Assessing the overall benefit of a medication: cumulative benefit of secukinumab over time in patients with moderate-to-severe plaque psoriasis

Abstract

Background: Conventional measurements for assessing psoriasis treatment effects capture improvements at fixed, pre-specified timepoints, failing to account for cumulative clinical benefit over time.

Objective: Explore the innovative concept of “cumulative clinical benefit” by examining the effect of secukinumab over 52 weeks in moderate-to-severe psoriasis patients.

Methods: Cumulative clinical benefit was determined as the area-under-the-curve of the percentage of responders over 52 weeks (AUC_{0–52 wks}), using pooled data from two phase III trials for patients receiving secukinumab (300 or 150 mg) or etanercept.

Results: Normalized cumulative benefit with secukinumab 300 mg, secukinumab 150 mg, and etanercept was 74.2%, 63.2%, and 50.5%, respectively, for PASI 75; 58.0%, 42.5%, and 29.5%, respectively, for PASI 90; 32.3%, 18.8%, and 8.7%, respectively, for PASI 100; and 58.3%, 47.9%, and 38.3%, respectively, for DLQI 0/1. 52-week PASI 75 clinical benefit ratios for secukinumab 300 and 150 mg versus etanercept were 1.47 and 1.25, respectively; the ratio of the two secukinumab doses was 1.17, favoring 300 mg.

Limitations: Post hoc analysis.

Conclusion: Cumulative clinical benefit estimated by AUC_{0-52 wks} is a novel measure for comparing psoriasis treatments. Secukinumab 300 mg provides greater cumulative clinical benefit than secukinumab 150 mg; both provide greater cumulative benefit than etanercept.

Keywords:

• Biologics
• cumulative clinical benefit
• etanercept
• interleukin-17A
• psoriasis
• secukinumab

Disclosure Statement

A. W. Armstrong has served as investigator and/or consultant to AbbVie, Amgen, Celgene, Janssen, Merck, Lilly, Novartis, and Pfizer. S. R. Feldman has received research support and speaking and/or consulting fees from AbbVie, Advance Medical, Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Caremark, Celgene, Eli Lilly, Galderma, GSK/Stiefel, Informa, Janssen, LEO Pharma, Merck, Merz, Mylan, National Biological, National Psoriasis Foundation, Novartis, Pfizer, Qurient, Suncare Research, UpToDate, and Valeant; is founder and majority owner of www.DrScore.com; and is founder and part owner of Causa Research. N. J. Korman has been an advisor, consultant, investigator, and/or speaker for AbbVie, Amgen, Celgene, Chugai, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and Regeneron. X. Meng, A. Guana, J. Nyirady, V. Herrera, and Y. Zhao are full-time employees of Novartis.