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C1‐ INH concentrate for treatment of acute hereditary angioedema: a pediatric cohort from the I.M.P.A.C.T. studies
Author(s) -
Schneider Lynda,
Hurewitz David,
Wasserman Richard,
Obtulowicz Krystyna,
Machnig Thomas,
Moldovan Dumitru,
Reshef Avner,
Craig Timothy J.
Publication year - 2013
Publication title -
pediatric allergy and immunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.269
H-Index - 89
eISSN - 1399-3038
pISSN - 0905-6157
DOI - 10.1111/pai.12024
Subject(s) - medicine , hereditary angioedema , angioedema , cohort , gastroenterology , surgery , pediatrics , dermatology
Background We analyzed the clinical response of pediatric and adolescent hereditary angioedema ( HAE ) patients to pd C 1‐ INH in the I nternational M ulticenter P rospective A ngioedema C 1‐ INH T rials ( I.M.P.A.C.T. ) 1 and 2. Methods Patients included in this post hoc analysis of prospectively collected data were between 10 and 18 yr old with type I or II HAE and a documented history of abdominal or facial attacks. Patients received a single injection of pd C 1‐ INH concentrate ( B erinert ® , CSL B ehring, M arburg, G ermany) 20 U/kg. Efficacy end‐points were time from the administration of study drug to onset of symptom relief and time to complete relief of all symptoms. Results Seven pediatric patients were included in I.M.P.A.C.T.1 with only 1 attack analyzed per patient. Median time to onset of relief was 0.42 h and to complete resolution was 8.08 h. No patient experienced a worsening of symptoms during the 0–4‐h assessment period. Nine patients who experienced a total of 115 attacks were included in the analysis of I.M.P.A.C.T .2. Abdominal attacks were rated as ‘severe’ more frequently than were other types of attacks. The number of attacks per patient ranged from 2 to 42, and study participation ranged from 1 to 38 months. Median times to onset of symptom relief and to complete symptom resolution were 0.49 h and 14.1 h, respectively. Of 4 treatment‐emergent adverse events in both studies, only 2 were considered related to treatment. Conclusions Study results showed that outcomes with pd C 1‐ INH treatment of HAE in pediatric patients are comparable with outcomes in adults.