THE RUSSIAN REGISTRY OF RITUXIMAB. ANALYSIS OF THE EFFICIENCY OF THERAPY AND THE FUNCTIONAL STATEOF PATIENTS WITH RHEUMATOID ARTHRITIS

Abstract

Objective: To evaluate the functional status of patients with rheumatoid arthritis (RA) receiving two courses of rituximab (RTМ) therapy and its efficiency from the Russian registrys data. Subjects and methods. The analysis covered 269 patients receiving 1 or 2 courses of RT therapy, their clinical follow-up schedules and quality of life (QL) questionnaires were filled in before drug administration and at 8, 16, and 24 weeks of a follow-up: 220 and 49 patients received 1 and 2 courses of RT therapy, respectively. The DAS28 index was used to evaluate disease activity; the patients functional status was assessed according to the Health Assessment Questionnaire (HAQ). Results. The patients' mean age was 46.5311.79 years; the disease duration was 9.806.87 years; disease activity scale (DAS28) scores were 6.501.06; the majority of patients had significant functional disorders estimated at 1.90 [1.37-2.38] scores according to the HAQ; 78% patients had extra-articular manifestations; rheumatoid factor was detected in 82.9%; the patients received more than 2 basic antiinflammatory drugs on average; 33.5% took TNF-р inhibitors. After the first course of therapy at 24 weeks of the follow-up, there was a gradual decline in DAS28 from 6.491.05 to 4.091.32 scores (p < 0.000001, ANOVA). A significant reduction in serum C-reactive protein was achieved during the first course of therapy just at 2 weeks of the follow-up. A decrease in DAS28 to і1.2 was seen in 79.9 of the patients after the first course at 24 weeks of the follow-up and in 85.7% after the second course. 13% of patients achieved drug-induced remission (DAS28 <2.6) at 24 weeks of the follow-up after the first course of RT therapy; the proportion of remission patients increased up to 14.3% after the second course. Median HAQ index decreased by 0.52, 0.77, and 0.78 scores at 8, 16, and 24 weeks of follow-up, respectively; 15% of the patients had population-based functional status values at 24 follow-up weeks. Logistic regression analysis indicated that the previous use of TNF-ƒ inhibitors was a predictor of the response to RT therapy during the first course; odds ratio (OR) = 2.27 [1.07-4.80]. Conclusion. RTМ therapy substantially improved functional capacities in patients with RA. Previous therapy with TNF-ƒ inhibitors had no negative impact on the results of treatment.