Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks

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Abstract

Current treatments for long-term prophylaxis in hereditary angioedema have limitations.

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Most cited references 18

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Clinical practice. Hereditary angioedema.

Bruce Zuraw (2008)

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Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema.

Robert Wilkinson, James Scott McClellan, Gery Ryan … (2010)

Hereditary angioedema due to C1 inhibitor deficiency is characterized by recurrent acute attacks of swelling that can be painful and sometimes life-threatening. We conducted two randomized trials to evaluate nanofiltered C1 inhibitor concentrate in the management of hereditary angioedema. The first study compared nanofiltered C1 inhibitor concentrate with placebo for treatment of an acute attack of angioedema. A total of 68 subjects (35 in the C1 inhibitor group and 33 in the placebo group) were given one or two intravenous injections of the study drug (1000 units each). The primary end point was the time to the onset of unequivocal relief. The second study was a crossover trial involving 22 subjects with hereditary angioedema that compared prophylactic twice-weekly injections of nanofiltered C1 inhibitor concentrate (1000 units) with placebo during two 12-week periods. The primary end point was the number of attacks of angioedema per period, with each subject acting as his or her own control. In the first study, the median time to the onset of unequivocal relief from an attack was 2 hours in the subjects treated with C1 inhibitor concentrate but longer than 4 hours in those given placebo (P=0.02). In the second study, the number of attacks per 12-week period was 6.26 with C1 inhibitor concentrate given as prophylaxis, as compared with 12.73 with placebo (P<0.001); the subjects who received the C1 inhibitor concentrate also had significant reductions in both the severity and the duration of attacks, in the need for open-label rescue therapy, and in the total number of days with swelling. In subjects with hereditary angioedema, nanofiltered C1 inhibitor concentrate shortened the duration of acute attacks. When used for prophylaxis, nanofiltered C1 inhibitor concentrate reduced the frequency of acute attacks. (Funded by Lev Pharmaceuticals; ClinicalTrials.gov numbers, NCT00289211, NCT01005888, NCT00438815, and NCT00462709.)

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WAO Guideline for the Management of Hereditary Angioedema

Timothy Craig, Emel Pürsün, Konrad Bork … (2012)

Hereditary Angioedema (HAE) is a rare disease and for this reason proper diagnosis and appropriate therapy are often unknown or not available for physicians and other health care providers. For this reason we convened a group of specialists that focus upon HAE from around the world to develop not only a consensus on diagnosis and management of HAE, but to also provide evidence based grades, strength of evidence and classification for the consensus. Since both consensus and evidence grading were adhered to the document meets criteria as a guideline. The outcome of the guideline is to improve diagnosis and management of patients with HAE throughout the world and to help initiate uniform care and availability of therapies to all with the diagnosis no matter where the residence of the individual with HAE exists.

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Journal

Title: JAMA

Abbreviated Title: JAMA

Publisher: American Medical Association (AMA)

ISSN (Print): 0098-7484

Publication date Created: November 27 2018

Publication date (Print): November 27 2018

Volume: 320

Issue: 20

Page: 2108

Affiliations

[1 ]Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston

[2 ]Division of Rheumatology, Allergy & Immunology, University of California, San Diego

[3 ]Department of Internal Medicine/Allergy Section Cincinnati, University of Cincinnati College of Medicine, Cincinnati, Ohio

[4 ]Department of Biomedical and Clinical Sciences, Luigi Sacco, University of Milan, ASST Fatebenefratelli Sacco, Milan, Italy

[5 ]Barts Health NHS Trust, London, United Kingdom

[6 ]Icahn School of Medicine at Mount Sinai, New York, New York

[7 ]Clinical Research Center of Alabama, Birmingham

[8 ]Department of Dermatology and Allergy, Dermatological Allergology, Charité—Universitätsmedizin Berlin, Berlin, Germany

[9 ]Haemophilia Centre Rhine Main, Mörfelden-Walldorf, Germany

[10 ]Rheumatology Allergy and Immunology, NYU Winthrop Hospital, Mineola, New York

[11 ]Institute for Asthma and Allergy, Chevy Chase, Maryland

[12 ]Department of Medicine and Pediatrics, Pennsylvania State University, Allergy, Asthma, and Immunology, Hershey

[13 ]Allergy and Asthma Clinical Research, Walnut Creek, California

[14 ]Clinical Research of Charlotte, Charlotte, North Carolina

[15 ]Immunology Department, Midwest Immunology Clinic, Plymouth, Minnesota

[16 ]Ottawa Allergy Research Corporation and University of Ottawa Medical School, Ottawa, Ontario, Canada

[17 ]Allergy Asthma Research Associates Research Center, Dallas, Texas

[18 ]Medical Research of Arizona, Scottsdale

[19 ]Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine, Virginia Commonwealth University, Richmond

[20 ]Triumpharma, Amman, Jordan

[21 ]Asthma and Allergy Associates PC, Colorado Springs, Colorado

[22 ]University of Puerto Rico School of Medicine, San Juan

[23 ]Division of Allergy, Clinical Immunology & Rheumatology, University of Kansas Medical Center, Kansas City

[24 ]Allergy Associates of Utah, Murray

[25 ]AIRE Medical of Los Angeles, University of California, Los Angeles

[26 ]Division of Allergy and Immunology, Washington University, St Louis, Missouri

[27 ]Centre de Recherche Appliqué en Allergie de Québec, Quebec, Canada

[28 ]Toledo Institute of Clinical Research, Toledo, Ohio

[29 ]Department of Dermatology, University Medicine Mainz, Mainz, Germany

[30 ]Shire, Lexington, Massachusetts

Article

DOI: 10.1001/jama.2018.16773

PMC ID: 6583584

PubMed ID: 30480729

SO-VID: 7f359999-37a7-44d2-81bc-2632d3740786

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Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks : A Randomized Clinical Trial

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Most cited references 18

Clinical practice. Hereditary angioedema.

Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema.

WAO Guideline for the Management of Hereditary Angioedema

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