Questionnaire to week 48. RESULTS: The efficacy of secukinumab increased to week 16 and was maintained to week 52. With secukinumab 300 mg at week 52, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 83.5%/68.0%/47.5% and 71.5% of patients when analyzed by multiple imputation, respectively, and by 75.9%/62.1%/43.1% and 63.8% of patients when analyzed by nonresponder imputation, respectively. With secukinumab 150 mg at week 52, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 63.5%/50.3%/31.1% and 43.6% of patients when analyzed by multiple imputation, respectively, and by 61.0%/49.2%/30.5% and 42.4% of patients when analyzed by nonresponder imputation, respectively. Self-reported acceptability of the prefilled syringe was high throughout the study. The incidence of adverse events (AE) was well balanced between groups, with AEs reported in 74.4% of patients receiving secukinumab 300 mg and 77.3% of patients receiving secukinumab 150 mg. Nasopharyngitis was the most common AE across both secukinumab groups. CONCLUSION: Self-administration of secukinumab by prefilled syringe was associated with robust and sustained efficacy and a favorable safety profile up to week 52.

J Drugs Dermatol. 2016;15(10):1226-1234.

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INTRODUCTION

Secukinumab is a human anti-interleukin (IL)-17A immunoglobulin G1κ monoclonal antibody with demonstrated efficacy in the treatment of moderate-to-severe plaque psoriasis.1-3 In the phase 3 ERASURE and FIXTURE trials, secukinumab was highly efficacious, beginning at early time points, with a sustained effect and a favorable safety profile.1 Secukinumab is currently approved in several countries for the treatment of moderate-to-severe psoriasis with a recommended dose of 300 mg.4,5Medication adherence is a key factor to sustaining initial treatment benefits in chronic diseases, such as psoriasis, and the mode of administration for a therapy may help improve treatment adherence.6,7 An important factor in maintaining treatment adherence is patient satisfaction, and considerable differences in treatment satisfaction have been observed between different therapies for moderate-to-severe psoriasis.8 In particular, treatment effectiveness and convenience influenced levels of treatment satisfaction, and higher levels of satisfaction were associated with longer treatment duration.8 It has also been suggested that patient satisfaction indicates higher levels of quality healthcare.9The mode of administration for a therapy can affect patient satisfaction. Higher treatment satisfaction in patients with psoriasis has been reported for injections compared with oral therapy, phototherapy, and topical agents, and patients using injectable agents attached great importance to efficiency and

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