The Effect of Tildrakizumab on Cardiometabolic Risk Factors in Psoriasis by Metabolic Syndrome Status: Post Hoc Analysis of Two Phase 3 Trials (ReSURFACE 1 and ReSURFACE 2)

August 2020 | Volume 19 | Issue 8 | Original Article | 703 | Copyright © August 2020


Published online July 22, 2020

M. Alan Menter MDa, Nehal N. Mehta MD MSCE FAHAb, Mark G. Lebwohl MDc, Alice B. Gottlieb MD PhDd, Alan M. Mendelsohn MDe, Stephen J. Rozzo PhDe, Craig Leonardi MDf

aDivision of Dermatology, Baylor Scott & White, and Texas A&M College of Medicine, Dallas, TX BNational Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD cDepartment of Dermatology, Mount Sinai Hospital, New York, NY dDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY eSun Pharmaceutical Industries, Inc., Princeton, NJ fCentral Dermatology and Saint Louis University School of Medicine, St. Louis, MO

els, which are implicated in glucose metabolism.11 In a pooled analysis of 3 phase 3 studies, ixekizumab had no impact on CVrelated parameters of TC, HDL-C, LDL-C, LDL-C:HDL-C, and TG.10 The effect of TNF-α antagonists on cardiometabolic risk factors remains controversial; anti-TNF-α treatment with some antagonists is associated with weight gain and differing effects on insulin resistance and CV biomarkers.17,26,27 Here, mean change in FG in MetS patients receiving tildrakizumab 200 mg at week 64/52 was numerically higher relative to baseline, although the median value (101.0) was identical at both time points. A previously reported positive correlation between IL-23 and FG in patients with plaque psoriasis suggests a potential role of IL-23 in metabolic processes, including glucose homeostasis.28

In conclusion, changes in cardiometabolic disease risk factors following tildrakizumab treatment were limited. Risk factors were not increased in patients with MetS vs without MetS. Study limitations include that the analyses were not powered to assess statistical differences between groups based on MetS status and the physiological variability of CV risk factors were not considered in reporting numerical changes. Additionally, the clinical meaningfulness of numerical differences is unclear. Further prospective analyses with larger sample size are needed to support these findings.

DISCLOSURES

M.A.M. 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.

N.N.M. is a full-time employee of the US government and has received support in the form of grants to the NIH from AbbVie, Celgene, Janssen, and Novartis.

M.G.L. is an employee of Mount Sinai, which receives research funds from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, Kadmon, LEO Pharma, MedImmune, Novartis, Ortho Dermatologics, Pfizer, SCIderm, UCB, and ViDac; and is a consultant for Allergan, Almirall, Arcutis, Avotres, BirchBioMed, Boehringer- Ingelheim, Bristol-Myers Squibb, Cara, Castle Biosciences, Dermavant, Encore, Inozyme, LEO Pharma, Meiji, Menlo, Mitsubishi Pharma, Neuroderm Ltd, Pfizer, Promius/Dr. Reddy, Theravance Biopharma, and Verrica.

A.B.G. has current consulting/advisory board agreements with Allergan; Avotres Therapeutics; Beiersdorf; Boehringer Ingelheim; Bristol-Myers Squibb; Celgene; Dermira; Eli Lilly; Incyte; Janssen; LEO Pharma; Novartis; Reddy Labs; Sun Pharmaceutical Industries, Inc.; UCB; Valeant; XBiotech; and has received research/educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, UCB, XBiotech.

A.M.M., and S.J.R. are employees of Sun Pharmaceutical Industries, Inc.

C.L. 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.

ACKNOWLEDGMENT

The authors would like to thank the patients who took part in this study. The authors would also like to thank Jeff Parno for his feedback and valuable contributions to statistical analysis. Studies were funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. These analyses were funded by Sun Pharmaceutical Industries, Inc. Medical writing support was provided by Puneet Dang, PhD, of AlphaBioCom, LLC, and funded by Sun Pharmaceutical Industries, Inc.

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