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An evidence-based appraisal of the surrogate markers of efficacy of allergen immunotherapy

Senna, Gianenrico; Calderon, Moises; Makatsori, Melina; Ridolo, Erminia; Passalacqua, Giovanni

Current Opinion in Allergy and Clinical Immunology: August 2011 - Volume 11 - Issue 4 - p 375–380
doi: 10.1097/ACI.0b013e328348a7cd
Pharmacotherapy and evidence based medicine: Edited by David A. Khan and Enrico Compalati

Purpose of review The assessment of clinical efficacy of immunotherapy in patients with respiratory allergy is highly affected by variability and lack of validated outcome measures such as symptom and medication scores. At the same time, there is a need to identify reliable predictive surrogate markers or biomarkers that may correlate with real clinical endpoints and lead to individually tailored immunotherapy treatment.

Recent findings In-vivo markers, such as early and late skin reaction as well as immunological parameters such as IgE levels, IgG subclasses, mucosal IgA, lymphocyte subsets, cytokines and local and systemic inflammatory markers, have been proposed as potential surrogate markers.

Summary Given the poor reproducibility and surrogacy to clinical outcomes shown in various clinical trials, the decreased availability in daily practice and anticipated high costs, an ideal surrogate marker is still not available to allergists.

aAllergy Unit, University of Verona, Verona, Italy

bSection of Allergy and Clinical Immunology. Royal Brompton Hospital and Imperial College, London, UK

cDepartment of Clinical Sciences University of Parma, Parma

dAllergy and Respiratory Diseases, University of Genoa, Genoa, Italy

Correspondence to Gianenrico Senna, MD, Unità Operativa di Allergologia, Azienda Ospedaliera-Universitaria Integrata, Piazza Stefani 1, 37126 Verona, ItalyTel: +39 0458123015; e-mail:

Copyright © 2011 Wolters Kluwer Health, Inc. All rights reserved.