Abstract：
BACKGROUND: Eblasakimab, an interleukin (IL)-13 receptor α1 antagonist, blocks IL-4 and IL-13 signaling through the type 2 receptor.
OBJECTIVE: The safety and efficacy of eblasakimab was evaluated in adults with moderate-to-severe atopic dermatitis (AD).
METHODS: In this phase 1b randomized, double-blinded study, 52 patients with moderate-to-severe AD received weekly subcutaneous injections of eblasakimab 200, 400, or 600 mg, or placebo for 8 weeks. Primary outcome was the incidence of treatment-emergent adverse events. Secondary outcomes included percentage change in the Eczema Area and Severity Index from baseline; Eczema Area and Severity Index improvement of at least 50%, 75%, or 90% from baseline; and percentage change in the peak-pruritus numeric rating scale score from baseline.
RESULTS: Treatment-emergent adverse events were reported in 47% placebo and 71% eblasakimab patients; most were considered mild or moderate and did not lead to study discontinuation. At week 8 eblasakimab 600 mg showed statistically significant improvement in mean percentage change in Eczema Area and Severity Index versus placebo (-65% vs -27%, P = .014). Other key secondary physician- and patient-reported end points were met.
CONCLUSIONS: Longer studies are required to confirm eblasakimab safety and efficacy in AD patients.
CONCLUSIONS: Treatment of adults with moderate-to-severe AD with eblasakimab was well-tolerated and associated with significant clinical improvements versus placebo.
OBJECTIVE: The safety and efficacy of eblasakimab was evaluated in adults with moderate-to-severe atopic dermatitis (AD).
METHODS: In this phase 1b randomized, double-blinded study, 52 patients with moderate-to-severe AD received weekly subcutaneous injections of eblasakimab 200, 400, or 600 mg, or placebo for 8 weeks. Primary outcome was the incidence of treatment-emergent adverse events. Secondary outcomes included percentage change in the Eczema Area and Severity Index from baseline; Eczema Area and Severity Index improvement of at least 50%, 75%, or 90% from baseline; and percentage change in the peak-pruritus numeric rating scale score from baseline.
RESULTS: Treatment-emergent adverse events were reported in 47% placebo and 71% eblasakimab patients; most were considered mild or moderate and did not lead to study discontinuation. At week 8 eblasakimab 600 mg showed statistically significant improvement in mean percentage change in Eczema Area and Severity Index versus placebo (-65% vs -27%, P = .014). Other key secondary physician- and patient-reported end points were met.
CONCLUSIONS: Longer studies are required to confirm eblasakimab safety and efficacy in AD patients.
CONCLUSIONS: Treatment of adults with moderate-to-severe AD with eblasakimab was well-tolerated and associated with significant clinical improvements versus placebo.
摘要：
背景：Eplasakimab，白细胞介素（IL）-13受体α1拮抗剂，阻断IL-4和IL-13通过2型受体的信号传导。
目的：在患有中度至重度特应性皮炎（AD）的成人中评估eblasakimab的安全性和有效性。
方法：在这个1b期随机，双盲研究，52例中度至重度AD患者每周皮下注射eblasakimab200、400或600mg，或安慰剂8周。主要结果是治疗引起的不良事件（TEAE）的发生率。次要结果包括湿疹面积和严重程度指数（EASI）相对于基线的百分比变化；EASI改善至少50％，75%,或基线的90％；以及峰值瘙痒数字评定量表评分相对于基线的百分比变化。
结果：在47%的安慰剂和71%的eblasakimab患者中报告了TEAE；大多数被认为是轻度或中度的，没有导致研究中止。在第8周，eblasakimab600mg显示EASI与EASI的平均百分比变化有统计学意义的显着改善。安慰剂(-65%vs.-27%，P=0.014)。符合其他关键次要医师和患者报告的终点。
结论：需要更长时间的研究来确认eblasakimab在AD患者中的安全性和有效性。
结论：用eblasakimab治疗成人中重度AD患者的耐受性良好，并且与显着的临床改善有关。安慰剂。
目的：在患有中度至重度特应性皮炎（AD）的成人中评估eblasakimab的安全性和有效性。
方法：在这个1b期随机，双盲研究，52例中度至重度AD患者每周皮下注射eblasakimab200、400或600mg，或安慰剂8周。主要结果是治疗引起的不良事件（TEAE）的发生率。次要结果包括湿疹面积和严重程度指数（EASI）相对于基线的百分比变化；EASI改善至少50％，75%,或基线的90％；以及峰值瘙痒数字评定量表评分相对于基线的百分比变化。
结果：在47%的安慰剂和71%的eblasakimab患者中报告了TEAE；大多数被认为是轻度或中度的，没有导致研究中止。在第8周，eblasakimab600mg显示EASI与EASI的平均百分比变化有统计学意义的显着改善。安慰剂(-65%vs.-27%，P=0.014)。符合其他关键次要医师和患者报告的终点。
结论：需要更长时间的研究来确认eblasakimab在AD患者中的安全性和有效性。
结论：用eblasakimab治疗成人中重度AD患者的耐受性良好，并且与显着的临床改善有关。安慰剂。
