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