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Rituximab safely treated RA patients in long-term follow-up
Prolonged treatment with rituximab was well tolerated with no increased safety risk or adverse events for patients with rheumatoid arthritis, according to study results.
Roy M. Fleischmann, MD, clinical professor in the internal medicine department at the University of Texas Southwestern Medical School, and colleagues conducted a case analysis of data from patients with moderate to severe rheumatoid arthritis (RA) who received rituximab in a global clinical trial program.
Roy M. Fleischmann
There were 3,194 patients (mean age, 51.5 years; 80.8% women) who had been treated with a maximum of 17 courses of rituximab plus methotrexate (MTX) for up to 9.5 years (all exposure patients; 11,962 patient-years) through September 2011. Six hundred twenty-seven of those patients had more than 5 years of follow-up. A pooled placebo group (n=818 patients; mean age, 51 years; 80.4% women) included all patients who received placebo plus MTX and patients who initially received placebo but were switched to rituximab.
During multiple course treatments, serious adverse event and infection rates were generally stable. The all exposure patients had an overall serious infection event (SIE) rate of 3.94 per 100 patient-years (3.26 per 100 patient-years for patients observed more than 5 years), compared with 3.79 per 100 patient-years in the placebo/MTX cohort.
Serious opportunistic infections were rare among patients. “Overall, 22.4% of rituximab-treated patients developed low immunoglobulin (Ig)M and 3.5% low IgG levels for [at least] 4 months after [at least] 1 course,” the researchers reported.
Before and during or after development of Ig levels, SIE rates were similar. Myocardial infarction and stroke rates were consistent with rates among RA patients in the general population, and malignancy risks remained stable over time.
“Rituximab remains generally well tolerated over time and multiple courses,” the researchers concluded. “Overall, the findings indicate there was no evidence of an increased safety risk or increased reporting rates of any types of adverse events … during the 9.5 years of observation.”
Disclosure: See the study for a full list of relevant financial disclosures.