RESEARCH - Continued inhibition of RA structural damage over 2 years with rituximab plus MTX

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Continued inhibition of structural damage over 2 years in patients

with rheumatoid arthritis treated with rituximab in combination with

methotrexate.

Cohen SB, Keystone E, Genovese MC, Emery P, fy C, Tak PP, Cravets

M, Shaw T, Hagerty D.

1Metroplex Clinical Research Center, Dallas, Texas, USA.

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: /st> Intention-to-treat patients with one post-baseline

radiograph (rituximab n=281; placebo n=187) received background

methotrexate (MTX) and were randomised to rituximab (2x1000 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.

PMID: 20439295

http://www.ncbi.nlm.nih.gov/pubmed/20439295

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