Guy Shalom1, Luigi Naldi2, Mark Lebwohl3, Arjen Nikkels4, Elke M G J de Jong5, Steven Fakharzadeh6, Kavitha G Goyal7, Bhaskar Srivastava7, Wayne Langholff6, Claudia Galindo6, Arnon D Cohen8,9. 1. a Department of Dermatology and Venereology, Soroka Medical Center , Beer-Sheva , Israel. 2. b Department of Dermatology, Azienda Ospedaliera Papa Giovanni XXIII, Study Center of the Italian Group for Epidemiologic Research in Dermatology (GISED) , Bergamo , Italy. 3. c Icahn School of Medicine at Mount Sinai , New York, NY , USA. 4. d Liège University Hospital CHU , Liège , Belgium. 5. e Radboud University Medical Centre, and Radboud University Nijmegen , Nijmegen , The Netherlands. 6. f Janssen Research & Development, LLC , Horsham , PA , USA. 7. g Janssen Scientific Affairs, LLC , Horsham , PA , USA. 8. h Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev , Beer Sheva , Israel. 9. i Clalit Health Services , Tel Aviv , Israel.
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.
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.
Authors: Linda Davidson; Juul M P A Van den Reek; Florence Van Hunsel; Elke M G J De Jong; Bart Jan Kullberg Journal: Acta Derm Venereol Date: 2022-02-11 Impact factor: 3.875