Can we use rituximab to prevent the return of ANCA vasculitis?

Disease - Vasculitis

Lead applicant - Professor David Jayne

Organisation - University of Cambridge

Type of grant - Clinical Studies

Status of grant - Active

Amount of the original award - £822,955.50

Start date - 1 August 2011

Reference - 19706

Public Summary

What are the aims of this research?

We aim to show that rituximab is better than standard treatments at stopping ANCA vasculitis returning over a four-year period. This is a particular problem for patients in whom the disease has already returned; these are the group of patients that we will invite to take part in the study.

Why is this research important?

ANCA vasculitis is a severe disease of unknown cause, in which the immune system attacks and injures various tissues in the body. These patients develop kidney and lung disease and their lives are threatened. Doctors can use high doses of steroids or drugs that suppress the immune system to control the disease.  However, not all patients respond to these treatments and their disease continues uncontrolled. In addition the disease often returns when the drugs are reduced or stopped, the drugs themselves are toxic and they have a number of side effects.

Rituximab removes a type of white blood cell called a B cell from the body, and we know that B cells contribute to vasculitis. This drug has been widely used in other immune disorders such as rheumatoid arthritis. Although a single course of this drug can control the disease initially, it often returns. We have been using repeat dosing of rituximab for four years. In our experience, it can control the disease and stops it from returning over several years and repeat dosing is safe. No other large international studies are looking at this aspect of treatment at present.

This study will look at the use of repeated doses of rituximab for longer term disease control. There are a number of questions that we will address in our study. Is rituximab better than current standard treatments, such as azathioprine, at preventing the return of vasculitis, once it has been brought under control? Does rituximab modify how the disease behaves in the long term which could allow patients to stop taking these immunosuppressive drugs? We also want to find out if rituximab is less toxic than current treatments for maintaining disease control.

How will the findings benefit patients?

We are very aware of the limitations of the current treatments and the need to find better drugs to prevent damage and improve the health of patients with vasculitis. This study will build on previous research investigating the use of rituximab as a treatment for vasculitis. If the results show rituximab to be better than current standard treatments at keeping the disease under control, this will directly benefit patients with vasculitis.