Rituximab shows long-term efficacy in antibody-associated vasculitis
medwireNews: A single course of rituximab is a viable alternative to conventional cyclophosphamide/azathioprine immunosuppression in patients with severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, long-term results of the RAVE trial suggests.
Conducted by the Immune Tolerance Network, the Rituximab in Associated Vasculitis (RAVE) study found the two regimens to be similarly effective for the induction and maintenance of remission over 18 months, with comparable toxicity profiles.
Describing the study as “remarkable,” lead investigator Ulrich Specks (Mayo Clinic Foundation, Rochester, Minnesota, USA) said in a press statement that the results demonstrate “that a short course of 4 infusions of rituximab is as effective as 18 months of ongoing daily oral therapy with immunosuppressive drugs that require frequent blood test monitoring to assure their safe use.”
Specks also highlighted the Network’s unusual approach to providing access to raw trial data, with all datasets and statistical analyses being freely available to the public through the ITN TrialShare portal
RAVE was a randomized, double-blind, placebo-controlled trial that included 197 patients with severe, organ-threatening ANCA-associated vasculitis. They received either rituximab (375 mg/m2 body surface area, once a week for 4 weeks) followed by placebo or cyclophosphamide for 3 to 6 months followed by azathioprine for 12 to 15 months.
All patients also received glucocorticoids, which were tapered once the patient was in remission.
Rates of the primary endpoint, complete remission at 6 months, were 64% in the rituximab group and 53% in the cyclophosphamide–azathioprine group. And among patients in the rituximab group, 47% and 39% were still in remission at 12 and 18 months, respectively, compared with 39% and 33% in the usual care group.
Rituximab met the criterion for non-inferiority at 6, 12, and 18 months, note the researchers, and there were no between-group differences in any efficacy measure. Furthermore, the frequency of adverse events did not differ between the groups, with the exception of fewer cases of leukopenia and pneumonia in the rituximab group.
Writing in the New England Journal of Medicine, the researchers remark: “The data from this trial, in which rituximab was not readministered, reflect the reality of this disease, which is that relapses are common when the effects of immunosuppressive therapy wear off. The data also point the way to more effective, long-term disease control through intermittent retreatment.”
medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013
By Joanna Lyford, Senior medwireNews Reporter