References
- Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43, 679–373.
- Chen S, Golam S, Myers J, et al. Systematic literature review of the clinical, humanistic, and economic burden associated with asthma uncontrolled by GINA steps 4 or 5 treatment. Curr Med Res Opin. 2018;34(12):2075–2088.
- European Medicines Agency. Fasenra: EPAR. Product information. 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/fasenra
- European Medicines Agency. Dupixent: EPAR. Product information. 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/dupixent
- European Medicines Agency. Nucala: EPAR. Product information. 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/nucala
- European Medicines Agency. Xolair: EPAR. Product information. 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/xolair
- European Medicines Agency. Cinqaero: EPAR. Product information. 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/cinqaero
- Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3(5):355–366.
- Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115–2127.
- Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184–190.
- Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651–659.
- Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486–2496.
- US Food & Drug Administration. TEZSPIRE™ (tezepelumab-ekko) injection, for subcutaneous use Initial U.S. Approval: 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761224s000lbl.pdf
- US Food & Drug Administration. FDA approves maintenance treatment for severe asthma. 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-maintenance-treatment-severe-asthma
- Corren J, Parnes JR, Wang L, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377(10):936–946.
- Diver S, Khalfaoui L, Emson C, et al. Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (Cascade): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Respir Med. 2021;9(11):1299–1312.
- Gauvreau GM, Sehmi R, Ambrose CS, et al. Thymic stromal lymphopoietin: its role and potential as a therapeutic target in asthma. Expert Opin Ther Targets. 2020;24(8):777–792.
- Allakhverdi Z, Comeau MR, Jessup HK, et al. Thymic stromal lymphopoietin is released by human epithelial cells in response to microbes, trauma, or inflammation and potently activates mast cells. J Exp Med. 2007;204(2):253–258.
- Liu S, Verma M, Michalec L, et al. Steroid resistance of airway type 2 innate lymphoid cells from patients with severe asthma: the role of thymic stromal lymphopoietin. J Allergy Clin Immunol. 2018;141(1):257–268.e6.
- Soumelis V, Reche PA, Kanzler H, et al. Human epithelial cells trigger dendritic cell mediated allergic inflammation by producing TSLP. Nat Immunol. 2002;3(7):673–680.
- ClinicalTrials.gov. Study to evaluate tezepelumab in adults and adolescents with severe uncontrolled asthma (NAVIGATOR). 2021. https://clinicaltrials.gov/ct2/show/NCT03347279
- Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800–1809.
- Hoaglin DC, Hawkins N, Jansen JP, et al. Conducting indirect-treatment-comparison and network-Meta-analysis studies: report of the ISPOR task force on indirect treatment comparisons good research practices: part 2. Value Health. 2011;14(4):429–437.
- Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network Meta-analysis for health-care decision making: report of the ISPOR task force on indirect treatment comparisons good research practices: part 1. Value Health. 2011;14(4):417–428.
- Rouse B, Chaimani A, Li T. Network Meta-analysis: an introduction for clinicians. Intern Emerg Med. 2017;12(1):103–111.
- Higgins JP, Whitehead A. Borrowing strength from external trials in a Meta-analysis. Statist Med. 1996;15(24):2733–2749.
- Ishak KJ, Proskorovsky I, Benedict A. Simulation and matching-based approaches for indirect comparison of treatments. Pharmacoeconomics. 2015;33(6):537–549.
- CADTH. Guidelines for the economic evaluation of health technologies: Canada. 2022. https://www.cadth.ca/sites/default/files/pdf/guidelines_for_the_economic_evaluation_of_health_technologies_canada_4th_ed.pdf
- Eunethta. Methodological guideline for REA of pharmaceuticals: direct and indirect comparison. 2022. https://www.eunethta.eu/methodological-guideline-for-rea-of-pharmaceuticals-direct-and-indirect-comparison/
- Laws A, Tao R, Wang S, et al. A comparison of national guidelines for network Meta-analysis. Value Health. 2019;22(10):1178–1186.
- NICE Decision Support Unit (DSU). NICE DSU technical support document 2: a generalised linear modelling framework for pairwise and network meta-analysis of randomised controlled trials. 2021. https://www.ncbi.nlm.nih.gov/books/NBK310366/pdf/Bookshelf_NBK310366.pdf
- NICE Decision Support Unit (DSU). NICE DSU technical support document 18: methods for population-adjusted indirect comparisons in submissions to NICE. 2021. http://nicedsu.org.uk/wp-content/uploads/2017/05/Population-adjustment-TSD-FINAL.pdf
- Busse W, Chupp G, Nagase H, et al. Anti-IL-5 treatments in patients with severe asthma by blood eosinophil thresholds: indirect treatment comparison. J Allergy Clin Immunol. 2019;143(1):190–200 e120.
- Cabon Y, Molinari N, Marin G, et al. Comparison of anti-interleukin-5 therapies in patients with severe asthma: global and indirect Meta-analyses of randomized placebo-controlled trials. Clin Exp Allergy. 2017;47(1):129–138.
- Casale TB, Pacou M, Mesana L, et al. Reslizumab compared with benralizumab in patients with eosinophilic asthma: a systematic literature review and network Meta-analysis. J Allergy Clin Immunol Pract. 2019;7(1):122–130 e121.
- Bateman E, Khan A, Xu Y, et al. Pairwise indirect treatment comparison of dupilumab versus other biologics in patients with uncontrolled persistent asthma. Respir. Med. 2020; Pre-proof, doi:
- Cockle SM, Stynes G, Gunsoy NB, et al. Comparative effectiveness of mepolizumab and omalizumab in severe asthma: an indirect treatment comparison. Respir Med. 2017;123:140–148.
- Nachef Z, Krishnan A, Mashtare T, et al. Omalizumab versus mepolizumab as add-on therapy in asthma patients not well controlled on at least an inhaled corticosteroid: a network meta-analysis. J Asthma. 2018;55(1):89–100.
- NICE. Reslizumab for treating severe eosinophilic asthma. 2021. https://www.nice.org.uk/guidance/ta479
- NICE. Mepolizumab for treating severe eosinophilic asthma [ID3705] Committee Papers. 2020.
- Bourdin A, Husereau D, Molinari N, et al. Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review. Eur Respir J. 2018;52(5):1801393.
- Bourdin A, Husereau D, Molinari N, et al. Matching-adjusted comparison of oral corticosteroid reduction in asthma: systematic review of biologics. Clin Exp Allergy. 2020;50(4):442–452.
- International clinical trials registry platform. JPRN-UMIN000044672. 2022. https://trialsearch.who.int/?TrialID=JPRN-UMIN000044672
- Ando K, Fukuda Y, Tanaka A, et al. Comparative efficacy and safety of tezepelumab and other biologics in patients with inadequately controlled asthma according to thresholds of type 2 inflammatory biomarkers: a systematic review and network meta-analysis. Cells. 2022;11(5):819.
- Global Initiative for Asthma. 2021 GINA Report, Global Strategy for Asthma Management and Prevention. 2022. https://ginasthma.org/gina-reports/
- National Institute for Health and Care Excellence (NICE). Appendix F Quality appraisal checklist - quantitative intervention studies. 2021. https://www.nice.org.uk/process/pmg4/chapter/appendix-f-quality-appraisal-checklist-quantitative-intervention-studies
- Cochrane. Cochrane handbook for systematic reviews of interventions. 2022. https://training.cochrane.org/handbook
- PRISMA. PRISMA statement. 2022. http://www.prisma-statement.org/PRISMAStatement/PRISMAStatement
- Busse W, Spector S, Rosen K, et al. High eosinophil count: a potential biomarker for assessing successful omalizumab treatment effects. J Allergy Clin Immunol. 2013;132(2):485–486.e11.
- Ayres JG, Higgins B, Chilvers ER, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy. 2004;59(7):701–708.
- Humbert M, Beasley R, Ayres J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy. 2005;60(3):309–316.
- Bousquet J, Siergiejko Z, Świebocka E, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy. 2011;66(5):671–678.
- Daly CH, Neupane B, Beyene J, et al. Empirical evaluation of SUCRA-based treatment ranks in network Meta-analysis: quantifying robustness using cohen's kappa. BMJ Open. 2019;9(9):e024625.
- Wenzel S, Castro M, Corren J, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388(10039):31–44.
- Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573–582.
- Chastek B, Korrer S, Nagar SP, et al. Economic burden of illness among patients with severe asthma in a managed care setting. JMCP. 2016;22(7):848–861.
- PRISMA. PRISMA for Network Meta-Analyses (PRISMA-NMA). 2021. http://www.prisma-statement.org/Extensions/NetworkMetaAnalysis
- Harrison TW, Chanez P, Menzella F, et al. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial. The Lancet Respiratory Medicine. 2021;9(3):260–274.
- FitzGerald JM, Bleecker ER, Nair P, CALIMA study investigators, et al. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128–2141.
- Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198–1207.
- Chupp GL, Bradford ES, Albers FC, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5(5):390–400.
- AstraZeneca/Amgen. Data on file. Clinical study report. A multicentre, randomised, double-blind, placebo controlled, parallel group, phase 3 study to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe uncontrolled asthma (NAVIGATOR). 2020.
- Agache I, Beltran J, Akdis C, et al. 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;75(5):1023–1042.
- Borenstein M, Hedges LV, Higgins JPT, et al. An introduction to meta-analysis; John Wiley & Sons, Ltd: 2009.
- AstraZeneca/Amgen. Data on file. Clinical study report. A multicentre, randomized, double-blind, placebo controlled, phase 3 study to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma (SOURCE). 2021.