No difference in relapse rate (the primary efficacy endpoint) was observed between treatment arms in the overall patient population; however, a positive trend of improved efficacy (and higher infections) was seen in the subgroup of patients who received rituximab induction therapy followed by belimumab compared to placebo.
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A randomised study of rituximab and belimumab sequential therapy in PR3 ANCA-associated vasculitis (COMBIVAS): design of the study protocol.
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