Abstract

Review Article

Biologic therapy in severe asthma: An update

Maha A Al Ammari*

Published: 28 August, 2019 | Volume 3 - Issue 1 | Pages: 003-009

Asthma is a chronic inflammatory disease of the airways characterized by airway inflammation, bronchial hyperresponsiveness, reversible airflow obstruction and recurrent symptoms. Patients often present with coughing, wheezing, dyspnea, and chest tightness, were they usually responds to the mainstay of treatment that relies on inhaled glucocorticoids (ICS), and long acting β2 agonist (LABA), along with leukotriene. In around 20% of the patient’s morbidity, mortality and cost of therapy increased because they fail to benefit from the existing gold standard therapy regimen. Both immunoglobulin-E (IgE), interlukin-5 (IL-5) had proven to play important major role in asthma pathogenesis. Over the past two decades biologic therapy that targeting IgE begins the era in treating severe asthma, and recently anti-IL-5, revealed major role in eosinophils maturation, activation, survival, and recruitment process of severe asthma. The different biologic therapy that is currently available in the market are supported by solid evidence from controlled randomized clinical trials, to guide the clinician on the type of patients that will benefit from the therapy, with an insight on the appropriate monitoring parameters and patient evaluation plans. This review was conducted by searching PubMed, EMBASE, and Google Scholar to identify peer-reviewed clinical trials, guidelines, and review articles published in English in the role of biologic therapy in severe asthma. The main aim from publishing this review is to summarize the current available evidence on the approved biologic therapy in treating patients with severe asthma.

Read Full Article HTML DOI: 10.29328/journal.aaai.1001016 Cite this Article Read Full Article PDF

Keywords:

Biologic therapy; Severe asthma; Omalizumab; Mepolizumab; Benralizumab; Reslizumab

References

  1. Asthma GI. Global Strategy for Asthma Management and Prevention: GINA; 2018.
  2. Al-Moamary MS, Alhaider SA, Alangari AA, Al Ghobain MO, Zeitouni MO, et al. The Saudi Initiative for Asthma-2019 Update: Guidelines for the diagnosis and management of asthma in adults and children. Ann Thorac Med. 2019; 14: 3-48. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30745934
  3. McCracken J, Veeranki SP, Ameredes BT, Calhoun WJ. Diagnosis and Management of Asthma in Adults: A Review. JAMA. 2017; 318: 279-290. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28719697
  4. McCracken J, Tripple JW, Calhoun WJ. Biologic Therapy in the Management of Asthma. Curr Opin Allergy Clin Immunol. 2016; 16: 375–382. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27362324
  5. Al Ghobain MO, Algazlan SS, Oreibi TM. Asthma prevalence among adults in Saudi Arabia. Saudi Med J. 2018; 39: 179-184. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29436567
  6. Stephen T Holgate, Riccardo Polosa. The mechanisms, diagnosis, and management of severe asthma in adults. Lancet. 2006; 368: 780-793. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/16935689
  7. Canonica GW, Senna G, Mitchell PD, O'Byrne PM, Passalacqua G, et al. Therapeutic interventions in severe asthma. World Allergy Organ J. 2016; 9: 1-12. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27942351
  8. Yang X, Feng HR, Chen ZM, Ying SM. Biologic Targeting: New and Effective Therapeutic Approaches against Severe Asthma. Chin Med J. 2018; 31: 1009-1012. PubMed: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5937305/
  9. Diver S, Russell RJ, Brightling CE. New and emerging drug treatments for severe asthma. Clin Exp Allergy. 2018; 48: 241–252. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29315966
  10. Linda Zhu, Ciaccio CE, Casale TB. Potential new targets for drug development in severe asthma. World Allergy Organ J. 2018; 11: 1-9. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30386455
  11. Patel TR, Sanjiv Sur. Ige and eosinophils as therapeutic targets in asthma. Curr Opin Allergy Clin Immunol. 2017; 17: 42-49. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27906698
  12. Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, et al. Omalizumab in Severe Allergic Asthma Inadequately Controlled with Standard Therapy. Ann Intern Med. 2011; 154: 573-582. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/21536936
  13. Humbert M, Beasley R, Ayres J, Slavin R, Hébert 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: 309-316. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/15679715
  14. Braunstahl GJ, Chen CW, Maykut R, Georgiou P, Peachey G, et al. The eXpeRience registry: The ‘real-world ‘effectiveness of omalizumab in allergic asthma. Respir Med. 2013; 107: 1141-1151. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/23721684
  15. Iribarren C, Rahmaoui A, Long AA, Szefler SJ, Bradley MS, et al. Cardiovascular and cerebrovascular events among patients receiving omalizumab: Results from EXCELS, a prospective cohort study in moderate to severe asthma. J Allergy Clin Immunol. 2017; 139: 1489-1495. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27639934
  16. Caruso M, Morjaria J, Emma R, Amaradio MD, Polosa R. Biologic agents for severe asthma patients: clinical perspectives and implications. Intern Emerg Med. 2018; 13: 155–176. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29238905
  17. Menzella F, Lusuardi M, Montanari G, Galeone C, Facciolongo N, et al. Clinical usefulness of mepolizumab in severe eosinophilic asthma. Ther Clin Risk Manag. 2016; 12: 907–916. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27354806
  18. Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicenter, double-blind, placebo-controlled trial. Lancet. 2012; 380: 651-659. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/22901886
  19. Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, et al. Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma. N Engl J Med. 2014; 371: 1198-1207. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/25199059
  20. Elisabeth HB, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, et al. Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma. N Engl J Med. 2014; 371: 1189-1197. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/25199060
  21. Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, 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. 2017; 5: 390-400. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28395936
  22. Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, et al. 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: 2058-2069. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27553751
  23. Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019; 143: 1742-1751. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30359681
  24. Emma R, Morjaria JB, Fuochi V, Polosa R, Caruso M. Mepolizumab in the management of severe eosinophilic asthma in adults: current evidence and practical experience. Ther Adv Respir Dis. 2018; 12: 1–12. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30354852
  25. Galo AP, Labor M, Tiotiu A, Baiardini I, Scichilone N, et al. Impact of reslizumab on outcomes of severe asthmatic patients: current perspectives. Patient Relat Outcome Meas. 2018; 9: 267–273. PubMed: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6103306/
  26. Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, et al. Reslizumab for poorly controlled eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med 2011; 184: 1125–1132. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/21852542
  27. Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, 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: 355–366. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/25736990
  28. Corren J, Weinstein S, Janka L, Zangrilli J, Garin M. Phase 3 study of randomized in patients with poorly controlled asthma: effect across a board range of eosinophil counts. Chest. 2016; 150: 799-810. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27018175
  29. Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil levels: a randomized phase 3 study. Chest. 2016; 150: 789-798. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27056586
  30. Brusselle G, Canvin J, Weiss S, Sun SX, Buhl R. Stratification of eosinophilic asthma patients treated with reslizumab and GINA Step 4 or 5 therapy. ERJ Open Res. 2017; 3: 1-9. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28845430
  31. Pelaia C, Vatrella A, Bruni A, Terracciano R, Pelaia G. Benralizumab in the treatment of severe asthma: design, development and potential place in therapy. Drug Des Devel Ther. 2018; 12: 619–628. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29606855
  32. Pelaia C, Calabrese C, Vatrella A, Busceti MT, Garofalo E, et al. Benralizumab: From the Basic Mechanism of Action to the Potential Use in the Biological Therapy of Severe Eosinophilic Asthma. Biomed Res Int. 2018; 2018: 1-9. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29862274
  33. Menzella F, Lusuardi M, Galeone C, Facciolongo N, Zucchi L. The clinical profile of benralizumab in the management of severe eosinophilic asthma. Ther Adv Respir Dis. 2016; 10: 534–548. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27612492
  34. Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, 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: 2115–2127. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27609408
  35. FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, et al. Benralizumab, an anti-interleukin-5 receptor α 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: 2128–2141. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27609406
  36. Nair N. Oral Glucocorticoid–Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017; 376: 2448-2458.
  37. Ferguson GT, FitzGerald JM, Bleecker ER, Laviolette M, Bernstein D, et al. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2017; 5: 568–576. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28545978
  38. Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from BORA phase3 extension trial. Lancet. 2019; 7: 46-59. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30416083
  39. Bourdin A, Husereau D, Molinari N, Golam S, Siddiqui MK, 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: 1-13. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30309978
  40. Wenzel S, Ford L, Pearlman D, Spector S, Sher L, et al. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013; 368: 2455-2466. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/23688323
  41. Wenzel S, Castro M, Corren J, Maspero J, Wang L, 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: 31-44. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27130691
  42. Rabe KF, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018; 378: 2475-2485.
  43. Menzella F, Galeone C, Bertolini F, Castagnetti C, Facciolongo N. Innovative treatments for severe refractory asthma: how to choose the right option for the right patient? J Asthma Allergy. 2017; 10: 237–247. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28919788
  44. Pelaia G, Vatrella A, Busceti MT, Gallelli L, Preianò M, et al. Role of biologics in severe eosinophilic asthma focus on reslizumab. Ther Clin Risk Manag. 2016; 12: 1075–1082. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27445482
  45. Sahota J, Robinson DS. Update on new biologics for intractable eosinophilic asthma: impact of reslizumab. Drug Des Devel Ther. 2018; 12: 1173–1181. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/29780238

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