Clinical efficacy and safety of secukinumab in patients with psoriasis and comorbidities: pooled analysis of 4 phase 3 clinical trials

Abstract

Background

The influence of comorbidities on the efficacy and safety of biologic therapies in psoriasis has not been rigorously explored.

Objective

To assess the incremental burden of comorbidities on clinical efficacy and safety of secukinumab vs. etanercept and placebo among patients with plaque psoriasis pooled from 4 phase 3 trials.

Methods

Efficacy was assessed at week 12 according to achievement of Psoriasis Area and Severity Index (PASI) and Investigator’s Global Assessment (IGA; modified 2011) responses. Efficacy comparisons between treatment arms stratified by comorbidity status were made using logistic regression analysis with nonresponder imputation. Relationships between baseline characteristics and clinical responses were evaluated by χ² tests.

Results

Of 2401 patients, 1469 (61.2%) had ≥1 active baseline comorbidity. Regardless of comorbidity status, patients receiving secukinumab were more likely to achieve PASI and IGA responses than those receiving etanercept or placebo at week 12 (p < .05 for all comparisons). Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses (p < .01 for all comparisons). Safety was comparable across treatment arms stratified by comorbidity.

Conclusions

Secukinumab improved clinical outcomes and was well tolerated in patients with concomitant baseline comorbid conditions.

Keywords:

• Plaque psoriasis
• comorbidities
• secukinumab

Acknowledgements

The authors thank Richard Karpowicz, PhD, of Health Interactions, Inc, Hamilton, NJ, USA, for providing medical writing/editorial support, which was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

Disclosure statement

A.B. Gottlieb has received honoraria as an advisory board member and consultant for Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, Janssen, LEO Pharma, Eli Lilly, Novartis, Sun Pharmaceutical, UCB, and XBiotech (only stock options that she has not used); and has received research/educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, UCB, XBiotech, and Sun Pharmaceutical. J.J. Wu is or has been an investigator, consultant, and/or speaker for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Dr Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Regeneron, Sanofi Genzyme, Sun Pharmaceutical, UCB, and Valeant. C.E.M. Griffiths has received honoraria or research grants from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen-Cilag, LEO Pharma, Merck Sharp & Dohme, Novartis, Pfizer, Sandoz, Trident, and UCB; is a National Institute for Health Research (NIHR) Emeritus Senior Investigator; and is supported in part by the NIHR Manchester Biomedical Research Centre. K. Marfo, E. Muscianisi, X. Meng, and J. Frueh are employees and stockholders of Novartis. M. Lebwohl is an employee of Icahn School of Medicine at Mount Sinai, which receives research funds from AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen Research & Development, LEO Pharma, Ortho Dermatologics, Pfizer, and UCB; he is also a consultant for Aditum Bio, Allergan, Almirall, Arcutis, Avotres Therapeutics, BirchBioMed, BMD Skincare, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, NeuroDerm, Pfizer, Promius/Dr Reddy’s Laboratories, Serono, Theravance, and Verrica.

Additional information

Funding

This research project was funded by Novartis Pharmaceuticals Corporation.