Infliximab-related adverse events in patients with rheumatoid arthritis

Author(s): Eugenia Aronova

Objective: To assess the tolerance of infliximab (INF) in patients with rheumatoid arthritis (RA).

Material and methods: The annual study included 135 patients (114 women) with active RA. 105 patients received methotrexate (MT) 7.5-25 mg/week, 23 patients received other DMARDs. To seven patients INF was prescribed without associated DMARDs. 22.2% of patients dropped out of the study due to inefficiency of INF.

Results: Adverse events (AE) were reported in 28.1% of patients. Infusion reactions were often observed (15 patients, 11.1% of cases). AE that did not require cancellation of the drug were reported in 4 patients (2.9%). In 19 patients (14.1%) there were serious AE that required the cancellation of INF, and in one case the death of the patient was recorded for a reason unrelated to the treatment of INF. Among the serious AE, allergic and anaphylactoid reactions (in 8 patients) were most frequent. Another most frequent occurrence were serious infections, observed in 7 patients (5.2%). In two patients (1.5%) we observed cardiological symptoms (flickering arrhythmia after the first infusion and heart pain without signs of pathology on ECG, also occurring after the first infusion). In two cases (1.5%), the cancellation of INF was associated with skin lesion. A significantly higher percentage of AE was observed on combined therapy of leflunomide and INF (37.5%), both in comparison with the group receiving the combination of methotrexate and INF and with the group of monotherapy of INF. There were no significant differences in the incidence of AE between the INF monotherapy groups and the combination therapy (INF+ methotrexate).

Conclusion: INF is safe for use in actual clinical practice, but patients should be informed of the risks of AE and the need to be examined by a rheumatologist before each infusion