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

Giovanni Paoletti, Jack Pepys, Marta Casini, Danilo Di Bona, Enrico Heffler, Celine Y.Y. Goh, David B. Price, Giorgio Walter Canonica*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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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.

Original languageEnglish
Article number210278
Number of pages11
JournalEuropean Respiratory Review
Issue number164
Early online date7 Jun 2022
Publication statusPublished - 30 Jun 2022

Bibliographical note

Funding Information:
Conflict of interest: G. Paoletti reports no conflict of interest. J. Pepys reports no conflict of interest. M. Casini reports no conflict of interest. D. Di Bona reports no 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. C.Y.Y. Goh reports no conflicts 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. 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.

Funding Information:
To overcome the aforementioned limitations, the International Severe Asthma Registry (ISAR) was created [77–79]. ISAR ( is the first global adult severe asthma registry aiming to achieve sufficient statistical power to answer important research questions, and to standardise data, making them comparable across countries and regions. The global reach of ISAR is achieved by the already established collaboration with 25 countries, including national or regional registries from Europe, plus registries from the Americas, Asia, the Middle East and the Australasian Severe Asthma Web-based Database registry of Australia, New Zealand and Singapore [78]. ISAR’s research is overseen by the ISAR steering committee (ISC), consisting of global severe asthma experts, and is governed by the Respiratory Effectiveness Group via the Anonymised Data Ethics and Protocol Transparency committee [78]. ISAR is cofunded by Optimum Patient Care Global and AstraZeneca; however, ISAR is open to independent projects not funded by AstraZeneca. Participating countries may also have multiple additional sources of funding. Core variables for standardised data collection were derived from a modified Delphi process [79]; additional variables are also collected from some countries to assess patient safety and the impact of steroid reduction. Prospective data collection for the ISAR registry was initiated in 2018 in Italy, the United States, South Korea ( and the United Kingdom (UK) to better standardise data fields, increase the accuracy of cross-country comparisons and reduce any data incongruence in datasets [80].


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