
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,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.
Continuous treatment with upadacitinib is suggested to maintain skin clearance and antipruritic effects.
Conclusions:
Continuous treatment with upadacitinib is suggested to maintain skin clearance and antipruritic effects.
