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AB0598 Rituximab Treatment in Patients with Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: Results from A Russian Registry (NORMA)
  1. T. Beketova1,
  2. E. Alexandrova1,
  3. T. Novoselova1,
  4. E. Sazhina1,
  5. E. Nikolaeva1,
  6. A. Smirnov1,
  7. V. Sorotskaya2,
  8. E. Zemerova3,
  9. I. Nam4,
  10. N. Nikitina4,
  11. G. Arkhangelskaya5,
  12. Z. Bagautdinova6,
  13. I. Dashkov7,
  14. S. Chernykh8,
  15. O. Zhirnova9,
  16. Y. Lushpaeva10,
  17. L. Masneva11,
  18. I. Afanasjeva12,
  19. A. Arsenyev12,
  20. I. Kondratenko13,
  21. I. Bashkova14,
  22. S. Glukhova1,
  23. E. Nasonov1
  1. 1Nasonova V.A. Research Institute of Rheumatology, Moscow
  2. 2Tula Regional Clinical Hospital, Tula
  3. 3District Rheumatology Center, Khanty-Mansiysk
  4. 4Regional Hospital, Saratov
  5. 5Medical-and-Sanitary Unit Twelve, Samara
  6. 6Republican Consulting Diagnostic Center, Izhevsk
  7. 7Regional Hospital One, Bryansk
  8. 8Clinical Hospital One, Irkutsk
  9. 9Regional Clinical Hospital, Tver
  10. 10Regional Rheumatology Center, Tyumen
  11. 11Regional Clinical Hospital, Belgorod
  12. 12Regional Clinical Hospital, Ivanovo
  13. 13City Children's Hospital, Armavir
  14. 14Chuvash State University named I.N. Ulyanov, Cheboksary, Russian Federation

Abstract

Background Rituximab (RTX) therapy is a treatment option in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

Objectives Analysis of safety and efficacy of RTX in patients with ANCA-associated vasculitis treated in fourteen Russian clinical centers.

Methods In 2011, Nasonova V.A. Research Institute of Rheumatology and Association of Rheumatologists of Russia created the NORMA project, a multicenter study whose objective is to gather information concerning the use of RTX in adult patients with systemic autoimmune diseases.

Results 50 patients with ANCA-associated vasculitis treated with RTX are included in the NORMA registry (26 women and 24 men, mean age 40±15 years), including 35 patients with granulomatosis with polyangiitis, 13 with microscopic polyangiitis, 2 with eosinophilic granulomatosis with polyangiitis. 39 patients were cANCA/PR3 positive and 11 pANCA/MPO positive. 34% of patients had refractory ANCA-associated vasculitis, 36% high activity and/or signs of poor prognosis and 28% intolerance of standard agents. 25/50 patients were re-treatment at low-dose RTX (≤1000 mg) for partial responses/relapses (70%) or to maintain remission (30%). A total of 46 RTX subsequent cycles were completed, intervals between cycles averaged 6.4 months (range 4.5-11.3).

Among 25 patients followed for more than 12 months, 23 complete and 2 partial responses were observed. Table 1 shows Birmingham vasculitis activity score (BVAS), CD19+ B-cells in peripheral blood and serum IgG levels at enrolment and after RTX treatment. Re-treatment was effective in controlling disease activity and did not result in progressive reduction in IgG. Ten patients (20%) had serious adverse events (including 6 infections and 3 neutropenia), all received a single cycle of RTX. Five patients died, two due to pneumonia and late onset neutropenia, two due to acute pulmonary embolism and one patient due to refractory vasculitis and pneumonia.

Table 1.

BVAS, CD19+ B-cells and IgG levels at baseline, 3 and 6 months after each cycle of RTX

Conclusions This uncontrolled observational study shows good tolerance and clinical efficacy of RTX in patients with ANCA-associated vasculitis and suggest, that low-dose RTX for the re-treatment is also effective.

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.1960

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