Background Little is known regarding the use and effectiveness of rituximab (RTX) in patients with rheumatoid arthritis (RA) in the United States. Using a cohort of 26,877 patients with RA from 28-Feb-2006– 05-Dec-2011 from a multicenter observational registry within the U.S. (Consortium of Rheumatology Researchers of North America: CORRONA) we evaluated the use and effectiveness of RTX.
Methods Using data from CORRONA, we identified RA patients that initiated RTX with prior anti-TNF exposure (baseline visit) and were not in remission based on the Clinical Disease Activity Index (CDAI) at the time of initiation, with a follow-up visit at 1 year (±3 month) and at least 1 additional visit between baseline and 1 year visits. Outcomes assessed at 1 year included change in CDAI and the Disease Activity Score-28 joint (DAS-28), as well as achievement of remission (based on CDAI and DAS28). Rates of adverse events were identified.
Results We identified 265 patients that used RTX and met study inclusion criteria. Most patients were female (80%), rheumatoid factor seropositive (75%) with a median age of 57 (IQR 50-65), median disease duration of 13 years (IQR 7-22), and moderate to severe disease activity (median CDAI 22; IQR 13-33) at baseline. Most had prior exposure to nonbiologic disease modifying anti-rheumatic medications (DMARDs) (median 3; IQR 2-5) and biologics (median 2; IQR 1-3). RTX was commonly prescribed with a nonbiologic DMARD (77%) and prednisone (42%). Over the 1-year follow-up (outcomes in Table 1), 67% were retreated with RTX and 17% received a subsequent non-RTX biologic. Rates of cardiovascular events, serious infection, and malignancy 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.
Conclusions Patients initiating RTX had very active disease with prior exposure to several nonbiologic and biologic agents. Use of RTX was shown to be effective with a safety profile comparable to previous RTX clinical trials.
Disclosure of Interest L. Harrold Consultant for: CORRONA, A. John Employee of: Genentech, Inc, G. Reed Grant/Research support from: CORRONA, Consultant for: CORRONA, Employee of: University of Massachusetts Medical School, Paid Instructor for: Harvard Medical School, W. Reiss: None Declared, R. Magner: None Declared, C. Chung: None Declared, K. Saunders Employee of: CORRONA, J. Kremer Shareholder of: CORRONA, Grant/Research support from: Abbott, Amgen, AstraZeneca, BMS, Genentech, Lilly, Pfizer, Consultant for: Amgen, Genentech, Lilly, Pfizer, Employee of: CORRONA, Speakers Bureau: Abbott, Amgen, BMS, Pfizer, J. Greenberg Shareholder of: CORRONA, Consultant for: AstraZeneca, Novartis, Pfizer, CORRONA
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