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Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper.
O Pfaar
1 ,
P Demoly ,
R Gerth van Wijk ,
S Bonini ,
J Bousquet ,
G W Canonica ,
S R Durham ,
L Jacobsen ,
H J Malling ,
R Mösges ,
N G Papadopoulos ,
S Rak ,
P Rodriguez del Rio ,
E Valovirta ,
U Wahn ,
M A Calderon
Jul 2014
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Abstract
Allergen immunotherapy (AIT) has been thoroughly documented in randomized controlled trials (RCTs). It is the only immune-modifying and causal treatment available for patients suffering from IgE-mediated diseases such as allergic rhinoconjunctivitis, allergic asthma and insect sting allergy. However, there is a high degree of clinical and methodological heterogeneity among the endpoints in clinical studies on AIT, for both subcutaneous and sublingual immunotherapy (SCIT and SLIT). At present, there are no commonly accepted standards for defining the optimal outcome parameters to be used for both primary and secondary endpoints.