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Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials.

Authors
  • Simpson, E L1
  • Lacour, J-P2
  • Spelman, L3
  • Galimberti, R4
  • Eichenfield, L F5
  • Bissonnette, R6
  • King, B A7
  • Thyssen, J P8
  • Silverberg, J I9
  • Bieber, T10
  • Kabashima, K11
  • Tsunemi, Y12
  • Costanzo, A13
  • Guttman-Yassky, E14
  • Beck, L A15
  • Janes, J M16
  • DeLozier, A M16
  • Gamalo, M16
  • Brinker, D R16
  • Cardillo, T16
  • And 4 more
  • 1 Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.
  • 2 Department of Dermatology, University Hospital of Nice, Nice, France. , (France)
  • 3 Veracity Clinical Research, Brisbane, Australia. , (Australia)
  • 4 Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. , (Argentina)
  • 5 University of California, San Diego and Rady Children's Hospital, San Diego, CA, USA.
  • 6 Innovaderm Research, Montreal, QC, Canada. , (Canada)
  • 7 Yale University School of Medicine, New Haven, CT, USA.
  • 8 Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. , (Denmark)
  • 9 Department of Dermatology George Washington University School of Medicine, Washington, DC, USA.
  • 10 Department of Dermatology and Allergy, University of Bonn, Bonn, Germany. , (Germany)
  • 11 Department of Dermatology, Kyoto University, Kyoto, Japan. , (Japan)
  • 12 Department of Dermatology, Saitama Medical University, Saitama, Japan. , (Japan)
  • 13 Humanitas University and Dermatology Unit, Humanitas Research Hospital, Milan, Italy. , (Italy)
  • 14 Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • 15 Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.
  • 16 Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA. , (India)
  • 17 Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
  • 18 Department of Dermatology and Allergology, Ludwig Maximillian University, Munich, Germany. , (Germany)
  • 19 Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg, Germany. , (Germany)
  • 20 Dermatologikum Berlin, Berlin, Germany. , (Germany)
Type
Published Article
Journal
British Journal of Dermatology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Aug 01, 2020
Volume
183
Issue
2
Pages
242–255
Identifiers
DOI: 10.1111/bjd.18898
PMID: 31995838
Source
Medline
Language
English
License
Unknown

Abstract

Baricitinib, an oral selective Janus kinase 1 and 2 inhibitor, effectively reduced atopic dermatitis (AD) severity in a phase II study with concomitant topical corticosteroids. To evaluate the efficacy and safety of baricitinib in patients with moderate-to-severe AD who had an inadequate response to topical therapies. In two independent, multicentre, double-blind, phase III monotherapy trials, BREEZE-AD1 and BREEZE-AD2, adults with moderate-to-severe AD were randomized 2 : 1 : 1 : 1 to once-daily placebo, baricitinib 1 mg, 2 mg, or 4 mg for 16 weeks. At week 16, more patients achieved the primary end point of Validated Investigator's Global Assessment of AD (0, 1) on baricitinib 4 mg and 2 mg compared with placebo in BREEZE-AD1 [N = 624; baricitinib 4 mg 16·8% (P < 0·001), 2 mg 11·4% (P < 0·05), 1 mg 11·8% (P < 0·05), placebo 4·8%], and BREEZE-AD2 [N = 615; baricitinib 4 mg 13·8% (P = 0·001), 2 mg 10·6% (P < 0·05), 1 mg 8·8% (P = 0·085), placebo 4·5%]. Improvement in itch was achieved as early as week 1 for 4 mg and week 2 for 2 mg. Improvements in night-time awakenings, skin pain and quality-of-life measures were observed by week 1 for both 4 mg and 2 mg (P ≤ 0·05, all comparisons). The most common adverse events in patients treated with baricitinib were nasopharyngitis and headache. No cardiovascular events, venous thromboembolism, gastrointestinal perforation, significant haematological changes, or death were observed with any baricitinib dosage. Baricitinib improved clinical signs and symptoms in patients with moderate-to-severe AD within 16 weeks of treatment and induced rapid reduction of itch. The safety profile remained consistent with prior findings from baricitinib clinical development in AD, with no new safety concerns. © 2020 British Association of Dermatologists.

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