EDEMA4: a phase 3, double-blind study of subcutaneous ecallantide treatment for acute attacks of hereditary angioedema

Levy, Robyn J.; Lumry, William R.; McNeil, Donald L.; Li, H. Henry; Campion, Marilyn; Horn, Patrick T.; Pullman, William E.

doi:10.1016/j.anai.2010.04.012

Cited by 131 publications

(137 citation statements)

References 18 publications

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“…Level I evidence for acute treatment of C1‐INH‐HAE has been reviewed for pdC1‐INH Be , pdC1‐INH Ci , recombinant human C1‐INH (rhC1‐INH) (Rhucin/Ruconest ® ), kallikrein inhibitor ecallantide (Kalbitor ® ), and bradykinin B2 receptor antagonist icatibant (Firazyr ® ) 85, 91, 92, 95, 96, 97, 98, 99. Unfortunately, these treatments have been licensed mainly for adults with pediatric licensing pending and ages for licenses varying by jurisdiction.…”

Section: Resultsmentioning

confidence: 99%

International consensus on the diagnosis and management of pediatric patients with hereditary angioedema with C1 inhibitor deficiency

Farkas

Martinez‐Saguer²,

Bork

et al. 2016

Allergy

177

308

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BackgroundThe consensus documents published to date on hereditary angioedema with C1 inhibitor deficiency (C1‐INH‐HAE) have focused on adult patients. Many of the previous recommendations have not been adapted to pediatric patients. We intended to produce consensus recommendations for the diagnosis and management of pediatric patients with C1‐INH‐HAE.MethodsDuring an expert panel meeting that took place during the 9th C1 Inhibitor Deficiency Workshop in Budapest, 2015 (www.haenet.hu), pediatric data were presented and discussed and a consensus was developed by voting.ResultsThe symptoms of C1‐INH‐HAE often present in childhood. Differential diagnosis can be difficult as abdominal pain is common in pediatric C1‐INH‐HAE, but also commonly occurs in the general pediatric population. The early onset of symptoms may predict a more severe subsequent course of the disease. Before the age of 1 year, C1‐INH levels may be lower than in adults; therefore, it is advisable to confirm the diagnosis after the age of one year. All neonates/infants with an affected C1‐INH‐HAE family member should be screened for C1‐INH deficiency. Pediatric patients should always carry a C1‐INH‐HAE information card and medicine for emergency use. The regulatory approval status of the drugs for prophylaxis and for acute treatment is different in each country. Plasma‐derived C1‐INH, recombinant C1‐INH, and ecallantide are the only agents licensed for the acute treatment of pediatric patients. Clinical trials are underway with additional drugs. It is recommended to follow up patients in an HAE comprehensive care center.ConclusionsThe pediatric‐focused international consensus for the diagnosis and management of C1‐INH‐HAE patients was created.

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Section: Resultsmentioning

confidence: 99%

International consensus on the diagnosis and management of pediatric patients with hereditary angioedema with C1 inhibitor deficiency

Farkas

Martinez‐Saguer²,

Bork

et al. 2016

Allergy

177

308

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“…Our results are similar to those of a recent Phase IIIb, open-label, multicentre study of a single icatibant injection in adult patients with HAE types I and II, which reported that 91·8% of patients required only one icatibant injection and 6·6% of patients required rescue medication [18]. The relatively recent US approval of several therapies for the treatment of HAE attacks (pasteurized and nanofiltered C1-INH concentrate, ecallantide and icatibant) has resulted from controlled clinical trials demonstrating their efficacy in primarily single attacks [13,[19][20][21][22][23]. As patients with HAE will continue to suffer attacks throughout their lives, sometimes on a weekly basis [5][6][7], they require treatments which demonstrate consistent efficacy with repeated use.…”

Section: Discussionmentioning

confidence: 99%

Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial

Malbrán

Riedl

Ritchie

et al. 2014

Clinical and Experimental Immunology

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“…[89][90][91][92][93] The results from double-blind clinical trials concerning the efficacy of subcutaneous treatment for acute attacks of HAE are promising and indicate new treatment possibilities of bradykinin-mediated angioedema. 54,94,95 Supplementary material online Supplementary material is available with the online version of the article at www.pamw.pl.…”

Section: 60mentioning

confidence: 99%

Bradykinin-mediated angioedema

Obtułowicz¹

2016

Polish Archives of Internal Medicine

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EDEMA4: a phase 3, double-blind study of subcutaneous ecallantide treatment for acute attacks of hereditary angioedema

Cited by 131 publications

References 18 publications

International consensus on the diagnosis and management of pediatric patients with hereditary angioedema with C1 inhibitor deficiency

International consensus on the diagnosis and management of pediatric patients with hereditary angioedema with C1 inhibitor deficiency

Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial

Bradykinin-mediated angioedema

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