期待小分子藥物根治異位性皮膚炎?研究顯示,銳虎無法停,一停藥就會迅速復發
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本篇研究,“Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial”,請見這裡(外部網站),期刊摘要如下:
Background:
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritic eczematous lesions. The effect of treatment withdrawal after response to upadacitinib oral treatment is not fully characterized.
Objectives:
Assess the effect of upadacitinib withdrawal on skin clearance and itch improvement in adult patients with moderate-to-severe AD and evaluate the kinetics of recovery on rescue treatment.
Methods:
Data from a phase 2b randomized, placebo-controlled trial (NCT02925117)of upadacitinib in patients with moderate-to-severe AD were analysed.
Patients were randomized 1:1:1:1 to receive upadacitinib 7.5 mg, 15 mg, 30 mg or placebo, and then at Week 16, patients were re-randomized 1:1 to receive the same dose of upadacitinib(upadacitinib 30 mg for patients initialized to placebo) or placebo.
From Week 20,those who experienced loss of response defined as Eczema Area and Severity Index<50% improvement from baseline (EASI 50) received rescue treatment with upadacitinib 30 mg.
Results:
Patients who withdrew from upadacitinib experienced a rapid loss of skin clearance response, while those who switched from placebo to upadacitinib gained response.
Loss of skin clearance response occurred within 4 weeks and worsening of itch occurred within 5 days.
In patients who originally received placebo or a lower dose of upadacitinib leading to a loss of EASI response, rescue treatment with upa-dacitinib 30 mg resulted in rapid recovery or improvement of both skin and itch responses; most patients who were re-randomized to placebo achieved EASI 75 andIGA 0/1 by 8 weeks of rescue treatment.
No new safety risks were observed.
Conclusions:
Continuous treatment with upadacitinib is suggested to maintain skin clearance and antipruritic effects.
原始論文
Guttman-Yassky E, Silverberg JI, Thaçi D, Papp KA, et al. Journal of the European Academy of Dermatology and Venereology. 2023;37(12):2558-2568. doi:10.1111/jdv.19391
論文摘要(Google 翻譯)
以下為 Google 翻譯,並校正明顯錯誤,僅供參考,內容以英文原文為準。
中重度異位性皮膚炎患者停用與重新使用 upadacitinib:第 2b 期隨機對照試驗結果
背景:異位性皮膚炎(AD)是一種以搔癢性濕疹樣皮損為特徵的慢性發炎性皮膚病。口服 upadacitinib 治療有反應後停藥的影響,尚未完全釐清。
目的:評估停用 upadacitinib 對中重度 AD 成年患者皮膚清除與搔癢改善的影響,並評估接受救援治療後的恢復速度。
方法:分析 upadacitinib 用於中重度 AD 患者之第 2b 期隨機、安慰劑對照試驗(NCT02925117)的資料。
患者以 1:1:1:1 隨機分配接受 upadacitinib 7.5 mg、15 mg、30 mg 或安慰劑;第 16 週時再以 1:1 重新隨機分配,接受相同劑量的 upadacitinib(起始為安慰劑者改用 upadacitinib 30 mg)或安慰劑。
自第 20 週起,失去反應(定義為濕疹面積與嚴重度指數較基線改善未達 50%,即未達 EASI 50)者,接受 upadacitinib 30 mg 救援治療。
結果:停用 upadacitinib 的患者迅速失去皮膚清除反應,而由安慰劑改用 upadacitinib 的患者則獲得反應。
皮膚清除反應在 4 週內喪失,搔癢則在 5 天內惡化。
在原本接受安慰劑或較低劑量 upadacitinib 而失去 EASI 反應的患者中,以 upadacitinib 30 mg 救援治療可使皮膚與搔癢反應迅速恢復或改善;大多數重新隨機分配至安慰劑的患者,在救援治療 8 週內達到 EASI 75 與 IGA 0/1。
未觀察到新的安全風險。
結論:建議持續使用 upadacitinib 治療,以維持皮膚清除與止癢效果。
「口服小分子標靶藥物近年來逐漸成為治療的重要選擇,其能快速抑制體內過度活化的免疫反應,減少皮膚紅腫發炎與劇烈搔癢,讓患者在短時間內明顯感受到改善。
但由於藥效消退得也比較快,一旦停藥,復發的速度可能比傳統藥物停藥後的復發更快。」
銳虎治療後的中醫經方治療實例,請見這裡。
停中藥後的患者現況追蹤,請見
這裡。
異位性皮膚炎,中醫經方的治療實例,請見這裡。
小兒異位性皮膚炎,中醫經方的治療實例,請見這裡。
成人異位性皮膚炎,中醫經方的治療實例,請見這裡。
異位性皮膚炎,期刊研究,請看這裡。
期刊研究整理,請見這裡。
原文發表於 作者部落格(舊部落格)。