BIOBADADERM, the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology: first report

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). 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. 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