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Insights into Patient Experiences with Facilitated Subcutaneous Immunoglobulin Therapy in Primary Immune Deficiency: A Prospective Observational Cohort.
Yalcin Gungoren, Ezgi; Yorgun Altunbas, Melek; Dikici, Ummugulsum; Meric, Zeynep; Eser Simsek, Isil; Kiykim, Ayca; Can, Salim; Karabiber, Esra; Yakici, Nalan; Orhan, Fazil; Cokugras, Haluk; Aydogan, Metin; Ozdemir, Oner; Bilgic Eltan, Sevgi; Baris, Safa; Ozen, Ahmet; Karakoc-Aydiner, Elif.
Afiliación
  • Yalcin Gungoren E; Depatment of Pediatrics, Division of Allergy and Immunology, Faculty of Medicine, Marmara University, Istanbul, Turkey.
  • Yorgun Altunbas M; Istanbul Jeffrey Modell Diagnostic and Research Center for Primary Immunodeficiencies, Istanbul, Turkey.
  • Dikici U; The Isil Berat Barlan Center for Translational Medicine, Division of Pediatric Allergy and Immunology, Marmara University, Istanbul, Turkey.
  • Meric Z; Depatment of Pediatrics, Division of Allergy and Immunology, Faculty of Medicine, Marmara University, Istanbul, Turkey.
  • Eser Simsek I; Istanbul Jeffrey Modell Diagnostic and Research Center for Primary Immunodeficiencies, Istanbul, Turkey.
  • Kiykim A; The Isil Berat Barlan Center for Translational Medicine, Division of Pediatric Allergy and Immunology, Marmara University, Istanbul, Turkey.
  • Can S; Department of Pediatrics, Division of Allergy and Immunology, Sakarya University, Training and Research Hospital, Sakarya, Turkey.
  • Karabiber E; Depatment of Pediatrics, Division of Allergy and Immunology, Istanbul University- Cerrahpasa, Istanbul, Turkey.
  • Yakici N; Department of Pediatrics, Division of Allergy and Immunology, Faculty of Medicine, Kocaeli University, Kocaeli, Turkey.
  • Orhan F; Depatment of Pediatrics, Division of Allergy and Immunology, Istanbul University- Cerrahpasa, Istanbul, Turkey.
  • Cokugras H; Depatment of Pediatrics, Division of Allergy and Immunology, Faculty of Medicine, Marmara University, Istanbul, Turkey.
  • Aydogan M; Istanbul Jeffrey Modell Diagnostic and Research Center for Primary Immunodeficiencies, Istanbul, Turkey.
  • Ozdemir O; The Isil Berat Barlan Center for Translational Medicine, Division of Pediatric Allergy and Immunology, Marmara University, Istanbul, Turkey.
  • Bilgic Eltan S; Department of Chest Diseases, Division of Allergy and Immunology, Faculty of Medicine, Marmara University, Istanbul, Turkey.
  • Baris S; Depatment of Pediatrics, Division of Allergy and Immunology, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
  • Ozen A; Depatment of Pediatrics, Division of Allergy and Immunology, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
  • Karakoc-Aydiner E; Depatment of Pediatrics, Division of Allergy and Immunology, Istanbul University- Cerrahpasa, Istanbul, Turkey.
J Clin Immunol ; 44(8): 169, 2024 Aug 05.
Article en En | MEDLINE | ID: mdl-39098942
ABSTRACT

BACKGROUND:

Immunoglobulin G replacement therapy (IgRT), intravenous (IV) and subcutaneous (SC) routes, is pivotal in treatment of primary immunodeficiencies (PID). In recent years, facilitated subcutaneous immunoglobulin (fSCIG), a combination of rHuPH20 and 10% IgG has emerged as a delivery method to combine advantages of both IV and SC.

METHOD:

In an observational prospective cohort, we investigated patient experience with fSCIG in PID patients from 5 PID centers for up to 12 months. We assessed the efficacy and safety of this treatment with patient/caregiver- and physician-reported indicators. Additionally, we analyzed patient treatment satisfaction (TSQM-9) and quality of life (QoL).

RESULTS:

We enrolled 29 patients (22 pediatric and 7 adults; 14 females and 15 males; (median 15, min-max 2-40.9 years) who initiated fSCIG as IgRT-naive (n = 1), switched from conventional rapid-push 10% SCIG (n = 6) or IVIG (n = 22). Among the participants, 19 (65%) exhibited antibody deficiencies, 8 (27%) combined immunodeficiencies, and 2 (7%) immune dysregulations. Remarkably, targeted trough immunoglobulin G levels were achieved under all previous IgRTs as well as fSCIG. No severe systemic adverse drug reactions were documented, despite prevalent local (%86.45) and mild systemic (%26.45) adverse reactions were noted with fSCIG. Due to mild systemic symptoms, 2 patients switched from fSCIG to 10% SCIG. The patient satisfaction survey revealed a notable increase at 2-4th (p = 0.102); 5-8th (p = 0.006) and 9-12th (p < 0.001) months compared to the baseline. No significant trends were observed in QoL surveys.

CONCLUSION:

fSCIG demonstrates admissable tolerability and efficacy in managing PIDs in addition to notable increase of patients' drug satisfaction with IgRT. The identified benefits support the continuation of this therapy despite the local reactions.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Inmunoglobulina G / Satisfacción del Paciente / Inmunoglobulinas Intravenosas Límite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: J Clin Immunol Año: 2024 Tipo del documento: Article País de afiliación: Turquía Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Inmunoglobulina G / Satisfacción del Paciente / Inmunoglobulinas Intravenosas Límite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: J Clin Immunol Año: 2024 Tipo del documento: Article País de afiliación: Turquía Pais de publicación: Países Bajos