Allergen-Specific Immunotherapy: Which Outcome Measures are Useful in Monitoring Clinical Trials? - 11/08/11
Résumé |
Various clinical outcome measures are commonly applied in clinical trials on specific immunotherapy for allergic rhinoconjunctivitis with or without asthma to provide evidence of its clinical efficacy. These “primary endpoints” measure clinical symptoms as well as the use for concomitant medication. “Secondary outcome endpoints” are represented by health-related quality of life (HRQoL), “well-days,” provocation-tests, in vitro tests and others. This article reviews different methods assessing the clinical outcome of trials on both subcutaneous and sublingual immunotherapy, and highlights potential advantages and drawbacks of each method.
Le texte complet de cet article est disponible en PDF.Keywords : Allergic rhinoconjunctivitis, Clinical studies, Allergen-outcome parameters, Study end points, Quality of life, Specific immunotherapy, Responder-analysis, Allergen challenge
Plan
Financial disclosure: O. Pfaar and L. Klimek have received research grants from ALK-Abello, Denmark; Allergopharma, Germany; Stallergenes, France; HAL, The Netherlands; Artu Biologicals, The Netherlands; Allergy-Therapeutics/Bencard, UK/Germany; Hartington, Spain; Lofarma, Italy; Novartis/Leti, Germany/Spain, and Roxall, Germany. These 2 authors have also served as advisors and on the speakers’ bureaus for the above-mentioned pharmaceutical companies. J. Kleine-Tebbe has received lecture fees from Allergopharma, ALK-Abelló, AstraZeneca, Bencard, Essex, HAL Allergy, Leti, Novartis, Phadia, Roxall, Stallergenes, and has received grants for industry-sponsored research projects from Allergopharma, ALK-Abelló, Dr Fooke, HAL Allergy, Phadia, and was consultant for ALK-Abelló, Bencard, HAL Allergy, Novartis, Parexel International, Paul-Ehrlich-Institut, European Medicines Agency (EMA). |
Vol 31 - N° 2
P. 289-309 - mai 2011 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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