title: [Safety of biological therapies: new data from BIOBADASER].
abstract: The study of the long-term safety of biological therapies has been made possible because of the creation of several national registries. These have resolved some of the safety-derived doubts from the initial clinical trials, observational studies and meta-analyses. The main problem associated with biological therapy use is a moderate increase in the risk of serious infections when compared to conventional therapies. However, this risk can be reduced with adequate preventative measures. It seems that there is neither an increased risk of cancer nor elevated mortality with the use of biological drugs. These adverse events, along with others such as paradoxical induction of psoriasis, demyelinating diseases and administration-related reactions, have been studied in BIOBADASER, the Spanish Registry of Biological Therapies. This paper reviews the safety of biological agents with a special focus on BIOBADASER studies.
authors.affiliation: Servicio de Reumatología, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, España. crodloz@gobiernodecanarias.org
authors.forename: Carlos
authors.initials: C
authors.lastname: Rodríguez Lozano
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology; D001327:Autoimmune Diseases / Q000139:chemically induced; D001691:Biological Therapy / Q000009:adverse effects / Q000706:statistics & numerical data; D003711:Demyelinating Diseases / Q000139:chemically induced; D004198:Disease Susceptibility; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D006801:Humans; D007239:Infections / Q000209:etiology; D008297:Male; D015201:Meta-Analysis as Topic; D009369:Neoplasms / Q000139:chemically induced; D064887:Observational Studies as Topic; D011247:Pregnancy; D011565:Psoriasis / Q000139:chemically induced; D012042:Registries; D013030:Spain; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D014409:Tumor Necrosis Factor-alpha