Aim: A double-blind placebo-controlled study was conducted according to EMA guidelines, to evaluate safety, tolerability and short-term treatment effects of three up-dosing regimens of Phleum pratense subcutaneous immunotherapy. Materials & methods: Forty-two patients were randomized to groups: A (6 weekly doses), B (8 weekly doses) or C (eight doses, two clustered increasing doses over 3 weeks). Results: The most frequent adverse events were local reactions. No serious adverse events were found. Higher number and more severe systemic reactions were reported in group C. A decrease in cutaneous responses and an increase of specific antibodies was shown in all active groups even at very short-term. Conclusion: Phleum pratense subcutaneous immunotherapy in depot presentation exhibited good safety and tolerability. Group A seemed to show the best profile.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest.

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Vol. 7, No. 4

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Published online 28 April 2015

Published in print April 2015

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Keywords

Financial & competing interests disclosure

The study has been sponsored by Bial-Industrial Farmacéutica S.A.; Zamudio, Spain. A Landeta, B Madariaga and A Martínez are working in R&D of Bial-Industrial Farmacéutica S.A. 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.

Writing assistance was utilized in the production of this manuscript. The authors thank J Cuesta-Herranz for providing editorial assistance in the preparation of this manuscript, with funding from Bial Industrial Farmacéutica S.A.

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.

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