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Evidence-Based Medicine and Real-World Data in Allergen Immunotherapy Today and in the Future: Quality or Quantity?

  • Specific Immunotherapy (L Cox, Section Editor)
  • Published:
Current Treatment Options in Allergy Aims and scope Submit manuscript

Abstract

Purpose of the review

Data obtained from controlled clinical trials remains the gold standard for the evaluation of treatment efficacy and safety. This information is used in systematic reviews and meta-analysis providing data for evidence-based medicine (EBM) statements and conclusions which are preferred by regulatory and academic groups when decisions and recommendations need to be given.

Recent findings:

The quantity and diversity of real-world data (RWD) have been increasing exponentially as technology and integrated electronic medical records have made this information increasingly accessible and useful for outcomes research and regulatory purposes.

There are increasing interest and potential for converting RWD into real-world evidence that, through careful analysis and interpretation, can be used to inform healthcare decision-making.

Summary

In this article, we present a concise summary of the literature about the role of EBM and RWD in allergen immunotherapy. We are aiming to evaluate their influence on current and future decisions for good clinical practice parameter recommendations.

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References and Recommended Reading

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

  1. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence-based medicine: what it is and what it is not. BMJ. 1996;312(7023):71–2.

    Article  CAS  Google Scholar 

  2. Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. BMJ. 1999;318:593–6.

    Article  CAS  Google Scholar 

  3. •• Calderon MA, Casale TB, Togias A, Bousquet J, Durham SR, Demoly P. Allergen-specific immunotherapy for respiratory allergies: from meta-analysis to registration and beyond. J Allergy Clin Immunol. 2011;127:30–8. The paper provides a critical global view of AIT assessing different clinical and research issues.

    Article  Google Scholar 

  4. Calderon MA. Meta-analyses of specific immunotherapy trials. Drugs Today. 2008;44:S31–4.

    Google Scholar 

  5. Oxford Centre for Evidence-based Medicine scores (Oxford Centre for Evidence-based Medicine). Levels of evidence and grades of recommendation. 2013. http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/

  6. World Health Organization (WHO). Annex 1. GRADE evidence profiles. http://www.who.int/hrh/retention/annex1_grade_evidence_profiles.pdf.

  7. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. http://handbook.cochrane.org/chapter_12/12_2_1_the_grade_approach.htm.

  8. •• Calderón MA, Boyle RJ, Penagos M, Sheikh A. Immunotherapy: the meta-analyses. What have we Learned? Immunol Allergy Clin N Am. 2011;31(2):159–73. The paper provides a clear and simple evaluation of Systematic Reviews and Meta-Analysis in AIT.

    Article  Google Scholar 

  9. Calderon MA, Penagos M, Durham SR. Sublingual immunotherapy for allergic rhinoconjunctivitis, allergic asthma and prevention of allergic diseases. Clin Allergy Immunol. 2008;21:359–75.

    CAS  PubMed  Google Scholar 

  10. Makady A, de Boer A, Hillege H, Klungel O, Goettsch W, on behalf of Get Real Work Package 1. What is real-world data? A review of definitions based on literature and stakeholder interviews. Value Health. 2017;20:858–65.

    Article  Google Scholar 

  11. Garrison LP, Neumann PJ, Erickson P, et al. Using real world data for coverage and payment decisions: the ISPOR Real World Data Task Force Report. Value Health. 2007;10:326–35.

    Article  Google Scholar 

  12. Schünemann HJ, Jaeschke R, Cook DJ, et al. An Official ATS statement: grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations. Am J Respir Crit Care Med. 2006;174:605–14.

    Article  Google Scholar 

  13. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924–6.

    Article  Google Scholar 

  14. Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, et al. Allergic rhinitis and its impact on asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA2LEN and AllerGen). Allergy. 2008;63:S8–160.

    Article  Google Scholar 

  15. • Campbell JD, Perry R, Papadopoulos NG, Krishnan J, Brusselle G, Chisholm A, et al. The REal Life EVidence AssessmeNt Tool (RELEVANT): development of a novel quality assurance asset to rate observational comparative effectiveness research studies. Clin Transl Allergy. 2019;9:21. https://doi.org/10.1186/s13601-019-0256-9. The paper provides a practical example on how to use RWD.

    Article  PubMed  PubMed Central  Google Scholar 

  16. •• Roche N, Campbell JD, Krishnan JA, Brusselle G, Chisholm A, Bjermer L, et al. Quality standards in respiratory real-life effectiveness research: the REal Life EVidence AssessmeNt Tool (RELEVANT): report from the Respiratory Effectiveness Group-European Academy of Allergy and Clinical Immunology Task Force. Clin Transl Allergy. 2019;9:20. https://doi.org/10.1186/s13601-019-0255-x. The paper provides an expert evaluation of a tool in RWD.

    Article  PubMed  PubMed Central  Google Scholar 

  17. • Bachert C, Larché M, Bonini S, Canonica GW, Kündig T, Larenas-Linnemann D, et al. Allergen immunotherapy on the way to product-based evaluation -a WAO statement. World Allergy Organ J. 2015;8:29. https://doi.org/10.1186/s40413-015-0078-8. The paper provides new concepts to applied in AIT.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. • Zielen S, Devillier P, Heinrich J, Richter H, Wahn U. Sublingual immunotherapy provides long-term relief in allergic rhinitis and reduces the risk of asthma: a retrospective, real world database analysis. Allergy. 2017;73(1):165–77 1–13. The paper provides an example of new AIT data generated by RWD.

    Article  Google Scholar 

  19. • Devillier P, Molimard M, Ansolabehere X, Bardoulat I, Coulombel N, Maurel F, Le Jeunne P, Demoly P. Immunotherapy with grass pollen tablets reduces medication dispensing for allergic rhinitis and asthma: a retrospective database study in France. Allergy. 2018. doi: https://doi.org/10.1111/all.13705. The paper provides an example of new AIT data generated by RWD.

  20. Hankin CS, Cox L, Bronstone A, Wang Z. Allergy immunotherapy: reduced health care costs in adults and children with allergic rhinitis. J Allergy Clin Immunol. 2013;131(4):1084–91.

    Article  Google Scholar 

  21. Kroon AM. The EAMG position on the regulation of existing products for treatment with special reference to named patient products (NPPs). Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 2003; (94): 7–14; discussion 14–6.

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Authors and Affiliations

  1. Section of Allergy and Clinical Immunology, Imperial College London, Dovehouse Street, London, SW3 6LY, UK

    Moisés A. Calderon MD, PhD

  2. Institute of Applied Molecular Medicine, Department of Basic Medical Sciences, Faculty of Medicine, San Pablo CEU University, Madrid, Spain

    Pilar Rico Nieto MD

  3. Department of Pulmonology, Division of Allergy, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Montpellier, France

    Pascal Demoly MD, PhD

  4. Equipe EPAR – IPLESP, UMR-S 1136 INSERM-Sorbonne Université, Paris, France

    Pascal Demoly MD, PhD

Authors
  1. Moisés A. Calderon MD, PhD
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  2. Pilar Rico Nieto MD
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  3. Pascal Demoly MD, PhD
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Corresponding author

Correspondence to Moisés A. Calderon MD, PhD.

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Conflict of interest

Dr. Demoly reports personal fees from ALK, personal fees from StallergènesGreer, personal fees from Iqvia, personal fees from Chiesi, personal fees from AstraZeneca, personal fees from ThermoFisherScientific, personal fees from Sanofi-Regeneron, personal fees from Ménarini, personal fees from Bausch&Lomb and personal fees from Novartis, outside the submitted work.

Prof Dr. Moisés A. Calderon has received an honorarium as speaker from AKL-Abello, AKL-USA, ALK-Canda, Stallergenes Greer and HAL-Allergy and as an advisory board member from ALK-Abello, Stallergenes Greer, HAL-Allergy and ASIT-Biotech.

Dr. Rico has nothing to disclose.

Human and animal rights and informed consent

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

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This article is part of the Topical Collection on Specific Immunotherapy

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Calderon, M.A., Nieto, P.R. & Demoly, P. Evidence-Based Medicine and Real-World Data in Allergen Immunotherapy Today and in the Future: Quality or Quantity?. Curr Treat Options Allergy 6, 377–387 (2019). https://doi.org/10.1007/s40521-019-00213-2

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  • DOI: https://doi.org/10.1007/s40521-019-00213-2

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