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Free Content Efficacy of recombinant human C1 esterase inhibitor across anatomic locations in acute hereditary angioedema attacks

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Background:

Hereditary angioedema (HAE) may occur at or spread to multiple anatomic locations during an acute attack. Recombinant human C1 esterase inhibitor (rhC1-INH) is approved for treating acute HAE attacks.

Objective:

To examine the time to the beginning of symptom relief with rhC1-INH by attack location.

Methods:

Data for patients ≥12 years of age with an acute HAE attack who received rhC1-INH 50 IU/kg or placebo were pooled from two double-blind clinical trials with open-label extensions. The time to the beginning of symptom relief was defined as the first time point that the visual analog scale severity score at an attack location decreased by ≥20 mm versus baseline, with persistence. Data were reported as median time values (95% confidence interval [CI]).

Results:

For abdominal attacks, the median time to the beginning of symptom relief was 60.0 minutes (95% CI, 47.0‐62.0 minutes; n = 194 attacks) with rhC1-INH versus 240.0 minutes (95% CI, 45.0‐720.0 minutes; n = 15 attacks) with placebo. The median time to the beginning of symptom relief for peripheral attacks was 105.0 minutes (95% CI, 90.0‐120.0 minutes; n = 169 attacks) with rhC1-INH versus 303.0 minutes (95% CI, 180.0‐720.0 minutes; n = 17 attacks) with placebo. For oro-facial-pharyngeal-laryngeal attacks or urogenital attacks, the median time to the beginning of symptom relief with rhC1-INH was 64.5 minutes (95% CI, 60.0‐120.0 minutes; n = 36 attacks) and 119.0 minutes (95% CI, 40.0‐270.0 minutes; n = 13 attacks), respectively, versus 306.0 minutes (95% CI, 30.0‐495.0 minutes; n = 6 attacks) and 320.0 minutes (n = 1 attack) with placebo.

Conclusion:

In shortening the median time to the beginning of symptom relief of acute HAE attacks, rhC1-INH 50 IU/kg was efficacious, regardless of attack location.
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Keywords: C1 esterase inhibitor; Ruconest; abdominal; hereditary angioedema; laryngeal; oro-facial; peripheral; pharyngeal; urogenital

Document Type: Research Article

Affiliations: 1: From the Allergies and Asthma, Baker Allergy Asthma Dermatology Research Center, Portland, Oregon 2: Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio 3: Department of Medical Affairs, Pharming Healthcare Inc., Bridgewater, New Jersey 4: Clinical Research and Medical Affairs, Pharming Healthcare Inc., Bridgewater, New Jersey 5: Division of Rheumatology, Allergy, and Immunology, University of California-San Diego, San Diego, California

Publication date: 01 September 2018

This article was made available online on 28 June 2018 as a Fast Track article with title: "Efficacy of recombinant human C1 esterase inhibitor across anatomic locations in acute hereditary angioedema attacks ".

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  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

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    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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