Session Type: Abstract Submissions (ACR)
Background/Purpose: Rituximab (RTX) in combination with methotrexate is used for the treatment of adult RA with an inadequate response to TNF antagonists. We aimed to describe the real-world use and effectiveness of RTX in a large cohort of patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) registry.
Methods: All patients with RTX initiations in CORRONA between Feb 2006 and May 2011, with available clinical disease activity index (CDAI) score at baseline and at 12-months and not in remission (CDAI ≤2.8) at the time of RTX initiation, were included. Demographic and disease characteristics at baseline; change in CDAI at 12 months (overall and based on number of prior TNFs); and reported safety events were summarized.
Results: Overall, 615 patients (mean 2.3 previous non-biologic disease-modifying anti-rheumatic drugs [DMARDs] and 2.2 prior biologic DMARDS) initiated RTX. Lack of efficacy was most commonly (65%) reported reason for discontinuing prior biologic. Of these, 265 patients (80% female; median age 57 years; median disease duration 13 years) met the inclusion criteria. Approximately 43% of the patients had received 1 prior TNF and 57% had ≥2 prior TNFs. Approximately 77% patients started RTX in combination with DMARDs and 42% with concomitant prednisone. Mean change in CDAI was -8.1 (95% CI: -9.8; -6.4) for all RTX initiators not in remission, with similar results when stratified by number of prior TNFs. Among the subset of patients with active disease (moderate/high disease activity; CDAI >10) at baseline (Table), 8% went into remission and 29% achieved low disease activity (LDA). The mean change in CDAI in these patients was -10.3 (95% CI: -12.3; -8.4) with similar results when stratified by 1 or ≥2 prior TNFs. However, more patients with 1 prior TNF went into remission or achieved LDA versus patients with ≥2 prior TNFs. Patients with 1 prior TNF were more likely to achieve remission or LDA (unadjusted odds ratio 0.40 [95% CI: 0.22; 0.73]). Among patients who started RTX with concomitant prednisone, 43% decreased and 26% had no change in their prednisone dose at 12 months. Reported rates of all cardiovascular events, serious infections, and malignancies were 1.9 (95% CI: 0.6; 4.0), 1.6 (95% CI: 0.5; 4.9), and 1.5 (95% CI: 0.6; 4.0) per 100 person-years, respectively.
|CDAI at 12-months||All RTX initiators
|IR to 1 prior TNF
|IR to ≥2 prior TNFs
|Remission (CDAI ≤2.8)
|18 (8.3)||9 (10.3)||9 (6.9)|
|Low disease activity (2.8
||64 (29.4)||35 (40.2)||29 (22.1)|
|Mean change in CDAI (95% CI)||-10.3 (-12.2; -8.4)||-10.1 (-13.2; -7.0)||-10.5 (-12.9; -8.0)|
Conclusion: RTX appeared effective in usual care in patients with previous exposure to one or more prior TNFs, with a safety profile comparable to randomized controlled trials of RTX. More patients with 1 prior TNF versus ≥2 prior TNFs appeared to achieve improvement in disease activity at 12 months after initiating RTX. The magnitude of response in CDAI seemed to be similar regardless of number of prior TNFs, even with ≥2 prior TNFs, suggesting good response in more refractory RA patients.
CDAI = clinical disease activity index; CI = confidence interval; TNF = tumor necrosis factor-α antagonist.
L. R. Harrold,
G. W. Reed,
University of Massachusetts Medical School,
Harvard Medical School,
R. P. Magner,
K. C. Saunders,
J. D. Greenberg,
AstraZeneca, Novartis, Pfizer, CORRONA,
J. M. Kremer,
Genentech, Pfizer, HGS, UCB, BMS,
Genentech, Pfizer, Abbott, Amgen,
BMS, Pfizer, Genentech, Abbott,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/rituximab-for-treatment-of-rheumatoid-arthritis-treatment-effectiveness-in-the-corrona-database/