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

• DOI: 10.1186/s12865-016-0169-5
• Publication Date: 2016-09-28T23:56:38Z
• Authors: 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; B. Slama
• Keywords: Tolerability; Clinical endpoint

Although Hizentra is indicated for immunoglobulin replacement therapy in patients with primary and secondary immunodeficiencies, phase III trials have focused on immunodeficiencies. In this 9-month, real-life, prospective, non-interventional, longitudinal, multicenter study of immunodeficiencies France, treatment modalities (primary endpoint), efficacy, safety, tolerability, quality life, satisfaction were evaluated using descriptive statistics.Starting January 2012, 117 enrolled (99 adults, 18 children). Secondary present 48.7 % patients. At follow-up, injections administered every 7 days 92.2 Nine (7.8 %) taking 10-14 days. The median dose was 0.1 g/kg/injection. Fifty-six doses <0.1 g/kg/injection 13 >0.2 Mean trough IgG titers 9.0 ± 3.3 g/L (median 8.3 g/L). mean yearly rate infection 1.2 1.9. scores the Short Form-36 physical mental component summaries 46.3 10.0 46.6 9.3, respectively. Scores Treatment Satisfaction Questionnaire Medication ranged from 69.9 19.9 to 88.3 21.2 depending domain. well tolerated. No single drug-related systemic reaction occurred more than one patient few local reactions reported (n = 5).Under real-life conditions a cohort that included effective tolerated generally satisfied treatment.