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Posted by on May 2, 2016 in Rheumatoid Arthritis | 7 comments

In a nutshell

This study evaluated the long-term safety of rituximab (Rituxan) in the treatment of rheumatoid arthritis (RA). Researchers reported that prolonged and repeated use of rituximab is safe and well-tolerated.

Some background

RA is a chronic autoimmune disease that leads to inflammation of the joints. Rituximab is an immune-modifying biological agent used in the treatment of severe RA. Rituximab has been demonstrated to improve symptoms and delay joint damage. It is often used in combination with methotrexate (Trexall) in patients not responding to other treatments. Some studies are suggesting that such immune-modifying agents may increase the risk of developing infections, heart disease and certain cancers. Rituximab is often used over the course of many years. It is therefore necessary to understand the potential risks associated with its long-term and repeated use. 

Methods & findings

The aim of this study was to examine the safety of rituximab in RA over the course of 11 years.

An analysis was conducted involving 11 separate trials and 3,595 patients. All patients had moderate to severe RA and received treatment with rituximab plus methotrexate. 1,246 of these patients were followed for more than 5 years. A further 818 patients received placebo (substance with no active effect on the body).

The rate of side effects and serious side effects was similar between rituximab and placebo. The relative number of observed side effects remained stable after the first 6 months of treatment, and did not change after 9.5 years of treatment. Dosage of rituximab did not influence the rate of side effects. Serious side effects of rituximab were infrequent. These included worsening of RA symptoms, pneumonia, osteoarthritis, and falls (all occurring in about 2% of cases). 7% of patients discontinued rituximab due to side effects.

There was no evidence of an increased rate of any type of fatal event associated with prolonged rituximab use. The rate of infections, heart disease and new cancers diagnosed also did not differ between patients treated with rituximab and the placebo group. The occurrence of these was comparable to those observed in the general population.

The bottom line

Researchers concluded that long-term use of rituximab is safe and well-tolerated among RA patients.

Published By :

The Journal of Rheumatology

Date :

Aug 15, 2015

Original Title :

Longterm Safety of Rituximab: Final Report of the Rheumatoid Arthritis Global Clinical Trial Program over 11 Years.

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