Jonathan I Silverberg1, Gil Yosipovitch2, Eric L Simpson3, Brian S Kim4, Jashin J Wu5, Laurent Eckert6, Isabelle Guillemin7, Zhen Chen8, Marius Ardeleanu8, Ashish Bansal8, Mandeep Kaur9, Ana B Rossi9, Neil M H Graham8, Naimish Patel10, Abhijit Gadkari8. 1. Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC. Electronic address: jonathanisilverberg@gmail.com. 2. Department of Dermatology and Itch Center, University of Miami Miller School of Medicine, Miami, Florida. 3. Department of Dermatology, Oregon Health and Science University, Portland, Oregon. 4. Division of Dermatology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri. 5. Dermatology Research and Education Foundation, Irvine, California. 6. Sanofi, Chilly-Mazarin, France. 7. Sanofi, Lyon, France. 8. Regeneron Pharmaceuticals, Inc, Tarrytown, New York. 9. Sanofi Genzyme, Cambridge, Massachusetts. 10. Sanofi, Cambridge, Massachusetts.
Abstract
BACKGROUND: Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD). OBJECTIVE: To evaluate the timing and effect of dupilumab on itch. METHODS: Analysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (AD ADOL: NCT03054428). RESULTS:Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of Peak Pruritus Numerical Rating Scale scores: SOLO -47.5% vs -20.5%; AD-ADOL -47.9% vs -19.0%; CHRONOS -57.3% vs -30.9% (P < .0001 for all). LIMITATIONS: Short duration of monotherapy trials (16 weeks). CONCLUSION: Across 4 randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year.
RCT Entities:
BACKGROUND:Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD). OBJECTIVE: To evaluate the timing and effect of dupilumab on itch. METHODS: Analysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (ADADOL: NCT03054428). RESULTS:Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of Peak Pruritus Numerical Rating Scale scores: SOLO -47.5% vs -20.5%; AD-ADOL -47.9% vs -19.0%; CHRONOS -57.3% vs -30.9% (P < .0001 for all). LIMITATIONS: Short duration of monotherapy trials (16 weeks). CONCLUSION: Across 4 randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year.
Authors: Jonathan I Silverberg; Jacob P Thyssen; Eric L Simpson; Gil Yosipovitch; Sonja Ständer; Hernan Valdez; Ricardo Rojo; Pinaki Biswas; Daniela E Myers; Claire Feeney; Marco DiBonaventura Journal: Am J Clin Dermatol Date: 2021-05-05 Impact factor: 7.403
Authors: Simon de Lusignan; Helen Alexander; Conor Broderick; John Dennis; Andrew McGovern; Claire Feeney; Carsten Flohr Journal: BMJ Open Date: 2020-09-16 Impact factor: 2.692
Authors: Sylvia A Martinez-Cabriales; Mark G Kirchhof; Cora M Constantinescu; Luis Murguia-Favela; Michele L Ramien Journal: Am J Clin Dermatol Date: 2021-06-02 Impact factor: 7.403