Article Text

THU0116 Safety and efficacy of courses of rituximab in patients with rheumatoid arthritis - ritam study
  1. N.S. Damjanov1,
  2. D. Stefanovic2,
  3. A. Dimic3,
  4. T. Ilic4,
  5. M. Lazarevic5
  1. 1Head Office, School of Medicine-Institute of Rheumatology
  2. 2Clinical of Rheumatology, Military Academy, Belgrade
  3. 3Head Office, Institute of Rheumatology, Niska Banja
  4. 4Clinical of Nephrology, Clinical centre
  5. 5Head Office, Special hospital for rheumatic diseases, Novi Sad, Serbia


Background Rituximab (RTX) is monoclonal antibody that selectively targets CD20+ B cells. The combination of RTX with MTX significantly improves disease symptoms in rheumathodi arthritis (RA) patients who have had an inadequate response to conventional DMARD therapy, and has been shown to improve quality of life in those patients. This is the only study that assessed efficacy and safety of RTX in daily practice in Serbia

Objectives To determine the safety and efficacy of additional courses of RTX in patients with RA.

Methods This is interim analysis of prospective noninterventional trial that enrolled 130 RA patients with inadequate response to previous biologic and/or synthetic DMARDs treated with RTX (age 50.37±11.59 years; 85.3% females and 14.7% males; disease duration 8.4±6.5 years). Patients were eligible for additional RTX courses (2 infusions of 1,000 mg given 2 weeks apart) if they exhibited disease reactivation measeured by DAS28. Efficacy was assessed by DAS28 (number of tender and swollen joints, VAS-GH, sedimentation) and the disability index of the Health Assessment Questionnaire at baseline and 24 weeks after first, second and third course. Safety was assessed by the number and severity of registered adverse events (AE).

Results 114 patients received >1 course of RTX (58 received 2 courses and 10 received 3 courses). Mean DAS28 scores decreased significantly from 6.41±0.97 at baseline to 4.91±1.65/4.33±1.23 and 3.86±1.43, 24 weeks after first/second/third RTX courses; p<0.001. The proportions of patients with low disease activity (DAS28<3.2) and in remission (DAS28<2.6), increased following third RTX course (4.3% and 17.4%) compared to baseline. Proportion of patients with moderate disease activity (DAS28, 3.2-5.1) increased after 3 RTX course from 7.8% to 60.9%. Total HAD-DI score, before and after third RTX course was 2,25 (1,19) and 1,37 (1,78), respectively; p<0,004. During the first/second/third courses AE were reported in 8/2/1 patients. No SAEs were reported.

Conclusions During 3 courses of treatment, rituximab showed significant decrease of DAS28 and and increased quality of life measured by HAQ-DI questionnaire after each following rituximab course.

Disclosure of Interest None Declared

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