Mark Boguniewicz1, Lisa A Beck2, Lawrence Sher3, Emma Guttman-Yassky4, Diamant Thaçi5, Andrew Blauvelt6, Margitta Worm7, Jonathan Corren8, Weily Soong9, Peter Lio10, Ana B Rossi11, Yufang Lu12, Jingdong Chao12, Laurent Eckert13, Abhijit Gadkari12, Thomas Hultsch11, Marcella Ruddy12, Leda P Mannent13, Neil M H Graham12, Gianluca Pirozzi14, Zhen Chen12, Marius Ardeleanu12. 1. National Jewish Health, Denver, Colo; University of Colorado School of Medicine, Denver, Colo. Electronic address: boguniewiczm@njhealth.org. 2. Department of Dermatology, University of Rochester Medical Center, Rochester, NY. 3. Peninsula Research Associates, Rolling Hills Estates, Calif. 4. Department of Dermatology, Icahn School of Medicine at Mount Sinai Medical Center, New York, NY; Laboratory for Investigative Dermatology, Rockefeller University, New York, NY. 5. Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany. 6. Oregon Medical Research Center, Portland, Ore. 7. Division of Allergy and Immunology, Allergy Center Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany. 8. David Geffen School of Medicine at UCLA, Los Angeles, Calif. 9. Alabama Allergy and Asthma Center, Birmingham, Ala. 10. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Ill. 11. Sanofi Genzyme, Cambridge, Mass. 12. Regeneron Pharmaceuticals, Inc, Tarrytown, NY. 13. Sanofi, Chilly-Mazarin, France. 14. Sanofi, Bridgewater, NJ.
Abstract
BACKGROUND: Dupilumab has demonstrated efficacy with acceptable safety in clinical trials in patients with moderate to severe atopic dermatitis (AD). OBJECTIVE: To assess dupilumab's impact on asthma and sinonasal conditions in adult patients with moderate to severe AD in four randomized, double-blinded, placebo-controlled trials. METHODS: In LIBERTY AD SOLO 1 (NCT02277743), SOLO 2 (NCT02755649), CHRONOS (NCT02260986), and CAFÉ (NCT02755649), patients received placebo, dupilumab 300 mg every 2 weeks (q2w), or dupilumab 300 mg weekly (qw). In CHRONOS and CAFÉ, patients received concomitant topical corticosteroids. This post hoc analysis assessed Asthma Control Questionnaire-5 (ACQ-5) scores in patients with asthma, Sino-Nasal Outcome Test-22 (SNOT-22) scores in patients with sinonasal conditions, and AD signs and symptoms in all patients. RESULTS: Of the 2444 patients, 463 had asthma with baseline ACQ-5 ≥ 0.5 (19%); 1171 had sinonasal conditions (48%); and 311 had both (13%). At week 16, ACQ-5 scores (least squares mean change from baseline [standard error]) improved by 0.27 (0.07), 0.59 (0.08), and 0.56 (0.07) in placebo-, q2w-, and qw-treated patients with asthma, respectively, whereas SNOT-22 scores improved by 5.1 (0.8), 9.9 (0.9), and 10.8 (0.8) in patients with sinonasal conditions (P < .01 for all dupilumab vs placebo). Improvements in ACQ-5 and SNOT-22 were also seen in patients with both conditions. Dupilumab also significantly improved AD signs and symptoms among all subgroups. CONCLUSIONS: In this first analysis of patients with comorbid moderate to severe AD, asthma, and/or chronic sinonasal conditions, dupilumab improved all three diseases in a clinically meaningful and statistically significant manner (vs placebo), based on validated outcome measures.
BACKGROUND: Dupilumab has demonstrated efficacy with acceptable safety in clinical trials in patients with moderate to severe atopic dermatitis (AD). OBJECTIVE: To assess dupilumab's impact on asthma and sinonasal conditions in adult patients with moderate to severe AD in four randomized, double-blinded, placebo-controlled trials. METHODS: In LIBERTY AD SOLO 1 (NCT02277743), SOLO 2 (NCT02755649), CHRONOS (NCT02260986), and CAFÉ (NCT02755649), patients received placebo, dupilumab 300 mg every 2 weeks (q2w), or dupilumab 300 mg weekly (qw). In CHRONOS and CAFÉ, patients received concomitant topical corticosteroids. This post hoc analysis assessed Asthma Control Questionnaire-5 (ACQ-5) scores in patients with asthma, Sino-Nasal Outcome Test-22 (SNOT-22) scores in patients with sinonasal conditions, and AD signs and symptoms in all patients. RESULTS: Of the 2444 patients, 463 had asthma with baseline ACQ-5 ≥ 0.5 (19%); 1171 had sinonasal conditions (48%); and 311 had both (13%). At week 16, ACQ-5 scores (least squares mean change from baseline [standard error]) improved by 0.27 (0.07), 0.59 (0.08), and 0.56 (0.07) in placebo-, q2w-, and qw-treated patients with asthma, respectively, whereas SNOT-22 scores improved by 5.1 (0.8), 9.9 (0.9), and 10.8 (0.8) in patients with sinonasal conditions (P < .01 for all dupilumab vs placebo). Improvements in ACQ-5 and SNOT-22 were also seen in patients with both conditions. Dupilumab also significantly improved AD signs and symptoms among all subgroups. CONCLUSIONS: In this first analysis of patients with comorbid moderate to severe AD, asthma, and/or chronic sinonasal conditions, dupilumab improved all three diseases in a clinically meaningful and statistically significant manner (vs placebo), based on validated outcome measures.
Authors: Louise De Prins; Ulrike Raap; Tara Mueller; Peter Schmid-Grendelmeier; Christiane H Haase; Vibeke Backer; Wytske Fokkens; Linda B Benoist; Emmanuel Prokopakis; Claire Hopkins; Nele Claeys; Thijs Teeling; Lindsay Cypers; Leen Cools; Leif H Bjermer; Zuzana Diamant; Ulrich Wahn; Glenis Scadding; Claus Bachert; Sunni R Patel; Elizabeth Van Staeyen; Peter Hellings Journal: Front Allergy Date: 2022-06-02
Authors: Diamant Thaçi; Andrea Bauer; Ralph von Kiedrowski; Florian Schenck; Konstantin Ertner; Sophie Möller; Anja Fait; Mike Bastian; Matthias Augustin Journal: Dermatol Ther (Heidelb) Date: 2022-08-19