Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial. (31st December 2023)

• Record Type: Journal Article
• Authors: Thyssen, Jacob P.; Werfel, Thomas; Barbarot, Sebastien; Hunter, Hamish J.A; Pierce, Evangeline; Sun, Luna; Cirri, Lisa; Buchanan, Andrew S.; Lu, Na; Wollenberg, Andreas
• Is Part Of: Journal of dermatological treatment. Volume 34:Number 1(2023)
• Publication Date: 2023-12-31
• Subjects: Atopic dermatitis -- baricitinib -- long-term extension; Skin -- Diseases -- Treatment -- Periodicals; Skin Diseases -- drug therapy -- Periodicals; Skin Diseases -- therapy -- Periodicals; 616.5
• DOI: 10.1080/09546634.2023.2190430
• Languages: English
• ISSNs: 0954-6634

Abstract

Abstract: Background: Patients who completed the originating studies, BREEZE-AD1 (NCT03334396), BREEZE-AD2(NCT03334422), and BREEZE-AD7 (NCT03733301), were eligible for enrollment in the multicenter, phase-3, long-term extension study BREEZE-AD3 (NCT03334435). Methods: At week 52, responders and partial responders to baricitinib 4 mg were re-randomized (1:1) into the sub-study to dose continuation (4 mg, N = 84), or dose down-titration (2 mg, N = 84). Maintenance of response was assessed from week 52 to 104 of BREEZE-AD3. Physician-rated outcomes included vIGA-AD (0, 1), EASI75, and mean change from baseline in EASI. Patient-reported outcomes included DLQI, P OEM total score, HADS, and from baseline: WPAI (presenteeism, absenteeism, overall work impairment, daily activity impairment) and change from baseline in SCORAD itch and sleep loss. Results: With continuous treatment with baricitinib 4 mg, efficacy was maintained up to week 104 in vIGA-AD (0, 1), EASI75, EASI mean change from baseline, SCORAD itch, SCORAD sleep loss, DLQI, P OEM, HADS, and WPAI (all scores). Patients down-titrated to 2 mg maintained most of their improvements in each of these measures. Conclusion: The sub-study of BREEZE AD3 supports flexibility in baricitinib dosing regimens. Patients who continued treatment with baricitinib 4 mg and down-titrated to 2 mg maintained improvements in skin, itch, sleep, and quality of life for up to 104 weeks.