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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] - severe COPD, frequent exacerbations despite optimized triple inhaled therapy, & blood eosinophil count >= 300/uL [18] - 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] - dupilumab use in atopic dermatitis is associated with 58% increased risk of psoriasis [16] - nasopharyngitis & headaches most common adverse effects equally as common in placebo recipients [] Laboratory: - eosinophil count of > 150-300/uL or a dependence on systemic glucocorticoids - eosinophil count > 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. Lin TL, et al. Psoriasis Risk in Patients With Atopic Dermatitis Treated With Dupilumab. JAMA Dermatol. 2025. PMID: 40531497 https://jamanetwork.com/journals/jamadermatology/fullarticle/2835236
  17. Laidlaw TM, Bachert C, Amin N, et al. Dupilumab improves upper and lower airway disease control in chronic rhinosinusitis with nasal polyps and asthma. Ann Allergy Asthma Immunol. 2021;126:584-92 PMID: 33465455
  18. Medical Knowledge Self Assessment Program (MKSAP) 20 American College of Physicians, Philadelphia 2025 - Bhatt SP, Rabe KF, Hanania NA, et al; BOREAS Investigators. Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. N Engl J Med. 2023;389:205-14. PMID: 37272521
  19. HIGHLIGHTS OF PRESCRIBING INFORMATION DUPIXENT (dupilumab) injection, for subcutaneous use https://www.regeneron.com/downloads/dupixent_fpi.pdf