Reviews and feature articleEvaluating primary end points in peanut immunotherapy clinical trials
Section snippets
Methods
A systematic review of the literature was performed by using the same methodology as in the meta-analysis by Nurmatov and colleagues,24, 25 although in this case the search was limited to peanut-related key words. This strategy was complemented by a manual search of the relevant databases, and every study on peanut immunotherapy was considered, regardless of the route of administration (oral immunotherapy [OIT], epicutaneous immunotherapy, sublingual immunotherapy [SLIT], or subcutaneous
Definition of clinical efficacy
There are clear similarities between conventional (aeroallergen and Hymenoptera venom) AIT and food AIT, such as the use of a dose-escalation scheme and the immunomodulation driven by the treatment. Patient safety is the main objective in both cases and also a factor that limits a broader use of the treatment.49, 50 However, although there is a robust and well-developed consensus guiding population selection in aeroallergen AIT51 and the selection of validated clinical end points52 for clinical
Assessment of clinical efficacy
Once clinical efficacy has been defined, researchers must state how this variable will be measured. In some cases a treatment is considered efficacious if patients reach the MP,43, 48 but usually, an exit challenge is required. Despite DBPCFC being the gold standard in food allergy diagnosis,9 it is a cumbersome procedure. In some studies an open exit challenge has been used to evaluate patients' clinical reactivity, as well as treatment efficacy.33, 46, 47 Studies in which efficacy is measured
Discussion
This is a momentous period in the history of food AIT, despite several unanswered questions62 and an ongoing debate on whether this management approach is ready for routine clinical practice.63, 64, 65, 66, 67, 68, 69 The most recent EAACI guidelines marked a step toward widespread introduction of immunotherapy, signaling that it could soon be suitable for everyday care delivery1 in specialized centers. Now is the time to build up a solid evidence base, designing harmonized studies for the most
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Disclosure of potential conflict of interest: P. Rodriguez del Rio received research funding from the Health Research Fund of Carlos III Health Institute, Foundation for Biomedical Research of the Niño Jesús University Children's Hospital, and Spanish Society of Allergology and Clinical Immunology Foundation and reports honoraria for consultancy and/or advisory board and/or lectures from ALK-Abelló, HAL-Allergy, FAES Pharma, LETI Pharma, Merck, Aimmune, Allergy Therapeutics, MEDA Pharma, and Novartis. C. Escudero received research funding from the Health Research Fund of Carlos III Health Institute, Foundation for Biomedical Research of the Niño Jesús University Children's Hospital, Spanish Society of Allergology and Clinical Immunology Foundation, and Aimmune Therapeutics; serves as a consultant for ALK-Abelló, Leti, and Novartis Pharma; and has received lecture fees from Spanish Society of Allergology and Clinical Immunology and Porto University. S. Sánchez-García received research funding from the Health Research Fund of Carlos III Health Institute, Foundation for Biomedical Research of the Niño Jesús University Children's Hospital, and Spanish Society of Allergology and Clinical Immunology Foundation; is a consultant for ALK-Abelló and Allergy Therapeutics; and receives lecture fees from Nutricia, Novartis, GlaxoSmithKline, Leti, and Allergy Therapeutics. M. D. Ibáñez receives research funding from the Health Research Fund of Carlos III Health Institute and Aimmune Therapeutics, serves as a consultant for Merck and Novartis, and has received lectures fees from the Spanish Society of Allergology and Clinical Immunology, Leti, Merck, FAES, and MSD. B. P. Vickery is a consultant to Aimmune Therapeutics, reports employment and stock options from Aimmune in the 12 months before publication, is a consultant to the Gerson Lehman Group, and is a member of the Outcomes Research Advisory Board at Food Allergy Research and Education.