title: [Anakinra, a recombinant human IL-1 receptor antagonist, in clinical practice. Outcome in 60 patients with severe rheumatoid arthritis].
abstract: OBJECTIVE
  We evaluated both the efficacy and safety of anakinra in daily routine rheumatoid arthritis clinical practice.
  
  
  METHODS
  We studied 60 cases, including patients with previous anti-TNFalpha exposure, treated with anakinra (100 mg/daily s.c.) in combination with methotrexate (7.5-10 mg/week i.m.) or leflunomide (20 mg/die) in a two year observational study. Efficacy measures were assessed using the American College of Rheumatology (ACR) response criteria. Safety was evaluated according to a modified World Health Organization adverse reaction term dictionary.
  
  
  RESULTS
  At week 14, ACR 20% response criteria have been fulfilled by 53 (91.3%) out of 58 patients, 51 (87.9%) of them achieving also an ACR 50%and 15 (25.8%) an ACR 70%response. Thirteen patients touched 102 weeks of treatment: ACR 20% response was achieved in 92.3%, while ACR 50% and ACR 70% were respectively found in 84.6% and 38.4% of the cases. The mean decrease in HAQ score was 0.38, p<0.001. Of the 16 patients who were previously treated with anti-TNFalpha blockers, 81.2% responded to anakinra. There was no significant difference in the ACR response between groups with and without previous anti-TNFalpha exposure. Seventeen patients (28.3%) stopped anakinra because of side-effects (5%) or failure to respond (23.3%). Only 4 cases of pulmonitis, of which 2 have been hospitalised, and 1 case with tuberculosis (previously treated with infliximab) were observed.
  
  
  CONCLUSIONS
  Our clinical experience confirms that anakinra is effective and safe in the treatment of rheumatoid arthritis. Anakinra seems also useful in patients with previous anti-TNFalpha blockers failures. Even though major adverse events were rare, clinicians should be aware of such a possibility.
authors: Cattedra e U.O.C. Reumatologia, Università-Azienda Ospedaliera di Padova, Italia. constantin.botsios@unipd.it
authors: C
authors: C
authors: Botsios
authors: P
authors: P
authors: Sfriso
authors: A
authors: A
authors: Furlan
authors: P
authors: P
authors: Ostuni
authors: M
authors: M
authors: Biscaro
authors: U
authors: U
authors: Fiocco
authors: S
authors: S
authors: Todesco
authors: L
authors: L
authors: Punzi
mesh_terms: D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053590:Interleukin 1 Receptor Antagonist Protein / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007555:Isoxazoles / Q000627:therapeutic use; D000077339:Leflunomide; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D053590:Interleukin 1 Receptor Antagonist Protein; D007555:Isoxazoles; D011994:Recombinant Proteins; D000077339:Leflunomide; D008727:Methotrexate