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

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 = 0.116) for tumor necrosis factor-alpha (TNF) inhibitors, 2.73 (0.98-7.58; p = 0.054) for ustekinumab, and 1.04 (0.20-5.41; p = 0.966) for methotrexate vs. reference (combined phototherapy, systemic steroids, topical therapy, and immunomodulators other than methotrexate). CONCLUSIONS: Exposure to ustekinumab, TNF-alpha inhibitors, and methotrexate was not associated with a statistically significant increased risk of HZ. However, HRs were elevated for ustekinumab and TNF-alpha inhibitors; a larger number of herpes zoster events would be needed to assess the presence or absence of risk