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B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis
Arthritis & Rheumatism, 02/02/09
Lafyatis R et al. – Treatment with rituximab in diffuse cutaneous systemic sclerosis (dcSSC) pts was safe and well tolerated; treatment resulted in both depletion of circulating B cells and depletion of dermal B cells; had little effect on the levels of SSc-associated autoantibodies. Rituximab treatment had no beneficial effect on skin disease; its potential efficacy in other organs such as lungs could not be clearly evaluated in this small open-label trial.
Methods- Aim was to determine the safety, and efficacy of rituximab on autoimmunity and fibrosis in pts with dcSSc
- 15 pts; received 2 iv doses of rituximab (1,000 mg), administered 2 wks apart
- Safety, clinical, and exploratory outcomes were evaluated at baseline and at 6 mo
- Primary outcome was change in the modified Rodnan skin thickness score (MRSS) at 6 mo
- AEs: frequent infusion reactions and rare infections
- Mean change in the MRSS between baseline and 6 mo was not significant
- Results of pulmonary function tests and other measures of major organ involvement were stable
- The modest B cell infiltrates at baseline were completely depleted at 6 mo in most pts
- Autoantibody titers showed only modest and variable changes after treatment
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