Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5)
| Autor: | George Han, Daniel Marnell, Fabio P. Nunes, Orin Goldblum, Amy M. DeLozier, Eric L. Simpson, Emanual Michael Maverakis, Jonathan Janes, Robinette Angle, Emma Guttman-Yassky, Robert Bissonnette, Kim A. Papp, Katrin Holzwarth, Jonathan I. Silverberg, Seth Forman, Matthew J. Zirwas, Jill Waibel, Margaret Gamalo, Jinglin Zhong |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Canada medicine.medical_specialty Baricitinib Dermatology Placebo Severity of Illness Index Eczema Area and Severity Index Dermatitis Atopic 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine medicine Clinical endpoint Humans Adverse effect Protein Kinase Inhibitors Sulfonamides Dose-Response Relationship Drug business.industry Atopic dermatitis Middle Aged medicine.disease United States Clinical trial Treatment Outcome Purines 030220 oncology & carcinogenesis Rheumatoid arthritis Azetidines Pyrazoles Female business |
| Zdroj: | Journal of the American Academy of Dermatology. 85:62-70 |
| ISSN: | 0190-9622 |
| Popis: | Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults.To evaluate the efficacy and safety of baricitinib monotherapy in a North American phase 3 trial (BREEZE-AD5/NCT03435081) of adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy.Patients (N = 440) were randomized 1:1:1 to once-daily placebo or baricitinib (1 mg or 2 mg). The primary endpoint was the proportion of patients achieving ≥75% reduction in the Eczema Area and Severity Index at week 16. A key secondary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD score of 0 (clear)/1(almost clear) with ≥2-point improvement.At week 16, the proportion of patients achieving Eczema Area and Severity Index was 8%, 13%, and 30% (P .001, 2 mg vs placebo) and those with a validated Investigator Global Assessment for AD score of 0/1 were 5%, 13%, and 24% (P .001, 2 mg vs placebo) for placebo, baricitinib 1 mg, and baricitinib 2 mg, respectively. Safety findings were similar to those of other baricitinib AD studies.Short-term clinical trial results may not be generalizable to real-world settings.Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks. |
| Databáze: | OpenAIRE |
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