Flohr Carsten, Cork Michael J, Ardern-Jones Michael R, Eichenfield Lawrence F, Barbarot Sébastien, Feeney Claire, Rojo Ricardo, Lazariciu Irina, Nesnas John
Department of Paediatric Dermatology, St John's Institute of Dermatology, Guy's & St Thomas' NHS Foundation Trust and King's College London, UK.
Department of Infection, Immunity and Cardiovascular Disease, Sheffield Dermatology Research, University of Sheffield and Sheffield Children's Hospital, Sheffield, UK.
J Dermatolog Treat. 2023 Dec;34(1):2200866. doi: 10.1080/09546634.2023.2200866.
Differences in atopic dermatitis (AD) disease course and manifestation with age may extend to treatment response.
To evaluate response maintenance with continuous-/reduced-dose abrocitinib or withdrawal and response to treatment reintroduction after flare in adolescent and adult participants in JADE REGIMEN (NCT03627767).
Adolescents (12-17 years) and adults with moderate-to-severe AD responding to abrocitinib 200-mg induction were randomly assigned to 40-week maintenance with abrocitinib (200 mg/100 mg) or placebo. Patients who experienced flare during maintenance received rescue treatment.
Of 246 adolescents and 981 adults, 145/246 (58.9%) and 655/981 (66.8%), respectively, responded to induction. Similar proportions of adolescents and adults experienced flare during maintenance with abrocitinib 200 mg (14.9%/16.9%), 100 mg (42.9%/38.9%), and placebo (75.5%/78.0%). From the abrocitinib 200-mg, 100-mg, and placebo arms, respectively, Eczema Area and Severity Index response was recaptured by 28.6%, 25.0%, and 52.9% of adolescents and 34.3%, 33.7%, and 58.0% of adults; Investigator's Global Assessment response, by 42.9%, 50.0%, and 73.5% of adolescents and 34.3%, 50.6%, and 74.1% of adults. Abrocitinib had a similar safety profile regardless of age; nausea incidence was higher in adolescents.
Adolescents represented 20% of the trial population.
Abrocitinib was effective in preventing flare in adolescents and adults.Clinicaltrials.gov listing: NCT03627767.
特应性皮炎（AD）病程及表现随年龄的差异可能延伸至治疗反应。
在JADE REGIMEN（NCT03627767）研究中，评估青少年及成年参与者使用连续/减量剂量阿布昔替尼或停药后反应维持情况，以及复发后重新治疗的反应。
对200mg诱导剂量阿布昔替尼有反应的中度至重度AD青少年（12 - 17岁）和成年人被随机分配接受40周的阿布昔替尼（200mg/100mg）或安慰剂维持治疗。维持治疗期间出现病情复发的患者接受救援治疗。
246名青少年和981名成年人中，分别有145/246（58.9%）和655/981（66.8%）对诱导治疗有反应。青少年和成年人中，使用200mg阿布昔替尼（14.9%/16.9%）、100mg阿布昔替尼（42.9%/38.9%）和安慰剂（75.5%/78.0%）维持治疗期间出现病情复发的比例相似。分别从200mg、100mg阿布昔替尼组和安慰剂组中，青少年湿疹面积和严重程度指数反应恢复率分别为28.6%、25.0%和52.9%，成年人分别为34.3%、33.7%和58.0%；研究者整体评估反应恢复率，青少年分别为42.9%、50.0%和73.5%，成年人分别为34.3%、50.6%和74.1%。无论年龄如何，阿布昔替尼的安全性概况相似；青少年恶心发生率较高。
青少年占试验人群的20%。
阿布昔替尼在预防青少年和成年人病情复发方面有效。Clinicaltrials.gov登记号：NCT03627767。
