Long-term Persistence, Safety and Efficacy Profile of Dupilumab in Atopic Dermatitis: A Real-world Retrospective Multicenter Study From Spain

IF 2.9 Q1 DERMATOLOGY

Actas dermo-sifiliograficas Pub Date : 2026-04-01 Epub Date: 2025-12-13 DOI:10.1016/j.ad.2025.104563

J.F. Silvestre-Salvador , S. Santos-Alarcón , A. Mengual-Sendra , V. Zaragoza-Ninet , M.P. Ortega-García , M. Rodriguez , E. Monte-Boquet , R.F. Ruiz de Apodaca , N. Pérez Prior , F.J. Miquel-Miquel , J. Borras-Blasco

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Abstract

Background

The safety and efficacy profile of dupilumab in the management of atopic dermatitis (AD) are established in clinical trials. However, long-term real-world persistence data in Spain are limited.

Objective

The primary endpoint of the study was to assess the 4-year persistence of dupilumab in routine clinical practice in patients with moderate-to-severe AD. Secondary endpoints included the analysis of safety and efficacy profile during the same period of time.

Methods

We conducted a retrospective cohort study of dispensation registries and health records from 5 hospitals. Adults with moderate-to-severe AD starting on dupilumab treatment were followed for 4-years. Dupilumab persistence was estimated using Kaplan–Meier analysis. Efficacy was measured by changes in EASI and IGA scores. Significant adverse events (AEs) leading to discontinuation were recorded.

Results

A total of 251 patients included (mean age, 46 years; 59.4%, men; 64.5% with at least 1 atopic comorbidity; mean time from AD diagnosis, 14.5 years). Of these, 196 (78.1%) had been on ≥2 systemic therapies before starting dupilumab. Baseline EASI and IGA values averaged 27.9 and 4.0, respectively. Persistence rates were 90%, 80%, 78%, and 73% after 1, 2, 3, and 4-years, respectively. By 16 weeks, 47.8% and 54.7% of patients achieved EASI ≤3 or IGA ≤1, increasing to 76.3% and 77.2% by 52 weeks, and reaching 90.9% in the group followed for >3 years. A total of 38 patients (13.5%) discontinued dupilumab, mainly due to inefficacy (5.6%) and AEs (1.2%).

Conclusion

Dupilumab effectively reduced AD severity within the first few weeks, with most patients achieving mild/minimal disease activity or complete clearance by year 1. The observed safety profile was consistent with known data. High persistence rates up to 4-years suggest satisfaction with dupilumab long-term safety and efficacy profile in managing moderate-to-severe AD.

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杜匹单抗治疗特应性皮炎的长期持久性、安全性和有效性：一项来自西班牙的真实世界回顾性多中心研究

背景：杜匹单抗治疗特应性皮炎（AD）的安全性和有效性已经在临床试验中得到证实。然而，西班牙的长期实际持久性数据是有限的。目的：该研究的主要终点是评估dupilumab在中重度AD患者常规临床实践中的4年持续性。次要终点包括同一时期的安全性和有效性分析。方法：我们对5家医院的配药登记和健康记录进行了回顾性队列研究。接受dupilumab治疗的中度至重度AD成人患者随访4年。使用Kaplan-Meier分析估计Dupilumab的持久性。通过EASI和IGA评分的变化来衡量疗效。记录导致停药的重大不良事件（ae）。结果：共纳入251例患者（平均年龄46岁；男性占59.4%；64.5%至少有1种特应性合并症；从AD诊断到平均时间为14.5年）。其中，196例（78.1%）患者在开始dupilumab治疗前接受过2次以上的全身治疗。基线EASI和IGA值平均分别为27.9和4.0。1年、2年、3年和4年后的持续率分别为90%、80%、78%和73%。16周时，EASI≤3或IGA≤1的患者比例分别为47.8%和54.7%，52周时分别为76.3%和77.2%，随访3年组达到90.9%。共有38名患者（13.5%）停药，主要是由于无效（5.6%）和不良事件（1.2%）。结论：Dupilumab在最初几周内有效降低了AD的严重程度，大多数患者在第1年达到轻度/最小疾病活动或完全清除。观察到的安全性与已知数据一致。长达4年的高持续率表明dupilumab在治疗中重度AD方面的长期安全性和有效性令人满意。

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来源期刊

Actas dermo-sifiliograficas DERMATOLOGY-

CiteScore

1.90

自引率

9.40%

发文量

473

审稿时长

56 weeks

期刊介绍： Actas Dermo-Sifiliográficas, publicación Oficial de la Academia Española de Dermatología y Venereología, es una revista de prestigio consolidado. Creada en 1909, es la revista mensual más antigua editada en España.En 2006 entró en Medline, y hoy resulta imprescindible para estar al día sobre la dermatología española y mundial.