一项关于度普利尤单抗治疗6至11岁特应性皮炎儿童有效性和安全性的52周多中心回顾性真实世界研究。
A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years.
作者信息
Patruno Cataldo, Fabbrocini Gabriella, Lauletta Giuseppe, Boccaletti Valeria, Colonna Cristiana, Cavalli Riccardo, Neri Iria, Ortoncelli Michela, Schena Donatella, Stingeni Luca, Hansel Katharina, Piccolo Vincenzo, Di Brizzi Veronica, Potenza Concetta, Tolino Ersilia, Bianchi Luca, Manti Sara, De Pasquale Rocco, Di Lernia Vito, Caminiti Lucia, Galli Elena, Coppo Paola, Chiricozzi Andrea, De Simone Clara, Guerriero Cristina, Amoruso Fabrizio Giuseppe, Provenzano Eugenio, Leonardi Salvatore, Licari Amelia, Marseglia Gian Luigi, Palermo Antonino, Di Pillo Sabrina, Russo Daniele, Moschese Viviana, Patella Vincenzo, Peduto Tiziana, Ferreli Caterina, Zangari Paola, Veronese Federica, Berti Samantha Federica, Gruber Michaela, Pezzolo Elena, Termine Stefania, Satta Rosanna, Dragoni Federica, Esposito Maria, Fargnoli Maria Concetta, Chiodini Paolo, Vallone Ylenia, di Vico Francesca, Picone Vincenzo, Napolitano Maddalena
机构信息
Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II, Naples, Italy.
出版信息
J Dermatolog Treat. 2023 Dec;34(1):2246602. doi: 10.1080/09546634.2023.2246602.
Dupilumab has been shown to be a safe and effective drug for the treatment of atopic dermatitis (AD) in children from 6 months to 11 years in randomized clinical trials. Aim: The aim of this real-life study was to determine the effectiveness in disease control and safety of dupilumab at W52 in moderate-to-severe AD children aged 6-11 years. All data were collected from 36 Italian dermatological or paediatric referral centres. Dupilumab was administered at label dosage with an induction dose of 300 mg on day 1 (D1), followed by 300 mg on D15 and 300 mg every 4 weeks (Q4W). Treatment effect was determined as overall disease severity, using EASI, P-NRS, S-NRS and c-DLQI at baseline, W16, W24, and W52. Ninety-six AD children diagnosed with moderate-to-severe AD and treated with dupilumab were enrolled. Ninety-one (94.8%) patients completed the 52-week treatment period and were included in the study. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to weeks 16, 24 and 52. Our real-life data seem to confirm dupilumab effectiveness and safety in paediatric patients. Moreover, our experience highlighted that patients achieving clinical improvement at W16 preserved this condition over time.
在随机临床试验中，度普利尤单抗已被证明是一种治疗6个月至11岁儿童特应性皮炎（AD）的安全有效药物。目的：本真实世界研究的目的是确定度普利尤单抗在6至11岁中度至重度AD儿童中第52周时疾病控制的有效性和安全性。所有数据均来自36个意大利皮肤科或儿科转诊中心。度普利尤单抗按标签剂量给药，第1天（D1）诱导剂量为300mg，随后在D15给予300mg，每4周（Q4W）给予300mg。在基线、第16周、第24周和第52周，使用EASI、P-NRS、S-NRS和c-DLQI将治疗效果确定为整体疾病严重程度。96名诊断为中度至重度AD并接受度普利尤单抗治疗的AD儿童入组。91名（94.8%）患者完成了52周的治疗期并纳入研究。从基线到第16周、第24周和第52周，观察到EASI评分、P-NRS、S-NRS和c-DLQI有显著改善。我们的真实世界数据似乎证实了度普利尤单抗在儿科患者中的有效性和安全性。此外，我们的经验强调，在第16周实现临床改善的患者随时间推移保持了这种状况。
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