Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up)

被引:27
作者
Blauvelt, Andrew [1 ]
Ladizinski, Barry [2 ]
Prajapati, Vimal H. [3 ,4 ,5 ,6 ,7 ,8 ]
Laquer, Vivian [9 ]
Fischer, Alison [10 ,11 ]
Eisman, Samantha [12 ]
Hu, Xiaofei [2 ]
Wu, Tianshuang [2 ]
Calimlim, Brian M. [2 ]
Kaplan, Blair [2 ]
Liu, Yingyi [2 ]
Teixeira, Henrique D. [2 ]
Liu, John [2 ]
Eyerich, Kilian [13 ,14 ,15 ]
机构
[1] Oregon Med Res Ctr, 9495 SW Locust St,Ste G, Portland, OR 97223 USA
[2] AbbVie Inc, N Chicago, IL USA
[3] Univ Calgary, Dept Med, Div Dermatol, Calgary, AB, Canada
[4] Univ Calgary, Dept Pediat, Sect Community Pediat, Calgary, AB, Canada
[5] Univ Calgary, Dept Pediat, Sect Pediat Rheumatol, Calgary, AB, Canada
[6] Skin Hlth & Wellness Ctr, Calgary, AB, Canada
[7] Dermatol Res Inst, Calgary, AB, Canada
[8] Prob Med Res, Calgary, AB, Canada
[9] First OC Dermatol Res, Fountain Valley, CA USA
[10] Southside Dermatol, Tulsa, OK USA
[11] Oklahoma State Univ, Ctr Hlth Sci, Tulsa, OK USA
[12] Sinclair Dermatol, East Melbourne, Vic, Australia
[13] Karolinska Inst, Stockholm, Sweden
[14] Karolinska Univ Hosp, Stockholm, Sweden
[15] Univ Freiburg, Sch Med, Dept Dermatol & Venerol, Freiburg, Germany
关键词
~atopic dermatitis; dupilumab; safety; treatment outcome; upadacitinib; DOUBLE-BLIND; PLACEBO; ADOLESCENTS; ADULTS;
D O I
10.1016/j.jaad.2023.05.033
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background: Characterization of upadacitinib use and switching from dupilumab to upadacitinib among patients with moderate-to-severe atopic dermatitis (AD) is needed. Objective: To evaluate the long-term safety and efficacy of continuous upadacitinib 30 mg and switching to upadacitinib after 24 weeks of dupilumab. Methods: Adults who completed the phase 3b clinical trial of oral upadacitinib 30 mg vs injectable dupilumab 300 mg (Heads Up) and entered a 52-week open-label extension (OLE) (NCT04195698) were included. All patients received 30-mg upadacitinib during the open-label period. We report results of a prespecified interim OLE 16-week analysis. Results: Patients (n = 239) continuing upadacitinib maintained high levels of skin and itch response. Patients (n = 245) switching from dupilumab experienced additional incremental improvements in clinical responses within 4 weeks of starting upadacitinib. Most patients who did not achieve adequate clinical responses with dupilumab did so with upadacitinib. The safety profile of upadacitinib up to 40 weeks (week 16 of OLE) was consistent with previous phase 3 AD studies, with no new safety risks observed. Limitations: Open-label study design. Conclusions: Clinical responses are maintained with continuous upadacitinib through 40 weeks and patients regardless of prior dupilumab response experienced improved outcomes when switched to upadacitinib. No new safety risks were observed. ( J Am Acad Dermatol 2023;89:478-85.)
引用
收藏
页码:478 / 485
页数:8
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