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Ann Rheum Dis. 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.

Author information

  • 1Metroplex Clinical Research Center, Dallas, Texas, USA. scohen@arthdocs.com

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.

PMID:
20439295
[PubMed - indexed for MEDLINE]
PMCID:
PMC2935326
Free PMC Article

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