BIOBADADERM, the Spanish Registry of Adverse Events Associated With Biologic Drugs in Dermatology: First Report

Abstract

Background and objectives The Working Group on Psoriasis of the Spanish Academy of Dermatology and Venereology has initiated BIOBADADERM, a registry of patients with psoriasis receiving treatment with biologic drugs, in order to assess the long-term risk of adverse events (AEs). Material and methods A multicenter study was undertaken in 2 cohorts of patients with psoriasis: patients receiving biologic therapy and patients receiving nonbiologic systemic therapy other than phototherapy. Similar numbers of patients were included in each group. Information was recorded on demographic and clinical variables, treatment, and relevant AEs. The risk of specific AEs was determined by comparison of the frequencies for those events in the 2 cohorts. Results Data on the 2 cohorts were evaluated for the period from October, 2008 to November, 2009 alongside retrospective data on patients treated with biologics since 2005. Thirteen Spanish hospitals participated in the study. A total of 632 patients were included in the analysis: 417 treated with biologic drugs and 215 controls. Suspension of biologic therapy due to AEs was rare (72 cycles, 10%). A total of 232 AEs were reported in patients receiving biologic therapy. The majority were not serious. The most frequent AEs were infections (mostly upper respiratory tract infections and nasopharyngitis), followed by conditions affecting the skin or subcutaneous tissue. Forty-three AEs were reported in control subjects. The most frequent events were metabolic and nutritional abnormalities and abnormal transaminase levels. Comparison of the incidence of any AE in patients treated with biologics compared with control subjects revealed a relative risk of 2.2 (P<.001) The relative risks of infections or infestations and disorders of the skin or subcutaneous tissue in patients receiving biologic drugs were 23 (P<.01) and 4.9 (P<.05), respectively. Conclusions Patients treated with biologic drugs had a greater number of AEs, particularly infections and skin conditions. Definitive conclusions, however, are difficult to draw due to the small number of patients included in the registry, particularly in the control cohort, and the short follow-up period. Differences in the percentages of events reported by the different hospitals reveal the difficulties associated with the concept of AEs in clinical practice and highlight the need to harmonize criteria in the future. Since the problems identified in this analysis should be overcome in future years, we expect BIOBADADERM to become an important source of information on the safety profile of biologic drugs in dermatology.