dupilumab (Dupixent)
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Indications
- treatment of moderate-severe atopic dermatitis[6]
- may be combined with topical glucocorticoids
- moderate-to-severe eczema[4][5]
- add-on therapy for nasal polyposis insufficiently responsive to nasal glucocorticoids[2][10]
- 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]
- 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]
- 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
More general terms
References
- ↑ Beck LA et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med 2014 Jul 10; 371:130 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25006719 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1314768
- ↑ 2.0 2.1 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: https://www.ncbi.nlm.nih.gov/pubmed/26836729
- ↑ 3.0 3.1 3.2 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27130691 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27130690 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2816%2930311-7/abstract - ↑ 4.0 4.1 4.2 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: https://www.ncbi.nlm.nih.gov/pubmed/27690741
- ↑ 5.0 5.1 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 - ↑ 6.0 6.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28478972 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31191-1/fulltext
- ↑ 7.0 7.1 7.2 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/29782236 Free full text https://www.nejm.org/doi/full/10.1056/NEJMe1806037 - ↑ 8.0 8.1 Brown T FDA Approves Dupilumab for Moderate-to-Severe Asthma Medscape - Oct 22, 2018. https://www.medscape.com/viewarticle/903761
- ↑ 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
- ↑ 10.0 10.1 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: https://www.ncbi.nlm.nih.gov/pubmed/31543428
Stevens WW. A new treatment for chronic rhinosinusitis with nasal polyps. Lancet 2019 Sep 19; S0140-6736(19)32133-6; PMID: https://www.ncbi.nlm.nih.gov/pubmed/31543427 - ↑ 11.0 11.1 11.2 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: https://www.ncbi.nlm.nih.gov/pubmed/34022319 - ↑ 12.0 12.1 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 - ↑ 13.0 13.1 Dellon ES et al. Dupilumab in adults and adolescents with eosinophilic esophagitis. N Engl J Med 2022 Dec 22; 387:2317. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36546624 https://www.nejm.org/doi/10.1056/NEJMoa2205982
- ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION DUPIXENT (dupilumab) injection, for subcutaneous use https://www.regeneron.com/downloads/dupixent_fpi.pdf