BRIGHTON, England -- Treatment with rituximab (Rituxan) in real-world clinical settings was effective for many patients with rheumatoid arthritis, even those who had no benefit from other biologic drugs, the largest observational study to date found.
Among a cohort of 550 patients enrolled in the British Society for Rheumatology Biologics Register, 16% had a good response to the drug at six months, 43% had a moderate response, and 8% were in remission, according to European League Against Rheumatism (EULAR) criteria, according to Moetaza M. Soliman, a PhD student at the University of Manchester in England, and colleagues.
Better results were seen among patients who had not previously received a tumor necrosis factor (TNF) inhibitor, with disease activity scores falling by 1.7 points, compared with a 1.3-point drop in patients who had failed one of the TNF inhibitors (P=0.05), Soliman reported in an oral presentation here at the British Society for Rheumatology meeting.
Rituximab has demonstrated efficacy in rheumatoid arthritis in randomized trials that enrolled specific and often limited populations, such as patients who had not responded to methotrexate or anti-TNF drugs, and in specific regimens such as in combination with disease-modifying drugs or as monotherapy.
Currently, rituximab is recommended for patients who have failed anti-TNF therapy, and in combination with methotrexate.
However, Soliman explained, the use of rituximab in the clinic must take into account the fact that methotrexate and anti-TNF therapy are contraindicated in some patients, so alternative approaches are needed.
To see if the efficacy demonstrated in clinical trials translated to real-world clinical use, with mixed patient populations and variable symptomatology and therapeutic histories, the investigators followed their registry patients beginning with enrollment and following them for at least six months after a first course of rituximab treatment.
Patients' mean age was 60, mean disease duration was 15 years, and the majority were women.
A total of 85% had previously received anti-TNF treatment and had either not responded or had stopped treatment because of adverse effects.
Two-thirds were seropositive, with detectable rheumatoid factor.
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