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dupilumab (Dupixent)

Indications: - treatment of moderate-severe atopic dermatitis [6] - may be combined with topical glucocorticoids - moderate-to-severe eczema [4,5] - add-on therapy for rhinosinusitis with nasal polyposis insufficiently responsive to nasal glucocorticoids [2,10,15] - uncontrolled glucorticoid-dependent asthma [3,7] - may be greater benefit in patients with eosinophilia (eosinophilic asthma) [7] - FDA-approved for moderate-severe eosinophilic asthma [8] - seems to prevent asthma exacerbations more effectively than other agents [14] - FDA-approved for treatment of eosinophilic esophagitis in adults & children >= 12 years, 40 Kg (88 lbs) [12,13] Dosage: - 300 mg SQ 3 times a week - 200-300 mg SQ every 2-4 weeks (asthma) [3] - 300 mg SQ every other week (eczema) [4] Adverse effects: - new onset psoriasis 1.7% same as general population [11] - latency period for the onset of psoriasis is 3.7 months - 40% of patients with complete resolution of psoriasis following treatment or dupilumab discontinuation [11] - nasopharyngitis & headaches most common adverse effects equally as common in placebo recipients [] Laboratory: - eosinophil count of > 300/uL predicts response Mechanism of action: - monoclonal IgG4 antibody - IL-4 receptor alpha antagonist - inhibits both IL-4 & IL-13 signaling

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

biological response modifier; immune factor; immunomodulator; biomodulator dermatologic agent pharmaceutical monoclonal antibody

References

  1. Beck LA et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med 2014 Jul 10; 371:130 PMID: 25006719 http://www.nejm.org/doi/full/10.1056/NEJMoa1314768
  2. Bachert C, Mannent L, Naclerio RM et al Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):469-479. PMID: 26836729
  3. Wenzel S 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 beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. April 26, 2015 PMID: 27130691 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2816%2930307-5/abstract - Chung KF Dupilumab: a potential new treatment for severe asthma. Lancet. April 26, 2015 PMID: 27130690 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2816%2930311-7/abstract
  4. Simpson EL, Bieber T, Guttman-Yassky E et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med 2016 Sep 30; PMID: 27690741
  5. FDA News Release. March 28, 2017 FDA approves new eczema drug Dupixent https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  6. Blauvelt A et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): A 1-year, randomised, double-blinded, placebo- controlled, phase 3 trial. Lancet 2017 May 4 PMID: 28478972 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31191-1/fulltext
  7. Rabe KF, Nair P, Brusselle G et al Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med 2018; 378:2475-2485 PMID: 29782224 Free full text https://www.nejm.org/doi/full/10.1056/NEJMoa1804093 - Castro M, Corren J, Pavord ID et al Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med 2018;378:2486-2496 PMID: 29782217 Free full text https://www.nejm.org/doi/full/10.1056/NEJMoa1804092 - Drazen JM, Harrington D. New Biologics for Asthma. N Engl J Med 2018;378:2533-2534 PMID: 29782236 Free full text https://www.nejm.org/doi/full/10.1056/NEJMe1806037
  8. Brown T FDA Approves Dupilumab for Moderate-to-Severe Asthma Medscape - Oct 22, 2018. https://www.medscape.com/viewarticle/903761
  9. From The Medical Letter on Drugs and Therapeutics Dupilumab (Dupixent) for Asthma JAMA. 2019;321(10):1000-1001. March 12. https://jamanetwork.com/journals/jama/fullarticle/2727443
  10. FDA News Release. June 26, 2109 FDA approves first treatment for chronic rhinosinusitis with nasal polyps. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-rhinosinusitis-nasal-polyps - Bachert C, Han JK, Desrosiers M et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): Results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet 2019 Sep 19; S0140-6736(19)31881-1; PMID: 31543428 - Stevens WW. A new treatment for chronic rhinosinusitis with nasal polyps. Lancet 2019 Sep 19; S0140-6736(19)32133-6; PMID: 31543427
  11. Jenkins K Matthew J. Zirwas, MD, on Development of Psoriasis in Dupilumab-Treated AD. The incidence of new-onset psoriasis appears similar to prevalence in the general population. - Brumfiel CM, Patel MH, Zirwas MJ Development of psoriasis during treatment with dupilumab: A systematic review. J Am Acad Dermatol. 2021 May 19:S0190-9622(21)00995-6 PMID: 34022319
  12. George J First Treatment Approved for Eosinophilic Esophagitis. FDA expands dupilumab's label to treat inflammatory condition. MedPage Today May 20, 2022 https://www.medpagetoday.com/gastroenterology/generalgastroenterology/98858 - FDA News Release. May 20, 2022 FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-eosinophilic-esophagitis-chronic-immune-disorder
  13. Dellon ES et al. Dupilumab in adults and adolescents with eosinophilic esophagitis. N Engl J Med 2022 Dec 22; 387:2317. PMID: 36546624 https://www.nejm.org/doi/10.1056/NEJMoa2205982
  14. Kearney CM et al. Comparative effectiveness of mepolizumab, benralizumab, and dupilumab among patients with difficult-to-control asthma: A multicenter retrospective propensity- matched analysis. Ann Am Thorac Soc 2024 Jun; 21:866. PMID: 38241013 PMCID: PMC11160126 (available on 2025-06-01) https://www.atsjournals.org/doi/10.1513/AnnalsATS.202306-566OC
  15. Bachert C, Khan AH, Fokkens WJ et al. Dupilumab response onset, maintenance, and durability in patients with severe CRSwNP. J Allergy Clin Immunol. 2024 Aug 14:S0091-6749(24)00820-0. PMID: 39151476 Free article https://www.jacionline.org/article/S0091-6749(24)00820-0/fulltext
  16. HIGHLIGHTS OF PRESCRIBING INFORMATION DUPIXENT (dupilumab) injection, for subcutaneous use https://www.regeneron.com/downloads/dupixent_fpi.pdf