Mind the gaps: Clinical trial concepts to address unanswered questions in aeroallergen immunotherapy—An NIAID/AHRQ Workshop - 04/05/19
, Robert Wood, MD b, Kari Nadeau, MD, PhD c, Andrew Liu, MD d, Edward Zoratti, MD e, Leonard Bacharier, MD f, Erica Brittain, PhD g, Moises Calderon, MD h, Thomas Casale, MD i, Bradley Chipps, MD j, Linda Cox, MD k, Peter S. Creticos, MD l, Manisha Desai, PhD m, Sten Dreborg, MD, PhD n, Stephen Durham, MD, FRCP h, Peter J. Gergen, MD, MPH a, Rebecca Gruchalla, MD, PhD o, Harold Nelson, MD p, Robyn E. O'Hehir, PhD, FRACP, FAHMS q, Marshall Plaut, MD a, Julie M. Schwaninger, MS a, Stephen Tilles, MD r, Brian Vickery, MD s, Kim M. Wittenberg, MA t, Alkis Togias, MD aAbstract |
The Agency for Healthcare Research and Quality and the National Institute of Allergy and Infectious Diseases organized a workshop to develop trial concepts that could improve the use and effectiveness of aeroallergen immunotherapy (AAIT). Expert groups were formed to accomplish the following tasks: (1) propose a study design to compare the effectiveness and safety of subcutaneous versus sublingual AAIT; (2) propose a study design to compare the effectiveness and safety of AAIT by using 1 or a few allergens versus all or most allergens to which a patient is sensitized; (3) propose a study design to determine whether AAIT can alter the progression of childhood allergic airways disease; and (4) propose a study design to determine the optimal dose and duration of AAIT to achieve maximal effectiveness with acceptable safety. Study designs were presented by the workgroups, extensively discussed at the workshop, and revised for this report. The proposed trials would be of long duration and require large highly characterized patient populations. Scientific caveats and feasibility matters are discussed. These concepts are intended to help the development of clinical trials that can address some of the major questions related to the practice of AAIT for the management and prevention of allergic airways disease.
Le texte complet de cet article est disponible en PDF.Key words : Aeroallergen, immunotherapy, asthma, allergic rhinitis, rhinoconjunctivitis, multi-allergen, prevention
Abbreviations used : AAIT, AHRQ, HDM, PAT, SCIT, SLIT, TCRS
Plan
| The workshop was supported by funds from the Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases (NIAID). The associated AHRQ product was funded under contract no. HHSA 290-2007-10061-I (Task Order 2) from the Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services (HHS). The authors of this manuscript are responsible for its content. Statements in the manuscript do not necessarily represent the official views of or imply endorsement by AHRQ, NIAID, or HHS. |
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| Disclosure of potential conflict of interest: R. Wood receives grants from the NIH/NIAID, DBV, Astellas, Sanofi, and HAL Allergy and receives royalties from UpToDate. A. Liu receives personal fees from Merck Sharpe & Dohme, and from Phadia Thermo Fisher. E. Zoratti receives grants from the NIH/NIAID. M. Calderon receives consultancy fees from ALK-Abelló, Merck, Allergopharma, and Hal Allergy and lecture fees from ALK-Abelló, Merck, Allergopharma, Hal Allergy, and STGG. T. Casale receives grant support and consultant fees from Stallergenes. B. Chipps receives speakers' honoraria from AstraZeneca, Boehringer Ingelheim, Circassia, Genentech, Novartis, Regeneron, Sanofi, and Teva. P. S. Creticos receives grants and personal fees from Stallergenes-Greer, Circassia, and Merck and personal fees from ASIT, Allergy Therapeutics, and UpToDate. S. Durham reports grants from ALK-Abelló, the Food Standards Agency (United Kingdom), the Medical Research Council (United Kingdom), GlaxoSmithKline, and the National Institutes of Health (NIH) and personal fees from Anergis, Biomay, Allergy Therapeutics, Med Update, and Tori Pharmaceuticals. R. Gruchalla reports grants from NIH/National Institute of Allergy and Infectious Diseases Biologics Evaluation and Research and personal fees from Consulting Massachusetts Medical Society. S. Tilles receives grants and personal fees from DBV Technologies, Genentech, and the Immune Tolerance Network; receives grants from Aimmune, Astellas, Stanford University, Amgen, Circassia, Gilead, GlaxoSmithKline, Merck, Novartis, Pulmagen, Teva, Mylan, AstraZeneca, and FARE; and receives personal fees from Sanofi. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 143 - N° 5
P. 1711-1726 - mai 2019 Retour au numéro
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