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Dr. Grey AI

Peptide

Ecallantide (Kalbitor)

Ecallantide is a 60-amino acid recombinant polypeptide kallikrein inhibitor for hereditary angioedema. FDA-approved December 2009. First subcutaneous HAE treatment approved. EDEMA3 & EDEMA4 Phase 3 (n=168): Significantly greater symptom improvement at 4h vs placebo (P<0.01). Treatment outcome score 53.4 vs 8.1 placebo (P=0.003). Effect apparent within 2h and maintained through 24h. SAFETY CONCERN: Anaphylaxis risk 3.9% - must be administered by healthcare professional with anaphylaxis treatment available.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
1
Outcomes
6
Graded outcomes
3102

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Hereditary Angioedema

Hereditary Angioedema: outcomes studied for Ecallantide (Kalbitor)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Anaphylaxis Risk

SAFETY CONCERN: Anaphylaxis in 3.9% of patients (10/255) in clinical trials. Most within first hour after injection. Black box warning. Must be administered by healthcare professional. Have anaphylaxis treatment available. Self-administration not recommended.

Worsens (the measure goes up)Small effect203 studies

Studies that measured anaphylaxis risk

and 193 more in the citations list

Symptom Improvement at 4 Hours

EDEMA3 & EDEMA4 Phase 3 (n=168): Treatment outcome score at 4h significantly greater with ecallantide vs placebo (53.4 vs 8.1, P=0.003 in EDEMA4). Mean symptom complex severity score change -0.8 vs -0.4 placebo (P=0.01). Led to FDA approval.

Improves (the measure goes up)Large effect202 studies

Studies that measured symptom improvement at 4 hours

and 192 more in the citations list

Time to Symptom Relief

EDEMA3+4 pooled analysis: Benefit apparent within 2 hours of dosing. Maintained through 24 hours. Need for rescue intervention: 14% ecallantide vs 36% placebo within 24h. Earlier treatment associated with better outcomes.

Changes; see studiesModerate effect202 studies

Studies that measured time to symptom relief

and 192 more in the citations list

Laryngeal Attack Efficacy

Subset analysis of laryngeal attacks: Significant improvement in treatment outcome scores. Potential life-saving for airway-threatening attacks. Limited patient numbers in trials - use with close monitoring for severe attacks.

Improves (the measure goes up)Moderate effect203 studies

Studies that measured laryngeal attack efficacy

and 193 more in the citations list

General

General: outcomes studied for Ecallantide (Kalbitor)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Safety/Tolerability

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect4 studies

Studies that measured safety/tolerability

Immune Function

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect4 studies

Studies that measured immune function

Key findings

  • Anaphylaxis RiskHereditary AngioedemaWorsens (the measure goes up)
  • Symptom Improvement at 4 HoursHereditary AngioedemaImproves (the measure goes up)
  • Time to Symptom ReliefHereditary AngioedemaChanges; see studies

Safety notes in the studies

  • Black box warning.

Studies cited

16 studies from PubMed

  1. Short review of SEC, a potential dexamethasone-sparing regimen for glioblastoma: Spironolactone, ecallantide, clotrimazole.Neuro-Chirurgie, 2021 · PMID 33450263
  2. Immunotargeting and therapy of cancer by advanced multivalence antibody scaffolds.Journal of drug targeting, 2020 · PMID 32434407
  3. Novel Therapies for Angiotensin-Converting Enzyme Inhibitor-Induced Angioedema: A Systematic Review of Current Evidence.The Journal of emergency medicine, 2017 · PMID 28939396
  4. Outcomes after ecallantide treatment of laryngeal hereditary angioedema attacksAnn Emerg Med, 2015 · PMID 23548529
  5. Management of acute attacks of hereditary angioedema: role of ecallantideJ Blood Med, 2015 · PMID 25770240
  6. Hereditary angioedema therapy: kallikrein inhibition and bradykinin receptor antagonismJ Allergy Clin Immunol Pract, 2013 · PMID 23609142
  7. Efficacy and safety of ecallantide in treatment of recurrent attacks of hereditary angioedema: open-label continuation study.Allergy and asthma proceedings, 2013 · PMID 23484891
  8. Ecallantide for treatment of acute hereditary angioedema attacks: analysis of efficacy by patient characteristicsAllergy Asthma Proc, 2012 · PMID 22525395
  9. Immunotherapy for primary immunodeficiency diseases.The Medical clinics of North America, 2012 · PMID 22703850
  10. A phase 2 prospective, randomized, double-blind trial comparing the effects of tranexamic acid with ecallantide on blood loss from high-risk cardiac surgery with cardiopulmonary bypass (CONSERV-2 Trial).The Journal of thoracic and cardiovascular surgery, 2012 · PMID 21724197
  11. Ecallantide for the treatment of hereditary angiodema in adultsExpert Opin Biol Ther, 2011 · PMID 21695090
  12. Response to ecallantide treatment of acute attacks of hereditary angioedema based on time to intervention: results from the EDEMA clinical trialsAllergy Asthma Proc, 2011 · PMID 21781409
  13. Ecallantide (DX-88) for acute hereditary angioedema attacks: integrated analysis of 2 double-blind, phase 3 studies.The Journal of allergy and clinical immunology, 2011 · PMID 21481442
  14. EDEMA4: a phase 3, double-blind study of subcutaneous ecallantide treatment for acute attacks of hereditary angioedemaAnn Allergy Asthma Immunol, 2010 · PMID 20568386
  15. Ecallantide: its pharmacology, pharmacokinetics, clinical efficacy and tolerability.Expert review of clinical immunology, 2010 · PMID 20383888
  16. Critical role of kallikrein in hereditary angioedema pathogenesis: a clinical trial of ecallantide, a novel kallikrein inhibitorJ Allergy Clin Immunol, 2007 · PMID 17559913