Treatment with Hizentra in patients with primary and secondary ă immunodeficiencies: a real-life, non-interventional trial

J. F. Viallard, P. Agape, V. Barlogis, G. Cozon, C. Faure, F. Fouyssac, C. Gaud, M. P. Gourin, M. Hamidou, C. Hoarau, F. Husseini, M. Ojeda-Uribe, M. Pavic, I. Pellier, A. Perlat, N. Schleinitz and B. Slama
Additional contact information
V. Barlogis: SPMC - Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants - AMU - Aix Marseille Université - APHM - Assistance Publique - Hôpitaux de Marseille
G. Cozon: LBBE - Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 - UCBL - Université Claude Bernard Lyon 1 - Université de Lyon - VAS - VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement - CNRS - Centre National de la Recherche Scientifique
M. Hamidou: Département d'Hydraulique [M’Sila] - Uni M'sila - University of M'sila / Université Mohamed Boudiaf - M'sila
M. Pavic: CdR & CdL group - Courbes de rotation d'astéroïdes, de comètes et d'étoiles variables - CdR & CdL group
I. Pellier: CHU Angers - Centre Hospitalier Universitaire d'Angers - UNAM - PRES Université Nantes Angers Le Mans
A. Perlat: Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
B. Slama: Centre Hospitalier Henri Duffaut (Avignon)

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Abstract: Background: Although Hizentra is indicated for immunoglobulin ă replacement therapy in patients with primary and secondary ă immunodeficiencies, phase III trials have focused on patients with ă primary immunodeficiencies. In this 9-month, real-life, prospective, ă non-interventional, longitudinal, multicenter study of patients with ă primary and secondary immunodeficiencies in France, treatment modalities ă (primary endpoint), efficacy, safety, tolerability, quality of life, and ă treatment satisfaction were evaluated using descriptive statistics. ă Results: Starting in January 2012, 117 patients were enrolled (99 ă adults, 18 children). Secondary immunodeficiencies were present in 48.7 ă % of patients. At follow-up, injections were administered every 7 days ă in 92.2 % of patients. Nine patients (7.8 %) were taking Hizentra ă every 10-14 days. The median dose of Hizentra administered was 0.1 ă g/kg/injection. Fifty-six patients were administered doses 0.2 ă g/kg/injection. Mean trough IgG titers were 9.0 +/- 3.3 g/L (median 8.3 ă g/L). The mean yearly rate of infection was 1.2 +/- 1.9. Mean scores on ă the Short Form-36 physical and mental component summaries were 46.3 +/- ă 10.0 and 46.6 +/- 9.3, respectively. Scores on the Treatment ă Satisfaction Questionnaire for Medication ranged from 69.9 +/- 19.9 to ă 88.3 +/- 21.2 depending on the domain. Treatment with Hizentra was well ă tolerated. No single drug-related systemic reaction occurred in more ă than one patient and few local reactions were reported (n = 5). ă Conclusions: Under real-life conditions and in a cohort that included ă patients with primary and secondary immunodeficiencies, treatment with ă Hizentra was effective and well tolerated and patients were generally ă satisfied with the treatment.

Keywords: quality (search for similar items in EconPapers)
Date: 2016-09
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Published in BMC Immunology, 2016, 17, ⟨10.1186/s12865-016-0169-5⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-01482353

DOI: 10.1186/s12865-016-0169-5

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