ORIGINAL RESEARCH article

Front. Immunol.

Sec. Primary Immunodeficiencies

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1598491

This article is part of the Research TopicMethods in Primary Immunodeficiencies: 2022View all 4 articles

Рrospective multicenter study of treatment efficacy, safety, and quality of life in a large cohort of patients with inborn errors of immunity receiving subcutaneous immunoglobulin

Provisionally accepted
Asmik  AvedovaAsmik Avedova*Elena  DeripapaElena DeripapaYulia  RodinaYulia RodinaAnna  A MukhinaAnna A MukhinaElena  LATYSHEVAElena LATYSHEVADaria  YukhachevaDaria YukhachevaVasily  BurlakovVasily BurlakovNellie  KanNellie KanDaria  BogdanovaDaria BogdanovaAnna  MoiseevaAnna MoiseevaNatalia  KuzmenkoNatalia KuzmenkoZoya  NesterenkoZoya NesterenkoEkaterina  DeordievaEkaterina DeordievaNataliya  ZinovyevaNataliya ZinovyevaYulia  SevostyanovaYulia SevostyanovaLinara  Rinatovna KalmetevaLinara Rinatovna KalmetevaLudmila  BarychevaLudmila BarychevaОльга  СелезневаОльга СелезневаNatalia  ShakhovaNatalia ShakhovaOlga  LabaOlga LabaElena  VlasovaElena VlasovaAlla  GorenkovaAlla GorenkovaElena  TimofeevaElena TimofeevaOlga  TrusovaOlga TrusovaNatalya  YudinaNatalya YudinaZema  BambaevaZema BambaevaDina  MashkovskayaDina MashkovskayaSvetlana  IsakovaSvetlana IsakovaEkaterina  SelinaEkaterina SelinaTatyana  ShilovaTatyana ShilovaAnastasia  MandzhievaAnastasia MandzhievaSvetlana  StarikovaSvetlana StarikovaNikolay  GrachevNikolay GrachevAnna  ShcherbinaAnna Shcherbina
  • Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russia

The final, formatted version of the article will be published soon.

Subcutaneous immunoglobulin (SCIG) preparations are widely used in patients with inborn errors of immunity (IEI), with proven efficacy and good tolerance. We assessed treatment efficacy, safety, and quality of life in a large cohort of IEI patients who switched from intravenous immunoglobulin (IVIG) to SCIG. Our observational study included 200 patients aged 1‒65 years with IEI. SCIG Cutaquig (16.5%) was administered every 7–10 days for at least 12 months via the rapid push method. We assessed the rate of infection, immunoglobulin G (IgG) concentration, adverse events, and quality of life. A total of 8,787 SCIG doses were administered during the study. The rate of infections (per person/month) during SCIG treatment was 0.05, which was significantly lower compared to 0.19 during the IVIG period (p<0.001). The median trough IgG was 6.9 g/L on IVIG, compared to 9.0 g/L during the first six months, and 9.2 g/L during the next six months on SCIG. Systemic reactions occurred in 12.4% of the IVIG infusions and 1.9% of the SCIG infusions. The total scores on quality of life summary assessments of physical and mental health were higher on SCIG therapy compared with IVIG (p<0.001). At the end of the study, 85.6% of the patients chose to remain on SCIG. Our data suggest that SCIG infusion via the rapid push method is effective, well tolerated, and feasible in large groups of IEI patients, including those in large countries such as Russia.

Keywords: inborn errors of immunity, Subcutaneous immunoglobulin, Intravenous Immunoglobulin, efficacy, Safety, tolerability, Quality of Life, Rapid push

Received: 23 Mar 2025; Accepted: 02 Jun 2025.

Copyright: © 2025 Avedova, Deripapa, Rodina, Mukhina, LATYSHEVA, Yukhacheva, Burlakov, Kan, Bogdanova, Moiseeva, Kuzmenko, Nesterenko, Deordieva, Zinovyeva, Sevostyanova, Kalmeteva, Barycheva, Селезнева, Shakhova, Laba, Vlasova, Gorenkova, Timofeeva, Trusova, Yudina, Bambaeva, Mashkovskaya, Isakova, Selina, Shilova, Mandzhieva, Starikova, Grachev and Shcherbina. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Asmik Avedova, Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russia

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