Advertisement
Original Research| Volume 210, 107170, April 2023

Patient characteristics and eligibility for biologics in severe asthma: Results from the Greek cohort of the RECOGNISE “real world” study

Published:February 23, 2023DOI:https://doi.org/10.1016/j.rmed.2023.107170

      Highlights

      • Most Greek severe asthma patients were eligible for biologics by investigator's assessment and by label criteria.
      • Most patients had poor asthma control and markedly impaired health-related quality of life due to high symptom burden.
      • Over 80% of the patients received systemic corticosteroids but a minority of them reported chronic oral corticosteroid use.
      • Greek patients with severe asthma are more often never smokers.

      Abstract

      Background

      Some patients with severe asthma do not achieve sufficient symptom control despite guideline-based treatment, and therefore receive oral (OCS) and systemic corticosteroids (SCS) on regular basis. The side effects of corticosteroid use negatively impact patients' health-related quality of life (HRQoL) and increase the disease burden. Biologics have shown promise in asthma therapy; however, identifying patients who might benefit from biologic therapy is complex due to the heterogeneous pathophysiology of the disease.

      Methods

      The European, non-interventional, multicentre RECOGNISE study (NCT03629782) assessed patient characteristics, asthma medication and control, HRQoL as assessed by St. George's Respiratory Questionnaire (SGRQ), and health care resource use in patients with severe asthma, as well as their eligibility for biologic treatment. Here, data from the Greek cohort (N = 97) are reported.

      Results

      In Greece, patients with severe asthma were more often female (71%) and never smokers (68%). 87% of patients were assessed as eligible for biologic treatment by investigator's judgement (per label criteria: 76%). Most patients had been previously treated with SCS (82% eligible vs 85% non-eligible), with OCS use being more common in non-eligible patients (23.1% vs 11.9%). More eligible patients had poorly controlled asthma (76% vs 54%), and more impaired HRQoL (mean total SGRQ score: 46% vs 39%); symptom burden was significantly higher (mean symptom score: 60% vs. 44%, p: 0.0389).

      Conclusions

      A high proportion of Greek patients with severe asthma are eligible for biologic therapy; however, individual risk factors and differences between asthma types must be considered before the introduction of targeted therapy.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Respiratory Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Global Initiative for Asthma (GINA)
        From the global strategy for asthma management and prevention.
        (updated)
        • Chung K.F.
        • Wenzel S.E.
        • Brozek J.L.
        • Bush A.
        • Castro M.
        • Sterk P.J.
        • Adcock I.M.
        • Bateman E.D.
        • Bel E.H.
        • Bleecker E.R.
        • Boulet L.P.
        • Brightling C.
        • Chanez P.
        • Dahlen S.E.
        • Djukanovic R.
        • Frey U.
        • Gaga M.
        • Gibson P.
        • Hamid Q.
        • Jajour N.N.
        • Mauad T.
        • Sorkness R.L.
        • Teague W.G.
        International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma.
        Eur. Respir. J. 2014 Feb; 43 (Erratum in: Eur Respir J. 2014 Apr;43(4):1216. Dosage error in article text. Erratum in: Eur Respir J. 2018 Jul 27;52(1): Erratum in: Eur Respir J. 2022 Jun 9;59(6)): 343-373https://doi.org/10.1183/09031936.00202013
        • von Bülow A.
        • Kriegbaum M.
        • Backer V.
        • Porsbjerg C.
        The prevalence of severe asthma and low asthma control among Danish adults.
        J. Allergy Clin. Immunol. Pract. 2014 Nov-Dec; 2: 759-767https://doi.org/10.1016/j.jaip.2014.05.005
        • Hekking P.W.
        • Wener R.R.
        • Amelink M.
        • Zwinderman A.H.
        • Bouvy M.L.
        • Bel E.H.
        The prevalence of severe refractory asthma.
        J. Allergy Clin. Immunol. 2015 Apr; 135: 896-902https://doi.org/10.1016/j.jaci.2014.08.042
        • Nagase H.
        • Adachi M.
        • Matsunaga K.
        • Yoshida A.
        • Okoba T.
        • Hayashi N.
        • Emoto K.
        • Tohda Y.
        Prevalence, disease burden, and treatment reality of patients with severe, uncontrolled asthma in Japan.
        Allergol. Int. 2020 Jan; 69: 53-60https://doi.org/10.1016/j.alit.2019.06.003
        • Ryan D.
        • Heatley H.
        • Heaney L.G.
        • Jackson D.J.
        • Pfeffer P.E.
        • Busby J.
        • Menzies-Gow A.N.
        • Jones R.
        • Tran T.N.
        • Al-Ahmad M.
        • Backer V.
        • Belhassen M.
        • Bosnic-Anticevich S.
        • Bourdin A.
        • Bulathsinhala L.
        • Carter V.
        • Chaudhry I.
        • Eleangovan N.
        • FitzGerald J.M.
        • Gibson P.G.
        • Hosseini N.
        • Kaplan A.
        • Murray R.B.
        • Rhee C.K.
        • Van Ganse E.
        • Price D.B.
        Potential severe asthma hidden in UK primary care.
        J. Allergy Clin. Immunol. Pract. 2021 Apr; 9 (Erratum in: J Allergy Clin Immunol Pract. 2021 Nov;9(11):4182): 1612-1623https://doi.org/10.1016/j.jaip.2020.11.053
        • Loftus P.A.
        • Wise S.K.
        Epidemiology and economic burden of asthma.
        Int. Forum. Allergy Rhinol. 2015 Sep; 5: S7-S10https://doi.org/10.1002/alr.21547
        • Ehteshami-Afshar S.
        • FitzGerald J.M.
        • Doyle-Waters M.M.
        • Sadatsafavi M.
        The global economic burden of asthma and chronic obstructive pulmonary disease.
        Int. J. Tubercul. Lung Dis. 2016 Jan; 20: 11-23https://doi.org/10.5588/ijtld.15.0472
        • Nordon C.
        • Grimaldi-Bensouda L.
        • Pribil C.
        • Nachbaur G.
        • Amzal B.
        • Thabut G.
        • Marthan R.
        • Aubier M.
        • COBRA Study Group
        Clinical and economic burden of severe asthma: a French cohort study.
        Respir. Med. 2018 Nov; 144: 42-49https://doi.org/10.1016/j.rmed.2018.10.002
        • Vellopoulou K.
        • Bakakos P.
        • Loukides S.
        • Maniadakis N.
        • Kourlaba G.
        The economic burden of asthma in Greece: a cross-sectional study.
        Appl. Health Econ. Health Pol. 2019 Oct; 17: 629-640https://doi.org/10.1007/s40258-019-00469-4
        • Tan L.
        • Reibman J.
        • Ambrose C.
        • Chung Y.
        • Desai P.
        • Ackert J.L.
        • Moynihan M.
        • Tkacz J.
        Clinical and economic burden of uncontrolled severe noneosinophilic asthma.
        Am. J. Manag. Care. 2022 Jun; 28: e212-e220https://doi.org/10.37765/ajmc.2022.89159
        • Sweeney J.
        • Patterson C.C.
        • Menzies-Gow A.
        • Niven R.M.
        • Mansur A.H.
        • Bucknall C.
        • Chaudhuri R.
        • Price D.
        • Brightling C.E.
        • Heaney L.G.
        British thoracic society difficult asthma network. Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the optimum patient care research database and the British thoracic difficult asthma registry.
        Thorax. 2016 Apr; 71: 339-346https://doi.org/10.1136/thoraxjnl-2015-207630
        • Volmer T.
        • Effenberger T.
        • Trautner C.
        • Buhl R.
        Consequences of long-term oral corticosteroid therapy and its side-effects in severe asthma in adults: a focused review of the impact data in the literature.
        Eur. Respir. J. 2018 Oct; 521800703https://doi.org/10.1183/13993003.00703-2018
        • Deeks E.D.
        • Brusselle G.
        Reslizumab in eosinophilic asthma: a review.
        Drugs. 2017 May; 77: 777-784https://doi.org/10.1007/s40265-017-0740-2
        • Rönnebjerg L.
        • Axelsson M.
        • Kankaanranta H.
        • Backman H.
        • Rådinger M.
        • Lundbäck B.
        • Ekerljung L.
        Severe asthma in a general population study: prevalence and clinical characteristics.
        J. Asthma Allergy. 2021 Sep; 14: 1105-1115https://doi.org/10.2147/JAA.S327659
        • Wenzel S.E.
        Asthma phenotypes: the evolution from clinical to molecular approaches.
        Nat. Med. 2012 May; 18: 716-725
        • Kuruvilla M.E.
        • Lee F.E.
        • Lee G.B.
        Understanding asthma phenotypes, endotypes, and mechanisms of disease.
        Clin. Rev. Allergy Immunol. 2019 Apr; 56: 219-233https://doi.org/10.1007/s12016-018-8712-1
        • McGregor M.C.
        • Krings J.G.
        • Nair P.
        • Castro M.
        Role of biologics in asthma.
        Am. J. Respir. Crit. Care Med. 2019 Feb; 199: 433-445https://doi.org/10.1164/rccm.201810-1944CI
        • Agache I.
        • Beltran J.
        • Akdis C.
        • Akdis M.
        • Canelo-Aybar C.
        • Canonica G.W.
        • Casale T.
        • Chivato T.
        • Corren J.
        • Del Giacco S.
        • Eiwegger T.
        • Firinu D.
        • Gern J.E.
        • Hamelmann E.
        • Hanania N.
        • Mäkelä M.
        • Hernández-Martín I.
        • Nair P.
        • O'Mahony L.
        • Papadopoulos N.G.
        • Papi A.
        • Park H.S.
        • Pérez de Llano L.
        • Posso M.
        • Rocha C.
        • Quirce S.
        • Sastre J.
        • Shamji M.
        • Song Y.
        • Steiner C.
        • Schwarze J.
        • Alonso-Coello P.
        • Palomares O.
        • Jutel M.
        Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma.
        Allergy. 2020 May; 75: 1023-1042https://doi.org/10.1111/all.14221
        • Schoettler N.
        • Strek M.E.
        Recent advances in severe asthma: from phenotypes to personalized medicine.
        Chest. 2020 Mar; 157: 516-528https://doi.org/10.1016/j.chest.2019.10.009
        • Stubbs M.A.
        • Clark V.L.
        • McDonald V.M.
        Living well with severe asthma.
        Breathe. 2019 Jun; 15: e40-e49https://doi.org/10.1183/20734735.0165-2019
        • Côté A.
        • Godbout K.
        • Boulet L.P.
        The management of severe asthma in 2020.
        Biochem. Pharmacol. 2020 Sep; 179114112https://doi.org/10.1016/j.bcp.2020.114112
        • Schleich F.
        • Brusselle G.
        • Louis R.
        • Vandenplas O.
        • Michils A.
        • Pilette C.
        • Peche R.
        • Manise M.
        • Joos G.
        Heterogeneity of phenotypes in severe asthmatics. The Belgian severe asthma registry (BSAR).
        Respir. Med. 2014 Dec; 108: 1723-1732https://doi.org/10.1016/j.rmed.2014.10.007
        • Miller R.L.
        • Grayson M.H.
        • Strothman K.
        Advances in asthma: new understandings of asthma's natural history, risk factors, underlying mechanisms, and clinical management.
        J. Allergy Clin. Immunol. 2021 Dec; 148: 1430-1441https://doi.org/10.1016/j.jaci.2021.10.001
        • Buhl R.
        • Humbert M.
        • Bjermer L.
        • Chanez P.
        • Heaney L.G.
        • Pavord I.
        • Quirce S.
        • Virchow J.C.
        Holgate S; expert group of the European Consensus Meeting for Severe Eosinophilic Asthma. Severe eosinophilic asthma: a roadmap to consensus.
        Eur. Respir. J. 2017 May; 491700634https://doi.org/10.1183/13993003.00634-2017
        • Jones T.L.
        • Neville D.M.
        • Chauhan A.J.
        Diagnosis and treatment of severe asthma: a phenotype-based approach.
        Clin. Med. 2018 Apr; 18: s36-s40https://doi.org/10.7861/clinmedicine.18-2-s36
        • Kanniess F.
        • Tamasi L.
        • Mroz R.R.
        • Bakakos P.
        • Tubis S.
        • Resler Plat G.
        • Shavit A.
        Real-world patient characteristics and eligibility for biologics in severe asthma (RECOGNISE).
        Eur. Respir. J. 2021; 58: PA3729
        • Jones P.W.
        • Quirk F.H.
        • Baveystock C.M.
        The St george's respiratory questionnaire.
        Respir. Med. 1991 Sep; 85 (; discussion 33-7): 25-31https://doi.org/10.1016/s0954-6111(06)80166-6
        • Jones P.W.
        • Quirk F.H.
        • Baveystock C.M.
        • Littlejohns P.
        A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire.
        Am. Rev. Respir. Dis. 1992 Jun; 145: 1321-1327https://doi.org/10.1164/ajrccm/145.6.1321
        • Juniper E.F.
        • O'Byrne P.M.
        • Guyatt G.H.
        • Ferrie P.J.
        • King D.R.
        Development and validation of a questionnaire to measure asthma control.
        Eur. Respir. J. 1999 Oct; 14: 902-907https://doi.org/10.1034/j.1399-3003.1999.14d29.x
        • Fildan A.P.
        • Rajnoveanu R.M.
        • Cirjaliu R.
        • Pohrib I.
        • Tudorache E.
        • Ilie A.C.
        • Oancea C.
        • Tofolean D.
        Biological therapies targeting the type 2 inflammatory pathway in severe asthma (Review).
        Exp. Ther. Med. 2021 Nov; 22: 1263https://doi.org/10.3892/etm.2021.10698
        • Tiotiu A.
        Biomarkers in asthma: state of the art.
        Asthma Res. Pract. 2018 Dec; 4: 10https://doi.org/10.1186/s40733-018-0047-4
        • Wan X.C.
        • Woodruff P.G.
        Biomarkers in severe asthma.
        Immunol. Allergy Clin. 2016 Aug; 36: 547-557https://doi.org/10.1016/j.iac.2016.03.004
        • Narendra D.
        • Blixt J.
        • Hanania N.A.
        Immunological biomarkers in severe asthma.
        Semin. Immunol. 2019 Dec; 46101332https://doi.org/10.1016/j.smim.2019.101332
        • Aaron S.D.
        • Vandemheen K.L.
        • FitzGerald J.M.
        • Ainslie M.
        • Gupta S.
        • Lemière C.
        • Field S.K.
        • McIvor R.A.
        • Hernandez P.
        • Mayers I.
        • Mulpuru S.
        • Alvarez G.G.
        • Pakhale S.
        • Mallick R.
        • Boulet L.P.
        Canadian respiratory research network. Reevaluation of diagnosis in adults with physician-diagnosed asthma.
        JAMA. 2017 Jan; 317: 269-279https://doi.org/10.1001/jama.2016.19627
        • Gibson P.G.
        • McDonald V.M.
        Management of severe asthma: targeting the airways, comorbidities and risk factors.
        Intern. Med. J. 2017 Jun; 47: 623-631https://doi.org/10.1111/imj.13441
        • Caminati M.
        • Vaia R.
        • Furci F.
        • Guarnieri G.
        • Senna G.
        Uncontrolled asthma: unmet needs in the management of patients.
        J. Asthma Allergy. 2021 May; 14: 457-466https://doi.org/10.2147/JAA.S260604
        • Souliotis K.
        • Kousoulakou H.
        • Hillas G.
        • Bakakos P.
        • Toumbis M.
        • Loukides S.
        • Vassilakopoulos T.
        Direct and indirect costs of asthma management in Greece: an expert panel approach.
        Front. Public Health. 2017 Apr; 5: 67https://doi.org/10.3389/fpubh.2017.00067
        • Castillo Vizuete J.A.
        • Sastre J.
        • Del Cuvillo Bernal A.
        • Picado C.
        • Martínez Moragón E.
        • Ignacio García J.M.
        • Cisneros Serrano C.
        • Álvarez Gutiérrez F.J.
        • Mullol Miret J.
        Asthma, rhinitis, and nasal polyp multimorbidities.
        Arch. Bronconeumol. 2019 Mar; 55: 146-155https://doi.org/10.1016/j.arbres.2018.09.001
        • Kourlaba G.
        • Bakakos P.
        • Loukides S.
        • Vellopoulou K.
        • Solakidi A.
        • Maniadakis N.
        The self-reported prevalence and disease burden of asthma in Greece.
        J. Asthma. 2019; 56 (May): 478-497https://doi.org/10.1080/02770903.2018.1471704
        • Richards L.B.
        • van Bragt J.J.M.H.
        • Aarab R.
        • Longo C.
        • Neerincx A.H.
        • Sont J.K.
        • Weersink E.J.M.
        • Braunstahl G.J.
        • Brinke A.T.
        • Bel E.H.D.
        • Maitland-van der Zee A.H.
        Treatment eligibility of real-life mepolizumab-treated severe asthma patients.
        J. Allergy Clin. Immunol. Pract. 2020 Oct; 8 (Erratum in: J Allergy Clin Immunol Pract. 2021 Jan;9(1):604): 2999-3008https://doi.org/10.1016/j.jaip.2020.04.029
        • Lam R.W.
        • Inselman J.W.
        • Jeffery M.M.
        • Maddux J.T.
        • Shah N.D.
        • Rank M.A.
        Asthma biologic trial eligibility and real-world outcomes in the United States.
        J. Asthma. 2021 Dec 6; : 1-8https://doi.org/10.1080/02770903.2021.2010749
        • Marques Mello L.
        • Viana K.P.
        • Moraes Dos Santos F.
        • Saturnino L.T.M.
        • Kormann M.L.
        • Lazaridis E.
        • Torreão C.D.
        • Soares C.R.
        • Abreu G.A.
        • Lima V.B.
        • Pinheiro G.P.
        • Lima-Matos A.
        • Ponte E.V.
        • Mohan D.
        • Riley J.H.
        • Cruz A.A.
        Severe asthma and eligibility for biologics in a Brazilian cohort.
        J. Asthma. 2021 Jul; 58: 958-966https://doi.org/10.1080/02770903.2020.1748049