Background Rituximab inhibited structural damage at 1 year in patients with rheumatoid arthritis (RA) who had had a previous inadequate response to tumour necrosis factor (TNF) inhibitors.
Objective To assess structural damage progression through 2 years.
Methods Intention-to-treat patients with one post-baseline radiograph (rituximab n=281; placebo n=187) received background methotrexate (MTX) and were randomised to rituximab (2×1000 mg infusions, 2 weeks apart) or placebo; patients were eligible for rituximab re-treatment every 6 months. By week 104, 82% of the placebo population had received ≥1 dose of rituximab. Radiographic end points included the change in total Sharp score (TSS), erosion and joint space narrowing scores at week 104.
Results At week 104, significantly lower changes in TSS (1.14 vs 2.81; p<0.0001), erosion score (0.72 vs 1.80; p<0.0001) and joint space narrowing scores (0.42 vs 1.00; p<0.0009) were observed with rituximab plus MTX vs placebo plus MTX. Within the rituximab group, 87% who had no progression of joint damage at 1 year remained non-progressive at 2 years.
Conclusions Rituximab plus MTX demonstrated significant and sustained effects on joint damage progression in patients with RA and a previously inadequate response to TNF inhibitors.
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Funding This study was sponsored by F Hoffmann-La Roche Ltd, Genentech, Inc and Biogen Idec, Inc. A portion of this work (Stanford University) was supported in part by a grant from the National Institutes of Health National Center for Research Resources (5 M01 RR000070).
Competing interests SC has received consulting and speaker fees and research grants from Genentech and Biogen Idec. PE and PPT have received consulting and speaker fees and research grants from Roche. EK has received consulting and speaker fees from Roche and Genentech and research grants from Roche. MCG has received speaker fees and research grant support from Roche and has served as a consultant for Roche, Biogen Idec and Genentech. DH and MWC are employees of Biogen Idec. TS is an employee and owns shares in Roche Products Ltd. CP has received consulting and speaker fees from Genentech and Biogen Idec and is an employee of Synarc Inc.
Ethics approval This study was conducted with the approval of the protocol for this study and any accompanying material provided to the patient (eg, patient information sheets and descriptions of the study used to obtain informed consent) were submitted by the investigator to the associated independent ethics committee (IEC) or institutional review board (IRB). Approval from the committee was obtained before starting the study, and was documented in a letter to the investigator specifying the date on which the committee met and granted the approval. Any modifications made to the protocol after receipt of the IEC/IRB approval were also to be submitted by the investigator to the committee in accordance with local procedures and regulatory requirements.
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