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Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations.

Carmen Vidal1, Laura Romero1, Sara Lopez-Freire1

  • 1Complejo Hospitalario de Santiago, Santiago de Compostela, Spain.

Immunity, Inflammation and Disease
|December 19, 2024
PubMed
Summary
This summary is machine-generated.

Subcutaneous immunotherapy (SCIT) with high-concentration mite allergen extracts demonstrated a favorable safety profile in adults with allergic rhinitis and asthma. Most adverse events were mild, with no severe systemic reactions observed.

Keywords:
allergic asthmaallergic rhinitisblomia tropicalisdermatophagoides pteronyssinushouse dust miteslepidoglyphus destructormaximum extract concentrations safety

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Area of Science:

  • Allergy and Immunology
  • Clinical Trials
  • Pharmacology

Background:

  • Allergen immunotherapy efficacy is dose-dependent, but higher doses may increase adverse reaction risks.
  • Assessing safety and tolerability of specific mite allergen extracts is crucial for effective treatment.

Purpose of the Study:

  • To evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) using high-concentration mite allergen extracts (Dermatophagoides pteronyssinus/Blomia tropicalis and Dermatophagoides pteronyssinus/Lepidoglyphus destructor).
  • To assess these extracts in adult patients diagnosed with allergic rhinitis, rhinoconjunctivitis, and controlled allergic asthma.

Main Methods:

  • A phase IIb, open-label, noncontrolled clinical trial conducted in Spain from September 2014 to May 2018.
  • Patients received SCIT with Dpt/Bt or Dpt/Ld extracts at maximum concentrations, involving a rush build-up phase and monthly maintenance for up to 48 months.

Main Results:

  • Forty patients were enrolled; seven in the Dpt/Bt group and 33 in the Dpt/Ld group.
  • No severe systemic reactions (Grade ≥2) or deaths occurred; most systemic reactions were Grade 1.
  • Local reactions were predominantly mild. 97.5% experienced at least one adverse event, with 2.8% systemic and 4.9% local reactions.

Conclusions:

  • SCIT with Dpt/Bt and Dpt/Ld allergen extracts at maximum concentrations exhibits a favorable safety profile.
  • This treatment approach is suitable for patients with allergic rhinitis, rhinoconjunctivitis, and controlled asthma sensitized to these mites.