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Review
. 2022 Jun 7;31(164):210278.
doi: 10.1183/16000617.0278-2021. Print 2022 Jun 30.

Biologics in severe asthma: the role of real-world evidence from registries

Giovanni Paoletti  1   2 , Jack Pepys  2 , Marta Casini  2 , Danilo Di Bona  3 , Enrico Heffler  1   2 , Celine Y Y Goh  4   5 , David B Price  4   5   6 , Giorgio Walter Canonica  7   2
Affiliations
Review

Biologics in severe asthma: the role of real-world evidence from registries

Giovanni Paoletti et al. Eur Respir Rev. .

Abstract

Asthma is one of the most common noncommunicable diseases; in the majority of patients it is well controlled with inhaled bronchodilators and inhaled corticosteroids, but the management of severe asthma has been a significant challenge historically. The introduction of novel biologic drugs in the past few decades has revolutionised the field, presenting physicians with a variety of biologic drugs with different mechanisms for the treatment of severe asthma.It is of crucial importance to evaluate the effectiveness of these drugs by following their "real-life" effectiveness rather than relying solely on their efficacy, established in carefully designed clinical trials, which therefore do not necessarily match the profile of the real-life patient. Understanding the actual effectiveness of the specific drugs in real-life patients is a crucial part of tailoring the right drugs to the right patients. Registries serve as an important tool in obtaining real-life evidence, since they are in effect observational studies, following the entire patient population.

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Conflict of interest statement

Conflict of interest: G. Paoletti reports no conflict of interest. Conflict of interest: J. Pepys reports no conflict of interest. Conflict of interest: M. Casini reports no conflict of interest. Conflict of interest: D. Di Bona reports no conflict of interest. Conflict of interest: E. Heffler reports personal fees from AstraZeneca, Sanofi, Novartis, Teva, GSK, Circassia, Boehringer Ingelheim, Valeas, and Nestlè Purina, outside the submitted work. Conflict of interest: C.Y.Y. Goh reports no conflicts of interest. Conflict of interest: D.B. Price has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Viatris, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, and Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Viatris, Mundipharma Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Viatris, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Viatris, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, and Teva Pharmaceuticals; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma, Novartis, Teva Pharmaceuticals, and Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. Conflict of interest: G.W. Canonica has received grants and consultancy fees from A. Menarini, ALK-Abelló, Allergy Therapeutics, AstraZeneca-Medimmune, Boehringer Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, GlaxoSmithKline, Hal Allergy, Merck Sharp & Dohme, Mundipharma, Novartis, Orion, Sanofi-Aventis, Sanofi Genzyme/Regeneron, Stallergenes Greer, Uriach Pharma, Teva, Valeas and Vifor Pharma.

Figures

FIGURE 1
FIGURE 1
Strength of evidence of drug efficacy and effectiveness from real-life research and randomised controlled trials.
See this image and copyright information in PMC

References

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