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Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks

Radiant Research, Dallas, Texas 75235, USA.
Arthritis & Rheumatology (Impact Factor: 7.87). 09/2006; 54(9):2793-806. DOI: 10.1002/art.22025
Source: PubMed

ABSTRACT In addition, for the first time in a patient population who had an inadequate response to 1 or more anti-TNF agents, an exploratory analysis of radiographic data at 24 weeks demonstrated a trend toward less progression of structural joint damage. The mean increases from baseline in the total Genant-modified Sharp scores, erosion scores, and joint space narrowing scores at 24 weeks in rituximab-treated patients were half those in placebo-treated patients, with the joint space narrowing score reaching statistical significance at week 24. It is important to recognize that this portion of the trial was only 6 months in duration, allowed rescue therapy between weeks 16 and 24 (with 40% of the placebo group and 13% of the rituximab group entering the rescue protocol at or after week 16), and included intravenous and oral steroids for the first 2 weeks in both the placebo and rituximab groups. While glucocorticoids have been shown to reduce the rate of radiographic progression of RA (31), all patients in this trial received glucocorticoids. Therefore, the effects of glucocorticoids on radiographic progression could not be assessed. Additionally, all patients had previously taken anti-TNF agents. Glucocorticoid administration and previous therapy with anti-TNF agents may have affected the ability to detect significant differences in radiographic changes between treatment groups. The effect of rituximab on radiographic progression will be further evaluated in longer-term followup from this study as well as in an additional study.

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Available from: Paul Emery, Sep 23, 2014
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