Durable improvements in atopic dermatitis in the head and neck and across other anatomic regions with rocatinlimab

IF 1.8 4区 医学 Q3 DERMATOLOGY Archives of Dermatological Research Pub Date : 2024-11-06 DOI:10.1007/s00403-024-03426-x
Emma Guttman-Yassky, Ehsanollah Esfandiari, Hirotaka Mano, Takahiro Arai, Alan D. Irvine, Michael J. Cork, Kenji Kabashima, Camilla Chong, Eric Simpson
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Abstract

In a randomized phase 2b trial (NCT03703102) for adult patients with moderate-to-severe atopic dermatitis (AD), treatment with the T cell rebalancing anti-OX40 receptor antibody rocatinlimab (AMG 451/KHK4083) led to significant improvements in clinical measurements versus placebo including whole-body Eczema Area and Severity Index (EASI) score. AD manifestations can impact variable anatomic regions, and involvement of the head and neck, a sensitive, hard-to-treat area, can negatively impact quality of life. In this post hoc analysis, we investigated response to rocatinlimab treatment across anatomic regions, including the head and neck. Least squares mean change from baseline to Week 56 in EASI score was analyzed by anatomic region (head and neck, trunk, upper extremities, or lower extremities) for patients with baseline moderate-to-severe AD in the respective anatomic region, using mixed models for repeated measures. Rocatinlimab groups were compared with placebo at Week 16. The proportion of patients achieving at least 75% reduction from baseline in EASI (EASI-75) was calculated. Probability of relapsing in EASI-75 during the off-treatment follow-up period (Weeks 36–56) was estimated using a Kaplan − Meier approach. At Week 16, decrease from baseline in mean EASI score was greater with all rocatinlimab regimens versus placebo across all anatomic regions for patients with baseline moderate-to-severe AD in the respective region (all P < 0.001). EASI scores continued to improve on treatment after Week 16 and were maintained during the off-treatment period across all regions. Among patients with baseline moderate-to-severe AD in the head and neck (n = 219; rocatinlimab, n = 174; placebo, n = 45), mean difference (rocatinlimab vs placebo) at Week 16 in LS mean percent change in head and neck EASI score ranged from − 30.4% to − 42.6% across treatment regimens. In patients who received rocatinlimab from the start of the trial, 47% − 71% achieved EASI-75 in the head and neck at Week 36. Among EASI-75 responders at Week 36, the probability of relapsing in EASI-75 in any region was low (< 25% in the head and neck) 20 weeks after treatment discontinuation until Week 56.

Rocatinlimab treatment led to durable improvements in AD across multiple anatomic regions, including the sensitive head and neck region.

Graphical abstract

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使用罗卡替尼(rocatinlimab)可持久改善头颈部和其他解剖区域的特应性皮炎。
在一项针对中度至重度特应性皮炎(AD)成年患者的随机 2b 期试验(NCT03703102)中,使用 T 细胞再平衡抗 OX40 受体抗体 rocatinlimab(AMG 451/KHK4083)治疗后,患者的临床指标(包括全身湿疹面积和严重程度指数 (EASI) 评分)与安慰剂相比有了显著改善。AD表现可影响不同的解剖区域,而头颈部是一个敏感而难以治疗的区域,其受累可对生活质量产生负面影响。在这项事后分析中,我们研究了包括头颈部在内的不同解剖区域对罗卡替尼治疗的反应。采用重复测量混合模型,按解剖区域(头颈部、躯干、上肢或下肢)分析了基线中度至重度AD患者从基线到第56周EASI评分的最小二乘法平均变化。第 16 周时,将 Rocatinlimab 组与安慰剂组进行比较。计算EASI(EASI-75)较基线下降至少75%的患者比例。在非治疗随访期间(第36-56周),采用卡普兰-麦尔法估算EASI-75复发的概率。第16周时,对于基线为中度至重度AD的患者,在所有解剖区域,所有罗卡单抗方案与安慰剂相比,EASI平均得分从基线下降的幅度更大(所有P<0.05)。
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来源期刊
CiteScore
4.10
自引率
3.30%
发文量
30
审稿时长
4-8 weeks
期刊介绍: Archives of Dermatological Research is a highly rated international journal that publishes original contributions in the field of experimental dermatology, including papers on biochemistry, morphology and immunology of the skin. The journal is among the few not related to dermatological associations or belonging to respective societies which guarantees complete independence. This English-language journal also offers a platform for review articles in areas of interest for dermatologists and for publication of innovative clinical trials.
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