Certain types of patients with ANCA-associated vasculitis do not require maintenance therapy if treated with a specific Rituxan (rituximab) approach, according to researchers at the University of Turin in Italy who followed patients for up to 11 years.
The study, albeit small, might clear up some confusion about the feasibility of maintenance treatment in patients who cannot be treated with conventional therapy. ANCA stands for antineutrophil cytoplasmic antibodies.
The study, “The “4 plus 2” rituximab protocol makes maintenance treatment unneeded in patients with refractory ANCA-associated vasculitis: A 10 years observation study,” was published in the journal Oncotarget.
To examine if maintenance therapy is needed in patients treated with Rituxan, the research team recruited 11 patients with various types of ANCA-associated vasculitis. Among them, five had granulomatosis with polyangiitis (GPA), four had microscopic polyangiitis (MPA), and two had eosinophilic granulomatosis with polyangiitis (EGPA).
All patients received what the researchers referred to as a 4+2 Rituxan treatment. In this approach, patients receive 375 mg/m² of Rituxan when they have an acute phase of the disease. The treatment, in the form of an infusion, is given on days 1, 8, 15 and 22. Physicians then add two more doses one and two months after the last infusion.
At the end of the treatment course, patients did not receive any further immunosuppressive treatment, and oral prednisone was tapered to 5 mg/day within three months. Patients received more Rituxan only if they showed definite signs of a relapse.
Researchers followed patients for an average of 85 months. During this time, patients experienced a stark reduction in their disease activity, measured by the Birmingham Vasculitis Activity Score (BVAS).
At the beginning of the study, patients had an average BVAS score of 22. At the three-year and end-of study follow-up visits, the score was 0.
Seven patients remained relapse-free for at least 60 months after one 4+2 Rituxan cycle. Four patients did not experience a relapse during their follow-up of 60–108 months. These four participants tested positive for MPO (myeloperoxidase) antibodies.
Of the seven relapsing patients, four relapsed within five years, and all received a second course of the 4+2 Rituxan regimen after a median of 54 months. Six of them were disease-free after six months, while one experienced a minor relapse.
The remaining patients stayed relapse-free for a median of 32 months after the second treatment round.
The therapy also improved laboratory parameters, including levels of ANCA and amount of protein in the urine.
Researchers could not identify any factors that would predict a relapse, likely because of the small size of the study, they said.