Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study,Pediatric Drugs

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Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
Pediatric Drugs ( IF 3.4 ) Pub Date : 2022-08-27 , DOI: 10.1007/s40272-022-00531-0
Maddalena Napolitano ₁ , Gabriella Fabbrocini ₂ , Iria Neri ₃ , Luca Stingeni ₄ , Valeria Boccaletti ₅ , Vincenzo Piccolo ₆ , Giuseppe Fabrizio Amoruso ₇ , Giovanna Malara ₈ , Rocco De Pasquale ₉ , Eugenia Veronica Di Brizzi ₆ , Laura Diluvio ₁₀ , Luca Bianchi ₁₀ , Andrea Chiricozzi _{11,

12} , Adriana Di Guida ₂ , Elisabetta Del Duca ₁₃ , Viviana Moschese ₁₃ , Vito Di Lernia ₁₄ , Federica Dragoni ₁₅ , Michaela Gruber ₁₆ , Katharina Hansel ₄ , Amelia Licari ₁₇ , Sara Manti ₁₈ , Salvatore Leonardi ₁₈ , Luca Mastorino ₁₉ , Michela Ortoncelli ₁₉ , Eugenio Provenzano ₇ , Antonino Palermo ₂₀ , Vincenzo Patella ₂₁ , Tiziana Peduto ₂₁ , Elena Pezzolo ₂₂ , Viviana Piras ₂₃ , Luca Potestio ₂ , Teresa Battista ₂ , Rosanna Satta ₂₄ , Stefania Termine ₂₅ , Paolo Palma ₂₆ , Paola Zangari ₂₆ , Cataldo Patruno ₂₇

Affiliation

Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, Italy.
Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Division of Dermatology, IRCCS di Policlinico S Orsola, University of Bologna, Bologna, Italy.
Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
Section of Dermatology, Department of Medicine, University of Brescia, Brescia, Italy.
Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.
UOC Dermatologia, AO Cosenza, Cosenza, Italy.
Struttura Complessa di Dermatologia, Grande Ospedale Metropolitano "Bianchi Melacrino Morelli", Reggio Calabria, Italy.
U.O. Dermatologia, Ospedale San Marco, 95123, Catania, Italy.
Dermatology Unit, Policlinico Tor Vergata, System Medicine Department, University of Tor Vergata, Rome, Italy.
UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy.
Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
Pediatric Immunopathology and Allergology Unit, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, Rome, Italy.
Dermatology Unit, Arcispedale S. Maria Nuova IRCCS, Reggio Emilia, Italy.
UOC Dermatologia Ospedale San Donato, Arezzo, Italy.
Department of Pediatrics, Central Hospital of Bolzano, Bolzano, Italy.
Pediatric Unit, Fondazione IRCCS Policlinico San Matteo, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
Pediatric Respiratory Unit, Department of Clinical and Experimental Medicine, San Marco Hospital, University of Catania, Catania, Italy.
Dermatology Clinic, Department of Clinical, Sciences, University of Turin, Turin, Italy.
Department of Pediatrics, Garibaldi Hospital, Catania, Italy.
Division of Allergy and Clinical Immunology, Department of Medicine, "Santa Maria della Speranza" Hospital, 84091, Battipaglia, Italy.
Dermatology Unit, Ospedale San Bortolo, Vicenza, Italy.
Dermatological Clinic, Department of Medical Science and Public Health, AOU Cagliari, Cagliari, Italy.
Dipartimento Scienze Mediche, Chirurgiche e Sperimentali, Università di Sassari, Sassari, Italy.
Division of Dermatology, Santa Chiara Hospital, Trento, Italy.
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.

Background

The management of paediatric atopic dermatitis (AD) is challenging, mostly relying on emollients and topical corticosteroids. Dupilumab, a fully human monoclonal antibody, has been recently approved for the treatment of children aged 6–11 years with moderate-to-severe AD not adequately controlled with topical therapies or when those therapies are not advisable.

Objectives

The aim of this study was to evaluate in real life the effectiveness and safety of dupilumab in the treatment of children aged from 6 to 11 years.

Methods

Demographic and clinical data of children aged 6–11 years, affected by moderate-to-severe AD and treated with dupilumab, were retrospectively collected from 24 dermatological and paediatric referral centres. Dupilumab was administered subcutaneously at an induction dose of 300 mg on day (D) 1, followed by 300 mg on D15 and 300 mg every 4 weeks. Disease severity was assessed at baseline and after week 2 (W2), W4 and W16 of dupilumab therapy using Eczema Area Severity Index (EASI), Pruritus Numerical Rating Scale (P-NRS) and Sleep NRS (S-NRS) and Children’s Dermatology Life Quality Index (c-DLQI) score.

Results

A total of 55 AD children (24 males [43.64%], 31 females [56.36%]; mean age 9.35 ± 1.75 years) were included. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to W16 of treatment with dupilumab. In particular, at W16 the proportion of patients achieving EASI75 was 74.54%. Moreover, at the same timepoint a significant mean percentage reduction for P-NRS, S-NRS and c-DLQI was also observed (68.39%, 70.22% and 79.03%, respectively).

Conclusions

Our real-life data seem to confirm the effectiveness of dupilumab in paediatric patients on all disease aspects, including extent and severity of signs, intensity of symptoms, sleep and QoL, with a good safety profile.

中文翻译：

Dupilumab 治疗 6-11 岁特应性皮炎儿童：一项多中心、真实的研究

背景

小儿特应性皮炎 (AD) 的管理具有挑战性，主要依赖于润肤剂和外用皮质类固醇。Dupilumab 是一种全人源单克隆抗体，最近被批准用于治疗 6-11 岁的中度至重度 AD 且局部治疗无法充分控制或不建议使用这些治疗的儿童。

目标

本研究的目的是在现实生活中评估 dupilumab 治疗 6 至 11 岁儿童的有效性和安全性。

方法

从 24 个皮肤病学和儿科转诊中心回顾性收集了 6-11 岁受中度至重度 AD 影响并接受 dupilumab 治疗的儿童的人口统计学和临床数据。Dupilumab 在第 (D) 1 天以 300 mg 的诱导剂量皮下给药，随后在 D15 给药 300 mg，每 4 周给药 300 mg。使用湿疹区域严重程度指数 (EASI)、瘙痒数字评定量表 (P-NRS) 和睡眠 NRS (S-NRS) 和儿童皮肤病学生活在基线和第 2 周 (W2)、dupilumab 治疗后第 4 周和第 16 周评估疾病严重程度质量指数 (c-DLQI) 评分。

结果

共纳入 55 名 AD 儿童（24 名男性 [43.64%]，31 名女性 [56.36%]；平均年龄 9.35 ± 1.75 岁）。从基线到使用 dupilumab 治疗的第 16 周，观察到 EASI 评分、P-NRS、S-NRS 和 c-DLQI 有显着改善。特别是在第 16 周，达到 EASI75 的患者比例为 74.54%。此外，在同一时间点，还观察到 P-NRS、S-NRS 和 c-DLQI 的平均百分比显着降低（分别为 68.39%、70.22% 和 79.03%）。