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Herpes Zoster, Hepatitis C, and Tuberculosis Risk with Apremilast Compared to Biologics, DMARDs and Corticosteroids to Treat Psoriasis and Psoriatic Arthritis

Authors Hagberg KW, Persson R, Vasilakis-Scaramozza C, Niemcryk S, Peng M, Paris M, Lindholm A, Jick S

Received 22 November 2019

Accepted for publication 24 January 2020

Published 12 February 2020 Volume 2020:12 Pages 153—161


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Vera Ehrenstein

Katrina Wilcox Hagberg,1 Rebecca Persson,1 Catherine Vasilakis-Scaramozza,1 Steve Niemcryk,2 Michael Peng,2 Maria Paris,2 Anders Lindholm,2 Susan Jick1,3

1Boston Collaborative Drug Surveillance Program, Lexington, MA 02421, USA; 2Celgene Corporation, Summit, NJ 07901, USA; 3Boston University School of Public Health, Lexington, MA 02421, USA

Correspondence: Susan Jick
Boston Collaborative Drug Surveillance Program, 11 Muzzey Street, Lexington, MA 02421, USA
Tel +1-781-862-6660
Fax +1-781-862-1680

Purpose: Psoriasis and psoriatic arthritis (PsA) are associated with an increased infection risk. In this cohort study of patients with treated psoriasis or PsA, we used MarketScan (2014– 2018) to estimate rates of herpes zoster, hepatitis C (HepC) and tuberculosis (TB) with apremilast compared to other systemic treatments.
Materials and Methods: Patients were exposed from first apremilast [APR], DMARD, TNF-inhibitor [TNF], IL-inhibitor [IL], or corticosteroids [CS] prescription after March 21, 2014. Study exposures were APR, DMARDs only, TNF-only, IL-only, CS-only, DMARDs+CS, TNF+DMARDs and/or CS, IL+DMARDs and/or CS. Cases had treated herpes zoster, HepC, or TB event. We calculated incidence rates (IRs) [95% confidence intervals] per 1000 patient-years.
Results: The study population included 131,604 patients. For herpes zoster (N=2271), IRs were highest for users of DMARDs+CS (12.5 [9.8– 15.7]), CS-only (12.5 [10.4– 14.1]), and TNF+DMARDs and/or CS (11.9 [10.6– 13.4]), compared with DMARDs only (9.9 [8.7– 11.2]). IRs were lowest for users of IL-only (6.7 [5.8– 7.8]) and APR (7.0 [5.8– 8.4]). IRs of HepC (N=150) and TB (N=81) were low and between-treatment differences were not significant.
Conclusion: Rates of herpes zoster varied by treatment: highest among those who received polytherapy, lowest in users of apremilast only. IRs for HepC and TB were low for all exposures.

Keywords: apremilast, psoriasis, psoriatic arthritis, herpes zoster, hepatitis C, tuberculosis

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