Fast Up-Dosing with a Birch Allergoid is Safe and Well Tolerated in Allergic Rhinitis Patients with or without Asthma

Abstract

Aim: Subcutaneous immunotherapy is effective in treating allergic rhinoconjunctivitis and asthma, but is still inconvenient when heavy schedules are used. A faster dose escalation is desirable. Materials & methods: In this open-label, Phase II trial, 130 adults were randomized 1:1 to receive a birch pollen allergoid subcutaneous immunotherapy. Group I with four weekly injections and Group II with seven weekly injections. Safety, tolerability and immunogenicity were assessed. Results: Mild-to-moderate treatment-related adverse events were reported for 57.7% of the patients (Group I: 36, Group II: 39). Tolerability was assessed by physicians and rated as ‘good’ or ‘very good’ for 55 patients in Group I (87.3%) and for 63 patients in Group II (94.0%). Levels of IgG and IgG₄ increased before and after treatment significantly (p < 0.0001) in both groups. Conclusion: Standard versus fast dose escalation is comparable in terms of safety and tolerability.

Keywords::

• accelerated dose escalation
• allergen immunotherapy
• allergic rhinitis
• allergoid
• safety
• tolerability

Financial & competing interests disclosure

S Zielen received fees for lectures and advisory boards from the following companies: bene-Arzneimittel GmbH; Vifor Pharma Deutschland GmbH; Novartis AG; GlaxoSmithKline GmbH; ALK-Abelló Arzneimittel GmbH; Allergy Therapeutics; Boehringer Ingelheim, Lofarma GmbH, IMS Health GmbH & Co. and Biotest Pharma GmbH. M Rosewich received fees for lectures from the following companies: Novartis AG, GlaxoSmithKline, Allergopharma GmbH & Co. KG and Allergy Therapeutics. J Rieker-Schwienbacher has received grant from Allergopharma GmbH & Co. KG, Germany, for performing the clinical trial. U Thieme has received grant from Allergopharma GmbH & Co. KG, Germany, for performing the clinical trial. Y Akboga and K Plückhahn are employees of Allergopharma GmbH & Co. KG. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate insti­tutional review board approval or have followed the princi­ples outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investi­gations involving human subjects, informed consent has been obtained from the participants involved.

Author contributions

S Zielen and M Rosewich contributed to planning and conduct of the trial, data collection and analysis and editing the manuscript. K Plückhahn and Y Akboga were involved in planning and conducting the trial, in analysis of the data and on manuscript preparation. J Rieker-Schwienbacher and U Thieme were involved in the conduct of the trial and manuscript editing.

Availability of data

All data are available at [email protected]

Additional information

Funding

S Zielen received fees for lectures and advisory boards from the following companies: bene-Arzneimittel GmbH; Vifor Pharma Deutschland GmbH; Novartis AG; GlaxoSmithKline GmbH; ALK-Abelló Arzneimittel GmbH; Allergy Therapeutics; Boehringer Ingelheim, Lofarma GmbH, IMS Health GmbH & Co. and Biotest Pharma GmbH. M Rosewich received fees for lectures from the following companies: Novartis AG, GlaxoSmithKline, Allergopharma GmbH & Co. KG and Allergy Therapeutics. J Rieker-Schwienbacher has received grant from Allergopharma GmbH & Co. KG, Germany, for performing the clinical trial. U Thieme has received grant from Allergopharma GmbH & Co. KG, Germany, for performing the clinical trial. Y Akboga and K Plückhahn are employees of Allergopharma GmbH & Co. KG. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.