Background Infliximab is a chimeric anti-tumour necrosis factor α (anti-TNFα) monoclonal IgG1 antibody, neutralising the soluble cytokine and blocking the membrane bound cytokine that is used successfully for the treatment of active rheumatoid arthritis (RA) not controlled with other disease modified anti-rheumatic drugs (DMARDs).
Objectives The clinical evaluation of infliximab in the treatment of active RA.
Methods Twenty-four (24) patients (pts) with active RA (20 women and 4 men), mean age 46.4 ± 10.17 (years), and mean disease duration 9.9 ± 7.77 (years) received infliximab in a combination with Methotrexate 10 mg/week and Prednizolone 7.5–10 mg/day in an open unrandomized trial. Thirteen (13) pts completed three months therapy with infliximab and 11 pts six months. Infliximab was given at a dose of 3 mg/kg of body weight at week 0, 2 and 6 of treatment protocol and then every 8 weeks. All these pts had received combination therapy with DMARDs for more than three months, before enrolling in the study, without sufficient improvement. Active RA was defined by 10 or more swollen joints (10.9 ± 4.7), 12 or more tender joints (13.4 ± 5.11), ESR >28 mm (48.0 ± 19.23 mm) and C-reactive protein >5.0 mg/dl (37.4 ± 12.69 mg/dl). A statistical analysis was done after the third and sixth month of treatment.
Results At three months, the number of swollen joints was reduced to 3.3 ± 2.73 (p < 0.001) and the number of tender joints was, also, reduced to 4.1 ± 3.17 (p < 0.001), ESR was 29.0 ± 20.5 mm (p < 0.001) and CRP 18.6 ± 13.05 mg/dl (p < 0.001). At six months, statistically significant difference was not observed in any of the parameters of disease activity: swollen joints were 2.8 ± 2.01 (NS), tender joints 5.6 ± 4.3 (NS), ESR 24.6 ± 19.3 mm (NS) and CRP 15.4 ± 12.3 mg/dl (NS). Four female pts were excluded from the study and the statistical analysis: one patient because of unsufficient respond, another patient because of allergic reaction during the 5th infusion, and 2 pts because of uncontrolled urinary track infection after the 3rd infusion. All the pts declare dizziness, light headache, nausea, 2 pts reported abdominal pain after the first infusion and 2 pts increased hairing loss. One patient with alopecia areata universalis reported hair improvement but this result was only for a small period of time.
Conclusion The initiation of infliximab therapy in patients with active RA resulted in a fast and significant improvement of peripheral articular manifestations and quality of life. Even though major adverse events were not reported, the clinicians should be aware of this possibility.
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