• Am J Clin Dermatol · Aug 2020

    Multicenter Study

    Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis.

    • Lisa A Beck, Diamant Thaçi, Mette Deleuran, Andrew Blauvelt, Robert Bissonnette, Marjolein de Bruin-Weller, Michihiro Hide, Lawrence Sher, Iftikhar Hussain, Zhen Chen, Faisal A Khokhar, Bethany Beazley, Marcella Ruddy, Naimish Patel, GrahamNeil M HNMHRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA., Marius Ardeleanu, and Brad Shumel.
    • Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.
    • Am J Clin Dermatol. 2020 Aug 1; 21 (4): 567-577.

    BackgroundManagement of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment.ObjectiveThe aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD.MethodsThis ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety.ResultsOf 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, - 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, - 65.4%) at week 148.LimitationsNo control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose.ConclusionThese safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD.Trial RegistrationClinicalTrials.gov: NCT01949311. Dupilumab provides favorable safety and sustained efficacy for up to 3 years in an open-label study of adults with moderate-to-severe atopic dermatitis (MP4  139831 kb).

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…