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Efficacy and Safety of Subcutaneous Vivaglobin® Replacement Therapy in Previously Untreated Patients with Primary Immunodeficiency: A Prospective, Multicenter Study

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Abstract

Treatment of primary immunodeficiency (PI) is typically initiated with intravenous immunoglobulin (IVIG) loading and then continued with IVIG or subcutaneous IgG (SCIG). This prospective, open-label, multicenter, 6-month study evaluated a new regimen of initiating IgG therapy with SCIG in 18 previously untreated patients. In the loading phase, SCIG 100 mg/kg was administered for five consecutive days (total loading dose 500 mg/kg). During the maintenance phase, patients self-infused SCIG 100 mg/kg/week at home. The primary efficacy endpoint of IgG levels ≥5 g/L on day 12 was achieved in 17 patients (94.4%; 95% CI 0.727, 0.999). The rate of infections was 3.95 episodes/patient/year. Improvement was found in many subscales of the health-related quality of life questionnaires. SCIG treatment was well tolerated, with no related serious adverse events (AEs). Nine (50%) patients experienced related AEs, including local reactions (rate 0.105 events/infusion). The results suggest that therapy of newly diagnosed patients with PI can be initiated directly with SCIG.

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Acknowledgments

This study was supported by CSL Behring AG, Berne, Switzerland, who also provided the SCIG product (Vivaglobin®, CSL Behring GmbH, Marburg, Germany). The opinions expressed in this paper are those of the authors.

The authors would like to thank Maria Fasshauer (Hospital “St. Georg” GmbH Leipzig, Academic Teaching Hospital of the University of Leipzig, Leipzig, Germany), Silvia Sanchez-Ramón, Juana Gil, Javier Carbone, and Diana Alecsandru (Unidad de Inmunología Clinica, Hospital General Universitario Gregorio Marañón, Departamento Microbiología I e Inmunología, Universidad Complutense de Madrid, Madrid, Spain) for their invaluable support during the study. The assistance of Corinna Miede from Accovion GmbH for the statistical analyses is gratefully appreciated. The authors thank Othmar Zenker for help during the conduct of the study and Andrea Sebald and Jeff Baggish for critical review of the manuscript. We also acknowledge the editorial assistance of Phocus Services Ltd supported by CSL Behring.

Disclosure of Conflicts of Interest

Dr. Borte reports consultant fees from CSL Behring and Baxter, and honoraria for lectures from CSL Behring, Baxter, and Octapharma; Dr. Quinti, consultant fees from Baxter; Dr. Fernández-Cruz, honoraria for lectures from CSL Behring, investigator for Fondo de Investigacion Instituto Carlos III and GlaxoSmithKline; Dr. Ritchie, consulting work for Baxter, Bayer, CSL Behring, Candian Blood Services, Dyax, Novartis, Novo Nordisk, Pharming, Pfizer, Shire, Talecris and the Workers Compensation Board of Alberta, in lieu of payment, donations have been made to the University of Alberta; Dr. McCusker has participated in Advisory Boards for CSL Behring, Talecris and Baxter and has received honoraria for lectures from CSL Behring; Dr. Schmidt is an employee of CSL Behring. No other potential conflicts of interest were reported.

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Authors and Affiliations

  1. Hospital “St. Georg” GmbH Leipzig, Academic Teaching Hospital of the University of Leipzig, Delitzscher Straße 141, 04129, Leipzig, Germany

    Michael Borte

  2. Department of Internal Medicine, University “La Sapienza”, Rome, Italy

    Isabella Quinti

  3. Department of Pediatrics, University of Brescia, Brescia, Italy

    Annarosa Soresina

  4. Division Inmunología Clinica, Hospital General Universitario Gregorio Marañón, Departamento Microbiología I e Inmunología, Universidad Complutense de Madrid, Madrid, Spain

    Eduardo Fernández-Cruz

  5. Division of Hematology, Faculty of Medicine, University of Alberta, Edmonton, AB, Canada

    Bruce Ritchie

  6. CSL Behring GmbH, Marburg, Germany

    Dirk S. Schmidt

  7. Division of Allergy and Immunology, Montreal Children’s Hospital, McGill University Health Center, Montreal, QC, Canada

    Christine McCusker

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  1. Michael Borte
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  2. Isabella Quinti
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  3. Annarosa Soresina
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  4. Eduardo Fernández-Cruz
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  5. Bruce Ritchie
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  6. Dirk S. Schmidt
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  7. Christine McCusker
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Correspondence to Michael Borte.

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Borte, M., Quinti, I., Soresina, A. et al. Efficacy and Safety of Subcutaneous Vivaglobin® Replacement Therapy in Previously Untreated Patients with Primary Immunodeficiency: A Prospective, Multicenter Study. J Clin Immunol 31, 952–961 (2011). https://doi.org/10.1007/s10875-011-9588-5

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  • DOI: https://doi.org/10.1007/s10875-011-9588-5

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