title: The skin tissue is adversely affected by TNF-alpha blockers in patients with chronic inflammatory arthritis: a 5-year prospective analysis.
abstract: OBJECTIVE
  We evaluated the incidence of and the main risk factors associated with cutaneous adverse events in patients with chronic inflammatory arthritis following anti-TNF-α therapy.
  
  
  METHODS
  A total of 257 patients with active arthritis who were taking TNF-α blockers, including 158 patients with rheumatoid arthritis, 87 with ankylosing spondylitis and 12 with psoriatic arthritis, were enrolled in a 5-year prospective analysis. Patients with overlapping or other rheumatic diseases were excluded. Anthropometric, socioeconomic, demographic and clinical data were evaluated, including the Disease Activity Score-28, Bath Ankylosing Spondylitis Disease Activity Index and Psoriasis Area Severity Index. Skin conditions were evaluated by two dermatology experts, and in doubtful cases, skin lesion biopsies were performed. Associations between adverse cutaneous events and clinical, demographic and epidemiological variables were determined using the chi-square test, and logistic regression analyses were performed to identify risk factors. The significance level was set at p<0.05.
  
  
  RESULTS
  After 60 months of follow-up, 71 adverse events (73.85/1000 patient-years) were observed, of which allergic and immune-mediated phenomena were the most frequent events, followed by infectious conditions involving bacterial (47.1%), parasitic (23.5%), fungal (20.6%) and viral (8.8%) agents.
  
  
  CONCLUSIONS
  The skin is significantly affected by adverse reactions resulting from the use of TNF-α blockers, and the main risk factors for cutaneous events were advanced age, female sex, a diagnosis of rheumatoid arthritis, disease activity and the use of infliximab.
authors.affiliation: Rheumatology Division, Escola Paulista de Medicina, Universidade Federal de São Paulo, São PauloSP, Brazil.
authors.forename: Natalia P
authors.initials: NP
authors.lastname: Machado
authors.forename: Edgard Torres dos
authors.initials: ET
authors.lastname: Reis Neto
authors.forename: Maria Roberta M P
authors.initials: MR
authors.lastname: Soares
authors.forename: Daniele S
authors.initials: DS
authors.lastname: Freitas
authors.forename: Adriana
authors.initials: A
authors.lastname: Porro
authors.forename: Rozana M
authors.initials: RM
authors.lastname: Ciconelli
authors.forename: Marcelo M
authors.initials: MM
authors.lastname: Pinheiro
mesh_terms: D000328:Adult; D000367:Age Factors; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D018501:Antirheumatic Agents / Q000009:adverse effects*; D001168:Arthritis / Q000188:drug therapy*; D015535:Arthritis, Psoriatic / Q000188:drug therapy; D002908:Chronic Disease; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D012867:Skin / Q000187:drug effects; D012871:Skin Diseases / Q000139:chemically induced*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha