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

Россия

E. V. Deripapa

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

Москва

Россия

Yu. A. Rodina

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

Москва

Россия

A. A. Mukhina

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

Москва

Россия

E. A. Latysheva

The Institute of Immunology of the Federal Medical Biological Agency

Москва

Россия

D. V. Yukhacheva

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

Москва

Россия

V. I. Burlakov

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

Москва

Россия

N. Yu. Kan

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

Москва

Россия

D. V. Bogdanova

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

Москва

Россия

A. A. Moiseeva

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

Москва

Россия

N. B. Kuzmenko

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

Москва

Россия

Z. A. Nesterenko

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

Москва

Россия

E. A. Deordieva

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

Москва

Россия

A. L. Ogneva

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

Москва

Россия

V. O. Bludova

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

Москва

Россия

A. A. Roppelt

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

Москва

Россия

D. S. Fomina

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

Москва

Россия

N. V. Zinovieva

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

Москва

Россия

Yu. N. Sevostyanova

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

Москва

Россия

L. R. Kalmetyeva

Republican Children's Clinical Hospital

Ufa

Россия

D. D. Prolygina

Republican Children's Clinical Hospital

Ufa

Россия

L. Yu. Barycheva

Stavropol State Medical University of Ministry of Healthcare of Russia

Stavropol

Россия

O. S. Selezneva

Regional Children's Clinical Hospital

Rostov-on-Don

Россия

N. V. Shakhova

Altai State Medical University of Ministry of Healthcare of Russia

Barnaul

Россия

O. M. Laba

Regional Children's Clinical Hospital

Yaroslavl

Россия

E. V. Vlasova

Regional Children's Clinical Hospital

Yekaterinburg

Россия

A. V. Gorenkova

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

Arkhangelsk

Россия

E. V. Timofeeva

Nizhny Novgorod Regional Children's Clinical Hospital

Nizhny Novgorod

Россия

O. V. Trusova

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

Saint Petersburg

Россия

M. N. Guseva

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

Saint Petersburg

Россия

N. B. Yudina

Voronezh Regional Children's Clinical Hospital No. 1

Ulan-Ude

Россия

A. Kh. Ibisheva

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

Grozny 

Россия

Z. V. Bambaeva

Republican Children's Clinical Hospital

Ulan-Ude

Россия

D. V. Mashkovskaya

Republican Children's Clinical Hospital

Simferopol

Россия

S. N. Isakova

Research Institute of Fundamental and Clinical Immunology

Novosibirsk

Россия

A. R. Shakirova

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

Kazan

Россия

E. Yu. Selina

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

Kazan

Россия

T. V. Shilova

Chelyabinsk Regional Children's Clinical Hospital

Chelyabinsk

Россия

E. S. Zubova

Regional Children's Cilinical Hospital

Perm

Россия

E. V. Krasilova

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

Astrakhan

Россия

I. U. Khabaeva

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

Astrakhan

Россия

E. V. Kitova

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

Izhevsk

Россия

A. G. Mandzhieva

The Filatov Hospital

Tyumen

Россия

S. Yu. Starikova

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

Omsk

Россия

T. B. Pavlova

Irkutsk State Regional Children's Clinical Hospital

Irkutsk 

Россия

E. N. Tyulyakova

Kaluga Regional Children’s Clinical Hospital

Kaluga

Россия

P. A. Levin

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

Москва

Россия

A. Yu. Shcherbina

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

Москва

Россия

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