Emma Guttman-Yassky1, Jonathan I Silverberg2, Osamu Nemoto3, Seth B Forman4, August Wilke5, Randy Prescilla5, Amparo de la Peña5, Fabio P Nunes5, Jonathan Janes5, Margaret Gamalo5, David Donley6, Jim Paik5, Amy M DeLozier5, Brian J Nickoloff5, Eric L Simpson7. 1. Department of Dermatology, Icahn School of Medicine at the Mount Sinai Medical Center, New York, New York; Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at the Mount Sinai Medical Center, New York, New York. Electronic address: Emma.Guttman@mountsinai.org. 2. Department of Dermatology, Feinberg School of Medicine at Northwestern University, Chicago, Illinois; Department of Preventive Medicine, Feinberg School of Medicine at Northwestern University, Chicago, Illinois; Department of Medical Social Sciences, Feinberg School of Medicine at Northwestern University, Chicago, Illinois; Northwestern Medicine Multidisciplinary Eczema Center, Chicago, Illinois. 3. Department of Dermatology, Sapporo Skin Clinic, Hokkaido, Japan. 4. Forward Clinical Trials, Inc, Tampa, Florida. 5. Eli Lilly and Company, Indianapolis, Indiana. 6. EMB Statistical Solutions, LLC, Overland Park, Kansas. 7. Department of Dermatology, Oregon Health and Science University, Portland, Oregon.
Abstract
BACKGROUND: Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling. OBJECTIVES: The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD). METHODS: In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD appliedtopical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo. RESULTS: Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37% [P = .027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%). LIMITATIONS: A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD. CONCLUSIONS: Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD.
RCT Entities:
BACKGROUND:Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling. OBJECTIVES: The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD). METHODS: In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo. RESULTS: Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37% [P = .027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%). LIMITATIONS: A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD. CONCLUSIONS:Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD.
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