In a nutshell
This study evaluated the long-term safety of rituximab (Rituxan) in the treatment of rheumatoid arthritis.
Some background
Rheumatoid arthritis (RA) is known to be associated with an increased risk of serious infections, heart attacks and the development of certain cancers. It has been further suggested that the immune-modifying biological agents used in the treatment of RA may further increase these risks. Therefore, continuous monitoring of the long-term safety of patients receiving biological therapies is crucial.
Rituximab is an immune modifying agent who has been demonstrated to improve the symptoms of RA and delay joint damage when used in combination with methotrexate. Although previous studies have demonstrated that the overall rates of adverse events, including serious infections, were similar to those observed among patients treated with methotrexate alone, data regarding the long-term safety of rituximab treatment is limited.
Methods & findings
A pooled analysis was conducted including 10 trials and 3194 RA patients treated with rituximab plus methotrexate and followed for up to 19.5 years.
The majority of adverse effects occurred during the first infusion of the first course of rituximab, were reported in 734 of the 3194 (23.0%) patients treated, and were classified as mild to moderate. Serious infusion related adverse events, such as allergic reactions, were rare and occurred in only 17 (0.5%) patients.
The most commonly observed adverse effects were exacerbation of arthritis, occurring in 76 patients, and lung infections occurring in 59 patients. The rate of reported adverse effects remained stable after the first 6 months following the first treatment, irrespective of the number of rituximab courses received. Withdrawal from treatment due to adverse events was infrequent and occurred in 190 (6%) of patients treated. When compared to a group of patients treated with methotrexate alone, the rate of adverse effects, as well as withdraw from treatment rates, were not found to be increased among patients receiving rituximab. The rate of heart attacks, strokes and new cancers diagnosed also did not differ between patients treated with rituximab and those treated with methotrexate alone.
The bottom line
This study concluded that rituximab therapy is associated with a high long-term safety profile when employed in the treatment of rheumatoid arthritis.
The fine print
The study was funded by Hoffmann-La Roche, the marketers of rituximab in Canada.
Published By :
Annals of the rheumatic diseases
Date :
Sep 01, 2013
