Therapy ofActive Rheumatoid Arthritis with Infliximab Combined with Methotrexate. Results of a One-yearopen Trial

Overview

Objective:
The authors investigated the effect of therapy with infliximab combined with methothrexate(MTX) in patients with rheumatoid arthritis (RA). They evaluated the effectiveness of treatmentand the incidence of undesirable effects. Method: In the trial 37 patients were enrolled with aninadequate effect of hitherto applied MTX therapy. Infliximab was administered by the i.v. route, 3mg/kg as follows: week 0-2-6, and subsequently every 8 weeks combined with oral MTX. Selectedparameters were evaluated: the mean corticosteroid and MTX dose at the onset and at the end oftreatment, the drop of NSA consumption, morning stiffness at the onset and at the end of therapy,the rate of onset of the therapeutic effect, evaluation of the therapeutic effect by the patient anddoctor according to Likert’s scale, changes of ESR and CRP, incidence of side effects and prematuretermination of treatment. Evaluation of the investigated parameters was made at the onset and atthe end of treatment with infliximab, laboratory parameters were evaluated after each administrationof the drug. Results: After treatment a significant decline of the daily corticosteroid dose wasrecorded, reduction of the consumption of non-steroidal antirheumatics, a statistically significantreduction of the duration of morning stiffness and decline of the erythrocyte sedimentation rateand the CRP value (p < 0.001). The mean MTX dose did not change significantly. A positive effect oftreatment was recorded in 97% patients, incl. an excellent and very good effect in 83% (evaluated byphysician), and in 75% resp. (evaluated by patients). Side effects occurred in 14 patients (37.8%) incl.4 cases (10.8%) with a medium severity allergic reaction, in 5 patients (13.5%) with an infection ofthe upper airways and in one case each with a urinary infection, bronchopneumonia, skin exanthema,chills and lympadenopathy. Therapy was terminated prematurely in 7 patients (18.9%) incl. 6 onaccount of side effects (16.2%). Conclusion: The investigation confirmed the favourable effect oftreatment with infliximab combined with MTX in patients with active RA. Side effects of treatmentincluded in particular uncomplicated infections and allergic reactions, other side effects wereminimal. There was no case of tuberculosis.

Key words:
rheumatoid arthritis, therapy, infliximab, methotrexate, side effects