Recommendations for the Standardisation of Clinical Outcomes used in Allergen Immunotherapy (AIT) Trials for Allergic Rhinoconjunctivitis: an EAACI Position Paper
As gold standard in treatment of patients with allergic rhinoconjunctivitis (AR), allergen-specific immunotherapy (AIT) has been used for more than one century. In the last decades, more and more clinical trials have been performed to investigate the effects of this therapy. However, there is no generally accepted standard in analysing the effects of AIT by using so called “clinical-endpoints” in trials.
The aim of the EAACI-Task Force therefore was to evaluate the methods used in different trials on AIT and to outline pro’s and con’s of all these methods. Based on this review, the Task-Force group of 16 experienced delegates from the EAACI proposed specific recommendations on all endpoints. For this the TF-members had three working-meetings between 2012 and 2013 in Madrid, London and Milan.
Besides this thorough review, the group proposed a definition for the ‘Combined Symptom and Medication Score’ (CSMS) for the so called ‘primary’ endpoint as a simple and standardized method. The European Federation of Allergy and Airways Diseases Patients' Association (EFA) advised on the proposed terminology for the individual symptoms. It would be advisable to use this parameter in future clinical trials on AIT now which would be an important step to compare data on efficacy taken from different trials.