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Allergen Immunotherapy Clinical Trial Outcomes and Design: Working Toward Harmonization of Methods and Principles

  • Immunotherapy and Immunomodulators (B Vickery, Section Editor)
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Abstract

Progress has been made in the harmonization of efficacy and safety outcome measures for allergen immunotherapy (AIT) trials, but unresolved issues still remain. Furthermore, there are discrepancies in recommendations from professional medical societies and regulatory agencies regarding requirements for AIT trials. In this article, we reviewed published recommendations and current data from recent clinical trials, as well as the criteria applied by regulatory authorities for approval of AIT products, to provide updated considerations for conducting phase 3 AIT trials. Topics discussed include analysis of outcomes and trial designs for pediatric and asthma indications, as well as trial designs for perennial allergic rhinoconjunctivitis. In addition, the need for harmonization of safety reporting is emphasized. Considerations presented in this article may further effort to find common ground among professional medical societies and government agencies in developing future recommendations for AIT trial design.

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Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Acknowledgments

Medical writing and editorial assistance were provided by Erin P. Scott, PhD, of Scott Medical Communications, LLC. This assistance was funded by Merck & Co., Inc., Kenilworth, NJ, USA.

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Authors and Affiliations

  1. National Jewish Health, 1400 Jackson St, Denver, CO, 80206, USA

    Harold S. Nelson

  2. Royal Brompton and Harefield Hospitals NHS Trust and Imperial College London, London, UK

    Moises A. Calderon & Stephen R. Durham

  3. University of Cincinnati College of Medicine and Bernstein Allergy Group, Cincinnati, OH, USA

    David I. Bernstein

  4. University of South Florida Morsani College of Medicine, Tampa, FL, USA

    Thomas B. Casale

  5. ALK, Horsholm, Denmark

    Jens S. Andersen & Hendrik Nolte

  6. School of Natural Sciences, Lenoir-Rhyne University, Hickory, NC, USA

    Robert Esch

  7. Allergy and Asthma Center, Ft Lauderdale, FL, USA

    Linda S. Cox

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  1. Harold S. Nelson
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  2. Moises A. Calderon
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  3. David I. Bernstein
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  4. Thomas B. Casale
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Corresponding author

Correspondence to Harold S. Nelson.

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Funding

The editorial support for this manuscript was provided by Merck & Co., Inc., Kenilworth, NJ, USA. The final decision to submit this article for publication was made by the authors.

Conflict of Interest

H.S. Nelson has received consulting fees from Merck & Co., Inc., Kenilworth, NJ, USA. M.A. Calderon has served as a consultant and/or speaker for ALK, Stallergenes Greer, Merck, Hal Allergy, and Allergopharma. D.I. Bernstein has received consulting fees from Merck & Co., Inc., Kenilworth, NJ, USA, received grant support from Merck & Co., Inc., Kenilworth, NJ, USA, Circassia, and Stallergenes Greer, and received lecture fees from Merck & Co., Inc., Kenilworth, NJ, USA. T.B. Casale has been an investigator on grants to his university employer from Merck, Stallergenes Greer, and Circassia, and served on advisory boards for Circassia and Stallergenes Greer. S.R. Durham reports grants from Immune Tolerance Network NIAID USA, Food Standards Agency UK, Regeneron USA, Biotech Tools UK, and ALK, has received consultancy fees from Anergis Switzerland, Circassia UK, Biomay Austria, Merck USA, Allergy Therapeutics UK, Glaxo Smith Kline and Boehringer Ingelheim, and received lecture fees from Allergy Therapeutics and ALK. L.S. Cox has received personal fees from MedImmune and Novartis for the adjudication committee and from Circassia and Biotech for the Safety Data Monitoring Committee, and received consultation fees from ASIT Biotech SA. J.S. Andersen and H. Nolte are employees of ALK. R. Esch is a consultant with Stallergenes-Greer.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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Nelson, H.S., Calderon, M.A., Bernstein, D.I. et al. Allergen Immunotherapy Clinical Trial Outcomes and Design: Working Toward Harmonization of Methods and Principles. Curr Allergy Asthma Rep 17, 18 (2017). https://doi.org/10.1007/s11882-017-0687-0

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