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期刊研究整理文/黃于家醫師

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

JEADV 論文摘要:中重度異位性皮膚炎停用銳虎後的復發情形

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

Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial(外部網站)

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。

以下為台大皮膚科醫師之衛教報導(外部網站):

「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)。

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