Abstract

Background A number of studies show that neutralisation of tumour necrosis factor alpha (TNF-alpha), by using chimeric monoclonal anti-TNF alpha antibody (infliximab) for at least three months, improves the clinical outcome of rheumatoid arthritis. A combination therapy with a standard weekly dose of Methotrexate have been recommended to prevent the activation of autoimmune processes stimulated by the administration of infliximab. Objectives To evaluate the efficacy and safety of infliximab, when combined with methotrexate, in patients affected by chronic polyarthritis, refractory to other DMARDs. Methods An open study, including 30 patients affected by different kinds of chronic polyarthritis, is running. Methotrexate (5–15 mg/week) and infliximab (3 mg/kg intravenously at weeks 0, 2, 6, and then every 8th week) are administered to all the patients. Clinical evaluation (VAS for pain, VAS as a global assessment by patient and physician, swollen and painful joint count, HAQ score, morning stiffness) and laboratory tests (ESR and CRP), are simultaneously assessed. Results A marked improvement in clinical symptoms and signs and a reduction of ESR and CRP were seen after the first administration of infliximab. Morning stiffness, swollen and tender joints counts were remarkably reduced and HAQ score significantly improved. One patient experienced allergic reaction at the third infliximab infusion. A cutaneous capillaritis was observed in one patient. Only one patient did not respond to the therapy. Conclusion Our data show that, after 30 weeks of treatment, combination therapy with methotrexate and infliximab is a safe and efficient treatment for patients affected by chronic polyarthritis, not responding to other DMARDs. In most patients a remarkable improvement of clinical activity (VAS for pain, VAS as a global assessment by patient and physician, swollen and painful joint count, HAQ score, morning stiffness) and laboratory tests (ESR, CRP) have been observed. The updated data will be presented. References Elliott MJ, Maini RN, et al. Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis. Lancet 1994;344(8930):1105–10 Kavanaugh A, St Clair EW, et al. Chimeric anti-tumor necrosis factor-alpha monoclonal antibody treatment of patients with rheumatoid arthritis receiving methotrexate therapy. J Rheumatol. 2000;27(4):841–50 Lipsky PE, van der Heijde DM, et al. Infliximab and Methotrexate in the Treatment of Rheumatoid Arthritis. N Engl J Med. 2000;343(22):1594–602

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