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Studies Assess Rituximab in ANCA-Associated Vasculitis

Last Updated: July 14, 2010.

In patients with severe antineutrophil cytoplasmic antibody-associated vasculitis, a rituximab-based regimen and standard intravenous cyclophosphamide may both lead to high sustained-remission rates, and rituximab may be superior for relapsing disease, according to two studies published in the July 15 issue of the New England Journal of Medicine.

WEDNESDAY, July 14 (HealthDay News) -- In patients with severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a rituximab-based regimen and standard intravenous cyclophosphamide may both lead to high sustained-remission rates, and rituximab may be superior for relapsing disease, according to two studies published in the July 15 issue of the New England Journal of Medicine.

In the first study, Rachel B. Jones, M.D., of Addenbrooke's Hospital in Cambridge, U.K., and colleagues analyzed data from 44 patients with newly diagnosed ANCA-associated vasculitis and renal involvement. Subjects were randomly assigned to a standard glucocorticoid regimen plus either rituximab for four weeks and two pulses of cyclophosphamide or three to six months of cyclophosphamide followed by azathioprine (control group). Sustained remission occurred in 76 percent of the rituximab group compared to 82 percent of the control group, but the difference was not statistically significant. Severe adverse events also occurred in 42 percent of the rituximab group and 36 percent of the control group, also not a statistically significant difference.

In the other study, John H. Stone, M.D., of the Massachusetts General Hospital in Boston, and colleagues analyzed data from 197 ANCA-positive patients with Wegener's granulomatosis or microscopic polyangiitis. Patients were randomized to receive rituximab once weekly for four weeks or daily cyclophosphamide, plus the same glucocorticoid regimen. Sixty-four percent of the rituximab group had remission of disease without the use of prednisone at six months, compared to 53 percent of the control group, which was statistically significant and met the standard for non-inferiority. The rituximab regimen was more efficacious for inducing remission in relapsing disease (67 versus 42 percent).

"The practical implications of these two studies are substantial. Rituximab might be considered as an option for first-line therapy for induction of remission of ANCA-associated disease. It remains unclear whether rituximab should be used with glucocorticoids alone or in combination with intravenous cyclophosphamide," write the authors of an accompanying editorial.

The first study was supported by F. Hoffmann-La Roche, which also provided rituximab. Several co-authors disclosed financial relationships with this and/or other pharmaceutical companies. Genentech and Biogen partially funded the second study and provided medications.

Abstract - Jones
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Abstract - Stone
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