| 词条 | Dupilumab |
| 释义 |
| type = mab | image = | alt = | mab_type = mab | source = u | target = IL4 receptor alpha | tradename = Dupixent | Drugs.com = | MedlinePlus = | pregnancy_AU = | pregnancy_US = | pregnancy_category= | legal_AU = | legal_CA = | legal_UK = | legal_US = Rx only | legal_status = | routes_of_administration = Injection | bioavailability = | protein_bound = | metabolism = | elimination_half-life = | excretion = | CAS_number = 1190264-60-8 | ATC_prefix = D11 | ATC_suffix = AH05 | PubChem = | DrugBank = DB12159 | ChemSpiderID = none | KEGG = D10354 | UNII = 420K487FSG | C=6512 | H=10066 | N=1730 | O=2052 | S=46 | molecular_weight = 146.9 kg/mol }}Dupilumab, sold under the trade name Dupixent, is a monoclonal antibody designed for the treatment of allergic diseases such as eczema (atopic dermatitis).[1][2] Side effects include allergic reactions, cold sores, and inflammation of the cornea.[2] It was developed by Regeneron Pharmaceuticals and Sanofi Genzyme.[3][4] It received FDA approval for moderate-to-severe atopic dermatitis in 2017.[2] As of 2017 it costs about 37,000 USD per year.[5] Medical usesIt appears to be useful for moderate-to-severe atopic dermatitis for which it is approved in the United States.[6][9] It is also being evaluated for treatment of persistent asthma in adults and adolescents.[7][8] Side effectsDupilumab has the ability to cause several side effects including: allergic reactions, conjunctivitis, and keratitis.[2] There is one reported case of Dupilumab triggering hair growth in a patient with complete hair loss.[9] This is being investigated as an unintended, but positive side effect. PharmacologyMechanism of actionDupilumab binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα), making it a receptor antagonist.[10] Through blockade of IL-4Rα, dupilumab modulates signaling of both the interleukin 4 and interleukin 13 pathways. In clinical trials, patients saw decreased levels of Th2 bio-markers.[11] PharmacokineticsDupilumab shows a non-linear rate in regard to the target.[11] Dupilumab is also reported to have a bioavailability of 64%, with the average concentration occurring 1 week post injection.[11] DevelopmentDevelopment of dupilumab was a joint effort by Regeneron and Sanofi, the latter of which provided 130 million dollars to Regeneron for research and development towards monoclonal antibodies.[12] The US FDA granted it priority review status.[13][14] On March 28, 2017, the U.S. Food and Drug Administration approved dupilumab injection to treat adults with moderate-to-severe eczema.[2] As per the FDA, dupilumab was manufactured in accordance with current GMP.[15] In October 2016, Regeneron posted a phase III CHRONOS trial, contrasting dupilumab with topical corticosteroids. The study showed that in conjunction with topical corticosteroids, people had a larger decrease in symptoms than steroids alone.[16] Phase III SOLO 1 and SOLO 2 trials were also performed, which evaluated the efficacy of dupilumab in combination with topical corticosteroids. In these trials 38% and 36% of patients respectively, met the primary efficacy goal of the trial, compared to 8% and 10% under placebo.[11] Phase II trials for asthma treatment showed increased lung function for patients, showing increased levels of forced expiratory volume.[11] References1. ^Statement On A Nonproprietary Name Adopted By The USAN Council - Dupilumab, American Medical Association.{{dead link|date=June 2017}} {{Monoclonals for immune system}}{{Interleukin receptor modulators}}2. ^1 2 3 4 {{cite web|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm|title=FDA approves new eczema drug Dupixent|website=FDA}} 3. ^{{Cite web|url=http://en.sanofi.com/partners/developing_marketing_innovative_solutions/commercial_collaboration/commercial_collaboration.aspx|title=Sanofi - Commercial collaboration|website=Sanofi|language=en|access-date=2017-03-09}} 4. ^{{Cite web|url=https://www.regeneron.com/pipeline|title=Pipeline {{!}} A powerful research and development engine|website=www.regeneron.com|access-date=2017-03-09}} 5. ^{{cite news|last1=Thomas|first1=Katie|title=Severe Eczema Drug Is Approved by F.D.A.; Price Tag Is $37,000 a Year|url=https://www.nytimes.com/2017/03/28/health/drug-prices-fda-eczema-skin-disease.html|accessdate=30 March 2017|work=The New York Times|date=28 March 2017}} 6. ^{{cite journal|last1=Kraft|first1=M|last2=Worm|first2=M|title=Dupilumab in the treatment of moderate-to-severe atopic dermatitis.|journal=Expert Review of Clinical Immunology|date=April 2017|volume=13|issue=4|pages=301–310|doi=10.1080/1744666X.2017.1292134|pmid=28165826}} 7. ^1 {{cite journal|last1=Humbert|first1=M|last2=Busse|first2=W|last3=Hanania|first3=NA|title=Controversies and opportunities in severe asthma.|journal=Current Opinion in Pulmonary Medicine|volume=24|issue=1|pages=83–93|date=20 October 2017|doi=10.1097/MCP.0000000000000438|pmid=29059087}} 8. ^{{Cite journal|last=Castro|first=Mario|last2=Corren|first2=Jonathan|last3=Pavord|first3=Ian D.|last4=Maspero|first4=Jorge|last5=Wenzel|first5=Sally|last6=Rabe|first6=Klaus F.|last7=Busse|first7=William W.|last8=Ford|first8=Linda|last9=Sher|first9=Lawrence|date=2018-06-28|title=Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma|journal=New England Journal of Medicine|language=en|volume=378|issue=26|pages=2486–2496|doi=10.1056/nejmoa1804092|pmid=29782217|issn=0028-4793}} 9. ^{{Cite journal | url=https://jamanetwork.com/journals/jamadermatology/article-abstract/2705770 | doi=10.1001/jamadermatol.2018.2976| pmid=30304403| title=Hair Regrowth in a Patient with Long-standing Alopecia Totalis and Atopic Dermatitis Treated with Dupilumab| journal=JAMA Dermatology| volume=154| issue=11| pages=1358| year=2018| last1=Penzi| first1=Lauren R.| last2=Yasuda| first2=Mariko| last3=Manatis-Lornell| first3=Athena| last4=Hagigeorges| first4=Dina| last5=Senna| first5=Maryanne M.}} 10. ^[ Dupilumab in Persistent Asthma with Elevated Eosinophil Levels - Sally Wenzel, M.D., Linda Ford, M.D., David Pearlman, M.D., Sheldon Spector, M.D., Lawrence Sher, M.D., Franck Skobieranda, M.D., Lin Wang, Ph.D., Stephane Kirkesseli, M.D., Ross Rocklin, M.D., Brian Bock, D.O., Jennifer Hamilton, Ph.D., Jeffrey E. Ming, M.D., Ph.D., Allen Radin, M.D., Neil Stahl, Ph.D., George D. Yancopoulos, M.D., Ph.D., Neil Graham, M.D., and Gianluca Pirozzi, M.D., Ph.D.], NEJM. 11. ^1 2 3 4 {{Cite journal|last=Shirley|first=Matt|date=2017-07-01|title=Dupilumab: First Global Approval|journal=Drugs|language=en|volume=77|issue=10|pages=1115–1121|doi=10.1007/s40265-017-0768-3|issn=0012-6667}} 12. ^{{Cite web|url=https://www.sec.gov/Archives/edgar/data/872589/000153217617000027/regn-063017x10q.htm|title=SEC 10-Q Filing of Regeneron|last=|first=|date=2017-06-30|website=SEC.gov|archive-url=|archive-date=|dead-url=|access-date=2017-10-20}} 13. ^{{cite web|title=Novel Biologic Dupilumab Improves Eczema Symptoms|url=http://www.medpagetoday.com/MeetingCoverage/EADV/60571|accessdate=30 October 2017}} 14. ^{{Cite news|url=https://www.wsj.com/articles/new-eczema-treatments-could-be-available-soon-1464637182|title=New Eczema Treatments Could Be Available Soon|last=Walker|first=Joseph|date=2016-05-30|newspaper=Wall Street Journal|issn=0099-9660|access-date=2016-05-31}} 15. ^{{Cite web|url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761055Orig1s000SumR.pdf|title=FDA Active Division Director Summary Review|last=|first=|date=|website=FDA|archive-url=|archive-date=|dead-url=|access-date=2017-10-25}} 16. ^{{Cite journal|last=Hamilton|first=Jennifer D.|last2=Ungar|first2=Benjamin|last3=Guttman-Yassky|first3=Emma|date=2015|title=Drug evaluation review: dupilumab in atopic dermatitisjournal=Immunotherapy|journal=Immunotherapy|volume=7|issue=10|pages=1043–1058|doi=10.2217/imt.15.69|pmid=26598956}} 4 : Monoclonal antibodies|Experimental drugs|Breakthrough therapy|Sanofi |
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