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Poster eaaci 2013 haefner effects of scit with bet v 1-fv on asthma_din a0.indd

Effects of subcutaneous specifi c immunotherapy with recombinant
hypoallergenic Bet v 1 folding variant (rBet v 1-FV) on asthma symptoms

Haefner D; Tribanek M; Kettner J; Narkus A.
Allergopharma GmbH & Co. KG, Reinbek, Germany
The recombinant folding variant rBet v 1-FV has been shown to be eff ective in SCIT of birch pollen allergic rhinoconjunctivitis, and its optimum therapeutic dose has been established (1). Although prevention of asthma or improvement of asthma symptoms have been recognized as a further target of subcutaneous specifi c immuno-therapy (SCIT), evidence for the effi cacy of SCIT in allergic asthma from randomized, well controlled studies is limited. We analyzed the eff ects of SCIT with rBet v 1-FV on seasonal asthma symptoms in asthmatic patients included in a birch pollen rhinoconjunctivitis study.
A post-hoc analysis of a randomized, double-blind, placebo-controlled trial was performed. For entry, pati- Demographic Characteristics of Asthma Patients
ents (18-60 years) had to have a history of birch pollen allergic rhinoconjunctivitis +/- asthma, symptoms during the baseline birch pollen season (BL) in total eye-nose- Treatment Group
Placebo [n=51]
rBet v1-FV [n=55]
lung symptom score, a positive skin prick and conjunc-tival challenge test and serum IgE to birch (EAST class 41 (19-59)
38 (18-59)
≥ 2). Inhaled corticosteroids ≤ 400 μg budesonide-equi- valent and salbutamol p.r.n in GINA I/II patients were 3.7 (2.3-5.4)
3.5 (2.0-5.4)
The sum of cough, wheeze and dyspnoea scores (AUC 21days) at BL and after 1 & 2 years of perennial SCIT with 108 (87-168)
100 (81-159)
rBet v 1-FV was assessed in patients known to have asth-
ma, demography of whom is displayed in Table 1.
Tab. 1: Demographic characteristics of asthma patients (n=106)
Overall Symptom and Medication Score
The full analysis set (FAS) comprised 104 actively treated and 98 placebo patients. Clinically relevant reduction in the overall symptom medication score (SMS) was
observed after active treatment using rBet v1-FV: -121.5 versus -89.3 (placebo); p = 0.0137 in year 2. There were 55 rBet v 1-FV and 51 placebo patients known to have
asthma at entry into the study. In this patient group, the change in the overall SMS after 2 years was even higher: rBet v1-FV -180.0 (placebo -89.0); p = 0.029.
Asthma Score
In the asthmatic patient group, after one treatment year, a considerable median change in the lung symptom score of -58.0 for rBet v 1-FV (placebo: -51.0) occurred.
After two years of treatment, a signifi cantly more pronounced treatment eff ect of -47.5 for rBet v 1-FV treated patients in comparison to a decrease of -22.0 in the
placebo group was observed (p < 0.05) (Figure 1).
Change from baseline in asthma symptom score
Fig. 1: Change from baseline in asthma symptom score (sum scores for cough, wheezing & dyspnoea) in asthmatic patients (rBet v1-FV n=55, placebo n=51) after one and two years of SCIT
SCIT with the hypoallergenic recombinant birch pollen major allergen vaccine rBet v 1-FV improved lung symptoms in patients with birch pollen induced allergic asthma. Prospective trials in bronchial asthma are needed to substantiate our fi ndings. Reference List (1) Meyer W, Narkus A, Salapatek, A, Patel D, Mussler S, Haefner D. Effi
cacy and safety of four dose regimes of a hypoallergenic recombinant pollen major allergen (rBet v1-FV) in birch pollen allergic patients studied in an environmental exposure chamber. Allergy 2012; 67 (S96): 89.
Conflict of interest: The authors are employees of Allergopharma GmbH & Co. KG. A subsidiary of
EAACI & WAO World Allergy & Asthma Congress 2013, 22 - 26 June, Milan, Italy | Contact: Allergopharma GmbH & Co. KG | 21462 Reinbek, Germany | Phone ++49 40 72765-0•Fax ++49 40 7227713•


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