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Published on 6/22/2006 in the Prospect News Biotech Daily.

Genentech, Biogen say Rituxan reduces joint erosion, damage in arthritis patients

By Elaine Rigoli

Tampa, Fla., June 22 - Genentech, Inc. and Biogen Idec, Inc. announced positive results from an analysis of Reflex, a phase 3 clinical study of Rituxan (Rituximab) in patients with rheumatoid arthritis who have had an inadequate response to previous treatment with one or more tumor necrosis factor (TNF) antagonist therapies.

The findings showed that treatment with Rituxan in combination with a stable dose of methotrexate (MTX) reduced joint erosion and joint space narrowing at 56 weeks, compared to a placebo and MTX.

In this analysis at 56 weeks, patients treated with Rituxan and MTX displayed the following improvements, compared to patients who received a placebo and MTX:

• The mean change in the composite Genant-modified Sharp score, which assesses progression of both joint erosion and joint space narrowing, was lower among Rituxan-treated patients than placebo-treated patients (1.00 versus 2.31, respectively);

• Mean changes in the erosion score (0.59 versus 1.32) and joint space narrowing score (0.41 versus 0.99) were lower among Rituxan-treated patients than placebo-treated patients;

• A higher proportion of Rituxan-treated patients showed no additional erosion, compared to patients who received a placebo (61% vs. 52%, respectively).

These are the first data to measure the progression of joint damage in this difficult-to-treat patient population, according to a news release.

Rituxan, the only CD20-positive B-cell-targeted therapy for rheumatoid arthritis, was recently approved by the Food and Drug Administration for use in combination with MTX for reducing signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies, the release said.

Genentech is a global biotechnology company based in South San Francisco, Calif.

Biogen is a global pharmaceutical company based in Cambridge, Mass.


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