A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable
Summary
The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.
Timeline
- Start
- 2018-05-15
- Primary completion
- 2019-11-25
- Completion
- 2023-04-20
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Placebo vs 2 mg Baricitinib; p = 0.071; Odds Ratio (OR) 1.78 (95% CI 0.95 to 3.32); Regression, Logistic reads as mixed primary results NCT03428100 ↗
registry analysis (superiority test); Placebo vs 4 mg Baricitinib; p = 0.031; Odds Ratio (OR) 2.15 (95% CI 1.07 to 4.30); Regression, Logistic reads as mixed primary results NCT03428100 ↗
release “baricitinib met the primary endpoint in BREEZE-AD4” reads as met primary endpoint incyte.com ↗
Publications
- Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
- King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baricitinib | Small molecule | 1 mg | Oral |
| Subject | Baricitinib | Small molecule | 2 mg | Oral |
| Subject | Baricitinib | Small molecule | 4 mg | Oral |