Short-term efficacy and safety of biosimilar rituximab in patients with ANCA-associated vasculitis


To evaluate the short-term efficacy and safety of biosi mi lar rituximab (Acellbia, BIOCAD) in patients with ANCAassociated vasculitis.

Material and methods

We conducted a retrospective uncontrolled study of biosimilar rixuximab in patients with ANCA-associated vasculitis. Activity of vasculitis was assessed by BVAS v.3 score.


Forty two patients were enrolled in the study, including 29 patients with granulomatosis with polyangiitis, 12 patients with microscopic polyangiitis and 1 patient with eosinophilic granulomatosis with polyangiitis. Remissioninduction therapy with rituximab was effective in all 10 patients and induced a reduction in median BVAS score from 16 (10;24) to 1 (0;4) within 3 months and to 0 (0;2) within 6 months. In 32 patients who were treated with rituximab for maintenance of remission, there were no signs of vasculitis activity at 3 and 6 months. Treatment with rituximab was associated with depletion of B-cells. At 6 months, repopulation of B-lymphocytes was shown in 9 (20%) patients. Side effects included infusion-related reactions (n=2), moderately severe infections (n=8), hypogammaglobulinemia (n=2) and late-onset neutropenia (n=1).


Biosimilar rituximab was effective and relatively safe in patients with ANCA-associated vasculitis.

Key words

ANCA-assoiated vasulitis, rituximab, bio si milar, effiy, safety.