TY - JOUR
T1 - Baricitinib in adult patients with moderate-to-severe atopic dermatitis
T2 - A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study
AU - Guttman-Yassky, Emma
AU - Silverberg, Jonathan I.
AU - Nemoto, Osamu
AU - Forman, Seth B.
AU - Wilke, August
AU - Prescilla, Randy
AU - de la Peña, Amparo
AU - Nunes, Fabio P.
AU - Janes, Jonathan
AU - Gamalo, Margaret
AU - Donley, David
AU - Paik, Jim
AU - DeLozier, Amy M.
AU - Nickoloff, Brian J.
AU - Simpson, Eric L.
N1 - Funding Information:
Supported by Eli Lilly and Company.
Funding Information:
Disclosure: Dr Guttman-Yassky reports grants from Eli Lilly and Company during the conduct of the study and grants from Dermira, Leo Pharma, Novartis, Galderma, Regeneron Pharmaceuticals, Pfizer, Vitae Pharmaceuticals, Glenmark, Abbvie, Celgene, Medimmune, Innovaderm Research, Immune Pharmaceuticals, and Asana BioSciences and personal fees from Regeneron Pharmaceuticals, Sanofi, Stiefel/GSK, Pfizer, Galderma, Celgene, Dermira, Anacor Pharmaceuticals, AnaptysBio, Glenmark, Novartis, Abbvie, Sun Pharmaceutical Industries, Mitsubishi Tanabe, Vitae Pharmaceuticals, Allergan, Almirall, PuriCore, Asana BioSciences, Gilead Sciences, Concert Pharmaceuticals, Immune Pharmaceuticals, Kyowa Kirin Co, Ziarco Group, DS Biopharma, DBV Technologies, Eli Lilly and Company, and Escalier Biosciences outside the submitted work. Dr Silverberg reports grants from GSK and Regeneron-Sanofi and personal fees from Abbvie, Eli Lilly and Company, Galderma, Kiniksa Pharmaceuticals, Leo Pharma, Menlo Therapeutics, Pfizer, Realm Therapeutics, Regeneron-Sanofi, and Roivant Sciences during the conduct of the study and personal fees from Eli Lilly and Company outside the submitted work. Dr. Forman reports personal fees and nonfinancial support from Eli Lilly and Company during the conduct of the study and personal fees and nonfinancial support from Eli Lilly and Company, Pfizer, Abbvie, Regeneron/Sanofi and personal fees from Asana BioSciences, Valeant Pharmaceuticals, Genentech/Roche, Innovaderm Research, and Novartis outside the submitted work. Dr Donley is an employee of EMB Statistical Solutions, which was hired by Eli Lilly and Company for statistical support. Drs Wilke, Prescilla, de la Peña, Nunes, Janes, Gamalo, Paik, and Nickoloff and Ms DeLozier are employees of and stockholders in Eli Lilly and Company. Dr Simpson reports grants, personal fees, and nonfinancial support from Eli Lilly and Company during the conduct of the study and grants and personal fees from Anacor Pharma, Glaxo Smith Kline, and Regeneron Pharmaceuticals; personal fees from AbbVie, Celgene Corporation, Dermira, Galderma, Genentech, Leo Pharma, and Menlo Therapeutics; grants and personal fees from Sanofi Genzyme and Valeant Pharmaceuticals; and grants from MedImmune, Novartis, Roivant Sciences, Tioga Pharmaceuticals, and Vanda Pharmaceuticals outside the submitted work. Dr. Nemoto has no conflicts of interest to disclose.
Publisher Copyright:
© 2018
PY - 2019/4
Y1 - 2019/4
N2 - 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.
AB - 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.
KW - EASI
KW - JAK-STAT signaling
KW - SCORAD
KW - atopic dermatitis
KW - baricitinib
KW - phase 2
KW - pruritus
KW - topical corticosteroids
UR - http://www.scopus.com/inward/record.url?scp=85061652608&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85061652608&partnerID=8YFLogxK
U2 - 10.1016/j.jaad.2018.01.018
DO - 10.1016/j.jaad.2018.01.018
M3 - Article
C2 - 29410014
AN - SCOPUS:85061652608
VL - 80
SP - 913-921.e9
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
SN - 0190-9622
IS - 4
ER -