Universität zu Köln

Pfaar, O., Demoly, P., van Wijk, R. Gerth, Bonini, S., Bousquet, J., Canonica, G. W., Durham, S. R., Jacobsen, L., Malling, H. J., Moesges, R., Papadopoulos, N. G., Rak, S., Rodriguez del Rio, P., Valovirta, E., Wahn, U. and Calderon, M. A. (2014). Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy, 69 (7). S. 854 - 868. HOBOKEN: WILEY. ISSN 1398-9995

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Abstract

Background: 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. Methods: As elaborated by a Task Force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) Immunotherapy Interest Group, this Position Paper evaluates the currently used outcome parameters in different RCTs and also aims to provide recommendations for the optimal endpoints in future AIT trials for allergic rhinoconjunctivitis. Results: Based on a thorough literature review, the TF members have outlined recommendations for nine domains of clinical outcome measures. As the primary outcome, the TF recommends a homogeneous combined symptom and medication score (CSMS) as a simple and standardized method that balances both symptoms and the need for antiallergic medication in an equally weighted manner. All outcomes, grouped into nine domains, are reviewed. Conclusion: A standardized and globally harmonized method for analysing the clinical efficacy of AIT products in RCTs is required. The EAACI TF highlights the CSMS as the primary endpoint for future RCTs in AIT for allergic rhinoconjunctivitis.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pfaar, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Demoly, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED van Wijk, R. Gerth UNSPECIFIED UNSPECIFIED UNSPECIFIED Bonini, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bousquet, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Canonica, G. W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Durham, S. R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jacobsen, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Malling, H. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Moesges, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Papadopoulos, N. G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rak, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rodriguez del Rio, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Valovirta, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wahn, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Calderon, M. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-435105
DOI:	10.1111/all.12383
Journal or Publication Title:	Allergy
Volume:	69
Number:	7
Page Range:	S. 854 - 868
Date:	2014
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1398-9995
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language QUALITY-OF-LIFE; GRASS-POLLEN IMMUNOTHERAPY; VISUAL ANALOG SCALE; DERMATOPHAGOIDES-PTERONYSSINUS EXTRACT; RANDOMIZED CONTROLLED-TRIAL; HOUSE-DUST MITE; SUBLINGUAL IMMUNOTHERAPY; HEALTH-STATUS; DOUBLE-BLIND; CHALLENGE CHAMBER Multiple languages Allergy; Immunology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43510