Ecallantide (DX-88) for acute hereditary angioedema attacks: Integrated analysis of 2 double-blind, phase 3 studies

Sheffer, Albert L.; Campion, Marilyn; Levy, Robyn J.; Li, H. Henry; Horn, Patrick T.; Pullman, William E.

doi:10.1016/j.jaci.2011.03.006

Cited by 57 publications

(64 citation statements)

References 17 publications

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“…[58][59][60] En otras partes del mundo existen otras opciones de tratamiento, algunas reemplazan la proteína deficiente, como el C1 inhibidor humano derivado del plasma y el C1 inhibidor recombinante; [61][62][63] así como el ecallantide, un inhibidor reversible de la calicreína plasmática. [64][65][66] La elección del tratamiento depende de la edad, frecuencia y gravedad de los ataques y la disponibilidad de los medicamentos.…”

Section: Tratamientounclassified

Angioedema

Holguín-Gómez

Vásquez-Ochoa

Cardona

2016

RAM

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Angioedema is defined as edema of the skin or mucosa, including the respiratory and the gastrointestinal mucosa, which is self-limiting, and in most cases is completely resolved in less than 72 hours. It occurs due to increased permeability of the mucosal and submucosal capillaries and postcapillary venules, with resulting plasma extravasation. There are different types of angioedema: histaminergic (which may be mediated by immunoglobulin E), hereditary, from acquired C1 inhibitor deficiency, from angiotensin converting enzyme inhibitor, bradykinin-mediated, and nonhistaminergic idiopathic angioedema. Treatment depends on the cause of angioedema, age, and the frequency and severity of manifestations. The main measures are avoiding external triggers or causes, giving antihistamines, steroids, or adrenaline for histaminergic angioedema; replacing the deficient protein or blocking the action of bradykinin in C1 inhibitor deficiency and angioedema from angiotensin converting enzyme inhibitor.

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Section: Tratamientounclassified

Angioedema

Holguín-Gómez

Vásquez-Ochoa

Cardona

2016

RAM

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“…Among As shown in Table 3, efficacy of ecallantide was similar to that seen in patients age 16 and older treated with ecallantide in EDEMA3-DB and EDEMA4 (the double-blind, placebo-controlled phase III trials of ecallantide). 15,16 Individual attack details and efficacy outcomes are presented in Supplemental Table 4.…”

Section: Tos Over Time Is Depicted Inmentioning

confidence: 99%

“…d Significant improvement defined as the first time within 4 h after dosing that the patient reported feeling "a lot better or resolved" overall. 16 Sheffer et al 15 c Includes all attacks with evaluable data. d Beginning of improvement defined as the first time within 4 h after dosing that the patient reported feeling "a little better" or "a lot better or resolved" overall.…”

Section: Figurementioning

confidence: 99%

“…Episodes that did not reach the end point by 4 h were censored at the time of the last assessment before 4 h. EDEMA4, the 2 pivotal phase III trials that led to Food and Drug Administration approval of ecallantide. 10,11,15,16 In an integrated analysis of data from those 2 trials, 15 Fig 1) who were of adult size. This is consistent with the notion that HAE symptoms and attacks increase in frequency at the time of puberty.…”

Section: Figurementioning

confidence: 99%

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Use of Ecallantide in Pediatric Hereditary Angioedema

et al. 2013

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WHAT'S KNOWN ON THIS SUBJECT:Patients with hereditary angioedema (HAE) have recurrent episodes of painful swelling. Several new therapies to prevent and treat HAE attacks are approved by the Food and Drug Administration, but their safety and efficacy in children are largely unknown.WHAT THIS STUDY ADDS: Ecallantide appears effective for treatment of HAE attacks in pediatric patients age 10 to 17 years with an acceptable safety profile. It represents a potential treatment option for adolescents with HAE. abstract OBJECTIVE: Hereditary angioedema (HAE) due to C1-inhbitor deficiency is a rare autosomal dominant disease that manifests as sudden unpredictable attacks of subcutaneous or submucosal edema affecting the skin, intestine, and upper airway. Ecallantide is a plasma kallikrein inhibitor indicated for treatment of HAE attacks in patients aged 16 years and older. This analysis examines safety and efficacy of ecallantide for treatment of HAE attacks in patients ,18 years of age.METHODS: Data for patients aged 9 to 17 years treated subcutaneously with 30 mg ecallantide or placebo were pooled from 4 clinical studies (2 double-blind, placebo-controlled and 2 open-label). Efficacy end points included 2 HAE-specific patient-reported outcome measures: mean symptom complex severity (MSCS) score and treatment outcome score (TOS). Times to initial improvement, sustained improvement, and complete or near-complete symptom resolution were calculated. Treatment-emergent adverse events were examined. RESULTS:Overall, 29 pediatric patients were included; 25 of them received ecallantide for 62 total HAE attacks, and 10 received placebo for 10 total attacks. Ecallantide-treated attacks revealed clinically relevant reduction in symptom severity at 4 hours postdosing based on mean change in MSCS score (21.4 6 0.9 ecallantide versus 20.9 6 0.6 placebo) and TOS (73.9 6 35.50 ecallantide versus 45.0 6 43.78 placebo). Patients treated with ecallantide showed rapid improvement in symptoms (median time to complete or near-complete symptom resolution: 181 minutes). No serious adverse events related to treatment were observed.CONCLUSIONS: Ecallantide appears effective for HAE attacks in adolescents, with rapid symptom improvement. No unexpected safety issues were identified. Pediatrics 2013;132:e490-e497 AUTHORS:

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“…A recombinant human C1-INH concentrate (rhC1INH) has been developed called Ruconest® (conestat alfa) (77,78). In recent years, more treatments have been available, such as the bradykinin receptor inhibitor Firazyr® (icatibant), and a kallikrein inhibitor, Kalbitor® (ecallantide) (79,80).…”

Section: Treatmentmentioning

confidence: 99%

Hereditary Angioedema in Sweden : a National Project

Nordenfelt¹

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Ecallantide (DX-88) for acute hereditary angioedema attacks: Integrated analysis of 2 double-blind, phase 3 studies

Cited by 57 publications

References 17 publications

Angioedema

Angioedema

Use of Ecallantide in Pediatric Hereditary Angioedema

Hereditary Angioedema in Sweden : a National Project

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