Efficacy of guselkumab versus secukinumab in subpopulations of patients with moderate-to-severe plaque psoriasis: results from the ECLIPSE study

Abstract

Purpose

Guselkumab, an interleukin (IL)-23 inhibitor, effectively treats moderate-to-severe plaque psoriasis.

Materials and methods

ECLIPSE, was a Phase 3, multicenter, 56-week, double-blinded, active-comparator study of guselkumab vs. secukinumab (IL-17A inhibitor) in patients with moderate-to-severe psoriasis. Patients were treated with guselkumab 100 mg (n = 534) or secukinumab 300 mg (n = 514) through week 44. Efficacy (at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity Index [PASI 90 and PASI 100], Investigator’s Global Assessment [IGA] 0/1, and IGA 0) was analyzed across subpopulations defined by baseline: age (<45, 45 to <65, and ≥65 years old), body weight, body mass index (BMI), psoriasis disease severity (body surface area, disease duration, PASI, and IGA), psoriasis by body regions (head, trunk, upper and lower extremities), and prior psoriasis medication history at week 48.

Results

Overall, 1048 patients were randomized. At week 48, numerically greater proportions of patients achieved PASI 90, PASI 100, IGA 0/1, and IGA 0 with guselkumab vs. secukinumab regardless of baseline age, body weight, BMI, disease severity, body region, and prior medication. The largest differences were in patients ≥65 years old and patients weighing >100 kg.

Conclusions

Guselkumab treatment provided greater efficacy vs. secukinumab at week 48 in most subpopulations of patients with psoriasis.

Keywords:

• Guselkumab
• psoriasis
• secukinumab
• subpopulations

Acknowledgments

The authors wish to thank Kristin Ruley Sharples, PhD, of Janssen Scientific Affairs, LLC, Horsham, PA for her writing and editorial support in the preparation of this manuscript.

Ethical approval

The study protocol for the ECLIPSE study (NCT03090100) was approved by Institutional Review Boards at each site. All participants provided written informed consent.

Disclosure statement

A. Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharmaceutical, and UCB Pharma. A. W. Armstrong has served as a research investigator and/or scientific advisor to LEO Pharma, AbbVie, UCB, Janssen, Eli Lilly, Novartis, Ortho Dermatologics, Sun Pharmaceutical, Dermavant, Bristol Myers Squibb, Sanofi, Regeneron, Dermira, and Modmed. R. G. Langley has served/received compensation in the form and or Honoria as Principle I investigator for/or on the scientific advisory board/or served as a speaker for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Eli Lilly, Merck, Novartis, Pizer, Sun Pharmaceutical, and UCB Pharma. K. Gebauer has served as an advisory board member and investigator for AbbVie, Janssen, LEO Pharma, Sun Pharmaceutical, and UCB, and has received educational grants from AbbVie, Janssen, Sanofi, and Sun Pharmaceutical. L. C. Guenther has served as a consultant, investigator, and speaker for AbbVie, Amgen, Bausch Health, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, LEO Pharma, Merck, Novartis, Pfizer, and Sun Pharmaceutical; has been a speaker and consultant for Actelion; and has been an investigator for Boehringer Ingelheim, and UCB. C. Paul has served as an investigator or consultant for AbbVie, Almirall, Astellas, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen Cilag, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, and UCB Pierre Fabre; K. Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Covagen, Dermira, Eli Lilly, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline, Janssen, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharmaceutical, Takeda, UCB, Valeant, and Xenoport; B. Randazzo, S. Flavin, M.-C. Hsu, and Y. You are all employees of Janssen Research & Development, LLC, and own stock in Johnson & Johnson, of which Janssen is a subsidiary.

Data availability statement

The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu.

Additional information

Funding

This study was funded by Janssen Research & Development, LLC, Spring House, PA, USA. D. Thaçi reports personal fees from AbbVie, Almirall, Amgen, Asana Biosciences, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Eli Lilly, Novartis, Regeneron, Sandoz, Sanofi-Aventis, Pfizer, and UCB, grants from AbbVie, Celgene, LEO Pharma, and Novartis. J. Bagel has received research funds payable to Psoriasis Treatment Center from AbbVie, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corporation, Corrona LLC, Dermavant Sciences, LTD, Dermira, UCB, Eli Lilly, Glenmark Pharmaceuticals Ltd., Janssen Biotech, Kadmon Corporation, LEO Pharma, Lycera Corp, Menlo Therapueutics, Novartis, Pfizer, Regeneron Pharmaceuticals, Sun Pharma, Taro Pharmaceutical Industries Ltd., and Ortho Dermatologics; consultant fees from AbbVie, Amgen, Celgene Corporation, Bristol Myers Squibb, Eli Lilly, Janssen Biotech, Novartis, Sun Pharmaceutical , and UCB; and speaking fees from AbbVie, Celgene Corporation, Eli Lilly, Janssen Biotech, and Novartis.