Mette Deleuran1, Diamant Thaçi2, Lisa A Beck3, Marjolein de Bruin-Weller4, Andrew Blauvelt5, Seth Forman6, Robert Bissonnette7, Kristian Reich8, Weily Soong9, Iftikhar Hussain10, Peter Foley11, Michihiro Hide12, Jean-David Bouaziz13, Joel M Gelfand14, Lawrence Sher15, Marie L A Schuttelaar16, Chen Wang17, Zhen Chen18, Bolanle Akinlade18, Abhijit Gadkari18, Laurent Eckert19, John D Davis18, Manoj Rajadhyaksha18, Heribert Staudinger20, Neil M H Graham18, Gianluca Pirozzi20, Marius Ardeleanu18. 1. Aarhus University Hospital, Aarhus, Denmark. Electronic address: mettdele@rm.dk. 2. University of Lübeck, Lübeck, Germany. 3. University of Rochester Medical Center, Rochester, New York. 4. University Medical Center Utrecht, Utrecht, The Netherlands. 5. Oregon Medical Research, Portland, Oregon. 6. Forman Dermatology and Skin Cancer Institute, Tampa, Florida. 7. Innovaderm Research, Montreal, Canada. 8. Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation Center, Hamburg, Germany; Dermatologikum Berlin, Berlin, Germany. 9. Alabama Allergy & Asthma Center, Birmingham, Alabama. 10. Vital Prospects Clinical Research Institute, PC, Tulsa, Oklahoma. 11. University of Melbourne, Skin & Cancer Foundation, Inc., Carlton, Australia. 12. Hiroshima University, Hiroshima, Japan. 13. Saint-Louis Hospital, Paris, France. 14. University of Pennsylvania, Philadelphia, Pennsylvania. 15. Peninsula Research Associates, Rolling Hills Estates, California. 16. University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 17. Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey. 18. Regeneron Pharmaceuticals, Inc, Tarrytown, New York. 19. Sanofi, Chilly-Mazarin, France. 20. Sanofi, Bridgewater, New Jersey.
Abstract
BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD). OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD. METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life. LIMITATIONS: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks. CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.
BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD). OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD. METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life. LIMITATIONS: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks. CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.
Authors: Jonathan I Silverberg; Eric L Simpson; Mark Boguniewicz; Marjolein S De Bruin-Weller; Peter Foley; Yoko Kataoka; Gaëlle Bégo-Le-Bagousse; Zhen Chen; Brad Shumel; Jingdong Chao; Ana B Rossi Journal: Acta Derm Venereol Date: 2021-11-10 Impact factor: 3.875
Authors: Eva Conde; Romain Bertrand; Bianca Balbino; Jonathan Bonnefoy; Julien Stackowicz; Noémie Caillot; Fabien Colaone; Samir Hamdi; Raïssa Houmadi; Alexia Loste; Jasper B J Kamphuis; François Huetz; Laurent Guilleminault; Nicolas Gaudenzio; Aurélie Mougel; David Hardy; John N Snouwaert; Beverly H Koller; Vincent Serra; Pierre Bruhns; Géraldine Grouard-Vogel; Laurent L Reber Journal: Nat Commun Date: 2021-05-11 Impact factor: 14.919
Authors: 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; Neil M H Graham; Marius Ardeleanu; Brad Shumel Journal: Am J Clin Dermatol Date: 2020-08 Impact factor: 7.403