AB0226 EVALUATION OF RITUXIMAB EFFICACY WITH VARIOUS COMPOSITE MEASURES OF INFLAMMATORY ACTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS

Abstract

Background:Disease modifying anti-rheumatic drugs (DMARD) can provide an unbalanced effect on individual components of the inflammatory process, which in some cases leads to an insufficiently correct assessment of the patient’s status when using composite activity indices [1].Objectives:To compare the results of the rituximab (RTX) efficacy assessment in patients with rheumatoid arthritis (RA) using different composite indices of disease activity.Methods:Patients with active RA observed in 23 medical centers of the Russian Federation were included. They were randomized into 2 groups in a 2:1 ratio. In the main group methotrexate (MTX) was prescribed at 15 mg per week and RTX infusions 600 mg on days 1 and 15. Patients in the control group received MTX 15 mg per week and placebo on days 1 and 15. If after 15 weeks 20% reduction of tender joint count (TJC) and swollen joint count (SJC) was not achieved, another DMARD was prescribed.Results:159 RA patients (131 women and 18 men) were included. The mean age of patients was 51.4±11.8 years, the median duration of RA – 2.8 [0.6; 5.8] years. At baseline DAS28, SDAI and CDAI in all cases assessed disease activity as high. 6 months after RTX administration DAS28 showed remission in 9%, low, moderate and high activity activity in 7%, 47% and 37% of cases, SDAI – in 7%, 12%, 34% and 47%, CDAI – in 7%, 11%, 30% and 52%, respectively. In the control group remission, low, moderate and high activity by DAS28 were revealed in 2%, 2%, 38% and 58%, by SDAI – in 2%, 4%, 35%, 59%, by CDAI – in 2%, 6%, 29%, 63% of patients respectively. After 6 months, in patients achieved the treatment target (remission or low activity) according to DAS28, SJC in 12 cases was 0, in 3 – 1 and in 1 – 2. TJC was 0 in 9 cases and in 7 patients ranged from 1 to 14. The level of C-reactive protein (CRP) in 14 cases was within the normal range and in 2 – increased. Erythrocyte sedimentation rate (ESR) was normal in all cases. SDAI after 6 months showed the target activity in 18 patients treated with RTX. In 12 of them the SJC was 0, in 4 – 1 and in 2 – 2. In 9 cases TJC was 0, in the rest patients it varied from 2 to 5. The level of CRP was normal in 15 patients, ESR – in all patients. CDAI met the target activity in 17 patients. In 12 of them, SJC was 0, in 3 – 1, in 2 – 2. The level of CRP was normal in 14, ESR – in all patients.Conclusion:Assessment of RTX efficacy with DAS28, SDAI, and CDAI in RA provided comparable number of patients who achieved remission or low disease activity 6 months after administration of the drug. The groups of patients who reached this target level of activity by DAS28, SDAI, and CDAI did not have significant differences in the values of main measures characterizing residual inflammatory activity, including SJC, TJC, ESR, and CRP.