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Use of a C1 Esterase Inhibitor Concentrate in Elderly Patients with Hereditary Angioedema: Findings from the International Berinert® (C1-INH) Registry
Monday, March 7, 2016
South Exhibit Hall H (Convention Center)
Anette Bygum, MD, Inmaculada Martinez-Saguer, MD, Murat Bas, MD, Jeffrey M. Rosch, MD FAAAAI, Jonathan M. Edelman, MD, Mikhail Rojavin, PhD, Debora Williams-Herman, MD
Rationale:

Treatment of hereditary angioedema (HAE) in elderly patients is not well characterized. A large international patient registry evaluated the use of plasma-derived, pasteurized, nanofiltered C1-inhibitor concentrate (pnfC1-INH; Berinert®/CSL Behring) in patients of all ages.

Methods:

This observational registry, conducted from 2010-2014 at 34 US and 7 European sites, gathered prospective (post-enrollment) and retrospective (pre-enrollment, if available for 2009) usage and adverse event (AE) data on subjects treated with pnfC1-INH. Data from subjects ≥65 years of age were compared with those in adults 17 to <65 years of age. 

Results:

The registry documented 1701 pnfC1-INH infusions in 27 elderly subjects (maximum age 83 years). A total of 1511 HAE attacks treated with pnfC1-INH administration were reported among 25/27 (92.6%) elderly subjects. Among elderly subjects, mean ± SD (8.8 ± 4.1 IU/kg) and median (6.4 IU/kg) pnfC1-INH doses were lower than those reported for 252 adults (12.9 ± 6.2; 12.5 IU/kg, respectively). Nineteen AEs occurred in 8 of 23 (34.8%) elderly subjects with prospective data (safety set), for rates of 0.83 events/subject and 0.02 events/infusion, similar to corresponding rates in adults (0.91 and 0.03, respectively). None of the AEs were considered related to pnfC1-INH and all but two events (prostatectomy, GI bleeding) were mild or moderate in severity. There were four serious adverse events (prostatectomy; urinary tract infection requiring hospitalization; transient ischemic attack; and GI bleeding).

Conclusions:

These findings suggest a high degree of safety with pnfC1-INH administration in elderly HAE patients and reveal a pattern of lower weight-based dosing in elderly versus non-elderly adults.