title: Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease.
abstract: BACKGROUND
  As long-term treatment with antitumour necrosis factor (TNF) drugs becomes accepted practice, the risk assessment requires an understanding of anti-TNF long-term safety. Registry safety data in rheumatoid arthritis (RA) are available, but these patients may not be monitored as closely as patients in a clinical trial. Cross-indication safety reviews of available anti-TNF agents are limited.
  
  
  OBJECTIVE
  To analyse the long-term safety of adalimumab treatment.
  
  
  METHODS
  This analysis included 23 458 patients exposed to adalimumab in 71 global clinical trials in RA, juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, psoriasis (Ps) and Crohn's disease (CD). Events per 100 patient-years were calculated using events reported after the first dose through 70 days after the last dose. Standardised incidence rates for malignancies were calculated using a National Cancer Institute database. Standardised death rates were calculated using WHO data.
  
  
  RESULTS
  The most frequently reported serious adverse events across indications were infections with greatest incidence in RA and CD trials. Overall malignancy rates for adalimumab-treated patients were as expected for the general population; the incidence of lymphoma was increased in patients with RA, but within the range expected in RA without anti-TNF therapy; non-melanoma skin cancer incidence was raised in RA, Ps and CD. In all indications, death rates were lower than, or equivalent to, those expected in the general population.
  
  
  CONCLUSIONS
  Analysis of adverse events of interest through nearly 12 years of adalimumab exposure in clinical trials across indications demonstrated individual differences in rates by disease populations, no new safety signals and a safety profile consistent with known information about the anti-TNF class.
authors.affiliation: Correspondence to Professor G R Burmester, Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany. gerd.burmester@charite.de
authors.forename: Gerd R
authors.initials: GR
authors.lastname: Burmester
authors.forename: Remo
authors.initials: R
authors.lastname: Panaccione
authors.forename: Kenneth B
authors.initials: KB
authors.lastname: Gordon
authors.forename: Melissa J
authors.initials: MJ
authors.lastname: McIlraith
authors.forename: Ana P M
authors.initials: AP
authors.lastname: Lacerda
mesh_terms: D000068879:Adalimumab; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001171:Arthritis, Juvenile / Q000188:drug therapy / Q000401:mortality; D015535:Arthritis, Psoriatic / Q000188:drug therapy / Q000401:mortality; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000401:mortality; D003424:Crohn Disease / Q000188:drug therapy / Q000401:mortality; D014943:Global Health; D006801:Humans; D011565:Psoriasis / Q000188:drug therapy / Q000401:mortality; D012216:Rheumatic Diseases / Q000188:drug therapy* / Q000401:mortality*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy / Q000401:mortality
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab