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Efficacy and safety of fezakinumab (an IL-22 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by conventional.

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Presentation on theme: "Efficacy and safety of fezakinumab (an IL-22 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by conventional."— Presentation transcript:

1 Efficacy and safety of fezakinumab (an IL-22 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by conventional treatments: A randomized, double-blind, phase 2a trial  Emma Guttman-Yassky, MD, PhD, Patrick M. Brunner, MD, Avidan U. Neumann, PhD, Saakshi Khattri, MD, Ana B. Pavel, PhD, Kunal Malik, BA, Giselle K. Singer, BS, Danielle Baum, Patricia Gilleaudeau, Mary Sullivan-Whalen, Sharon Rose, MD, Shelbi Jim On, MD, Xuan Li, BA, Judilyn Fuentes-Duculan, MD, Yeriel Estrada, BS, Sandra Garcet, PhD, Claudia Traidl-Hoffmann, MD, James G. Krueger, MD, PhD, Mark G. Lebwohl, MD  Journal of the American Academy of Dermatology  Volume 78, Issue 5, Pages e6 (May 2018) DOI: /j.jaad Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

2 Fig 1 Patient disposition. SAE, Serious adverse event.
Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

3 Fig 2 Time course of efficacy variables for entire study population. Clinical responses for SCORAD (A), BSA (B), and IGA (C) are shown for the fezakinumab (red) and placebo (blue) arms. All panels depict the mean ± SEM (standard error of the means) change from baseline. Data was analyzed by mixed-effect model repeated measures. Red asterisks and blue asterisks by each curve indicate significant change from baseline for each arm; black asterisks at bottom indicate significant differences between drug and placebo arms; green asterisks indicate the significance of the combined factor: baseline severity and treatment arm. *P < .05, **P < .01, ***P < .001. BSA, Body surface area; IGA, Investigator Global Assessment; SCORAD, SCOring Atopic Dermatitis. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

4 Fig 3 Time course of efficacy variables stratified for nonsevere and severe patients. Patients were stratified as having nonsevere (SCORAD <50) or severe (SCORAD ≥50) AD at baseline (week 0). Panels depict the mean ± SEM (standard error of the means) change from baseline for SCORAD (A and B), BSA (C and D), and IGA (E and F). Data was analyzed by mixed-effect model repeated measures. Red asterisks and blue asterisks by each curve indicate significant change from baseline for each arm; black asterisks at the bottom indicate significant differences between drug and placebo arm. *P < .05, **P < .01, ***P < .001. BSA, Body surface area; IGA, Investigator Global Assessment; NS, nonsignificant; SCORAD, SCOring Atopic Dermatitis. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

5 Supplemental Fig 1 SCORAD (A) and BSA (B) pretreatment variation from the screening visit to baseline (week 0). Pretreatment variation for SCORAD and BSA were consistently below 30% and 15, respectively. BSA, Body surface area; SCORAD, SCOring Atopic Dermatitis. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

6 Supplemental Fig 2 Pruritus was assessed as component of SCOring Atopic Dermatitis (SCORAD) and shown for patients with a baseline pruritus >5. Panels depict the mean ± SEM (standard error of the means) change from baseline. Data was analyzed by mixed-effect model repeated measures. Red asterisks and blue asterisks by each curve indicate significant change from baseline for each arm; significant differences between fezakinumab and placebo arms were not found. *P < .05, **P < .01, ***P < .001. NS, Not significant. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

7 Supplemental Fig 3 Change over time in log10 IgE per treatment arm. No significant change from baseline and no significant difference between the arms was observed. NS, Not significant. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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