title: Concomitant medication use in a large, international, multicenter, placebo controlled trial of anakinra, a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis.
abstract: OBJECTIVE
  To examine the safety of anakinra when added to a background of standard rheumatoid arthritis (RA) medications in patients with RA with active disease.
  
  
  METHODS
  This analysis further evaluates data from the first 6 months of a blinded, placebo controlled safety trial that had a subsequent 30 month, open label portion (not reported here). Patients with RA with a wide range of comorbid conditions, disease activity, and background medications were randomly assigned in a 4:1 allocation ratio to treatment with anakinra 100 mg or placebo administered daily by injection. Safety was assessed by comparing adverse event profiles between anakinra and placebo patients according to concomitant medications received.
  
  
  RESULTS
  Anakinra patients (n = 1116) showed no difference in the incidence of upper respiratory infections or overall serious adverse events compared with placebo patients (n = 283). The anakinra group had more injection site reactions (72.6% vs 32.9% in placebo) and a small increase in serious infections (2.1% vs 0.4% in placebo). Anakinra's safety profile did not differ in patients receiving antihypertensive, antidiabetic, or statin drugs.
  
  
  CONCLUSIONS
  This study indicates that anakinra has a good safety profile in patients typically seen in a rheumatology practice who are considered candidates for therapy with agents that are immunomodulatory and disease modifying. Except for injection site reactions and a nonstatistically although potentially clinically significant increase in serious infections in the anakinra versus the placebo groups, the addition of anakinra to a stable background regimen of RA medications introduced no other important safety risk in patients with RA.
authors.affiliation: University of Arizona Health Sciences Center, Arizona Rheumatology Center, Phoenix, Arizona 85015-2160, USA. johntesser@radiantresearch.com
authors.forename: John
authors.initials: J
authors.lastname: Tesser
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.forename: Robin
authors.initials: R
authors.lastname: Dore
authors.forename: Ralph
authors.initials: R
authors.lastname: Bennett
authors.forename: Alan
authors.initials: A
authors.lastname: Solinger
authors.forename: Tenshang
authors.initials: T
authors.lastname: Joh
authors.forename: Dennis
authors.initials: D
authors.lastname: Modafferi
authors.forename: Joy
authors.initials: J
authors.lastname: Schechtman
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D015897:Comorbidity; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053590:Interleukin 1 Receptor Antagonist Protein; D007596:Joints / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D017472:Receptors, Interleukin-1 / Q000037:antagonists & inhibitors*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D012720:Severity of Illness Index; D012795:Sialoglycoproteins / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; C507763:IL1RN protein, human; D053590:Interleukin 1 Receptor Antagonist Protein; D017472:Receptors, Interleukin-1; D011994:Recombinant Proteins; D012795:Sialoglycoproteins