Treatment with Hizentra in patients with primary and secondary immunodeficiencies: a real-life, non-interventional trial.
BACKGROUND
Although Hizentra is indicated for immunoglobulin replacement therapy in patients with primary and secondary immunodeficiencies, phase III trials have focused on patients with primary immunodeficiencies. In this 9-month, real-life, prospective, non-interventional, longitudinal, multicenter study of patients with primary and secondary immunodeficiencies in France, treatment modalities (primary endpoint), efficacy, safety, tolerability, quality of life, and treatment satisfaction were evaluated using descriptive statistics.


RESULTS
Starting in January 2012, 117 patients were enrolled (99 adults, 18 children). Secondary immunodeficiencies were present in 48.7 % of patients. At follow-up, injections were administered every 7 days in 92.2 % of patients. Nine patients (7.8 %) were taking Hizentra every 10-14 days. The median dose of Hizentra administered was 0.1 g/kg/injection. Fifty-six patients were administered doses <0.1 g/kg/injection and 13 patients were administered doses >0.2 g/kg/injection. Mean trough IgG titers were 9.0 ± 3.3 g/L (median 8.3 g/L). The mean yearly rate of infection was 1.2 ± 1.9. Mean scores on the Short Form-36 physical and mental component summaries were 46.3 ± 10.0 and 46.6 ± 9.3, respectively. Scores on the Treatment Satisfaction Questionnaire for Medication ranged from 69.9 ± 19.9 to 88.3 ± 21.2 depending on the domain. Treatment with Hizentra was well tolerated. No single drug-related systemic reaction occurred in more than one patient and few local reactions were reported (n = 5).


CONCLUSIONS
Under real-life conditions and in a cohort that included patients with primary and secondary immunodeficiencies, treatment with Hizentra was effective and well tolerated and patients were generally satisfied with the treatment.
Centre Hospitalier Universitaire Haut-Lévêque, 5, Avenue de Magellan, 33604, Pessac Cedex, France. jean-francois.viallard@chu-bordeaux.fr.
J F
JF
Viallard
Institut de Cancerologie de l'Ouest, 11 Boulevard Jacques Monod, 44800, Saint-Herblain, France.
P
P
Agape
CHU de Marseille - Hôpital de la Timone, 264 rue Saint-Pierre, 13385, Marseille Cedex 5, France.
V
V
Barlogis
CHU Edouard Herriot, 5 place d'Arsonval, 69003, Lyon, France.
G
G
Cozon
Centre hospitalier intercommunal de la Haute-Saône, 2 rue Heymes BP 409, 70014, Vesoul Cedex, France.
C
C
Faure
CHU de Nancy, 29, avenue du Maréchal de lattre de Tassigny, 54035, Nancy Cedex, France.
F
F
Fouyssac
Centre hospitalier universitaire Felix Guyon, service d'immunologie clinique, 97405, Saint Denis Cedex Ile de la Reunion, France.
C
C
Gaud
CHU Limoges, 2, avenue Martin Luther King, 87042, Limoges cedex, France.
M P
MP
Gourin
CHU de Nantes - Hôtel Dieu, 1 place Alexis Ricordeau, 44093, Nantes Cedex 1, France.
M
M
Hamidou
Centre hospitalier universitaire de Tours, 37044, Tours Cedex 9, France.
C
C
Hoarau
Centre Hospitalier Hôpitaux Civils de Colmar, 39, avenue de la Liberté, 68024, Colmar cedex, France.
F
F
Husseini
Centre Hospitalier de la région de Mulhouse & Sud Alsace, 87, avenue d'altkirch, 68051, Mulhouse CEDEX, France.
M
M
Ojeda-Uribe
CHU Fleurimont, Sherbrooke, QC, J1H 5N4, Canada.
M
M
Pavic
CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.
I
I
Pellier
CHU de Rennes, 16 bd de Bulgarie, 35200, Rennes, France.
A
A
Perlat
CHU la Timone, 264 Rue Saint-Pierre, 13385, Marseille Cedex 5, France.
N
N
Schleinitz
CH Avignon, 305 rue Raoul Follereau, 84000, Avignon Cedex 9, France.
B
B
Slama
Hizentra; Primary immunodeficiency; Secondary immunodeficiency; Subcutaneous immunoglobulin
J Clin Immunol. 2010 Sep;30(5):734-45
20454851
J Clin Immunol. 2011 Oct;31(5):752-61
21674136
J Clin Immunol. 2006 Jan;26(1):65-72
16418804
Clin Exp Immunol. 2010 May;160(2):240-5
20041884
J Allergy Clin Immunol. 2004 Oct;114(4):936-42
15480339
Clin Exp Immunol. 2015 Sep;181(3):441-50
25761372
Clin Exp Immunol. 2008 Jan;151(1):42-50
18005364
Clin Exp Immunol. 2008 May;152(2):274-9
18341618
Clin Immunol. 2014 Feb;150(2):161-9
24412910
Drugs. 2013 Aug;73(12):1307-19
23861187
Health Qual Life Outcomes. 2004 Feb 26;2:12
14987333
BMJ. 1993 May 29;306(6890):1437-40
8518639
Patient Prefer Adherence. 2014 May 02;8:621-9
24833896
Clin Immunol. 2011 Oct;141(1):90-102
21705277
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9
11124729