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.
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.
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.
REFERENCES
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2. Gami AS, Witt BJ, Howard DE, et al. Metabolic syndrome and risk of incident cardiovascular events and death: a systematic review and meta-analysis of longitudinal studies. J Am Coll Cardiol. 2007;49(4):403-414.
3. Menter MA, Armstrong AW, Gordon KB, Wu JJ. Common and not-so-common comorbidities of psoriasis. Seminars in Cutaneous Medicine and Surgery. 2018;37:S48-S51.
4. Love TJ, Qureshi AA, Karlson EW, Gelfand JM, Choi HK. Prevalence of the metabolic syndrome in psoriasis: results from the National Health and Nutrition Examination Survey, 2003-2006. Archives of Dermatology. 2011;147(4):419-424.
5. Gisondi P, Tessari G, Conti A, et al. Prevalence of metabolic syndrome in patients with psoriasis: a hospital-based case-control study. Br J Dermatol. 2007;157(1):68-73.
6. Singh S, Young P, Armstrong AW. An update on psoriasis and metabolic syndrome: A meta-analysis of observational studies. PLoS One. 2017;12(7):e0181039.
7. Talamonti M, Galluzzo M, Bernardini N, et al. Psoriasis Area and Severity Index response in moderate-severe psoriatic patients switched to adalimumab: results from the OPPSA study. J Eur Acad Dermatol Venereol. 2018;32(10):1737-1744.
8. Jacobi A, Rustenbach SJ, Augustin M. Comorbidity as a predictor for drug survival of biologic therapy in patients with psoriasis. Int J Dermatol. 2016;55(3):296-302.
9. Pinter A, Gerdes S, Papavassilis C, Reinhardt M. Characterization of responder groups to secukinumab treatment in moderate to severe plaque psoriasis. J Dermatolog Treat. 2019:1-7.
10. Egeberg A, Wu JJ, Korman N, et al. Ixekizumab treatment shows a neutral impact on cardiovascular parameters in patients with moderate-to-severe plaque psoriasis: Results from UNCOVER-1, UNCOVER-2, and UNCOVER-3. J Am Acad Dermatol. 2018;79(1):104-109 e108.
11. Fassio A, Gatti D, Gisondi P, et al. Effects of secukinumab on serum adipocytokines: preliminary data. Reumatismo. 2017;69(3):105-110.
12. Gisondi P, Cotena C, Tessari G, Girolomoni G. Anti-tumour necrosis factor-alpha therapy increases body weight in patients with chronic plaque psoriasis: a retrospective cohort study. J Eur Acad Dermatol Venereol. 2008;22(3):341-344.
13. Owczarczyk-Saczonek A, Placek W, Rybak-d'Obyrn J, Wygonowska E. Influence of ustekinumab on body weight of patients with psoriasis: an initial report. Postepy Dermatol Alergol. 2014;31(1):29-31.
14. Saraceno R, Schipani C, Mazzotta A, et al. Effect of anti-tumor necrosis factor- alpha therapies on body mass index in patients with psoriasis. Pharmacol Res. 2008;57(4):290-295.
15. Tan E, Baker C, Foley P. Weight gain and tumour necrosis factor-alpha inhibitors in patients with psoriasis. Australas J Dermatol. 2013;54(4):259-263.
2. Gami AS, Witt BJ, Howard DE, et al. Metabolic syndrome and risk of incident cardiovascular events and death: a systematic review and meta-analysis of longitudinal studies. J Am Coll Cardiol. 2007;49(4):403-414.
3. Menter MA, Armstrong AW, Gordon KB, Wu JJ. Common and not-so-common comorbidities of psoriasis. Seminars in Cutaneous Medicine and Surgery. 2018;37:S48-S51.
4. Love TJ, Qureshi AA, Karlson EW, Gelfand JM, Choi HK. Prevalence of the metabolic syndrome in psoriasis: results from the National Health and Nutrition Examination Survey, 2003-2006. Archives of Dermatology. 2011;147(4):419-424.
5. Gisondi P, Tessari G, Conti A, et al. Prevalence of metabolic syndrome in patients with psoriasis: a hospital-based case-control study. Br J Dermatol. 2007;157(1):68-73.
6. Singh S, Young P, Armstrong AW. An update on psoriasis and metabolic syndrome: A meta-analysis of observational studies. PLoS One. 2017;12(7):e0181039.
7. Talamonti M, Galluzzo M, Bernardini N, et al. Psoriasis Area and Severity Index response in moderate-severe psoriatic patients switched to adalimumab: results from the OPPSA study. J Eur Acad Dermatol Venereol. 2018;32(10):1737-1744.
8. Jacobi A, Rustenbach SJ, Augustin M. Comorbidity as a predictor for drug survival of biologic therapy in patients with psoriasis. Int J Dermatol. 2016;55(3):296-302.
9. Pinter A, Gerdes S, Papavassilis C, Reinhardt M. Characterization of responder groups to secukinumab treatment in moderate to severe plaque psoriasis. J Dermatolog Treat. 2019:1-7.
10. Egeberg A, Wu JJ, Korman N, et al. Ixekizumab treatment shows a neutral impact on cardiovascular parameters in patients with moderate-to-severe plaque psoriasis: Results from UNCOVER-1, UNCOVER-2, and UNCOVER-3. J Am Acad Dermatol. 2018;79(1):104-109 e108.
11. Fassio A, Gatti D, Gisondi P, et al. Effects of secukinumab on serum adipocytokines: preliminary data. Reumatismo. 2017;69(3):105-110.
12. Gisondi P, Cotena C, Tessari G, Girolomoni G. Anti-tumour necrosis factor-alpha therapy increases body weight in patients with chronic plaque psoriasis: a retrospective cohort study. J Eur Acad Dermatol Venereol. 2008;22(3):341-344.
13. Owczarczyk-Saczonek A, Placek W, Rybak-d'Obyrn J, Wygonowska E. Influence of ustekinumab on body weight of patients with psoriasis: an initial report. Postepy Dermatol Alergol. 2014;31(1):29-31.
14. Saraceno R, Schipani C, Mazzotta A, et al. Effect of anti-tumor necrosis factor- alpha therapies on body mass index in patients with psoriasis. Pharmacol Res. 2008;57(4):290-295.
15. Tan E, Baker C, Foley P. Weight gain and tumour necrosis factor-alpha inhibitors in patients with psoriasis. Australas J Dermatol. 2013;54(4):259-263.
