RESEARCH - Rituxan (rituximab) inhibits structural joint damage in RA patients with an inadequate response to TNF inhibitor therapies

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Ann Rheum Dis. 2008 Apr 3

Rituximab inhibits structural joint damage in rheumatoid arthritis

patients with an inadequate response to tumour necrosis factor

inhibitor therapies.

Keystone EC, Emery P, fy CG, Tak PP, Cohen S, Genovese MC,

Dougados M, Burmester GR, Greenwald M, Kvien TK, S, Hagerty

D, Cravets MW, Shaw T.

Mount Sina Medical School, United States.

OBJECTIVE: To determine if treatment with a B cell-targeted therapy

can inhibit the progression of structural joint damage in patients

with rheumatoid arthritis (RA), exhibiting an inadequate response to

tumour necrosis factor (TNF) inhibitors. METHODS: In this Phase III

study, patients with an inadequate response to a TNF inhibitor and

receiving methotrexate were randomised to rituximab or placebo.

Radiographs were obtained at baseline, Week 24 and Week 56 after

randomisation. Patients with an inadequate response to their

randomised therapy could receive rescue medication from Week 16. From

Week 24, eligible patients from both treatment arms could receive

open-label rituximab. Patients were analysed according to their

original treatment group. Radiographs were scored using the

Genant-modified Sharp method. The primary radiographic endpoint was

change in total Genant-modified Sharp score at Week 56. RESULTS:

Rituximab treatment caused significant reduction in joint damage

progression compared with placebo. The mean change from baseline in

the total Genant-modified Sharp score at Week 56 was significantly

lower for rituximab-treated patients treated than for placebo-treated

patients (1.00 vs 2.31; p = 0.005), and was supported by changes in

erosion score (0.59 and 1.32 for rituximab plus methotrexate vs

placebo plus methotrexate, respectively; p = 0.011) and joint space

narrowing score (0.41 and 0.99, respectively; p < 0.001).

CONCLUSIONS: This study provides the first evidence that a B

cell-targeted therapy-rituximab-can significantly inhibit the

progression of structural joint damage in RA patients with

long-standing, active, and treatment-resistant disease.

PMID: 18388156

http://www.ncbi.nlm.nih.gov/pubmed/18388156

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