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Medicine Matters rheumatology

So the rationale behind the RITAZARAM trial was that we didn't know what the best maintenance strategy is in ANCA-associated vasculitis, following rituximab induction. And we wanted to focus on the patients with the greatest unmet need, those with purely relapsing disease. But the study compared a repeat dose rituximab to azathioprine for maintenance of remission after induction with rituximab. And we demonstrated that rituximab is superior to azathioprine for this indication.

The key primary was to demonstrate a reduced relapse risk, whether that be a major or a minor relapse. And the key secondary endpoints were, of course, safety. And we didn't notice any difference between safety in terms of severe adverse events or infections or hypogammaglobulinemia between the two groups.

But there is always a concern, particularly when you use repeat dose rituximab, that if you're depleting the B cells which produce the antibodies, that you're also going to deplete your protective antibodies. And so it was very reassuring that we didn't see a difference. But of course, we'll look in long term follow up.

This data really validates the data from the main RITSAN trial, showing that rituximab is superior to azathioprine for relapse prevention. And is being shown now in a newly diagnosed and a relapsing group. So I think, therefore, the recommendation should be that we were using repeat dose rituximab as a maintenance strategy in this condition.

The first thing that we need to do is to look at the long term follow up. So one of the objectives of the study was by using higher doses of rituximab, we'd lead to more sustained long term B cell depletion correlating with long term clinical effect. So that's the first key thing that we'll look at. And then I think that will guide future research from there.