Discontinuation of Rituximab compared with rituximab maintenance in ANCA-associated vasculitis – a randomised controlled trial (DISRITUX)

ANCA-associated vasculitis (AAV) are auto-immune diseases that involve inflammation of blood vessels leading to organ damage especially to the respiratory tract and kidneys. The burden of immunosuppressive therapies, which includes infections, also increase morbidity and mortality. Relapses occur in 50% of patients within 5-years.

Rituximab (RTX), a drug targeting B-cells, is increasingly used for induction and long-term maintenance therapy. Guidelines for discontinuing RTX are lacking.

During the Covid19 pandemic RTX use has been associated with poor outcome and vaccine response is low in B-cell depleted RTX patients.Purpose and aims: • To study discontinuation of RTX compared with RTX maintenance in AAV patients in remission during 36 months in 160 patients through a clinical trial network collaboration between nephrologists and rheumatologists in Sweden • To study and identify more reliable and predictive biomarkers for risk of relapse as well as quality of life • To nationally increase clinical trial participation in AAV with the purpose of decreasing the burden of disease and treatment related side effects.Importance: The information retrieved from this randomized trial will provide evidence of safety of discontinuation and better tools to select patients at high risk of relapse and in need of prolonged maintenance therapy while avoiding overtreating others.

This study is therefore likely to change clinical practice in AAV not only in Sweden but worldwide.