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Abstract：
BACKGROUND: Lebrikizumab demonstrated significant improvement versus placebo for measures of skin clearance and patient-reported outcomes at weeks 16 and 52 in patients with moderate-to-severe atopic dermatitis (AD). We report the sustained impact of lebrikizumab monotherapy, over 52 weeks and between visits, on the frequency of itch and sleep loss symptoms, as assessed by Patient-Oriented Eczema Measure (POEM), in patients with moderate-to-severe AD.
METHODS: In ADvocate1 and ADvocate2, Week-16 lebrikizumab responders (EASI75 or IGA 0/1 with ≥ 2-point improvement and without rescue medication) were randomized to lebrikizumab every 2 weeks (Q2W), every 4 weeks (Q4W), or placebo for 36 weeks. This pooled analysis reports improvement from Week 16 to 52 in patients achieving POEM response 0 (no days) or 1 (1-2 days) for Items 1 (itch) and 2 (sleep disturbance) for the lebrikizumab Q2W and Q4W treatment arms. Observed (excluding data collected after treatment discontinuation, rescue medication use, or patient transfer to escape arm) results were reported.
RESULTS: At Week 16, for lebrikizumab Q2W and Q4W, 35.9% (n = 37/103) and 39.3% (n = 42/107) of patients responded 0 or 1 to Item 1 of POEM (Itch) and 12.6% (n = 13/103) and 12.1% (n = 13/107) responded 0. A total of 66.0% (n = 68/103) and 72.6% (n = 77/106) of patients responded 0 or 1 to Item 2 of POEM (Sleep) and 37.9% (n = 39/103) and 44.3% (n = 47/106) responded 0, respectively. By Week 52, for lebrikizumab Q2W and Q4W, 44.6% (n = 29/65) and 48.0% (n = 36/75) responded 0 or 1 to Item 1 of POEM (Itch), and 21.5% (n = 14/65) and 18.7% (n = 14/75) of patients responded 0. A total of 83.1% (n = 54/65) and 78.4% (n = 58/74) responded 0 or 1 to Item 2 of POEM (Sleep), and 67.7% (n = 44/65) and 59.5% (n = 44/74) responded 0, respectively.
CONCLUSIONS: Weekly POEM responses for itch and sleep disturbance remained stable between doses and visits, and continued to improve from Week 16 through 52, in lebrikizumab-treated patients, demonstrating consistent improvement over time for key AD symptoms.
BACKGROUND: ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967).
METHODS: In ADvocate1 and ADvocate2, Week-16 lebrikizumab responders (EASI75 or IGA 0/1 with ≥ 2-point improvement and without rescue medication) were randomized to lebrikizumab every 2 weeks (Q2W), every 4 weeks (Q4W), or placebo for 36 weeks. This pooled analysis reports improvement from Week 16 to 52 in patients achieving POEM response 0 (no days) or 1 (1-2 days) for Items 1 (itch) and 2 (sleep disturbance) for the lebrikizumab Q2W and Q4W treatment arms. Observed (excluding data collected after treatment discontinuation, rescue medication use, or patient transfer to escape arm) results were reported.
RESULTS: At Week 16, for lebrikizumab Q2W and Q4W, 35.9% (n = 37/103) and 39.3% (n = 42/107) of patients responded 0 or 1 to Item 1 of POEM (Itch) and 12.6% (n = 13/103) and 12.1% (n = 13/107) responded 0. A total of 66.0% (n = 68/103) and 72.6% (n = 77/106) of patients responded 0 or 1 to Item 2 of POEM (Sleep) and 37.9% (n = 39/103) and 44.3% (n = 47/106) responded 0, respectively. By Week 52, for lebrikizumab Q2W and Q4W, 44.6% (n = 29/65) and 48.0% (n = 36/75) responded 0 or 1 to Item 1 of POEM (Itch), and 21.5% (n = 14/65) and 18.7% (n = 14/75) of patients responded 0. A total of 83.1% (n = 54/65) and 78.4% (n = 58/74) responded 0 or 1 to Item 2 of POEM (Sleep), and 67.7% (n = 44/65) and 59.5% (n = 44/74) responded 0, respectively.
CONCLUSIONS: Weekly POEM responses for itch and sleep disturbance remained stable between doses and visits, and continued to improve from Week 16 through 52, in lebrikizumab-treated patients, demonstrating consistent improvement over time for key AD symptoms.
BACKGROUND: ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967).
摘要：
背景：Lebrikizumab在16周和52周时在中度至重度特应性皮炎（AD）患者的皮肤清除率和患者报告结局方面与安慰剂相比显着改善。我们报告了lebrikizumab单药治疗的持续影响，在52周和两次访问之间，关于瘙痒和睡眠不足症状的频率，通过以患者为导向的湿疹测量(POEM)评估，在中度至重度AD患者中。
方法：在ADvocate1和ADvocate2中，第16周的lebrikizumab应答者（EASI75或IGA0/1，改善≥2点，无抢救药物）每2周（Q2W）随机分配给lebrikizumab，每4周（Q4W），或安慰剂36周。该汇总分析报告了lebrikizumabQ2W和Q4W治疗组的项目1(瘙痒)和2(睡眠障碍)实现POEM反应0(无天)或1(1-2天)的患者从第16周改善至第52周。观察到（不包括治疗停止后收集的数据，抢救药物的使用，或患者转移到逃生臂)报告结果。
结果：在第16周，对于lebrikizumabQ2W和Q4W，35.9%(n=37/103)和39.3%(n=42/107)的患者对POEM(Itch)项目1有0或1应答，12.6%(n=13/103)和12.1%(n=13/107)有0应答。共有66.0%(n=68/103)和72.6%(n=77/106)的患者对POEM(睡眠)项目2有0或1应答,37.9%(n=39/103)和44.3%(n=47/106)分别有0应答。到第52周，对于lebrikizumabQ2W和Q4W，44.6％（n=29/65）和48.0％（n=36/75）对POEM（Itch）的第1项做出0或1反应，21.5%(n=14/65)和18.7%(n=14/75)的患者应答0。共有83.1%(n=54/65)和78.4%(n=58/74)对POEM(睡眠)项目2做出0或1的反应，67.7%(n=44/65)和59.5%(n=44/74)的反应分别为0。
结论：每周POEM对瘙痒和睡眠障碍的反应在剂量和就诊之间保持稳定，从第16周到第52周，在接受lebrikizumab治疗的患者中继续改善，证明随着时间的推移，关键AD症状持续改善。
背景：ADvocate1（NCT04146363）和ADvocate2（NCT04178967）。
方法：在ADvocate1和ADvocate2中，第16周的lebrikizumab应答者（EASI75或IGA0/1，改善≥2点，无抢救药物）每2周（Q2W）随机分配给lebrikizumab，每4周（Q4W），或安慰剂36周。该汇总分析报告了lebrikizumabQ2W和Q4W治疗组的项目1(瘙痒)和2(睡眠障碍)实现POEM反应0(无天)或1(1-2天)的患者从第16周改善至第52周。观察到（不包括治疗停止后收集的数据，抢救药物的使用，或患者转移到逃生臂)报告结果。
结果：在第16周，对于lebrikizumabQ2W和Q4W，35.9%(n=37/103)和39.3%(n=42/107)的患者对POEM(Itch)项目1有0或1应答，12.6%(n=13/103)和12.1%(n=13/107)有0应答。共有66.0%(n=68/103)和72.6%(n=77/106)的患者对POEM(睡眠)项目2有0或1应答,37.9%(n=39/103)和44.3%(n=47/106)分别有0应答。到第52周，对于lebrikizumabQ2W和Q4W，44.6％（n=29/65）和48.0％（n=36/75）对POEM（Itch）的第1项做出0或1反应，21.5%(n=14/65)和18.7%(n=14/75)的患者应答0。共有83.1%(n=54/65)和78.4%(n=58/74)对POEM(睡眠)项目2做出0或1的反应，67.7%(n=44/65)和59.5%(n=44/74)的反应分别为0。
结论：每周POEM对瘙痒和睡眠障碍的反应在剂量和就诊之间保持稳定，从第16周到第52周，在接受lebrikizumab治疗的患者中继续改善，证明随着时间的推移，关键AD症状持续改善。
背景：ADvocate1（NCT04146363）和ADvocate2（NCT04178967）。
