@article {Frix00273-2022, author = {Anne-Noelle Frix and Liam G. Heaney and Barbro Dahl{\'e}n and Florin Mihaltan and Svetlana Sergejeva and Sanja Popovi{\'c}-Grle and Vratislav Sedlak and Lauri Lehtim{\"a}ki and Arnaud Bourdin and Stephanie Korn and Eleftherios Zervas and Zsuzsanna Csoma and Dora L{\'u}{\dh}v{\'\i}ksd{\'o}ttir and Marcus Butler and Giorgio Walter Canonica and Ineta Grisle and Kristina Bieksiene and Anneke Ten Brinke and Piotr Kuna and Claudia Chaves Loureiro and Natalia M Nenasheva and Zorica Lazic and Sabina {\v S}krgat and David Ramos-Barbon and Joerg Leuppi and Bilun Gemicioglu and Apostolos Bossios and Celeste M Porsbjerg and Elisabeth H Bel and Ratko Djukanovic and Renaud Louis}, title = {Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study}, elocation-id = {00273-2022}, year = {2022}, doi = {10.1183/23120541.00273-2022}, publisher = {European Respiratory Society}, abstract = {Introduction Treatment with biologics for severe asthma is informed by international and national guidelines and defined by national regulating bodies, but how these drugs are used in real-life is unknown.Materials and methods The ERS SHARP clinical research collaboration conducted a 3-step survey collecting information on asthma biologics use in Europe. Five geographically distant countries defined the survey questions, focusing on 7 endpoints: biologics availability and financial issues, prescription and administration modalities, inclusion criteria, continuation criteria, switching biologics, combining biologics, and evaluation of corticosteroid toxicity. The survey was then sent to SHARP National Leads of 28 European countries. Finally, selected questions were submitted to a broad group of 263 asthma experts identified by national societies.Results Availability of biologics varied between countries, with 17/28 countries having all 5 existing biologics. Authorised prescribers (pulmonologists and other specialists) also differed. In-hospital administration was the preferred deliverance modality. While exacerbation rate was used as an inclusion criterion in all countries, FEV1 was used in 46\%. Blood eosinophils were an inclusion criterion in all countries for IL5- and IL4/IL13- targeted biologics, with varying thresholds. There were no formally established criteria for continuing biologics. Reduction in exacerbations represented the most important benchmark, followed by improvement in asthma control and quality of life. Only 73\% (191/263) of surveyed clinicians assessed their patients for corticosteroid-induced toxicity.Conclusion Our study reveals important heterogeneity in the use of asthma biologics across Europe. To what extent this impacts on clinical outcomes relevant to patients and healthcare services needs further investigation.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: J{\"o}rg Leuppi reports the following relationships outside the submitted work: J.D. Leuppi is supported by grants from the Swiss National Science Foundation (SNF 160072 and 185592) as well as by Swiss Personalised Health Network (SPHN 2018DR108). J.D. Leuppi has also received unrestricted grants from AstraZeneca AG Switzerland, Boehringer Ingelheim GmbH Switzerland, GSK AG Switzerland, and Novartis AG Switzerland.Conflict of interest: Liam Heaney reports the following relationships outside the submitted work: Academic Lead for the UK MRC Consortium for Stratified Medicine in Severe Asthma {\textendash} Industrial Pharma partners Amgen, AstraZeneca, Medimmune, Janssen, Novartis, Roche / Genentech, GlaxoSmithKline, and Boehringer Ingelheim; project grant funding from Medimmune, Novartis UK, Roche / Genentech,and GlaxoSmithKline. Travel funding support to international respiratory meetings received from AstraZeneca, Chiesi, Novartis, Boehringer Ingelheim, Teva, and GlaxoSmithKline. Participated on Advisory Boards for Astra Zeneca, Novartis, GlaxoSmithKline, Chiesi, Teva, Theravance and Vectura.Conflict of interest: LOUIS Renaud reports receiving support for the present manuscript from SHARP CRC supported by GSK, Novartis, Sanofi, Chiesi and Teva. The following relationships are reported outside the submitted work: Grants or contracts received from GSK, AZ and Chiesi. Consulting fees received from AZ and Saofi. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, received from AZ, GSK and Chiesi. Patents planned, issued or pending WO 2017/050527 A1 {\textquotedblleft}Method for the diagnosis of airway disease inflammatory subtype{\textquotedblright}.Conflict of interest: Marcus W Butler reports the following relationships outside the submitted work: payment or honoraria received for lectures and presentations from AstraZeneca, Novartis and Glaxo SmithKline. Support received for international meeting attendance received from AstraZeneca. Participation on Advisory Boards for ALK Abello, AstraZeneca, Glaxo SmithKline and Novartis. Chair of Medical Advisory Group, Board member of Asthma Society of Ireland, Ireland member of GINA Assembly, resident of Irish Thoracic Society (2022-Present).Conflict of interest: Ratko Djukanovic reports the following relationships outside the submitted work: Funding received for the SHARP CRC from ERS, TEVA, GSK, Novartis, Sanofi and Chiesi. Consultancy fees paid to the author received from Synairgen plc, Sanofi-Genzyme Corporation and Galapagos. Honorarium for lectures paid to the author received from GlaxoSmithKline, Congress of Interasma, AstraZeneca and Airways Vista, Seoul. Personal shares owned for Synairgen.Conflict of interest: Sanja Popovi{\'c}-Grle reports the following relationships outside the submitted work: payment for educational events from Abbot, Alkaloid, AstraZeneca, BerlinChemie Menarini, Boehringer Ingelheim, Medis, Novartis, Pliva-Teva, PharmaS, Providens, Salvus, Sandoz, Sanofi-Aventis and SwixxPharma. Participation on Advisory Boards for AstraZeneca, Boehringer Ingelheim, BerlinChemie Menarini, GSK, Novartis, Pliva-Teva, PharmaS, Sanofi-Aventis and SwixxPharma.Conflict of interest: Stephanie Korn reports the following relationships outside the submitted work: consulting fees received from AstraZeneca, Novartis, GlaxoSmithKline and Sanofi. Payment or honoraria received for lectures and presentations from AstraZeneca, Novartis, GlaxoSmithKline and Sanofi. Participation on a Data Safety Monitoring Board or Advisory Board for AstraZeneca, Novartis and GlaxoSmithKline.Conflict of interest: Vratislav Sedl{\'a}k reports the following relationships outside the submitted work: payment for presentations received from AstraZeneca, Novartis, GlaxoSmithKline, TEVA and Sanofi. Payment for expert testimony payments received from AstraZeneca, Novartis, GlaxoSmithKline, TEVA and Sanofi. Payment for participation on a Data Safety Monitoring Board or Advisory Board received from AstraZeneca, Novartis, GlaxoSmithKline, TEVA and Sanofi.Conflict of interest: Zorica Lazic reports the following relationships outside the submitted work: payment or honoraria for educational events received from AstraZeneca, BerlinChemie Menarini, Boehringer Ingelheim, Novartis, PharmaS, Providens, Sandoz and Actavis-Teva Serbia. Participation on Advisory Boards for AstraZeneca, Boehringer Ingelheim, BerlinChemie Menarini, Novartis and Actavis-Teva Serbia.Conflict of interest: Piotr Kuna reports the following relationships outside the submitted work: personal fees received for lectures, presentations, speakers bureaus, manuscript writing or educational events received from Adamed, AstraZeneca, Boehringer Ingelheim, Berlin Chemie Menarini, Alvogen, Glenmark, Novartis, GSK, Chiesi, Polpharma and Teva.Conflict of interest: Sabina {\v S}krgat reports the following relationships outside the submitted work: Honoraria received for lectures and educational events from Astra Zeneca, Pliva Teva, Berlin Chemie and Chiesi, Medis. Participation on local Advisory boards organized by Astra Zeneca.Conflict of interest: Bilun Gemicioglu reports the following relationships outside the submitted work: grants or contracts received from AstraZeneca, Novartis, GlaxoSmithKline and Sanofi. Payment or honoraria received for lectures, presentations, speakers bureaus, manuscript writing or educational events received from Novartis. Support for attending meetings received from Novartis. Participation on a Data Safety Monitoring Board or Advisory Board for GlaxoSmithKline.Conflict of interest: Kristina Beiksiene reports the following relationships outside the submitted work: Payment or honoraria received for lectures, presentations, speakers bureaus, manuscript writing or educational events received from Astra Zeneca and Berlin Chemie.Conflict of interest: Lauri Lehtim{\"a}ki reports the following relationships outside the submitted work: Fees for lectures or advisory board meetings received from ALK, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, GSK, Mundipharma, Novartis, Orion Pharma and Sanofi. Owner of shares for Ausculthing OY.Conflict of interest: Anneke ten Brinke reports the following relationships outside the submitted work: unrestricted grants received from TEVA, GSK and AstraZeneca. Consulting fees paid to the institution from GSK, Sanofi, TEVA, AstraZeneca and Boehringer Ingelheim. Payments for lectures, paid to the institution, received from GSK, TEVA, AstraZeneca and Sanofi. Participation on Research Advisory Boards for GSK, Sanofi, AstraZeneca, Boehringer Ingelheim and TEVA. Chair of Dutch severe asthma registry: RAPSODI.Conflict of interest: Apostolos Bossios reports the following relationships outside the submitted work: Payment or honoraria received for lectures, presentations, speakers bureaus, manuscript writing or educational events received from Astra Zeneca, GSK and TEVA. Support for attending meetings and/or travel received from Novartis. Participation on a Data Safety Monitoring Board or Advisory Board for AstraZeneca, Novartis, GlaxoSmithKline, TEVA and Sanofi. Member of the steering Committee of SHARP, Secretary of Assembly 5 (Airway diseases, asthma, COPD and chronic cough) , European Respiratory Society; vice-chair of Nordic Severe Asthma Network (NSAN).Conflict of interest: Arnaud Bourdin reports the following relationships outside the submitted work: unrestricted grants received from Astra Zeneca and Boeringher Ingelheim. Consulting fees received from Astra Zeneca, GSK, Novartis, Sanofi Regeneron, Boeringher Ingelheim and Chiesi. Payment or honoraria received for lectures, presentations, speakers bureaus, manuscript writing or educational events received from Astra Zeneca, GSK, Novartis, Sanofi Regeneron, Boeringher Ingelheim and Chiesi. Support for attending meetings and/or travel received from Astra Zeneca, GSK, Novartis, Sanofi Regeneron, Boeringher Ingelheim and Chiesi.Conflict of interest: Barbro Dahl{\'e}n reports the following relationships outside the submitted work: Grant received from GSK and Novartis to support Karolinska Severe asthma Centre. Personal consulting fees received from GSK, Novartis, Teva and AstraZeneca. Consulting fees, paid to the institution received from Region Stockholm. Personal honoraria received from GSK, Novartis, Teva and AstraZeneca.Conflict of interest: Celeste Porsbjerg reports the following relationships outside the submitted work: Grants or contracts, paid to the institution received from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK. Consulting fees received from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK, fees paid to the institution and personal honoraria. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events received from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK, fees paid to the institution and personal honoraria. Participation on a Data Safety Monitoring Board or Advisory Board for AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK, fees paid to the institution and personal honoraria.Conflict of interest: Cl{\'a}udia Chaves Loureiro reports the following relationships outside the submitted work: Consulting fees received from AstraZeneca and GSK. Payment for r presentations and speakers bureaus received from AstraZeneca, GSK, Novartis and Sanofi-Aventis. Support for attending meetings received from AstraZeneca, Novartis, Nippon, Sanofi-Aventis, Tecnifarma and VitalAire. Participation on Advisory Boards for AstraZeneca, GSK, Novartis and Sanofi-Aventis.Conflict of interest: Elisabeth H. Bel reports the following relationships outside the submitted work: research grants received from GSK and Teva. Consulting fees received from Teva, Sanofi, AstraZeneca, GSK, Sterna and Chiesi. Participation on a Data Safety Monitoring Board or Advisory Board for AstraZeneca.Conflict of interest: Giorgio Walter Canonica reports the following relationships outside the submitted work: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events received from AstraZeneca, GSK, Novartis and Sanofi. Participation on a Data Safety Monitoring Board or Advisory Board for AstraZeneca, GSK, Novartis and Sanofi. Leadership or fiduciary role in other board, society, committee or advocacy group for EAACI Methodology Com, REG Vice president and SANI Steering Com.Conflict of interest: The remaining authors have nothing to disclose.}, URL = {https://openres.ersjournals.com/content/early/2022/08/11/23120541.00273-2022}, eprint = {https://openres.ersjournals.com/content/early/2022/08/11/23120541.00273-2022.full.pdf}, journal = {ERJ Open Research} }