Article Text

FRI0240 Correlation between objective and patient self-reported clinical improvement after multiple courses of rituximab in rheumatoid arthritis patients with inadequate response to tumour necrosis factor inhibitors: data from repeat study
  1. I. Ancuta1,
  2. C. Codreanu2,
  3. R. Ionescu3,
  4. D. Nemes4,
  5. R. Chirieac5,
  6. C. Paulina6,
  7. M. Suta7,
  8. A. Balanescu3,
  9. E. Mociran8,
  10. E. Rezus9,
  11. REPEAT Study Investigators Group
  1. 1Rheumatology, “Dr. I. Cantacuzino” Hospital
  2. 2Rheumatology, “Dr. I. Stoia” Center for Rheumatic Diseases
  3. 3Rheumatology, “Sfanta Maria” Clinical Hospital, Bucharest
  4. 4Rheumatology, Municipal Emergency Hospital, Timisoara
  5. 5Rheumatology, C.M.I. Rodica Chirieac, Iasi
  6. 6Rheumatology, Emergency County Hospital, Craiova
  7. 7Rheumatology, Clinical Emergency County Hospital, Constanta
  8. 8Rheumatology, Emergency County Hospital, Baia Mare
  9. 9Rheumatology, Recovering Clinical Hospital, Iasi, Romania


Background Rituximab (RTX) has been evaluated in many clinical trials and self-reporting instruments have been used in conjunction with objective measurements. Little is known about the relationship between objective and self-reported outcomes in RA patients treated with repeated courses of biologics over extended periods of time

Objectives To investigate and compare the evolution of clinical outcome measures and self-perceived health status in patients with severe active RA treated with multiple courses of RTX in routine clinical practice setting in Romania.

Methods In this open-label, multicentre, prospective observational study, patients were treated with initial (2x1000 mg IV, at 2 weeks apart) and subsequent RTX courses. Clinical assessments including 28-joint disease activity score (DAS-28) were performed at baseline (before treatment initiation), and after each retreatment course at 6, 12, 18 and 24 months. A visual analogue scale (VAS; 0=best, 100=worst) allowed patients to report health status at each clinical assessment. Delta DAS-28 and delta VAS were calculated as difference between values found at two consecutive evaluations. Linear regression models were estimated at baseline, 6, 12, 18, and 24 months with the DAS-28 as the outcome variable and the VAS as a predictor. Statistical analyses were performed with STATA SE 11.0 software.

Results A total of 943 adult (>18 years) patients with active RA and inadequate response to at least one TNF inhibitor received initial RTX treatment. In our cohort, 805 (85.37%) patients had only one anti-TNF treatment and 138 (14.63%) had more than one, with a median duration of anti-TNF treatment of 21 and 47 months, respectively. Median DAS-28 and VAS self-reported scores steadily decreased after each retreatment:

Conclusions We found strong correlation between objective clinical outcomes and self-reported health status, with clinical response maintained or improved after each fixed interval retreatment with Rituximab. Major improvements occurred early in our study, at 6 months, and were appreciated by patients. This synergy is important for doctor-patient relationship, increased patient confidence and treatment compliance, key factors for a successful therapy.

Disclosure of Interest: None Declared

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