Abstract | OBJECTIVE: 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.
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Authors | C Botsios, P Sfriso, A Furlan, P Ostuni, M Biscaro, U Fiocco, S Todesco, L Punzi |
Journal | Reumatismo
(Reumatismo)
2007 Jan-Mar
Vol. 59
Issue 1
Pg. 32-7
ISSN: 0048-7449 [Print] Italy |
Vernacular Title | Anakinra, antagonista umano ricombinante del recettore dell'IL-1, nella pratica clinica. Outcome in 60 pazienti con artrite reumatoide severa. |
PMID | 17435840
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
- Antirheumatic Agents
- Interleukin 1 Receptor Antagonist Protein
- Isoxazoles
- Recombinant Proteins
- Leflunomide
- Methotrexate
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Topics |
- Aged
- Antirheumatic Agents
(administration & dosage, adverse effects, therapeutic use)
- Arthritis, Rheumatoid
(drug therapy)
- Drug Therapy, Combination
- Female
- Humans
- Interleukin 1 Receptor Antagonist Protein
(administration & dosage, adverse effects, therapeutic use)
- Isoxazoles
(therapeutic use)
- Leflunomide
- Male
- Methotrexate
(therapeutic use)
- Middle Aged
- Recombinant Proteins
(therapeutic use)
- Retrospective Studies
- Treatment Outcome
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