RUSSIAN EXPERIENCE WITH USING MONOCLONAL ANTIBODIES TO B-LYMPHOCYTES (RITUXIMAB) IN SYSTEMIC VASCULITIDES ASSOCIATED WITH NEUTROPHIL CYTOPLASMIC ANTIBODIES (PRELIMINARY RESULTS OF THE RUSSIAN REGISTER NORMA)

T. V. Beketova; E. N. Aleksandrova; T. M. Novoselova; E. G. Sazhina; E. V. Nikolaeva; A. V. Smirnov; V. N. Sorotskaya; E. V. Zemerova; I. F. Nam; N. M. Nikitina; G. S. Arkhangelskaya; Z. R. Bagautdinova; I. N. Dashkov; S. Yu. Chernykh; O. V. Zhirnova; Yu. A. Lushpaeva; L. V. Masneva; I. P. Afanasieva; A. E. Arseniev; I. V. Kondratenko; I. B. Bashkova; S. I. Glukhova; E. L. Nasonov

doi:10.14412/1995-4484-2014-147-158

RUSSIAN EXPERIENCE WITH USING MONOCLONAL ANTIBODIES TO B-LYMPHOCYTES (RITUXIMAB) IN SYSTEMIC VASCULITIDES ASSOCIATED WITH NEUTROPHIL CYTOPLASMIC ANTIBODIES (PRELIMINARY RESULTS OF THE RUSSIAN REGISTER NORMA)

https://doi.org/10.14412/1995-4484-2014-147-158

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Abstract

In 2013, Russia registered officially the indications for the use of monoclonal antibodies to B-lymphocytes (rituximab, RTM) in systemic vasculitides associated with antineutrophil cytoplasmic antibodies (ANCA-SV). This communication presents the preliminary results of the Russian register of the RTM application in autoimmune diseases (NORMA) that has included 50 patients with ANCA-SV treated in 14 cities of the Russian Federation. Twenty-five of 50 (50%) patients received repeated courses of RTM.

RTM has demonstrated a high efficacy and a good profile of treatment safety in patients with ANCA-SV in real-life national clinical practice. Among 25 patients who had been followed up for over 12 months, the remission was achieved in 92% of cases, a decrease in the ANCA-SV activity was observed in 8%. The efficacy of RTM increased when performing repeated courses, while it has been noted that the positive results can be obtained by prescribing a repeated course of RTM at a reduced dose (500–1000 mg). Prescription of the repeated courses was primarily required in patients with granulomatosis and polyangiitis affecting the lungs.

Care should be taken when combining RTM treatment with cytostatics (primarily with cyclophosphamide) because of the risk of secondary immunodeficiency and infectious adverse events (AE), which have been the most frequent serious AE (12%) in patients with ANCA-SV.

Keywords

systemic vasculitis associated with neutrophil cytoplasmic antibodies, Wegener's granulomatosis with polyangiitis, microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrom), biological anti-B cell therapy, rituximab

About the Authors

T. V. Beketova

V.A. Nasonova Research Institute of Rheumatology of the Russian Academy of Medical Sciences, Moscow, Russia
Russian Federation

Competing Interests: ФГБУ «Научно-исследовательский институт ревматологии им. В.А.Насоновой» РАМН, Москва

E. N. Aleksandrova

T. M. Novoselova

E. G. Sazhina

E. V. Nikolaeva

A. V. Smirnov

V. N. Sorotskaya

Medical Institute, Tula State University, Tula, Russia
Russian Federation

Competing Interests: Медицинский институт ФГБОУ ВПО «Тульский государственный университет», Тула

E. V. Zemerova

County Clinical Hospital, Khanty-Mansiysk, Russia
Russian Federation

Competing Interests: БУ ХМАО-Югры «Окружная клиническая больница», Ханты- Мансийск

I. F. Nam

V.I. Razumovsky State Medical University, Ministry of Health of Russia, Saratov
Russian Federation

N. M. Nikitina

V.I. Razumovsky State Medical University, Ministry of Health of Russia, Saratov
Russian Federation

G. S. Arkhangelskaya

Samara City Hospital Four, Samara
Russian Federation

Z. R. Bagautdinova

Republican Clinical and Diagnostic Center, Ministry of Health of the Udmurt Republic, Izhevsk
Russian Federation

I. N. Dashkov

Bryansk Regional Hospital One, Bryansk
Russian Federation

S. Yu. Chernykh

Irkutsk City Clinical Hospital One, Irkutsk
Russian Federation

O. V. Zhirnova

Tver Regional Clinical Hospital, Tver
Russian Federation

Yu. A. Lushpaeva

Tyumen Regional Rheumatology Center, Regional Clinical Hospital One, Tumen
Russian Federation

L. V. Masneva

Saint Ioasaf Belgorod Regional Clinical Hospital, Belgorod
Russian Federation

I. P. Afanasieva

Ivanovo Regional Clinical Hospital, Ivanovo
Russian Federation

A. E. Arseniev

Ivanovo Regional Clinical Hospital, Ivanovo
Russian Federation

I. V. Kondratenko

Russian Children’s Clinical Hospital, Ministry of Health of Russia, Moscow
Russian Federation

I. B. Bashkova

I.N. Ulyanov Chuvash State University, Cheboksary
Russian Federation

S. I. Glukhova

V.A. Nasonova Research Institute of Rheumatology of the Russian Academy of Medical Sciences, Moscow, Russia
Russian Federation

E. L. Nasonov

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For citations:

Beketova T.V., Aleksandrova E.N., Novoselova T.M., Sazhina E.G., Nikolaeva E.V., Smirnov A.V., Sorotskaya V.N., Zemerova E.V., Nam I.F., Nikitina N.M., Arkhangelskaya G.S., Bagautdinova Z.R., Dashkov I.N., Chernykh S.Yu., Zhirnova O.V., Lushpaeva Yu.A., Masneva L.V., Afanasieva I.P., Arseniev A.E., Kondratenko I.V., Bashkova I.B., Glukhova S.I., Nasonov E.L. RUSSIAN EXPERIENCE WITH USING MONOCLONAL ANTIBODIES TO B-LYMPHOCYTES (RITUXIMAB) IN SYSTEMIC VASCULITIDES ASSOCIATED WITH NEUTROPHIL CYTOPLASMIC ANTIBODIES (PRELIMINARY RESULTS OF THE RUSSIAN REGISTER NORMA). Rheumatology Science and Practice. 2014;52(2):147-158. (In Russ.) https://doi.org/10.14412/1995-4484-2014-147-158

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Rheumatology Science and Practice

RUSSIAN EXPERIENCE WITH USING MONOCLONAL ANTIBODIES TO B-LYMPHOCYTES (RITUXIMAB) IN SYSTEMIC VASCULITIDES ASSOCIATED WITH NEUTROPHIL CYTOPLASMIC ANTIBODIES (PRELIMINARY RESULTS OF THE RUSSIAN REGISTER NORMA)

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