title: Patient reports of the frequency and severity of adverse reactions associated with biological agents prescribed for psoriasis in Brazil.
abstract: BACKGROUND
  The safety of biological agents used to treat psoriasis remains uncertain.
  
  
  OBJECTIVE
  The authors determined the frequency and severity of adverse effects associated with use of biologic agents for psoriasis through patient-registered lawsuits to the government of Sao Paulo, Brazil.
  
  
  METHODS
  Sources of information included legal records, dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients who used biologic drugs during 2004 - 2011, inquiring about medication-related adverse drug reactions (ADRs) and serious adverse events (SAEs).
  
  
  RESULTS
  Of the 218 patients identified, 15 proved ineligible or refused participation. 203 patients were interviewed, with 111 (54.7%) taking infliximab, 43 (21.2%) efalizumab, 35 (17.2%) etanercept and 14 (6.9%) adalimumab. Of 84 (41.4%) patients who experienced one or more ADR related to biological agents, 57 (67.9%) experienced one or more SAE. The only risk factor associated with ADRs was comorbidity odds ratio = 6.54 (95% confident interval [CI] 3.20 - 13.32), p < 0.0001.
  
  
  CONCLUSIONS
  Biologic agents were associated with high rates of ADRs and SAEs. The data suggests that for patients taking a biologic agent to treat psoriasis and who have one or more comorbidities, warnings of possible adverse events and enhanced surveillance are warranted.
authors: University of Sorocaba (UNISO) Pharmaceutical Science Post-Graduate Course , Rodovia Raposo Tavares, KM92,5, Sorocaba, Sao Paulo, CEP 18023-000 , Brazil luslopes@terra.com.br.
authors: Luciane Cruz
authors: LC
authors: Lopes
authors: Miriam Sanches do Nascimento
authors: MS
authors: Silveira
authors: Mayara Costa
authors: MC
authors: de Camargo
authors: Iara Alves
authors: IA
authors: de Camargo
authors: Tatiana Chama Borges
authors: TC
authors: Luz
authors: Claudia Garcia Serpa
authors: CG
authors: Osorio-de-Castro
authors: Silvio
authors: S
authors: Barberato-Filho
authors: Fernando de Sá
authors: Fde S
authors: Del Fiol
authors: Gordon
authors: G
authors: Guyatt
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001938:Brazil / Q000453:epidemiology; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012307:Risk Factors; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D007155:Immunologic Factors
keywords: adverse reaction; biologic; psoriasis