使用乐必妥单抗治疗52周的特应性皮炎患者瘙痒和睡眠症状的稳定反应及持续改善
Stable Response and Sustained Improvement of Itch and Sleep Symptoms in Patients with Atopic Dermatitis Treated with Lebrikizumab over 52 Weeks.
作者信息
Yosipovitch Gil, Lio Peter, Legat Franz J, Chovatiya Raj, Deleuran Mette, Pierce Evangeline, Casillas Marta, Ding Yuxin, Yang Fan E, Bardolet Laia, Ständer Sonja
机构信息
University of Miami Miller School of Medicine, Miami, USA.
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
出版信息
Dermatol Ther (Heidelb). 2024 Aug;14(8):2171-2180. doi: 10.1007/s13555-024-01225-w. Epub 2024 Jul 13.
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.
CONCLUSION
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.
TRIAL REGISTRATION NUMBERS
ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967).
背景
对于中度至重度特应性皮炎（AD）患者，在第16周和第52周时，与安慰剂相比，瑞莎珠单抗在皮肤清除率指标和患者报告的结局方面显示出显著改善。我们报告了在中度至重度AD患者中，瑞莎珠单抗单药治疗52周期间及访视间隔期，根据患者导向性湿疹评估量表（POEM）评估，对瘙痒和睡眠障碍症状发生频率的持续影响。
方法
在ADvocate1和ADvocate2研究中，第16周时对瑞莎珠单抗有反应的患者（湿疹面积和严重程度指数改善75%或静态医师全面评估为0/1且改善≥2分且未使用急救药物）被随机分为每2周（Q2W）、每4周（Q4W）接受瑞莎珠单抗治疗或接受安慰剂治疗36周。这项汇总分析报告了瑞莎珠单抗Q2W和Q4W治疗组中，在第16周至52周期间，在POEM第1项（瘙痒）和第2项（睡眠障碍）上达到反应0（无天数）或1（1 - 2天）的患者的改善情况。报告的是观察到的结果（不包括治疗中断、使用急救药物或患者转至退出组后收集的数据）。
结果
在第16周时，对于瑞莎珠单抗Q2W和Q4W治疗组，分别有35.9%（n = 37/103）和39.3%（n = 42/107）的患者在POEM第1项（瘙痒）上反应为0或1，分别有12.6%（n = 13/103）和12.1%（n = 13/107）的患者反应为0。对于POEM第2项（睡眠），分别有66.0%（n = 68/103）和72.6%（n = 77/106）的患者反应为0或1，分别有37.9%（n = 39/103）和44.3%（n = 47/106）的患者反应为0。到第52周时,对于瑞莎珠单抗Q2W和Q4W治疗组，分别有44.6%（n = 29/65）和48.0%（n = 36/75）的患者在POEM第1项（瘙痒）上反应为0或1，分别有21.5%（n = 14/65）和18.7%（n = 14/75）的患者反应为0。对于POEM第2项（睡眠），分别有83.1%（n = 54/65）和78.4%（n = 58/74）的患者反应为0或1，分别有67.7%（n = 44/65）和59.5%（n = 44/74）的患者反应为0。
结论
在接受瑞莎珠单抗治疗的患者中，瘙痒和睡眠障碍的每周POEM反应在不同剂量和访视期间保持稳定，并且从第16周持续改善至第52周，表明关键AD症状随时间持续改善。
试验注册号
ADvocate1（NCT04146363）和ADvocate2（NCT04178967）。
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