Clinical effects of immunotherapy with genetically modified recombinant birch pollen Bet v 1 derivatives

Authors: Purohit, A.¹; Niederberger, V.²; Kronqvist, M.³; Horak, F.²; Grönneberg, R.⁴; Suck, R.⁵; Weber, B.⁵; Fiebig, H.⁵; van Hage, M.³; Pauli, G.¹; Valenta, R.⁶; Cromwell, O.⁵

Source: Clinical & Experimental Allergy, Volume 38, Number 9, September 2008 , pp. 1514-1525(12)

Publisher: Wiley-Blackwell

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Abstract:

Summary Background

Birch pollen and pollen from related trees of the Fagales order are a major cause of allergic rhinitis, conjunctivitis, and asthma through the spring season in northern and central Europe. Objective

To investigate the clinical effects of injection immunotherapy with genetically modified derivatives of major birch pollen allergen Bet v 1 on pollen-induced allergic symptoms. Methods

A three-arm double-blind placebo-controlled immunotherapy study was conducted with one pre-seasonal course of treatment using two derivatives of Bet v 1, namely a recombinant Bet v 1 trimer and an equimolar mixture of two recombinant Bet v 1 fragments together representing the whole protein sequence. Analysis of local and systemic adverse events was performed for 124 patients who had received at least one dose of medication. Clinical efficacy was monitored by symptom medication scores and interval scoring in the per protocol-treated population (n=84). In addition, skin and nasal provocation responses and allergen-specific antibodies were assessed. Results

There were trends towards improvement in the subjects' well-being and clinical symptoms (nasal scores), although comparisons with a placebo group did not show statistical significance in the main end-point, the combined symptom medication score. Reductions in skin and nasal sensitivity were observed for some subjects with a trend for the Bet v 1 trimer to be more effective than the fragments. Treatment induced strong IgG1 and IgG4 allergen-specific antibody responses. Local injection-site reactions were most frequent in the trimer group affecting 59.5% of patients as opposed to 37.8% and 30.6% in the fragment and placebo groups, respectively. Systemic reactions were elicited more frequently by fragments. A large proportion of adverse side-effects appeared hours following injections, and might be attributable to concurrent exposure to related pollens. Conclusion

Single courses of injection immunotherapy with Bet v 1 allergen derivatives showed trends towards improved well-being and reduced reactivity to specific allergen provocation, but did not yield significant improvement in the combined symptom medication score in this study.

Cite this as: A. Purohit, V. Niederberger, M. Kronqvist, F. Horak, R. Grönneberg, R. Suck, B. Weber, H. Fiebig, M. van Hage, G. Pauli, R. Valenta and O. Cromwell, Clinical and Experimental Allergy, 2008 (38) 1514-1525.

Keywords: allergen variants; allergic rhinitis; allergy; Bet v 1; birch pollen; immunotherapy; recombinant allergens

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-2222.2008.03042.x

Affiliations: 1: Service de Pneumologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France, 2: Department of Otorhinolaryngology, Medical University of Vienna, Vienna, Austria, 3: Department of Medicine, Clinical Immunology and Allergy Unit, Karolinska Institutet and University Hospital, Stockholm, Sweden, 4: Department of Medicine, Unit of Respiratory Medicine, Karolinska Institutet and University Hospital, Stockholm, Sweden, 5: Allergopharma Joachim Ganzer KG, Reinbek, Germany and 6: Christian Doppler Laboratory for Allergy Research, Division of Immunopathology, Department of Pathophysiology, Medical University of Vienna, Vienna, Austria

Publication date: 2008-09-01

Clinical effects of immunotherapy with genetically modified recombinant birch pollen Bet v 1 derivatives

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