653
Views
0
CrossRef citations to date
0
Altmetric
Drug Evaluation

Dupilumab in the Treatment of Asthma

&
Pages 859-872 | Received 10 Jan 2019, Accepted 20 May 2019, Published online: 20 Jun 2019

References

  • Nurmagambetov T , KuwaharaR , GarbeP. The economic burden of asthma in the United States, 2008–2013. Annals ATS15(3), 348–356 (2018).
  • McCracken J , TrippleJ , CalhounWJ. Biologic therapy in the management of asthma. Curr. Opin. Allergy Clin. Immunol.16(4), 375–382 (2017).
  • FDA , supplemental Biologics Licence Application Approval (sBLA) 761055/S-007 (2018). www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761055Orig1s007ltr.pdf
  • Gandhi NA , BennettBL , GrahamNMet al. Targeting key proximal drivers of type 2 inflammation in disease. Nat. Rev. Drug. Discov.15, 35–50 (2016).
  • Swain SL , WeinbergAD , EnglishMet al. IL-4 directs the development of Th2-like helper effectors. J. Immunol.145, 3796–3806 (1990).
  • Wills-Karp M , LuyimbaziJ , XuXet al. Interleukin-13: central mediator of allergic asthma. Science282, 2258–2261 (1998).
  • Coffman RL , OharaJ , BondMW , CartyJ , ZlotnikA , PaulWE. B cell stimulatory factor-1 enhances the IgE response of lipopolysaccharide-activated B cells. J. Immunol.136, 4538–4541 (1986).
  • Moser R , FehrJ , BruijnzeelPL. IL-4 controls the selective endothelium-driven transmigration of eosinophils from allergic individuals. J. Immunol.149(4), 1432–1438 (1992).
  • Buttner C , SkupinA , ReimannTet al. Local production of interleukin-4 during radiation-induced pneumonitis and pulmonary fibrosis in rats: macrophages as a prominent source of interleukin-4. Am. J. Respir. Cell. Mol. Biol.17(3), 315–325 (1997).
  • Richter A , PuddicombeSM , LordanJLet al. The contribution of interleukin (IL)-4 and IL-13 to the epithelial mesenchymal trophic unit in asthma. Am J. Respir. Cell. Mol. Biol.25(3), 385–391 (2001).
  • Bossé Y , ThompsonC , AudetteK , StankovaJ , Rola-PleszczynskiM. Interleukin-4 and interleukin-13 enhance human bronchial smooth muscle cell proliferation. Int. Arch. Allergy. Immunol.146(2), 138–148 (2008).
  • Kondo M , TamaokiJ , TakeyamaKet al. Elimination of IL-13 reverses established goblet cell metaplasia into ciliated epithelia in airway epithelial cell culture. Allergol. Int.55(3), 329–336 (2006).
  • Hanania NA , KorenblatP , ChapmanKRet al. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, Phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir. Med.4(10), 781–796 (2016).
  • Panettieri RA Jr , SjobringU , PeterffyAet al. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, Phase 3 clinical trials. Lancet Respir. Med.6(7), 511–525 (2018).
  • Hart TK , BlackburnMN , Brigham-BurkeMet al. Preclinical efficacy and safety of pascolizumab (SB 240683): a humanized anti-interleukin-4 antibody with therapeutic potential in asthma. Clin. Exp. Immunol.130(1), 93–100 (2002).
  • Wenzel S , WilbrahamD , FullerR , GetzEB , LongphreM. Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: results of two Ohase 2a studies. Lancet370(9596), 1422–1431 (2007).
  • Slager RE , OtulanaBA , HawkinsGAet al. IL-4 receptor polymorphisms predict reduction in asthma exacerbations during response to an anti-IL-4 receptor α antagonist. J. Allergy Clin. Immunol.130(2), 516–522.e4 (2012).
  • Australian Public Assessment Report for Dupilumab (2018). www.tga.gov.au/sites/default/files/auspar-dupilumab-180612.pdf
  • Castro M , CorrenJ , PavordIet al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. New Engl. J. Med.378(26), 2486–2496 (2018).
  • Wenzel S , FordL , PearlmanDet al. Dupilumab in persistent asthma with elevated eosinophil levels. New Engl. J. Med.368(26), 2455–2466 (2013).
  • Fulkerson PC , RothenbergME. Targeting eosinophils in allergy, inflammation and beyond. Nat. Rev. Drug Discov.12, 117–129 (2013).
  • Evaluation of Dupilumab's Effects on Airway Inflammation in Patients with Asthma (EXPEDITION), NCT02573233.
  • Australian Product Information, Dupixent (2018).
  • Dupilumab Prescribing Information, FDA (2017). https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf
  • Rabe KF , ParameswaranN , BrusselleGet al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. New Engl. J. Med.378(26), 2475–2485 (2018).
  • Tepper RS , WiseRS , CovarRet al. Asthma outcomes: pulmonary physiology. J. Allergy Clin. Immunol.129(30), S65–S87 (2012).
  • Santanello NC , ZhangJ , SeidenbergB , ReissTF , BarberBL. What are minimal important changes for asthma measures in a clinical trial?Eur. Respir. J.14(1), 23–27 (1999).
  • Donohue JF . Minimal clinically important differences in COPD lung function. COPD.2(1), 111–124 (2005).
  • Wenzel S , CastroM , CorrenJet 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 randomized double-blind placebo-controlled pivotal Phase 2b dose-ranging trial. Lancet388(2), 31–44 (2016).
  • Weschler ME . Inhibiting interleukin-4 and interleukin-13 in difficult to control asthma. New Engl. J. Med.368(26), 2511–2513 (2013).
  • Zayed Y , KheiriB , MomenB. Dupilumab safety and efficacy in uncontrolled asthma: a systematic review and meta-analysis of randomized clinical trials. J. Asthma2018.https://doi.org/10.1080/02770903.2018.1520865
  • Ando K , TanakaA , MikuniHet al. Indirect comparison of dupilumab and mepolizumab treatments for uncontrolled eosinophilic asthma–Bayesian analysis of randomized controlled trials. Showa Univ. J. Med. Sci.30(2), 189–196 (2018).
  • Juniper EF , SvenssonK , MorkAC , StahlE. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir. Med.99, 553–558 (2005).
  • Juniper EF , GuyattGH , WillanA , GriffithLE. Determining a minimal important change in a disease-specific quality of life questionnaire. J. Clin. Epidemiol.47(1), 81–87 (1994).
  • Corren J , CastroM , ChanezPet al. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann. Allergy Asthma Immunol. doi:10.1016/j.anai.2018.08.005( Epub ahead of print).
  • Evaluation of dupilumab in children with uncontrolled asthma (VOYAGE), NCT02948959.
  • Assessment of the safety and efficacy of dupilumab in children with asthma (Liberty Asthma Excursion), NCT 03560466.
  • Effect of IL-4RαR576 polymorphism on response to dupilumab in children with asthma (I-DAG), NCT03694158.
  • Fokkens WJ , LundVJ , MullolJet al. European position paper on rhinosinusitis and nasal polyps. Rhinol. Suppl.23(3), 1–298 (2012).
  • Bachert C , MannentL , NaclerioRMet al. Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: a randomized clinical trial. JAMA315(5), 469–479 (2016).
  • Naclerio RM , HamilosDL , FergusonBJet al. Dupilumab improves sense of smell and reduces anosmia among patients with nasal polyposis and chronic sinusitis: results from a Phase 2a trial. J. Allergy Clin. Immunol.139(2), Suppl. AB90 (2017).
  • Hopkins C , GillettS , SlackR , LundVJ , BrowneJP. Psychometric validity of the 22-item SinoNasal outcome test. Clin. Otolaryngol.34(5), 447–454 (2009).
  • Han JK , BachertC , DesrosiersMet al. Efficacy and safety of dupilumab in patients with chronic rhinosinusitis with nasal polyps: results from the randomized phase 3 Sinus-24 study. J. Allergy Clin. Immunol. AB422 (Abstracts), L4 (2019). Oral abstract presented at: American Academy of Allergy, Asthma and Immunology Annual Meeting, 23 February 2019.
  • Bachert C , DesrosiersM , MullolJet al. A randomized Phase 3 study, Sinus-52, evaluating the efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps. J. Allergy Clin. Immunol. AB433 (Abstracts), L36 (2019). Poster presented at: American Academy of Allergy, Asthma and Immunology Annual Meeting, 25 February 2019.
  • Weinstein SF , KatialR , JayawardenaSet al. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J. Allergy Clin. Immunol.142(1), 171–177 (2018).
  • Dupilumab as an adjunct for subcutaneous grass immunotherapy, NCT03558997.
  • Simpson EL , BieberT , Guttman-YasskyEet al. Two Phase 3 trials of dupilumab vs placebo in atopic dermatitis. New Engl. J. Med.375(24), 2335–2348 (2016).
  • Blauvelt A , de Bruin-WellerM , GooderhamMet al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, Phase 3 trial. Lancet389(10086), 2287–2303 (2017).
  • Ou Z , ChenC , ChenA , YangY , ZhouW. Adverse events of Dupilumab in adults with moderate-to-severe atopic dermatitis: a meta-analysis. Int. Immunopharmacol.54, 303–310 (2018).
  • European Medicines Agency, New add-on treatment for patients with severe asthma. Press Release (2019). https://www.ema.europa.eu/en/news/new-add-treatment-patients-severe-asthma
  • FDA, Biologics Licence Application (BLA) 761055 Approval (2017). www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761055Orig1s000ltr.pdf
  • Regeneron, FDA approves Dupixent® (Dupilumab) for moderate-to-severe atopic dermatitis in adolescents. Press Release (2019). https://newsroom.regeneron.com/news-releases/news-release-details/fda-approves-dupixentr-dupilumab-moderate-severe-atopic
  • European Medicines Agency, Assessment Report: Dupixent, EMA/512262/2017 (2017). www.ema.europa.eu/documents/assessment-report/dupixent-epar-public-assessment-report_en.pdf
  • Therapeutic Goods Agency, ARTGA 283127 (2018).
  • Health Canada, Dupixent product monograph. https://pdf.hres.ca/dpd_pm/00042394.PDF
  • Regeneron, Press Release, Regeneron Announces Approval of Dupixent (Dupilumab) in Japan for the Treatment of Atopic Dermatitis (2018). https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-announces-approval-dupixentr-dupilumab-japan-treatment
  • Drazen JM , HarringtonD. New biologics for asthma. New Engl. J. Med.378, 2533–2534 (2018).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.