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Severe Asthma

Severe asthma: oral corticosteroid alternatives and the need for optimal referral pathways

, MD, PhDORCID Icon, , MD, PhD, , MD, PhD, , MD, , MD, PhD, , MD, PhD, , MD, PhD & , MD show all
Pages 448-458 | Received 09 Aug 2019, Accepted 11 Dec 2019, Published online: 11 Jan 2020

References

  • Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014;43(2):343–373. doi:10.1183/09031936.00202013.
  • Stone B, Davis JR, Trudo F, Schiffman B, Alzola C, Brown D, Fox KM. Characterizing patients with asthma who received Global Initiative for Asthma steps 4-5 therapy and managed in a specialty care setting. Allergy Asthma Proc 2018;39(1):27–35. doi:10.2500/aap.2018.39.4094.
  • Lang DM. Severe asthma: epidemiology, burden of illness, and heterogeneity. Allergy Asthma Proc 2015;36(6):418–424. doi:10.2500/aap.2015.36.3908.
  • Fernandes AG, Souza-Machado C, Coelho RC, Franco PA, Esquivel RM, Souza-Machado A, Cruz AA. Risk factors for death in patients with severe asthma. J Bras Pneumol 2014;40(4):364–372. doi:10.1590/S1806-37132014000400003.
  • World Allergy Organization (WAO). Economic Analysis of the Cost of Treatments for Severe Asthma. Available from: http://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [last accessed 15 March 2019].
  • Bahadori K, Doyle-Waters MM, Marra C, Lynd L, Alasaly K, Swiston J, FitzGerald JM. Economic burden of asthma: a systematic review. BMC Pulm Med 2009;9(1):24. doi:10.1186/1471-2466-9-24.
  • Godard P, Chanez P, Siraudin L, Nicoloyannis N, Duru G. Costs of asthma are correlated with severity: a 1-yr prospective study. Eur Respir J 2002;19(1):61–67. doi:10.1183/09031936.02.00232001.
  • Dean BB, Calimlim BM, Kindermann SL, Khandker RK, Tinkelman D. The impact of uncontrolled asthma on absenteeism and health-related quality of life. J Asthma 2009;46(9):861–866. doi:10.3109/02770900903184237.
  • Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med 2014;24(14009).
  • Blaiss MS, Castro M, Chipps BE, Zitt M, Panettieri RA, Jr., Foggs MB. Guiding principles for use of newer biologics and bronchial thermoplasty for patients with severe asthma. Ann Allergy Asthma Immunol 2017;119(6):533–540. doi:10.1016/j.anai.2017.09.058.
  • Bel EH, Sousa A, Fleming L, Bush A, Chung KF, Versnel J, Wagener AH, Wagers SS, Sterk PJ, Compton CH, on behalf of the members of the Unbiased Biomarkers for the Prediction of Respiratory Disease Outcome (U-BIOPRED) Consortium, Consensus Generation. Diagnosis and definition of severe refractory asthma: an international consensus statement from the Innovative Medicine Initiative (IMI). Thorax 2011;66(10):910–917. doi:10.1136/thx.2010.153643.
  • Hekking PP, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol 2015;135(4):896–902. doi:10.1016/j.jaci.2014.08.042.
  • Sweeney J, Brightling CE, Menzies-Gow A, Niven R, Patterson CC, Heaney LG, on behalf of the British Thoracic Society Difficult Asthma Network. Clinical management and outcome of refractory asthma in the UK from the British Thoracic Society Difficult Asthma Registry. Thorax 2012;67(8):754–756. doi:10.1136/thoraxjnl-2012-201869.
  • Ferns M. Real world OCS use in asthma in The Netherlands. In: Week van de Longen; 2018. Available from: https://www.weekvandelongen.nl/en/home
  • 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;108(12):1723–1732. doi:10.1016/j.rmed.2014.10.007.
  • Nguyen VQ, Ulrik CS. Measures to reduce maintenance therapy with oral corticosteroid in adults with severe asthma. Allergy Asthma Proc 2016;37(6):125–139. doi:10.2500/aap.2016.37.4004.
  • Fardet L, Kassar A, Cabane J, Flahault A. Corticosteroid-induced adverse events in adults: frequency, screening and prevention. Drug Saf 2007;30(10):861–881. doi:10.2165/00002018-200730100-00005.
  • Sarnes E, Crofford L, Watson M, Dennis G, Kan H, Bass D. Incidence and US costs of corticosteroid-associated adverse events: a systematic literature review. Clin Ther 2011;33(10):1413–1432. doi:10.1016/j.clinthera.2011.09.009.
  • Manson SC, Brown RE, Cerulli A, Vidaurre CF. The cumulative burden of oral corticosteroid side effects and the economic implications of steroid use. Respir Med 2009;103(7):975–994. doi:10.1016/j.rmed.2009.01.003.
  • Broersen LH, Pereira AM, Jorgensen JO, Dekkers OM. Adrenal Insufficiency in corticosteroids use: systematic review and meta-analysis. J Clin Endocrinol Metab 2015;100(6):2171–2180. doi:10.1210/jc.2015-1218.
  • Al Nofal A, Bancos I, Benkhadra K, Ospina NM, Javed A, Kapoor E, Muthusamy K, Brito JP, Turcu AF, Wang Z, et al. Glucocorticoid replacement regimens in chronic adrenal insufficiency: a systematic review and meta-analysis. Endocr Pract 2017;23(1):17–31. doi:10.4158/EP161428.OR.
  • Sweeney J, Patterson CC, Menzies-Gow A, Niven RM, Mansur AH, Bucknall C, Chaudhuri R, Price D, Brightling CE, Heaney LG. 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;71(4):339–346. doi:10.1136/thoraxjnl-2015-207630.
  • Sullivan PW, Ghushchyan VH, Globe G, Schatz M. Oral corticosteroid exposure and adverse effects in asthmatic patients. J Allergy Clin Immunol 2018;141(1):110–116.e117. doi:10.1016/j.jaci.2017.04.009.
  • Bleecker ER, Menzies-Gow AN, Price DB, Bourdin A, Sweet S, Martin AL, Alacqua M, Tran TN. Systematic literature review of systemic corticosteroid use for asthma management. Am J Respir Crit Care Med. [Epub ahead of print]. doi:10.1164/rccm.201904-0903SO.
  • Siergiejko Z, Świebocka E, Smith N, Peckitt C, Leo J, Peachey G, Maykut R. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin 2011;27(11):2223–2228. doi:10.1185/03007995.2011.620950.
  • Molimard M, de Blay F, Didier A, Le Gros V. Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. Respir Med 2008;102(1):71–76. doi:10.1016/j.rmed.2007.08.006.
  • Molimard M, Buhl R, Niven R, Le Gros V, Thielen A, Thirlwell J, Maykut R, Peachey G. Omalizumab reduces oral corticosteroid use in patients with severe allergic asthma: real-life data. Respir Med 2010;104(9):1381–1385. doi:10.1016/j.rmed.2010.06.001.
  • Pelaia G, Gallelli L, Romeo P, Renda T, Busceti MT, Proietto A, Grembiale RD, Marsico SA, Maselli R, Vatrella A. Omalizumab decreases exacerbation frequency, oral intake of corticosteroids and peripheral blood eosinophils in atopic patients with uncontrolled asthma. CP 2011;49(12):713–721. doi:10.5414/CP201586.
  • Domingo C, Moreno A, Jose Amengual M, Monton C, Suarez D, Pomares X. Omalizumab in the management of oral corticosteroid-dependent IGE-mediated asthma patients. Curr Med Res Opin 2011;27(1):45–53. doi:10.1185/03007995.2010.536208.
  • Costello RW, Long DA, Gaine S, Mc Donnell T, Gilmartin JJ, Lane SJ. Therapy with omalizumab for patients with severe allergic asthma improves asthma control and reduces overall healthcare costs. Ir J Med Sci 2011;180(3):637–641. doi:10.1007/s11845-011-0716-2.
  • Rottem M. Omalizumab reduces corticosteroid use in patients with severe allergic asthma: real-life experience in Israel. J Asthma 2012;49(1):78–82. doi:10.3109/02770903.2011.637598.
  • Lafeuille MH, Dean J, Zhang J, Duh MS, Gorsh B, Lefebvre P. Impact of omalizumab on emergency-department visits, hospitalizations, and corticosteroid use among patients with uncontrolled asthma. Ann Allergy Asthma Immunol 2012;109(1):59–64. doi:10.1016/j.anai.2012.04.015.
  • Subramaniam A, Al-Alawi M, Hamad S, O'Callaghan J, Lane SJ. A study into efficacy of omalizumab therapy in patients with severe persistent allergic asthma at a tertiary referral centre for asthma in Ireland. QJM 2013;106(7):631–634. doi:10.1093/qjmed/hct072.
  • Braunstahl GJ, Chlumsky J, Peachey G, Chen CW. Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting. Allergy Asthma Clin Immunol 2013;9(1):47. doi:10.1186/1710-1492-9-47.
  • Barnes N, Menzies-Gow A, Mansur AH, Spencer D, Percival F, Radwan A, Niven R. Effectiveness of omalizumab in severe allergic asthma: a retrospective UK real-world study. J Asthma 2013;50(5):529–536. doi:10.3109/02770903.2013.790419.
  • Gouder C, West LM, Montefort S. The real-life clinical effects of 52 weeks of omalizumab therapy for severe persistent allergic asthma. Int J Clin Pharm 2015;37(1):36–43. doi:10.1007/s11096-014-0034-7.
  • Sousa AS, Pereira AM, Fonseca JA, Azevedo LF, Abreu C, Arrobas A, Calvo T, Silvestre MJ, Cunha L, Falcao H, Drummond M, et al. Severe Asthma Specialist N. Asthma control and exacerbations in patients with severe asthma treated with omalizumab in Portugal. Rev Port Pneumol 2006;2015. doi:10.1016/j.rppnen.2015.03.002.
  • Gibson PG, Reddel H, McDonald VM, Marks G, Jenkins C, Gillman A, Upham J, Sutherland M, Rimmer J, Thien F, et al. Effectiveness and response predictors of omalizumab in a severe allergic asthma population with a high prevalence of comorbidities: the Australian Xolair Registry. Intern Med J 2016;46(9):1054–1062. doi:10.1111/imj.13166.
  • Niven RM, Saralaya D, Chaudhuri R, Masoli M, Clifton I, Mansur AH, Hacking V, McLain-Smith S, Menzies-Gow A. Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study). BMJ Open 2016;6(8):e011857. doi:10.1136/bmjopen-2016-011857.
  • Bhutani M, Yang WH, Hebert J, de Takacsy F, Stril JL. The real world effect of omalizumab add on therapy for patients with moderate to severe allergic asthma: the ASTERIX Observational study. PLoS One 2017;12(8):e0183869. doi:10.1371/journal.pone.0183869.
  • Celebi Sozener Z, Aydin O, Misirligil Z, Mungan D, Demirel YS, Celik GE, Sin BA, Bavbek S. Omalizumab in non-allergic asthma: a report of 13 cases. J Asthma 2018; 55:756–763. doi:10.1080/02770903.2017.1362427.
  • Lee JH, Lee HY, Jung CG, Ban GY, Shin YS, Ye YM, Nahm DH, Park HS. Therapeutic effect of omalizumab in severe asthma: a real-world study in Korea. Allergy Asthma Immunol Res 2018;10(2):121–130. doi:10.4168/aair.2018.10.2.121.
  • Pilon D, Kavati A, Ortiz B, Paknis B, Vegesna A, Schiffman B, Zhdanava M, Lefebvre P, Stone B. Asthma control, lung function, symptoms, and corticosteroid sparing after omalizumab initiation in patients with allergic asthma. Allergy Asthma Proc 2018;39(2):127–135. doi:10.2500/aap.2018.39.4111.
  • Tarraf HN, Masoud HH, Zidan M, Wahba B. Effectiveness and safety of omalizumab in severe, persistent IgE-mediated asthma in pediatric and adult patients: a real-world observational study in Egyptian population. J Asthma 2018;1–7. doi:10.1080/02770903.2018.1553051.
  • Hutyrová B, Bystroň J, Collaborators CA-IR. Czech Anti-IgE Registry collaborators. The effect of omalizumab treatment on severe allergic asthma and allergic comorbidities: real-life experience from the Czech Anti-IgE Registry. PDIA 2018;35(5):510–515. doi:10.5114/ada.2018.77243.
  • Pelaia C, Calabrese C, Barbuto S, Busceti MT, Preianò M, Gallelli L, Savino R, Vatrella A, Pelaia G. Omalizumab lowers asthma exacerbations, oral corticosteroid intake and blood eosinophils: results of a 5-YEAR single-centre observational study. Pulm Pharmacol Ther 2019;54:25–30. doi:10.1016/j.pupt.2018.11.002.
  • Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID, Investigators S. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014;371(13):1189–1197. doi:10.1056/NEJMoa1403291.
  • Kurosawa M, Sutoh E. Prospective open-label study of 48-week subcutaneous administration of mepolizumab in Japanese patients with severe eosinophilic asthma. J Investig Allergol Clin Immunol 2019;29(1):40–45. doi:10.18176/jiaci.0285.
  • Kurosawa M, Ogawa K, Dorwal P. Favorable clinical efficacy of mepolizumab on the upper and lower airways in severe eosinophilic asthma: a 48-week pilot study. Eur Ann Allergy Clin Immunol 2019;51(05):213–221. doi:10.23822/EurAnnACI.1764-1489.94.
  • Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, Barker P, Sproule S, Ponnarambil S, Goldman M, et al. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med 2017;376(25):2448–2458. doi:10.1056/NEJMoa1703501.
  • Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, Zhu H, Hamilton JD, Swanson BN, Khan A, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med 2018;378(26):2475–2485. doi:10.1056/NEJMoa1804093.
  • FDA (2/2007, updated 7/2007). Alert: information for healthcare professionals: Omalizumab (marketed as Xolair). Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126456.htm [last accessed 15 October 2009]
  • Fitzgerald JM, Bleecker ER, Bourdin A, Busse WW, Ferguson GT, Brooks L, Barker P, Martin U. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at the American Thoracic Society (ATS) International Conference; 2019 May 17–22; Dallas, Texas. doi:10.1164/ajrccm-conference.2019.199.1_MeetingAbstracts.A2676.
  • Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, et al. Long-term safety and clinical benefit of mepolizumab in patients with the most severe eosinophilic asthma: the COSMEX study. Clin Ther 2019; 41(10):2041–2056.e5. doi:10.1016/j.clinthera.2019.07.007.
  • GINA. 2018. Pocket Guide for Asthma Management and Prevention. Available from: https://ginasthma.org/2018-pocket-guide-for-asthma-management-and-prevention/ [last accessed 6 August 2018].
  • Brusselle GG, Van Braeckel E. AZALEA trial highlights antibiotic overuse in acute asthma attacks. JAMA Intern Med 2016;176(11):1637–1638. doi:10.1001/jamainternmed.2016.6046.
  • Coumou H, Bel EH. Improving the diagnosis of eosinophilic asthma. Expert Rev Respir Med 2016;10(10):1093–1103. doi:10.1080/17476348.2017.1236688.
  • Demarche SF, Schleich FN, Paulus VA, Henket MA, Van Hees TJ, Louis RE. Is it possible to claim or refute sputum eosinophils >/= 3% in asthmatics with sufficient accuracy using biomarkers? Respir Res 2017;18(1):133. doi:10.1186/s12931-017-0615-9.
  • Colak Y, Afzal S, Nordestgaard BG, Marott JL, Lange P. Combined value of exhaled nitric oxide and blood eosinophils in chronic airway disease: the Copenhagen General Population Study. Eur Respir J 2018;52:1800616. doi:10.1183/13993003.00616-2018.
  • Shaw DE, Sousa AR, Fowler SJ, Fleming LJ, Roberts G, Corfield J, Pandis I, Bansal AT, Bel EH, Auffray C, et al. Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Respir J 2015;46(5):1308–1321. doi:10.1183/13993003.00779-2015.
  • Kirkland SW, Cross E, Campbell S, Villa-Roel C, Rowe BH. Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma. Cochrane Database Syst Rev 2018;6:CD012629. doi:10.1002/14651858.CD012629.pub2.
  • Albers FC, Mullerova H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, Cockle SM, Suruki RY. Biologic treatment eligibility for real-world patients with severe asthma: the IDEAL study. J Asthma. 2018;55(2):152–160. doi:10.1080/02770903.2017.1322611.
  • Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma. (PREDICTUMAB). Available from: https://clinicaltrials.gov/ct2/show/NCT03476109 [last accessed 15 March 2019].
  • Anderson WC, Szefler SJ. Cost-effectiveness and comparative effectiveness of biologic therapy for asthma: to biologic or not to biologic?. Ann Allergy Asthma Immunol 2019;122(4):367–372. doi:10.1016/j.anai.2019.01.018.
  • Tice JA, Campbell JD, Synnott PG, Walsh JME, Kumar VM, Whittington M, Adair E, Rind D, Pearson SD. The effectiveness and value of biologic therapies for the treatment of uncontrolled asthma. JMCP 2019;25(5):510–514. doi:10.18553/jmcp.2019.25.5.510.