Rituximab therapy in patients with resistant rheumatoid arthritis: real-life experience.

OBJECTIVES: Rituximab has recently been shown to be effective in suppressing disease activity in patients with rheumatoid arthritis (RA) who fail anti-TNF therapy. We present our experience of treating patients with long-standing, multi-DMARD and anti-TNF resistant RA with rituximab in 'real-life' setting.

METHODS: Patients with RA resistant to more than two anti-TNF drugs and with persistent disease activity (DAS28 > 5.1) were considered for treatment with rituximab (two infusions 1000 mg each, a fortnight apart). DAS28 and HAQ scores were performed at baseline, 3 and 6 months post-treatment. Response to rituximab was defined as per the EULAR response criteria. Re-treatment with a second cycle of rituximab was offered if they had responded to the earlier one but flared.

RESULTS: Twenty patients received rituximab. Median disease duration was 16 yrs (range 5-39) and 90% were rheumatoid factor positive. Median number of biologics received pre-treatment was two (range 2-4). Rituximab treatment led to a significant reduction in DAS28 score (P < 0.0001) at 3 months and various other disease parameters. The benefit was sustained at 6 months. Moderate-to-good EULAR response was seen in 85% of patients at 3 months and 60% at 6 months. No significant side effects were observed. 50% of the patients flared and received re-treatment. Interval to re-treatment varied from 6 to 18 months. The majority of the RA patients responded to re-treatment with rituximab and no major side effects were observed.

CONCLUSION: Rituximab was effective in controlling disease activity in anti-TNF therapy resistant RA patients in 'real-life' setting. Rituximab was safe with no major side effects. Re-treatment with rituximab was safe and efficacy was maintained.