Background/Purpose: Patients with rheumatoid arthritis (RA) experience diminished quality of life and increased disability. Patient-reported outcomes (PROs) are important measures of response to therapy in patients with RA. The objective of this study was to examine the impact of rituximab on PROs in a US observational cohort of patients with RA.

Methods: Between March 1, 2006, and September 1, 2015, patients with RA who had prior exposure to ≥ 1 tumor necrosis factor inhibitor (TNFi) and newly initiated rituximab while not in remission (Clinical Disease Activity Index [CDAI] > 2.8) with a follow-up visit at 1 year (± 3 months) were identified. Changes in PROs, assessed 1 year from baseline and stratified by prior TNFi use, included patient global assessment (PtGA) of disease, pain and fatigue (visual analog score; 0-100); morning stiffness (hours); modified Health Assessment Questionnaire (mHAQ; 0-3) and Euro QoL 5 dimensions questionnaire (EQ-5D). Improvement in EQ-5D domains was defined as patients reporting improvement or resolution of impairment among those who reported impairment at baseline. Outcomes between the 1 and ≥ 2 prior TNFi groups were compared using χ² or t-tests, as appropriate; only statistically significant differences were noted.

Results: Of the > 40,000 patients in the Corrona RA registry, 667 patients met the study inclusion criteria; 284 (43%) had received 1 prior TNFi and 383 (57%) had received ≥ 2 prior TNFis. Overall, 79% of patients persisted on rituximab through 1 year, 80% of whom received retreatment. The median (IQR) age was 59 (50-66) years; 79% were female. Baseline mean (SD) CDAI was 25.6 (13.9; high disease activity = CDAI > 22). At baseline, patients were substantially impaired by their disease: patients reported median (IQR) PtGA, pain, fatigue and mHAQ scores of 50 (35-73), 60 (31-75), 65 (40-80) and 1 (0.6-1.6), respectively, and a median (IQR) of 1 (0.5-2) hour of morning stiffness. Baseline PROs were mostly similar between the 1 and ≥ 2 prior TNFi groups, although patients with 1 prior TNFi tended to have longer duration of morning stiffness and higher fatigue scores. At 1 year, improvements were reported in all PROs with no significant difference between patients with 1 or ≥ 2 prior TNFis. Overall median (IQR) improvements (baseline value minus the 1-year value) in PtGA, pain and fatigue were 7 (−10 to 25), 7 (−5 to 25) and 9 (−5 to 20), respectively. Improvement in EQ-5D categories is shown (Figure). 51.7% of patients reported no improvement in morning stiffness, 28.5% reported improvement of 1-60 minutes and 19.8% reported improvement of > 60 minutes.

Conclusion: Real-world data showed that quality of life in this cohort of patients with long-standing, refractory RA and prior TNFi exposure was substantially impacted by the disease. One year after initiation of rituximab, improvements were reported in all PROs, such as self-care and usual activities, and were similar between patients with exposure to 1 or ≥ 2 prior TNFis.