Therapeutic Modulation of Dupilumab in Patients with Severe Atopic Dermatitis®: Clinical Effectiveness in Real Life.

Luca Mastorino, Richard Borrelli, Nicole Macagno, Federica Gelato, Erica Baima, Irene Richiardi, Giovanni Cavaliere, Pietro Quaglino, Michela Ortoncelli, Simone Ribero
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Abstract

Background: De-escalation strategies have become increasingly used in the treatment of atopic Dermatitis® (AD) patients with dupilumab. Dose spacing (DS) refers to dose reduction by dosage elongation strategies from 2 to 8 weeks between dupilumab injections, in patients with stable response to treatment or affected by numerous adverse events. Objectives: Investigate safety and clinical effectiveness of DS strategy in AD patients treated with dupilumab. Methods: A retrospective cohort study was conducted on AD patients aged ≥18 years treated with dupilumab undergoing DS. Pre-post analyses were conducted on this cohort, termed cohort A, between effectiveness outcomes at baseline, at 16 weeks of treatment, at the index date identified as the mean follow-up time between dupilumab initiation and DS, and at subsequent two follow-up visits: T1 and T2. Based on the index date, a cohort B of AD patients on dupilumab treatment not experiencing DS was then compared with cohort A for the same outcomes at the same time points. Results: Seventy-three out of 452 patients treated with dupilumab underwent DS. The mean time since treatment initiation was 28.6 months. Mean Eczema Area Severity Index (EASI) from the index date remained stable until the second follow-up visit (T2) 0.2-0.8 with no significant pre-post differences (P > 0.05). Similar considerations can be made for mean number rating scale worst pruritus (NRSp), numerical rating scale disturbs of sleeping/sleeping disturb (NRSsd), mean Dermatology Life Quality Index (DLQI), and EASI Head and Neck. Attainment of relative outcomes remained stable for EASI75, 90, ≤ 7, DLQI ≤ 5, and NRSp ≤ 4. When compared with cohort B, no clinically significant differences were observed in mean reductions in all outcomes analyzed. Conclusions: DS in our study appears to be an effective and safe strategy in treating patients with severe AD after the initial therapeutic response.

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杜匹单抗对严重特应性皮炎患者的治疗调节:现实生活中的临床疗效
背景:在使用杜度单抗治疗特应性皮炎(AD)患者的过程中,减量策略的应用越来越广泛。剂量间隔(DS)是指在治疗反应稳定或受多种不良反应影响的患者中,通过剂量延长策略减少剂量,两次杜比单抗注射之间的间隔时间为 2 至 8 周。研究目的研究DS策略在接受杜比单抗治疗的AD患者中的安全性和临床有效性。方法:回顾性队列研究对接受杜比单抗治疗的年龄≥18岁的AD患者进行回顾性队列研究。对该队列(称为队列 A)在基线、治疗 16 周时、作为开始使用杜比单抗与 DS 之间平均随访时间的指数日期以及随后两次随访的有效性结果进行了前后分析:T1和T2。然后根据指数日期,将接受杜必鲁单抗治疗但未出现 DS 的 AD 患者队列 B 与队列 A 在相同时间点的相同结果进行比较。研究结果在接受杜比单抗治疗的 452 例患者中,有 73 例出现了 DS。开始治疗后的平均时间为 28.6 个月。湿疹面积严重指数(EASI)平均值从指数日开始一直稳定到第二次随访(T2)的0.2-0.8,前后无显著差异(P > 0.05)。最严重瘙痒评分量表(NRSp)、睡眠障碍评分量表(NRSsd)、皮肤科生活质量指数(DLQI)和头颈部 EASI 的平均值也有类似情况。EASI75、90、≤7、DLQI≤5和NRSp≤4的相对结果保持稳定。与队列 B 相比,所有分析结果的平均降低幅度均无临床显著差异。结论:在我们的研究中,DS似乎是一种治疗严重AD患者的有效且安全的策略。
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