Recent advances in the management of hereditary angioedema

Journal of the American Osteopathic Association

Volumn 113, Issue 7, 2013, Pages 546-555

  Hemperly, Stephen E ^a   Sardana Agarwal, Niti ^b   Xu, Ying Yang ^c   Zhi, Yu Xiang ^c   Craig, Timothy J ^d  

^a LEHIGH VALLEY HOSPITAL   (United States)

^b WEILL CORNELL MEDICAL CENTER   (United States)

^c PEKING UNION MEDICAL COLLEGE HOSPITAL   (China)

^d PENN STATE MILTON S HERSHEY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM SILICATE; BERINGITE; COMPLEMENT COMPONENT C1S INHIBITOR; ECALLANTIDE; KALLIKREIN; PEPTIDE; SERPING1 PROTEIN, HUMAN;

ANGIOEDEMAS, HEREDITARY; ANTAGONISTS AND INHIBITORS; CAPILLARY; DIFFERENTIAL DIAGNOSIS; HUMAN; PATHOPHYSIOLOGY; ANGIONEUROTIC EDEMA; DRUG ANTAGONISM; REVIEW;

ALUMINUM SILICATES; ANGIOEDEMAS, HEREDITARY; CAPILLARIES; COMPLEMENT C1 INACTIVATOR PROTEINS; COMPLEMENT C1 INHIBITOR PROTEIN; DIAGNOSIS, DIFFERENTIAL; HUMANS; KALLIKREINS; PEPTIDES;

EID: 84880589727     PISSN: 00986151     EISSN: 19451997     Source Type: Journal    
DOI: 10.7556/jaoa.2013.006     Document Type: Review

References (42)

1. Fields T, Ghebrehiwet B, Kaplan AP. Kinin formation in hereditary angioedema plasma: evidence against kinin derivation from C2 and in support of "spontaneous" formation of bradykinin. J Allergy Clin Immunol. 1983;72(1):54-60.
2. Han ED, MacFarlane RC, Mulligan AN, Scafidi J, Davis AE III. Increased vascular permeability in C1 inhibitor-deficient mice mediated by the bradykinin type 2 receptor. J Clin Invest. 2002;109(8):1057-1063.
3. Nussberger J, Cugno M, Cicardi M, Agostoni A. Local bradykinin generation in hereditary angioedema. J Allergy Clin Immunol. 1999;104(6):1321-1322.
4. Zuraw BL, Christiansen SC. Pathogenesis and laboratory diagnosis of hereditary angioedema. Allergy Asthma Proc. 2009;30(5):487-492.
5. Banerji A, Sheffer AL. The spectrum of chronic angioedema. Allergy Asthma Proc. 2009;30(1):11-16.
6. Bork K, Barnstedt S, Koch P, Traupe H. Hereditary angioedema with normal C1- inhibitor activity in women. Lancet. 2000;356(9225):213-217.
7. Bowen T, Cicardi M, Farkas H, et al. 2010 International consensus algorithm for the diagnosis, therapy and management of hereditary angioedema. Allergy Asthma Clin Immunol. 2010;6(1):24.
8. Wilson DA, Bork K, Shea EP, Rentz AM, Blaustein MB, Pullman WE. Economic costs associated with acute attacks and long-term management of hereditary angioedema. Ann Allergy Asthma Immunol. 2010;104(4):314-320.
9. October 10, 2008 approval letter-CINRYZE. US Food and Drug Administration website. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm093602.htm. Accessed June 6, 2013.
10. October 9, 2009 approval letter-Berinert. US Food and Drug Administration website. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm186265.htm. Accessed June 6, 2013.
11. Epstein TG, Bernstein JA. Current and emerging management options for hereditary angioedema in the US. Drugs. 2008;68(18):2561-2573.
12. Bernstein JA. Hereditary angioedema: a current state-of-the-art review, VIII: current status of emerging therapies. Ann Allergy Asthma Immunol. 2008;100(1 suppl 2):S41-S46.
13. Zuraw BL. Hereditary angioedema: a current state-of-the-art review, IV: short- and long-term treatment of hereditary angioedema: out with the old and in with the new? Ann Allergy Asthma Immunol. 2008;100(1 suppl 2):S13-S18.
14. Zuraw BL, Busse PJ, White M, et al. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010;363(6):513-522.
15. Zuraw BL, Schaefer O, Grant JA, et al. Results of a randomized double-blind placebo controlled study of nanofiltered C1-inhibitor for the treatment of HAE attacks. Ann Allergy Asthma Immunol. 2010;105(5 suppl):A100.
16. Sausville RA. C1 esterase inhibitor (human)(Cinryze) [untitled letter]. US Food and Drug Administration website. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm174489.htm. Updated July 30, 2009. Accessed May 28, 2013.
17. CYNRYZE [package insert]. Exton, PA: ViroPharma Biologics; 2010. http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM129918.pdf. Accessed June 6, 2013.
18. Czaller I, Visy B, Csuka D, Füst G, Tóth F, Farkas H. The natural history of hereditary angioedema and the impact of treatment with human C1-inhibitor concentrate during pregnancy: a long-term survey. Eur J Obstet Gynecol Reprod Biol. 2010;152(1):44-49.
19. Farkas H, Varga L, Széplaki G, Visy B, Harmat G, Bowen T. Management of hereditary angioedema in pediatric patients [published online ahead of print August 27, 2007]. Pediatrics. 2007;120(3):e713-e722. http://pediatrics.aappublications.org/content/120/3/e713.long. Accessed June 13, 2013.
20. Longhurst HJ, Farkas H, Craig T, et al. HAE international home therapy consensus document. Allergy Asthma Clin Immunol. 2010;6(1):22.
21. December 22, 2011 approval letter-Berinert. US Food and Drug Administration website. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm285112.htm. Accessed June 6, 2013.
22. Berinert [package insert]. Kankakee, IL: CSL Behring LLC; 2012. http://labeling.cslbehring.com/PI/US/Berinert/EN/Berinert-Prescribing-Information.pdf. Accessed May 28, 2013.
23. Craig TJ, Levy RJ, Wasserman RL, et al. Efficacy of human C1 esterase inhibitor concentrate compared with placebo in acute hereditary angioedema attacks. J Allergy Clin Immunol. 2009;124(4):801-808.
24. Craig TJ, Levy RJ, Wasserman RL, et al. Efficacy of human C1 inhibitor concentrate compared with placebo in acute hereditary angioedema attacks. J Allergy Clin Immunol. 2009;124(4):801-808.
25. Levy RL, Wasserman RL, Bewtra AK, et al. C1 esterase inhibitor concentrate (C1-INH) for treatment of acute attacks of hereditary angioedema: interim results of an ongoing prospective, open label study in North America after 640 attacks (I.M.P.A.C.T. 2) [abstract]. J Allergy Clin Immunol. 2009;123(2 suppl):S99.
26. UPDATE 1-Pharming starts new Rhucin trial for FDA approval [news release]. Amsterdam, Netherlands: Reuters; February 22, 2011. http://www.reuters.com/article/2011/02/22/pharming-idUSLDE71L05F20110222. Accessed June 12, 2013.
27. van Doorn MB, Burggraaf J, van Dam T, et al. A phase I study of recombinant human C1 inhibitor in asymptomatic patients with hereditary angioedema. J Allergy Clin Immunol. 2005;116(4):876-883.
28. Choi G, Soeters MR, Farkas H, et al. Recombinant human C1-inhibitor in the treatment of acute angioedema attacks. Transfusion. 2007;47(6):1028-1032.
29. Zuraw B, Cicardi M, Levy RJ, et al. Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema. J Allergy Clin Immunol. 2010;126(4):821-827:e14. http://pediatrics.aappublications.org/content/120/3/e713.long. Accessed June 13, 2013.
30. Bernstein JA. Hereditary angioedema: a current state-of-the-art review, VIII-current status of emerging therapies. Ann Allergy Asthma Immunol. 2008;100(1 suppl 2):S41-S46.
31. Zuraw BL. HAE therapies: past present and future. Allergy Asthma Clin Immunol. 2010;6(1):23-28.
32. Cicardi M, Levy RJ, McNeil DL, et al. Ecallantide for the treatment of acute attacks in hereditary angioedema. N Engl J Med. 2010;363(6):523-531.
33. Levy R, McNeil D, Li H, Hsu FI, Horn P, Roberts J. Results of a 2-stage, phase 3 pivotal trial, EDEMA3: a study of subcutaneous DX-88 (Ecallantide), a plasma kallikrein inhibitor, in patients with hereditary angioedema (HAE). J Allergy Clin Immunol. 2008; 121(2 suppl):S231.
34. Levy RJ, Lumry WR, McNeil DL, et al. EDEMA4: a phase 3, double-blind study of subcutaneous ecallantide treatment for acute attacks of hereditary angioedema. Ann Allergy Asthma Immunol. 2010;104(6):523-529.
35. BLA approval [letter]. US Food and Drug Administration website. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125277s000ltr.pdf. Accessed June 6, 2013.
36. Caballero T, López-Serrano C. Anaphylactic reaction and antibodies to DX-88 (kallikrein inhibitor) in a patient with hereditary angioedema. J Allergy Clin Immunol. 2006;117(2):476-477.
37. European Medicines Agency. CHMP Assessment Report for Firazyr. London, UK: European Medicines Agency; 2008. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000899/WC500022970.pdf. Accessed May 28, 2013.
38. Cicardi M, Banerji A, Bracho F, et al. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010;363(6):532-541.
39. Bernstein JA, Qazi M. Ecallantide: its pharmacology, pharmacokinetics, clinical efficacy and tolerability. Expert Rev Clin Immunol. 2010;6(1):29-39.
40. Lumry WR, Li HH, Levy RJ, et al. Randomized placebo-controlled trial of the bradykinin B2 receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011;107(6):529-537.
41. NDA approval [letter]. US Food and Drug Administration website. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022150s000ltr.pdf. Accessed June 6, 2013.
42. Craig T, Pürsün EA, Bork K, Bowen T, Boysen H. WAO guideline for the management of hereditary angioedema. World Allergy Organ J. 2012;5(12):182-199.