Infectious risk of biological drugs versus conventional systemic treatments in moderate to severe psoriasis

Abstract

INfeCTIouS rISk of bIologICal drugS VerSuS CoNVeNTIoNal SySTemIC TreaTmeNTS IN moderaTe To SeVere pSorIaSIS S. Couderc; R. Bourrel; C. Paul; J.L. Montastruc; M. Lapeyre-Mestre; and A. Sommet UMR 1027, Inserm, Universite Toulouse III, Toulouse, France; Caisse Nationale d’Assurance Maladie Midi-Pyrenees, Toulouse, France; Service de Dermatologie, Centre Hospitalier Universitaire, Toulouse, France; and Pharmacologie Medicale et Clinique, Centre Hospitalier Universitaire, Toulouse, France Introduction: Moderate to severe psoriasis affects about 0.5% of the population. Its management is based on conventional systemic treatments (TSC: phototherapy, acitretin, methotrexate, and cyclosporine) and biological second-line drugs (etanercept, infliximab, ustekinumab, adalimumab, golimumab). Results of studies comparing the infectious risk of TSC and biological drugs are divergent. Objective: To compare the infectious risk associated with biological drugs versus TSC for moderate to severe psoriasis. Material and Methods: We conducted a retrospective cohort in the French Health Insurance Database for the Midi-Pyrenees region from 01/01/2010 to 31/12/2013, with patients treated incidentally for moderate to severe psoriasis. After a 6-month observation period with all patients exposed to TSC, we compared patients exposed to biological drugs (“exposed”) versus TSC (“unexposed”). We performed a Cox model on the first infectious event, for up to 6 months after the last dispensation of psoriasis drug. An infectious event was defined as delivery of any anti-infectious systemic drug or a hospital diagnosis of infection. Results: The 101 “exposed: patients and 788 “unexposed” patients were comparable in terms of socio-demographic data and comorbidities. Considering the first infectious event over a period of 2 years, no significant difference was found between “exposed” and “unexposed” (HR = 0.94; 95% CI, 0.71–1.22; P = 0.62). Being a woman (HR = 1.23), benefit from the Universal Health Coverage (HR = 1.44), suffering from chronic hepatitis B or C (HR = 2.74), history of neoplasia (HR = 1.70), a previous infectious event during the observation period (HR = 1.74), and the number of drugs consumed during the observation period (HR = 1.03) significantly increased the risk of infection. Conclusions: We did not reveal any difference in infection risk between the TSC and biological drugs in the management of moderate to severe psoriasis. This risk appears constant the first 2 years of use.