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
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.
Authors
- М. Н. Гусева (ORCID: https://orcid.org/0000-0002-3997-3390)
- Е. В. Власова (ORCID: https://orcid.org/0000-0002-6678-5360)
- S.N. Isakova (ORCID: https://orcid.org/0000-0001-7945-5582)
- В. И. Бурлаков (ORCID: https://orcid.org/0000-0003-1267-9957)
- Elena Deripapa (ORCID: https://orcid.org/0000-0002-9083-4783)
- T. V. Shilova (ORCID: https://orcid.org/0000-0001-9826-9654)
- Е. А. Деордиева (ORCID: https://orcid.org/0000-0002-8208-2075)
- Zema V. Bambaeva (ORCID: https://orcid.org/0000-0002-7541-2793)
- A. V. Gorenkova
- D. V. Bogdanova (ORCID: https://orcid.org/0000-0003-2897-5208)
- A. Ya. Avedova (ORCID: https://orcid.org/0000-0002-9399-6534)
- Elena V. Krasilova
- N. Yu. Kan (ORCID: https://orcid.org/0000-0003-3564-6496)
- Elena Timofeeva (ORCID: https://orcid.org/0000-0003-3908-1947)
- Anna Roppelt (ORCID: https://orcid.org/0000-0001-5132-1267)
- A. А. Moiseeva (ORCID: https://orcid.org/0000-0002-6134-3811)
- Tatyana Pavlova (ORCID: https://orcid.org/0000-0003-3403-4447)
- Н В Шахова (ORCID: https://orcid.org/0000-0002-7143-8259)
- Philip Levin (ORCID: https://orcid.org/0000-0002-2410-1223)
- V. О. Bludova (ORCID: https://orcid.org/0000-0003-0960-3089)
- L. Yu. Barycheva (ORCID: https://orcid.org/0000-0002-4069-0566)
- N. B. Kuzmenko (ORCID: https://orcid.org/0000-0002-1669-8621)
- E. S. Zubova (ORCID: https://orcid.org/0000-0002-9755-8929)
- З. А. Нестеренко (ORCID: https://orcid.org/0000-0003-4427-054X)
- О. В. Трусова (ORCID: https://orcid.org/0000-0002-0854-1536)
- Elena A. Latysheva (ORCID: https://orcid.org/0000-0002-1606-205X)
- Anna Mukhinа (ORCID: https://orcid.org/0000-0002-3305-1694)
- Ekaterina Yu. Selina (ORCID: https://orcid.org/0009-0003-6545-1435)
- L. R. Kalmetyeva (ORCID: https://orcid.org/0000-0003-1866-0640)
- D. V. Yukhacheva (ORCID: https://orcid.org/0000-0001-9078-8206)
- О. М. Laba (ORCID: https://orcid.org/0000-0001-5784-1263)
- Daria Fomina (ORCID: https://orcid.org/0000-0002-5083-6637)
- S.Yu. Starikova (ORCID: https://orcid.org/0000-0002-4321-7301)
- D. V. Mashkovskaya
- Aset Kh. Ibisheva (ORCID: https://orcid.org/0000-0003-4732-4515)
- О. С. Селезнева (ORCID: https://orcid.org/0000-0003-1907-4168)
- N.V. Zinovieva (ORCID: https://orcid.org/0000-0002-6926-2055)
- Anna Shcherbina (ORCID: https://orcid.org/0000-0002-3113-4939)
- Д. Д. Пролыгина
- N. B. Yudina
- А. Р. Шакирова
- Yu. А. Rodina
- A. L. Ogneva
- Yu. N. Sevostyanova
- I. U. Khabaeva
- Ekaterina Kitova
- Anastasia Mandzhieva
- Elvira Tyulyakova
Institutions
- Altai State Medical University (RU)
- First Pavlov State Medical University of St. Petersburg (RU)
- Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan (RU)
- Regional Clinical Hospital No 4 (RU)
- Research Institute of Fundamental and Clinical Immunology (RU)
- Russian Children's Clinical Hospital (RU)
- Irkutsk Regional Clinical Hospital (RU)
- Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology (RU)
- Institute of Immunology (HR)
- Arkhangelsk Children's Clinical Hospital named P.G.Vyzhletsova (RU)
- City Clinical Hospital No15 named. O. M. Filatova (RU)
- Regional Children's Clinical Hospital No. 1 (RU)
- Ministry of Health (GR)
- Stavropol State Medical University (RU)
- Federal Medical-Biological Agency (RU)
Publication Details
- Journal
- Pediatric Hematology/Oncology and Immunopathology
- Published
- 2024-12-13
- DOI
- https://doi.org/10.24287/1726-1708-2024-23-4-119-130
- Primary Topic
- Immunodeficiency and Autoimmune Disorders
- Type
- article
- Field-Weighted Citation Impact
- 0.00