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Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis - 15/10/16

Doi : 10.1016/j.jaad.2016.06.012 
Jashin J. Wu, MD a, , Bruce E. Strober, MD, PhD b, c, Peter R. Hansen, MD, PhD, DSc d, Ole Ahlehoff, MD, PhD e, Alexander Egeberg, MD, PhD d, f, Abrar A. Qureshi, MD, MPH g, h, Debbie Robertson, MS, RDN, LDN i, Hernan Valdez, MD j, Huaming Tan, PhD k, Robert Wolk, MD, PhD, DSc k
a Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, California 
b University of Connecticut Health Center, Farmington, Connecticut 
c Probity Medical Research, Waterloo, Ontario, Canada 
d Department of Cardiology, Herlev and Gentofte Hospital, Hellerup, Denmark 
f Department of Dermato-Allergology, Herlev and Gentofte Hospital, Hellerup, Denmark 
e Department of Cardiology, Copenhagen University Hospital Rigshospitalet, The Heart Centre, Copenhagen, Denmark 
g Department of Dermatology, Warren Alpert Medical School, Brown University, Providence, Rhode Island 
h Department of Epidemiology, School of Public Health, Brown University, Providence, Rhode Island 
i Pfizer location in Collegeville, Collegeville, Pennsylvania 
j Pfizer location in New York, New York, New York 
k Pfizer location in Groton, Groton, Connecticut 

Reprint requests: Jashin J. Wu, MD, Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, 1515 N Vermont Ave, 5th fl, Los Angeles, CA 90027Department of DermatologyKaiser Permanente Los Angeles Medical Center1515 N Vermont Ave, 5th flLos AngelesCA90027

Abstract

Background

Psoriasis is a systemic inflammatory condition that is associated with a higher risk of cardiovascular (CV) disease. Tofacitinib is being investigated as a treatment for psoriasis.

Objective

We sought to evaluate the effects of tofacitinib on CV risk factors and major adverse CV events (MACEs) in patients with plaque psoriasis.

Methods

Changes in select CV risk factors and the incidence rate (IR) of MACEs were evaluated in patients who were treated with tofacitinib.

Results

Tofacitinib treatment was associated with small, dose-dependent increases in total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol, while the total/HDL cholesterol ratio was unchanged. There were no changes in blood pressure and glycated hemoglobin levels; C-reactive protein levels decreased. The IRs of a MACE were low and similar for both tofacitinib doses. Among 3623 subjects treated with tofacitinib, the total patient-years of exposure was 5204, with a median follow-up of 527 days, and the IR of MACEs was 0.37 (95% confidence interval, 0.22-0.57) patients with events per 100 patient-years.

Limitations

There was relatively short follow-up time for patients who had MACEs.

Conclusions

While treatment with tofacitinib is associated with a small increase in cholesterol levels, the total/HDL cholesterol ratio does not change, there are no unfavorable changes in several CV risk factors, and the incidence of MACEs is low.

Le texte complet de cet article est disponible en PDF.

Key words : cardiovascular outcomes, cardiovascular risk factors, major adverse cardiovascular events psoriasis, tofacitinib

Abbreviations used : BID, BP, CV, HbA1c, HDL, hsCRP, IR, LDL, LS, LTE, MACE, MI, OPT, PY, RA


Plan


 Supported by Pfizer.
 Dr Wu has received research funding from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Coherus Biosciences, Dermira, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, and Sun Pharmaceutical Industries and is a consultant for AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Pfizer, Regeneron, and Sun Pharmaceutical Industries. Dr Strober has received honoraria for serving as a consultant, advisory board member, or speaker for AbbVie, Amgen, Astra Zeneca, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Forward Pharma, Janssen, Leo, Maruho, Medac, Novartis, Pfizer, Stiefel/GlaxoSmithKline, Sun, and UCB; has received payments (to the University of Connecticut) as an investigator for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis, Xenoport, and Xoma; has received fees as a scientific director for the CORRONA Psoriasis Registry; and has received grant support (to the University of Connecticut for Fellowship Program) from AbbVie and Janssen. Dr Qureshi is a consultant for Abbvie, Amgen, the Centers for Disease Control and Prevention, Janssen, Merck, Novartis, and Pfizer, and is an investigator for Amgen. Dr Hansen received an unrestricted research grant from the LEO Foundation. Dr Ahlehoff received an unrestricted research grant from AbbVie and honoraria as a consultant or speaker from AbbVie, Janssen Pharmaceuticals, MSD, and Pfizer. Ms Robertson and Drs Valdez, Tan, and Wolk are employees and shareholders of Pfizer. Dr Egeberg is a former employee of Pfizer.


© 2016  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 75 - N° 5

P. 897-905 - novembre 2016 Retour au numéro
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