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Methods for Quantitative Detection of Antibody-induced Complement Activation on Red Blood Cells
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Human C1-esterase inhibitor concentrate (Berinert).

Gillian M Keating1

  • 1Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand. demail@adis.co.nz

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Human C1-esterase inhibitor concentrate (C1-INH concentrate) rapidly relieves hereditary angioedema symptoms. On-demand treatment and home therapy significantly improve quality of life and are well-tolerated.

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Area of Science:

  • Immunology
  • Hematology
  • Pharmacology

Background:

  • Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent swelling episodes.
  • Current treatments aim to manage acute attacks and improve patients' quality of life.

Purpose of the Study:

  • To evaluate the efficacy and safety of human C1-esterase inhibitor concentrate (C1-INH concentrate) for treating acute HAE episodes.
  • To assess the impact of self-administered home therapy with C1-INH concentrate on health-related quality of life.

Main Methods:

  • The IMPACT-1 trial was a randomized, double-blind, placebo-controlled study evaluating C1-INH concentrate (20 U/kg) versus placebo.
  • IMPACT-2 was a noncomparative extension trial assessing on-demand treatment.
  • Quality of life was measured using the Dermatology Life Quality Index and Short Form 36-item Health Survey.

Main Results:

  • C1-INH concentrate significantly reduced the time to symptom relief compared to placebo (median 0.5 hours vs. 1.5 hours).
  • On-demand treatment in IMPACT-2 showed symptom relief in a median of 30 minutes.
  • Self-administered home therapy led to significant improvements in quality of life scores.

Conclusions:

  • Intravenous C1-INH concentrate is an effective and well-tolerated treatment for acute HAE episodes.
  • On-demand and self-administered home therapy with C1-INH concentrate improve patient outcomes and quality of life.
  • No viral transmission was confirmed during the studies, indicating a favorable safety profile.