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Clinical trial with a Depigmented, Polymerized Mite Extract Mixture at Maximum Concentrations
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  • Carmen Vidal ,
  • Laura Romero,
  • Sara Lopez Freire,
  • Francisco Carballada González,
  • Jose Carlos García-Robaina,
  • María Teresa González Fernández,
  • Paula Méndez - Brea,
  • Eva Nieto,
  • Monica Ruiz Garcia
Carmen Vidal
Complejo Hospitalario Universitario de Santiago de Compostela
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Laura Romero
Complejo Hospitalario Universitario de Santiago de Compostela
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Sara Lopez Freire
Complejo Hospitalario Universitario de Santiago de Compostela
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Francisco Carballada González
Hospital Lucus Augusti
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Jose Carlos García-Robaina
Hospital Virgen de la Candelaria
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María Teresa González Fernández
Hospital Lucus Augusti
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Paula Méndez - Brea
Complejo Hospitalario Universitario de Santiago de Compostela
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Eva Nieto
Laboratorios Leti SL
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Monica Ruiz Garcia
Laboratorios Leti SL

Corresponding Author:[email protected]

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Abstract

Background: Efficacy of allergen immunotherapy is dose-dependent; however, high doses of allergen may imply a greater risk of adverse reactions. Objective: To assess the safety and tolerability of subcutaneous immunotherapy (SCIT) with mixtures of mite allergen extracts, Dermatophagoides pteronyssinus/Blomia tropicalis (Dpt/Bt) and Dermatophagoides pteronyssinus/Lepidoglyphus destructor (Dpt/Ld) at maximum concentrations, in adult patients with allergic rhinitis or rhinoconjunctivitis, and controlled allergic asthma due to a clinically relevant sensitisation to these mites. Methods: An open-label, non-controlled, non-randomised, phase IIb clinical trial was carried out in three hospitals in Spain between September 2014 and May 2018. Patients received SCIT of either Dpt/Bt (100/1000 DPP/mL) or Dpt/Ld (100/100 DPP/mL) in two phases: a rush build-up phase on the first day (0.2 mL and 0.3 mL with a 30-minute interval) and a monthly maintenance phase administration (0.5 mL) up to 48 months. Results: Forty patients were recruited for the study, seven allocated to the Dpt/Bt group and 33 to the Dpt/Ld. None experienced immediate or delayed systemic Grade ≥2 reactions (EAACI classification) (systemic reactions were mostly Grade 1) nor died during the study. Local reactions were mostly mild (0‒10 cm). Thirty-nine patients (97.5%) experienced at least one adverse event (AE). Of the 283 reported AEs, eight (2.8%) were systemic reactions experienced by six (15%) subjects and 14 (4.9%) were local reactions sustained by ten (25%) subjects. Conclusions: SCIT treatment of patients with allergic rhinitis or rhinoconjunctivitis and controlled asthma with mixtures of Dpt/Bt and Dpt/Ld allergen extracts at maximum concentrations showed a favourable safety profile. Keywords: allergic asthma, allergic rhinitis, Blomia tropicalis, Dermatophagoides pteronyssinus, House dust mites, Lepidoglyphus destructor, maximum extract concentrations. safety,
14 Feb 2024Submitted to Immunity, Inflammation and Disease
19 Mar 2024Review(s) Completed, Editorial Evaluation Pending
12 Jul 20241st Revision Received
16 Jul 2024Submission Checks Completed
16 Jul 2024Assigned to Editor
16 Jul 2024Review(s) Completed, Editorial Evaluation Pending
16 Jul 2024Reviewer(s) Assigned
16 Sep 2024Editorial Decision: Revise Minor
17 Sep 20242nd Revision Received
18 Sep 2024Submission Checks Completed
18 Sep 2024Assigned to Editor
18 Sep 2024Review(s) Completed, Editorial Evaluation Pending
18 Sep 2024Reviewer(s) Assigned
30 Sep 2024Editorial Decision: Revise Major
01 Oct 20243rd Revision Received
03 Oct 2024Submission Checks Completed
03 Oct 2024Assigned to Editor
03 Oct 2024Review(s) Completed, Editorial Evaluation Pending
07 Oct 2024Reviewer(s) Assigned