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Clinical Trial
. 2010 Jun;69(6):1158-61.
doi: 10.1136/ard.2009.119222. Epub 2010 May 3.

Continued inhibition of structural damage over 2 years in patients with rheumatoid arthritis treated with rituximab in combination with methotrexate

Stanley B Cohen  1 , Edward Keystone, Mark C Genovese, Paul Emery, Charles Peterfy, Paul Peter Tak, Matt Cravets, Tim Shaw, David Hagerty
Affiliations
Clinical Trial

Continued inhibition of structural damage over 2 years in patients with rheumatoid arthritis treated with rituximab in combination with methotrexate

Stanley B Cohen et al. Ann Rheum Dis. 2010 Jun.

Erratum in

  • Ann Rheum Dis. 2011 Aug;70(8):1519

Abstract

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 x 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 > or = 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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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Changes from baseline to 2 years in total Genant–modified Sharp, erosion and joint space narrowing (JSN) scores in patients treated with rituximab (2 × 1000 mg) plus methotrexate (MTX) or placebo plus MTX *p<0.005; **p<0.0001 versus placebo plus MTX.
Figure 2
Figure 2
(A) Proportion of patients not progressing over the duration of the study. (B) Proportion of patients with no new erosions over the duration of the study. (C) Treatment effect of placebo plus MTX and rituximab (2 × 1000 mg) plus MTX on total Genant–modified Sharp score. (D) Annualised rate of progression in total Genant–modified Sharp score. BL, baseline; MTX, methotrexate *p<0.005; **p<0.0001.
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