Clinical outcome measures of specific immunotherapy.
OBJECTIVE
To provide an overview of clinical parameters generally used for monitoring the clinical efficacy of specific immunotherapy (SIT) in clinical trials. In particular, it focuses on primary and secondary outcome measurements and reviews the advantages and disadvantages of each method.


RESULTS
In 2007, the World Allergy Organization defined the severity of symptoms and the need for concomitant medication as primary endpoint parameters in clinical outcome measures of SIT. Furthermore, it was stated that the symptom score should always be combined with the rescue medication score. The 'quality of life' is usually used as a secondary outcome measure in clinical trials on SIT.


CONCLUSIONS
In clinical trials on SIT, several clinical parameters are commonly used to provide evidence of the clinical efficacy of the therapy. These parameters should include a measurement of symptoms and of the use of concomitant medications, which represent the 'primary outcome' parameters. Both physician-rated and patient self-rate scores have been implemented in clinical studies. Furthermore, disease-unspecific (generic) and disease-specific questionnaires for evaluating the quality of life are widely used and partially validated as 'secondary outcome' parameters. This review provides an overview on the different methods to measure the clinical outcome of SIT and points out the advantages and disadvantages of each method.
Pfaar
Oliver
O
Center for Rhinology and Allergology, Wiesbaden, Germany. oliver.pfaar@hno-wiesbaden.de
Anders
Clemens
C
Klimek
Ludger
L
D000279:Administration, Cutaneous; D000286:Administration, Sublingual; D000485:Allergens / Q000008:administration & dosage; D000941:Antigens / Q000008:administration & dosage / Q000276:immunology; D002986:Clinical Trials as Topic / Q000592:standards*; D003888:Desensitization, Immunologic / Q000592:standards*; D023381:Endpoint Determination / Q000592:standards; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000628:therapy*; D016896:Treatment Outcome
D000485:Allergens; D000941:Antigens