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

Adverse events associated with discontinuation of the biologics/classic systemic treatments for moderate‐to‐severe plaque psoriasis: data from the Spanish Biologics Registry, Biobadaderm

“…12,13 The registry has been approved by the Hospital 12 de Octubre Ethics Committee (Madrid, Spain) and performed in compliance with the Declaration of Helsinki and local regulations. 12,13 The registry has been approved by the Hospital 12 de Octubre Ethics Committee (Madrid, Spain) and performed in compliance with the Declaration of Helsinki and local regulations.…”

“…[2][3][4][5][6][7] In general, the safety data come from randomized controlled trials (RCTs) or their extensions, 8 usually with short follow-up periods, and from the spontaneous reporting of adverse reactions. [10][11][12][13] Moreover, information about the conditions that lead to therapeutic suspension in RCTs does not necessarily correspond to those described in clinical practice, in which the patient's profile is different. [10][11][12][13] Moreover, information about the conditions that lead to therapeutic suspension in RCTs does not necessarily correspond to those described in clinical practice, in which the patient's profile is different.…”

“…11,13,16 Accordingly, with the objective to better assess the safety of currently available systemic therapies for psoriasis, we hereby study the AEs associated with the discontinuation of the biologics (i.e. 12 acitretin, cyclosporine and methotrexate), and their incidence in patients with moderate-to-severe plaque psoriasis in a clinical setting registered in the Spanish Registry for Systemic Treatments in Psoriasis (Biobadaderm).…”

Risk of Reactivation of Hepatitis B Virus Infection in Psoriasis Patients Treated With Biologics: A Retrospective Analysis of 20 Cases From the BIOBADADERM Database

“…The methodology used in this prospective registry has been described previously. 7 The following study inclusion criteria were applied:…”

Risk of Serious Adverse Events Associated With Biologic and Nonbiologic Psoriasis Systemic Therapy

“…13 Thirteen dermatology departments, widely distributed across Spain, participate in this registry. Biologics have been commercially available in Spain since 2005.…”