Background/Purpose: Rituximab (RTX) has been evaluated in many clinical trials and objective assessment of rheumatoid arthritis (RA) activity must comply with Treat to Target principles. Little is known about the relationship between objective clinical outcomes and self-reported health status in RA patients treated with repeated courses of biologics over extended periods of time.

We wanted to compare evolution of clinical outcome measures and self-perceived health status in patients with severe active RA treated with multiple courses of RTX in Romania.

Methods: In this open-label, multicentre, prospective observational study, patients were treated with initial (2×1000 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 and tested with unpaired t-tests and Pearson correlation coefficients R². 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 study, 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 scores steadily decreased after each retreatment:

Evaluation	DAS-28	VAS
1st (baseline)	5.67	50
2nd (6 months)	3.87	20
3rd (12 months)	3.38	12
4th (18 months)	2.96	10
5th (24 months)	2.80	10

Sustained, statistically significant delta DAS-28 changes (p<0.00001, p<0.0005 and p<0.0128) and delta VAS changes (p<0.00001, p<0.0026 and p<0.0005) were found at 12, 18 and 24 months, respectively. Linear regression analysis showed DAS-28 and VAS scores significantly correlated in all evaluations, with R²Pearson correlation coefficients of 0.7291, 0.5651 (n=877), 0.3951 (n=580), 0.3169 (n=302), and 0.2754 (n=112), at baseline, 6, 12, 18, and 24 months, respectively (p<0.0001 in all). Taken together, our results indicate that VAS score can have predictive value for clinical outcome.

Conclusion: 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, even in patients with a long history of inadequate response to TNF inhibitors. 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.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/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-inh/