An assessment of efficacy and safety of replacement therapy with subcutaneous immunoglobulin 16.5% administered by rapid push method in patients with inborn errors of immunity: the results of a prospective multicenter study

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Abstract

Subcutaneous immunoglobulins (SCIgs) have been widely used in patients with inborn errors of immunity (IEIs) and have been shown to be effective and well tolerated. Here, we assessed efficacy and safety of replacement therapy with SCIgs in a large heterogeneous cohort of patients with IEIs. The study was approved by the Independent Ethics Committee and the Scientific Council of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia. All the patients and/or their legal representatives signed informed consent for participation in the study. Patients with IEIs, previously treated with intravenous immunoglobulins (IVIgs) were switched to SCIgs 16.5%. The drug was administered every 7–10 days using rapid push method for 12 months. In the end, we analyzed the following efficacy and safety criteria: the rate of infections and associated events, serum immunoglobulin G concentrations, adverse reactions and patient compliance. We had recruited 233 patients (the median age was 11 years, the percentage of male patients was 66.0%), and 200 out of these completed the study. A total of 8787 SCIg infusions were administered during the study. The infection rate (per 1 patient per month) on SCIg treatment was 0.05, which was significantly lower compared to the IVIg therapy (p < 0.001). The median trough IgG level was 6.9 g/l on IVIgs, 9.0 g/l during the first 6 months of SCIgs and 9.2 g/l over 7–12 months of SCIg treatment. Systemic reactions were registered in 12.45% of IVIG infusions and in 1.93% of SCIg infusions (р < 0,001). Our study demonstrates the safety and efficacy of replacement therapy with SCIgs administered via rapid push method.

About the authors

A. Ya. Avedova

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Author for correspondence.
Email: asya.avedova95@mail.ru

Аведова Асмик Яковлевна, врач-аллерголог-иммунолог отделения иммунологии

17997, Москва, ул. Саморы Машела, 1

Russian Federation

E. V. Deripapa

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

Yu. A. Rodina

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

A. A. Mukhina

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

E. A. Latysheva

The Institute of Immunology of the Federal Medical Biological Agency

Москва

Russian Federation

D. V. Yukhacheva

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

V. I. Burlakov

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

N. Yu. Kan

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

D. V. Bogdanova

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

A. A. Moiseeva

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

N. B. Kuzmenko

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

Z. A. Nesterenko

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

E. A. Deordieva

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

A. L. Ogneva

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

V. O. Bludova

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

A. A. Roppelt

Moscow Center of Allergy and Immunology, Clinical Hospital No. 52 of Department of Health of Moscow

Москва

Russian Federation

D. S. Fomina

Moscow Center of Allergy and Immunology, Clinical Hospital No. 52 of Department of Health of Moscow

Москва

Russian Federation

N. V. Zinovieva

The G.N. Speransky Children's Clinical Hospital No. 9 of Department of Health of Moscow

Москва

Russian Federation

Yu. N. Sevostyanova

The G.N. Speransky Children's Clinical Hospital No. 9 of Department of Health of Moscow

Москва

Russian Federation

L. R. Kalmetyeva

Republican Children's Clinical Hospital

Ufa

Russian Federation

D. D. Prolygina

Republican Children's Clinical Hospital

Ufa

Russian Federation

L. Yu. Barycheva

Stavropol State Medical University of Ministry of Healthcare of Russia

Stavropol

Russian Federation

O. S. Selezneva

Regional Children's Clinical Hospital

Rostov-on-Don

Russian Federation

N. V. Shakhova

Altai State Medical University of Ministry of Healthcare of Russia

Barnaul

Russian Federation

O. M. Laba

Regional Children's Clinical Hospital

Yaroslavl

Russian Federation

E. V. Vlasova

Regional Children's Clinical Hospital

Yekaterinburg

Russian Federation

A. V. Gorenkova

The P.G. Vyzhletsov Arkhangelsk Regional Children's Clinical Hospital

Arkhangelsk

Russian Federation

E. V. Timofeeva

Nizhny Novgorod Regional Children's Clinical Hospital

Nizhny Novgorod

Russian Federation

O. V. Trusova

The I.P. Pavlov First St. Petersburg State Medical University of Ministry of Healthcare of Russia

Saint Petersburg

Russian Federation

M. N. Guseva

The I.P. Pavlov First St. Petersburg State Medical University of Ministry of Healthcare of Russia, Saint Petersburg

Saint Petersburg

Russian Federation

N. B. Yudina

Voronezh Regional Children's Clinical Hospital No. 1

Ulan-Ude

Russian Federation

A. Kh. Ibisheva

The E.P. Glinka Republican Children's Clinical Hospital

Grozny 

Russian Federation

Z. V. Bambaeva

Republican Children's Clinical Hospital

Ulan-Ude

Russian Federation

D. V. Mashkovskaya

Republican Children's Clinical Hospital

Simferopol

Russian Federation

S. N. Isakova

Research Institute of Fundamental and Clinical Immunology

Novosibirsk

Russian Federation

A. R. Shakirova

Republican Children's Clinical Hospital of Ministry of Healthcare of the Republic of Tatarstan

Kazan

Russian Federation

E. Yu. Selina

Republican Children's Clinical Hospital of Ministry of Healthcare of the Republic of Tatarstan

Kazan

Russian Federation

T. V. Shilova

Chelyabinsk Regional Children's Clinical Hospital

Chelyabinsk

Russian Federation

E. S. Zubova

Regional Children's Cilinical Hospital

Perm

Russian Federation

E. V. Krasilova

The N.N. Silishcheva Regional Children's Clinical Hospital

Astrakhan

Russian Federation

I. U. Khabaeva

The N.N. Silishcheva Regional Children's Clinical Hospital

Astrakhan

Russian Federation

E. V. Kitova

Republican Children's Clinical Hospital of Ministry of Healthcare of the Udmurt Republic

Izhevsk

Russian Federation

A. G. Mandzhieva

The Filatov Hospital

Tyumen

Russian Federation

S. Yu. Starikova

The V.P. Bisyarina Children's Clinical Hospital No. 2

Omsk

Russian Federation

T. B. Pavlova

Irkutsk State Regional Children's Clinical Hospital

Irkutsk 

Russian Federation

E. N. Tyulyakova

Kaluga Regional Children’s Clinical Hospital

Kaluga

Russian Federation

P. A. Levin

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

A. Yu. Shcherbina

The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of Russia

Москва

Russian Federation

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Copyright (c) 2024 Avedova A.Y., Deripapa E.V., Rodina Y.A., Mukhina A.A., Latysheva E.A., Yukhacheva D.V., Burlakov V.I., Kan N.Y., Bogdanova D.V., Moiseeva A.A., Kuzmenko N.B., Nesterenko Z.A., Deordieva E.A., Ogneva A.L., Bludova V.O., Roppelt A.A., Fomina D.S., Zinovieva N.V., Sevostyanova Y.N., Kalmetyeva L.R., Prolygina D.D., Barycheva L.Y., Selezneva O.S., Shakhova N.V., Laba O.M., Vlasova E.V., Gorenkova A.V., Timofeeva E.V., Trusova O.V., Guseva M.N., Yudina N.B., Ibisheva A.K., Bambaeva Z.V., Mashkovskaya D.V., Isakova S.N., Shakirova A.R., Selina E.Y., Shilova T.V., Zubova E.S., Krasilova E.V., Khabaeva I.U., Kitova E.V., Mandzhieva A.G., Starikova S.Y., Pavlova T.B., Tyulyakova E.N., Levin P.A., Shcherbina A.Y.

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