Thyssen Jacob P, Werfel Thomas, Barbarot Sebastien, Hunter Hamish J A, Pierce Evangeline, Sun Luna, Cirri Lisa, Buchanan Andrew S, Lu Na, Wollenberg Andreas
Department of Dermatology and Venersology, Bispebjerg Hospital, Copenhagen, Denmark.
Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany.
J Dermatolog Treat. 2023 Dec;34(1):2190430. doi: 10.1080/09546634.2023.2190430.
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).
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.
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.
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.
完成初始研究BREEZE - AD1（NCT03334396）、BREEZE - AD2（NCT03334422）和BREEZE - AD7（NCT03733301）的患者有资格参加多中心3期长期扩展研究BREEZE - AD3（NCT03334435）。
在第52周时，对巴瑞替尼4 mg的反应者和部分反应者以1:1的比例重新随机分组，进入剂量持续（4 mg，N = 84）或剂量递减（2 mg，N = 84）的子研究。在BREEZE - AD3的第52周至104周评估反应的维持情况。医生评估的结果包括vIGA - AD（0、1）、EASI75以及EASI相对于基线的平均变化。患者报告的结果包括DLQI、POEM总分、HADS以及相对于基线的：WPAI（出勤、缺勤、总体工作障碍、日常活动障碍）以及SCORAD瘙痒和睡眠丧失相对于基线的变化。
持续使用巴瑞替尼4 mg治疗，在vIGA - AD（0、1）、EASI75、EASI相对于基线的平均变化、SCORAD瘙痒、SCORAD睡眠丧失、DLQI、POEM、HADS和WPAI（所有评分）方面，疗效维持至第104周。剂量递减至2 mg的患者在这些指标中的大多数方面维持了大部分改善。
BREEZE AD3的子研究支持巴瑞替尼给药方案的灵活性。继续使用巴瑞替尼4 mg治疗并剂量递减至2 mg的患者在皮肤、瘙痒、睡眠和生活质量方面的改善维持了长达104周。
