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Efficacy prolonged in RA patients re-treated with rituximab
Re-treatment with rituximab for patients with rheumatoid arthritis maintained or improved efficacy and inhibited progression joint damage over 5 years, according to study results.
In a 5-year post hoc analysis, researchers reviewed results of a multicenter, double-masked clinical trial conducted with patients with rheumatoid arthritis (RA) who had an inadequate response to one or more tumor necrosis factor inhibitors. Patients were randomly assigned to placebo (PBO) and methotrexate (MTX; PBO cohort) or rituximab (RTX) and MTX (RTX cohort), with the PBO cohort given RTX when appropriate.
Patients who responded to initial RTX treatments could receive additional RTX. The PBO cohort received new baseline data before initiating RTX, with that data combined with RTX cohort data. Efficacy outcomes were calculated 24 weeks after each course. Radiographic outcomes also were assessed.
At least one RTX treatment course was received by 480 patients (mean age, 52.5 years; 80.6% women), including 308 from the RTX cohort and 172 from the PBO cohort. Patients treated with subsequent RTX courses numbered 317 (≥2 courses), 259 (≥3 courses), 195 (≥4 courses) and 122 (≥5 courses).
Across 5 years, patients received up to 12 courses of RTX. American College of Rheumatology 20/50/70 responses measured at 24 weeks were 62%, 30.8% and 13%, respectively, for the first treatment course and 70.3%, 41.8% and 22% for the fifth treatment. European League Against Rheumatism responses were good/moderate for 77.2% of patients in course 1 and 84.4% in course 5. Adverse and serious adverse events and infection rates remained stable. Progressive joint damage (PJD) rate decreased in the PBO (n=79) and RTX (n=105) cohorts. PBO patients had a higher mean PJD change from baseline through 5 years (5.51) compared with the RTX group (3.21).
“RTX [is] an effective long-term treatment option in this refractory RA population,” the researchers concluded. “RTX repeat treatment was associated with clinical efficacy and radiographic benefit out to 5 years, and a safety profile comparable with published long-term safety data. A delay in the onset of RTX therapy may result in adverse radiographic outcomes.”
Disclosures: See the study for a full list of relevant disclosures.