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Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: Long-term results from 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2) - 11/01/21

Doi : 10.1016/j.jaad.2020.09.047 
Mark G. Lebwohl, MD a, , Craig L. Leonardi, MD b, Nehal N. Mehta, MD, MSCE c, Alice B. Gottlieb, MD, PhD d, Alan M. Mendelsohn, MD e, Jeff Parno, MS e, Stephen J. Rozzo, PhD e, M. Alan Menter, MD f, g
a Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York 
b Central Dermatology and Saint Louis University School of Medicine, St Louis, Missouri 
c National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD 
d Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York 
e Sun Pharmaceutical Industries, Inc, Princeton, New Jersey 
f Division of Dermatology, Baylor Scott & White, Dallas, Texas 
g Texas A&M College of Medicine, Dallas, Texas 

Reprint requests: Mark G. Lebwohl, MD, Department of Dermatology, Icahn School of Medicine at Mount Sinai, 5 East 98th St, New York, NY 10029.Department of DermatologyIcahn School of Medicine at Mount Sinai5 East 98th StNew YorkNY10029

Abstract

Background

Data for the effect of metabolic syndrome (MetS) on the efficacy and safety of biologic agents for psoriasis treatment are limited.

Objective

To evaluate long-term tildrakizumab efficacy, drug survival, and safety in patients with psoriasis by baseline MetS status.

Methods

Post hoc analyses of up to 3 years of efficacy data and 5 years of safety data from the phase 3, double-blind, randomized controlled reSURFACE 1 and 2 trial (NCT01722331 and NCT01729754) base and extension studies were conducted for patients receiving continuous tildrakizumab 100 or 200 mg.

Results

Of 338 (n = 124/214 in reSURFACE 1/2) and 307 (n = 147/160 in reSURFACE 1/2) patients continuously receiving tildrakizumab 100 and 200 mg, respectively, throughout the studies, 26/44 (21%/21%) and 34/30 (23%/19%) met MetS criteria. Proportions of patients who achieved a 75% improvement in the Psoriasis Area and Severity Index (PASI) in reSURFACE 1/2 were generally comparable among those with versus without MetS at week 52 (tildrakizumab 100 mg, 85%/86% vs 86%/94%; tildrakizumab 200 mg, 76%/87% vs 76%/87%) and through week 148. Results were similar for responders with 90% and 100% improvement in the PASI. Tildrakizumab's safety profile did not vary by MetS status.

Limitations

Small sample size and post hoc analysis limit interpretation.

Conclusion

Long-term tildrakizumab efficacy and safety were comparable between patients with and without MetS.

Le texte complet de cet article est disponible en PDF.

Key words : clinical research, dermatology, efficacy, interleukin 23, metabolic syndrome, psoriasis, safety, tildrakizumab

Abbreviations used : AE, BMI, CV, CVD, IL, MACE, MedDRA SOC, MetS, NCEP ATP III, PASI, PY, SAE, TEAE


Plan


 Funding sources: Funded by Merck Sharp and Dohme, a subsidiary of Merck, Kenilworth, New Jersey. These analyses were funded by Sun Pharmaceutical Industries, Inc.
 Disclosure: Dr Lebwohl is an employee of Mount Sinai; receives research funds from AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen Research & Development, LLC, LEO Pharma, Ortho Dermatologics, Pfizer and UCB; and is a consultant for Aditum Bio, Allergan, Almirall, Arcutis; Inc, Avotres Therapeutics, BirchBioMed, Inc, BMD Skincare, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, Kyowa Kirin, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr Reddy's Laboratories, Serono, Theravance, and Verrica. Dr Leonardi has served as a consultant for and/or has been an investigator for and/or is on the speaker bureaus for AbbVie, Actavis, Amgen, Boehringer Ingelheim, Celgene, Coherus, Corrona, Dermira, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sandoz, Stiefel, UCB, Vitae, and Wyeth. Dr Mehta is a full-time employee of the US government and has received support in the form of grants to the National Institutes of Health from AbbVie, Celgene, Janssen, and Novartis. Dr Gottlieb has received honoraria as an advisory board member and consultant for Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Incyte, Janssen, LEO Pharma, Novartis, Sun Pharmaceutical Industries, Inc, UCB, and XBiotech (only stock options, which she has not used) and has received research/educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, Sun Pharmaceutical Industries Ltd., UCB, and XBiotech. Dr Mendelsohn is an employee of Sun Pharmaceutical Industries, Inc, and has individual shares in Johnson and Johnson and as part of retirement account/mutual funds. Author Parno and Dr Rozzo are employees of Sun Pharmaceutical Industries, Inc. Dr Menter has received grants and/or honoraria as a consultant, investigator, and/or speaker for AbbVie, Abbott Labs, Amgen, Anacor, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Biotech, LEO Pharma, Merck & Co, Novartis, Sienna, and UCB and has been on an advisory board for AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen Biotech, LEO Pharma, and Sienna.
 IRB approval status: Reviewed and approved by local IRB boards at each study site.


© 2020  American Academy of Dermatology, Inc. Tous droits réservés.
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Vol 84 - N° 2

P. 398-407 - février 2021 Retour au numéro
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