Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343–73. https://doi.org/10.1183/09031936.00202013. (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)).
Article CAS PubMed Google Scholar
Vianello A, Caminati M, Andretta M, Menti AM, Tognella S, Senna G, Degli EL. Prevalence of severe asthma according to the drug regulatory agency perspective: An Italian experience. World Allergy Organ J. 2019;12(4): 100032. https://doi.org/10.1016/j.waojou.2019.100032.
Article CAS PubMed PubMed Central Google Scholar
Chen S, Golam S, Myers J, Bly C, Smolen H, Xu X. 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):2075–88. https://doi.org/10.1080/03007995.2018.1505352.
Mavissakalian M, Brady S. The current state of biologic therapies for treatment of refractory asthma. Clin Rev Allergy Immunol. 2020;59(2):195–207. https://doi.org/10.1007/s12016-020-08776-8.
Article CAS PubMed Google Scholar
Holguin F, Cardet JC, Chung KF, Diver S, Ferreira DS, Fitzpatrick A, Gaga M, Kellermeyer L, Khurana S, Knight S, McDonald VM, Morgan RL, Ortega VE, Rigau D, Subbarao P, Tonia T, Adcock IM, Bleecker ER, Brightling C, Boulet LP, Cabana M, Castro M, Chanez P, Custovic A, Djukanovic R, Frey U, Frankemölle B, Gibson P, Hamerlijnck D, Jarjour N, Konno S, Shen H, Vitary C, Bush A. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020;55(1): 1900588. https://doi.org/10.1183/13993003.00588-2019.
Article CAS PubMed Google Scholar
Russo D, Di Filippo P, Attanasi M, Lizzi M, Di Pillo S, Chiarelli F. Biologic therapy and severe asthma in children. Biomedicines. 2021;9(7):760. https://doi.org/10.3390/biomedicines9070760.
Article CAS PubMed PubMed Central Google Scholar
Rogers L, Jesenak M, Bjermer L, Hanania NA, Seys SF, Diamant Z. Biologics in severe asthma: a pragmatic approach for choosing the right treatment for the right patient. Respir Med. 2023;218: 107414. https://doi.org/10.1016/j.rmed.2023.107414.
Lommatzsch M, Brusselle GG, Canonica GW, Jackson DJ, Nair P, Buhl R, Virchow JC. Disease-modifying anti-asthmatic drugs. Lancet. 2022;399(10335):1664–8. https://doi.org/10.1016/S0140-6736(22)00331-2.
Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for inadequately controlled asthma with elevated blood eosinophil levels: a randomized phase 3 study. Chest. 2016;150(4):789–98. https://doi.org/10.1016/j.chest.2016.03.032.
Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O’Brien C, Korn S. 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):355–66. https://doi.org/10.1016/S2213-2600(15)00042-9. (Erratum in: Lancet Respir Med. 2015 Apr;3(4):e15. Erratum in: Lancet Respir Med. 2016 Oct;4(10 ):e50).
Article CAS PubMed Google Scholar
Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, Rosen KE, Eisner MD, Wong DA, Busse W. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573–82. https://doi.org/10.7326/0003-4819-154-9-201105030-00002. (Erratum in: Ann Intern Med. 2019 Oct 1;171(7):528).
Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, van As A, Gupta N. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184–90. https://doi.org/10.1067/mai.2001.117880.
Article CAS PubMed Google Scholar
Ayres JG, Higgins B, Chilvers ER, Ayre G, Blogg M, Fox H. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy. 2004;59(7):701–8. https://doi.org/10.1111/j.1398-9995.2004.00533.x.
Article CAS PubMed Google Scholar
Ferguson GT, FitzGerald JM, Bleecker ER, Laviolette M, Bernstein D, LaForce C, Mansfield L, Barker P, Wu Y, Jison M, Goldman M; BISE Study Investigators. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2017;5(7):568–76. https://doi.org/10.1016/S2213-2600(17)30190-X.
Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma: a multi-center, open-label, phase IIIb study. Clin Ther. 2016;38(9):2058–20701. https://doi.org/10.1016/j.clinthera.2016.07.010.
Article CAS PubMed Google Scholar
Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, Stahl N, Yancopoulos GD, Teper A. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486–96. https://doi.org/10.1056/NEJMoa1804092.
Article CAS PubMed Google Scholar
Food and Drug Administration Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-approves-label-changes-asthma-drug-xolair-omalizumab-including. Accessed June 13, 2023.
Medicines and Healthcare products Regulatory Agency (MHRA). Omalizumab: potential risk of arterial thrombotic events. https://www.gov.uk/drug-safety-update/omalizumab-potential-risk-of-arterial-thrombotic-events. Accessed June 13, 2023.
Mota D, Rama TA, Severo M, Moreira A. Potential cancer risk with omalizumab? A disproportionality analysis of the WHO’s VigiBase pharmacovigilance database. Allergy. 2021;76(10):3209–11. https://doi.org/10.1111/all.15008.
Article CAS PubMed Google Scholar
Baddini-Martinez J, Leitão Filho FS, Caetano LSB. Anaphylactic risks associated with immunobiological agents in asthma therapy. Rev Assoc Med Bras. 2023;69(3):367–9. https://doi.org/10.1590/1806-9282.20221358.
Article PubMed PubMed Central Google Scholar
Tregunno PM, Fink DB, Fernandez-Fernandez C, Lázaro-Bengoa E, Norén GN. Performance of probabilistic method to detect duplicate individual case safety reports. Drug Saf. 2014;37(4):249–58. https://doi.org/10.1007/s40264-014-0146-y.
ICH. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Glossary of ICH terms and definitions; 2023. https://cioms.ch/publications/product/glossary-of-ich-terms-and-definitions. Accessed July 31, 2023.
European Medicines Agency (EMA). Inclusion/exclusion criteria for the “Important Medical Events” list. https://www.ema.europa.eu/en/documents/other/inclusion-exclusion-criteria-important-medical-events-list-meddra_en.pdf Accessed July 31, 2023.
Food and Drug Administration. FDA Online Label Repository. https://labels.fda.gov/. Accessed June 21, 2023.
European Medicines Agency (EMA). Medicines EPAR. https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_medicine. Accessed June 21, 2023.
Bate A, Evans SJ. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009;18(6):427–36. https://doi.org/10.1002/pds.1742.
Article CAS PubMed Google Scholar
Wisniewski AF, Bate A, Bousquet C, Brueckner A, Candore G, Juhlin K, Macia-Martinez MA, Manlik K, Quarcoo N, Seabroke S, Slattery J, Southworth H, Thakrar B, Tregunno P, Van Holle L, Kayser M, Norén GN. Good signal detection practices: evidence from IMI PROTECT. Drug Saf. 2016;39(6):469–90. https://doi.org/10.1007/s40264-016-0405-1.
Article PubMed PubMed Central Google Scholar
Candore G, Juhlin K, Manlik K, Thakrar B, Quarcoo N, Seabroke S, Wisniewski A, Slattery J. Comparison of statistical signal detection methods within and across spontaneous reporting databases. Drug Saf. 2015;38(6):577–87. https://doi.org/10.1007/s40264-015-0289-5.
Article CAS PubMed Google Scholar
Khouri C, Revol B, Lepelley M, Mouffak A, Bernardeau C, Salvo F, Pariente A, Roustit M, Cracowski JL. A meta-epidemiological study found lack of transparency and poor reporting of disproportionality analyses for signal detection in pharmacovigilance databases. J Clin Epidemiol. 2021;139:191–8. https://doi.org/10.1016/j.jclinepi.2021.07.014.
Hauben M, Aronson JK. Defining “signal” and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf. 2009;32(2):99–110. https://doi.org/10.2165/00002018-200932020-00003.
European Medicines Agency (EMA, 2017). Guideline on good pharmacovigilance practices (GVP)—Module IX Addendum I– Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions. EMA/209012/2015.
Council for International Organizations of Medical Sciences, editor. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII. Geneva: CIOMS; 2010.
European Medicines Agency (EMA, 2016). EMA/849944/2016. Screening for adverse reactions in EudraV
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