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Short-course subcutaneous treatment with birch pollen allergoids greatly improves symptom and medication scores in birch allergy
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  • Ralph Mosges,
  • Esther Raskopf,
  • Ludger Klimek,
  • Oliver Pfaar,
  • Stefan Zielen,
  • Elena Xenofontos,
  • Lea Decker,
  • Christian Neuhof,
  • Anna Rybachuk,
  • Cengiz Han Acikel,
  • Hacer Sahin,
  • Silke Allekotte,
  • Sandra del Pozo,
  • José Subiza,
  • Miguel Casanovas,
  • M. Cuevas
Ralph Mosges
ClinCompetence Cologne GmbH

Corresponding Author:[email protected]

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Esther Raskopf
ClinCompetence Cologne GmbH
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Ludger Klimek
Zentrum fur Rhinologie und Allergologie Wiesbaden
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Oliver Pfaar
University Hospital Marburg
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Stefan Zielen
University Hospital Goethe University Frankfurt
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Elena Xenofontos
University of Cologne
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Lea Decker
University of Cologne
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Christian Neuhof
ClinCompetence Cologne GmbH
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Anna Rybachuk
ClinCompetence Cologne GmbH
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Cengiz Han Acikel
ClinCompetence Cologne GmbH
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Hacer Sahin
ClinCompetence Cologne GmbH
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Silke Allekotte
ClinCompetence Cologne GmbH
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Sandra del Pozo
Inmunotek SL
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José Subiza
Inmunotek SL
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Miguel Casanovas
Inmunotek SL
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M. Cuevas
Technische Universität Dresden
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Abstract

Background: Subcutaneous immunotherapy has emerged as an effective option for treating allergic diseases. Here, we assessed the clinical impact of the mannan-conjugated birch pollen polallergoid T502 in birch pollen-induced allergic rhinoconjunctivitis. Methods: In this prospective, randomized, double-blind placebo-controlled phase III trial, 298 birch pollen–allergic adult patients were treated across 28 trial sites in Germany. Patients received either placebo or 23,000 mTU T502 subcutaneously over five pre-seasonal visits. Efficacy was assessed by comparing the combined symptom and medication score (CSMS) between placebo and T502 during the peak birch pollen season 2022. Safety, tolerability and immunologic effects were also analysed. Results: During the peak birch pollen season, the median CSMS of the T502 group was reduced by 33.00% (p=0.002) compared to placebo. The median daily symptom score and daily medication score were reduced by 30.43% (p<0.001) and 56.25% (p=0.045), respectively. Health related quality of life improved as reflected by reduction of RQLQ values by 31.54% (p<0.0001). Production of Bet v 1 sIgG4 and sIgG increased up to 6.2-fold and 3-fold respectively in the T502 group (p<0.0001). The sIgE/sIgG4 ratio was strongly reduced in the T502 group at V7 (-62.90%, p<0.0001). No fatalities nor serious adverse events were reported. In total, 16 systemic allergic reactions occurred (Grade I/II). Conclusions: Treatment with T502 significantly reduced symptoms and medication need in rhinoconjunctivitis patients. The treatment is well tolerated and safe.
18 Jul 2024Submitted to Allergy
20 Jul 2024Submission Checks Completed
20 Jul 2024Assigned to Editor
20 Jul 2024Review(s) Completed, Editorial Evaluation Pending
22 Jul 2024Reviewer(s) Assigned
20 Aug 2024Editorial Decision: Revise Minor
09 Oct 20241st Revision Received
11 Oct 2024Submission Checks Completed
11 Oct 2024Assigned to Editor
11 Oct 2024Review(s) Completed, Editorial Evaluation Pending
17 Oct 2024Reviewer(s) Assigned
22 Oct 2024Editorial Decision: Accept