Background Anti-tumour necrosis factor-alpha; (TNF-alpha) antibody has been recently introduced for the treatment of Rheumatoid Arthritis (RA).
Objectives To evaluate the efficacy of anti-tumour necrosis factor-alpha (TNF-alpha) antibody associated with low-dose methotrexate (MTX) on disease activity, disability and quality of life in a group of RA patients non responder to traditional DMARDs.
Methods Forty-five non responder patients (42 F, 3 M; age 52 ± 11.7) with long-standing refractory active (DAS28 >4) rheumatoid arthritis (disease duration 15.5 ± 8.8 years) were included in an open study. Before entry most of the patients were on a combination DMARDs regimen. Patients were treated with slow i.v. infusions (at day 0, 15, 45 and then every 45 days) with monoclonal anti-TNF-alpha antibody (Infliximab, 3 mg/Kg) associated with low-dose weekly MTX (median dose 13 mg). Symptomatic treatment was stable during the observation. At every control the following parameters were evaluated: number of tender and swollen joints, pain VAS, General Health assessment VAS (GH VAS), ESR, CRP, haemoglobin level, DAS index, Health Assessment Questionnaire (HAQ), Short Form 36 (SF-36). Until now 37 patients completed a 6 months (6 infusions) whereas 11 patients completed a 12 months (10 infusions) course of treatment.
Results After 45 days a statistically significant improvement of all the parameters with the exception of CRP and haemoglobin level was observed. The long-term observation, up to month 6 (37 pts) and month 12 (11 pts), showed a statistically significant decrease of DAS, number of tender joints and pain VAS. The same statistically significant trend was observed also for parameters related to quality of life. The infusion was generally well tolerated. Major side effects leading to drug withdrawal were registered in 6 patients (hiperpyrexia in 2 patients, allergic reactions in 3 patients and pulmonary tuberculosis in 1 patient).
Conclusion Monoclonal anti-TNF-alpha antibody in association with MTX induced a prompt and long-lasting (at least one year) symptomatic response with a significant decrease of disease activity and disability and an improvement of quality of life in a series of patients with rheumatoid arthritis refractory to traditional DMARDs.
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