The findings of a pooled analysis of long term safety data from patients with rheumatoid arthritis (RA) treated with rituximab in combination with methotrexate in a global clinical trial programme have been published in the Journal of Rheumatology.

The analysis involved 2578 patients who received at least 1 course of rituximab and were based on 5013 patient-years of rituximab exposure. This found the following:

• The most frequent adverse event (AE) was infusion-related reactions (25% of patients during the first infusion of course 1).

• Less than 1% of infusion-related reactions were considered serious.

• Rates of AE (359.6 events per 100 pt-yrs) and serious AE (SAE; 17.85 events/100 patient-yrs) were stable following each course.

• The overall serious infection rate was 4.31/100 patient-years.

• Infections and serious infections over time remained stable across 5 courses at 4 to 6 events/100 patient-years.

• Compared with other patients with RA and with the general US population, there was no increased risk of malignancy.

The researchers conclude “in patients with RA treated with rituximab, the long term safety profile in selected clinical trial populations was consistent with observations from placebo-controlled clinical trials. Over 5 courses of rituximab treatment, serious adverse events, including serious infection and infusion reactions, did not increase over time.”