Biological treatment for psoriasis and the risk of herpes zoster: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR)

Abstract

Purpose: To describe the risk of herpes zoster (HZ) in patients with psoriasis and its relation to non-biologic systemic therapies or biologic treatment.

Materials and methods: Psoriasis Longitudinal Assessment and Registry (PSOLAR) is an international, prospective, registry that follows adult patients with psoriasis eligible to receive non-biologic systemic therapies or biologic therapies. Mutually exclusive therapy cohorts were defined. HZ incident rates were calculated for each therapy cohort and rates between cohorts were compared using hazard ratios (HR) adjusted for potential confounders, in new users and prevalent-exposure patients.

Results: A total of 55 HZ events were identified in 10,469 patients in PSOLAR. The adjusted hazard ratio in the overall study population (new user and prevalent-exposed patients) was 2.22 (95% CI: 0.82–5.97; p = .116) for tumor necrosis factor-α (TNF) inhibitors, 2.73 (0.98–7.58; p = .054) for ustekinumab, and 1.04 (0.20–5.41; p = .966) for methotrexate versus reference (combined phototherapy, systemic steroids, topical therapy, and immunomodulators other than methotrexate).

Conclusions: Exposure to ustekinumab, TNF-α inhibitors, and methotrexate was not associated with a statistically significant increased risk of HZ. However, HRs were elevated for ustekinumab and TNF-α inhibitors; a larger number of HZ events would be needed to assess the presence or absence of risk.

Keywords:

• Biologics
• herpes zoster
• psoriasis
• PSOLAR
• tumor necrosis factor

Acknowledgements

The authors would like to thank Kristin Ruley Sharples, PhD, of Janssen Scientific Affairs, LLC (Spring House, PA) and Teresa Tartaglione, PharmD, of Synchrogenix, a Certara Company (Wilmington, DE) for their writing and editorial support.

Disclosure statement

G. Shalom has no conflicts of interest; L. Naldi has received consultant fees from Abbvie, Eli Lilly, Janssen-CILAG, Menarini, Novartis, Pfizer, and Sanofi; M. Lebwohl is an employee of Mount Sinai, which receives research funds from: Abbvie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen/Johnson & Johnson, Kadmon, Medimmune/Astra Zeneca, Novartis, Pfizer, and ViDac; A. Nikkels has no conflicts of interest; E.M.G.J. de Jong has received research grants for the independent research fund of the Department of Dermatology of the Radboud University Medical Centre, Nijmegen, the Netherlands (Radboud) from AbbVie, Janssen, and Pfizer; has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis including: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, and Pfizer. All funding goes to the independent research fund of “Radboud”; A. D. Cohen has served as a consultant, advisor, or speaker for AbbVie, Dexcel Pharma, Janssen, Novartis, Perrigo, Pfizer, and Rafa; S. Fakharzadeh, K. G. Goyal, B. Srivastava, W. Langholff, and C. Galindo are all employees of Janssen Scientific Affairs, LLC, and own stock in Johnson & Johnson, of which Janssen is a subsidiary.

Additional information

Funding

The PSOLAR study was funded by Janssen Scientific Affairs, LLC, Horsham, PA, USA.