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.
Dermatol Ther. 2022 Aug;35(8):e15588. doi: 10.1111/dth.15588. Epub 2022 May 22.
Dupilumab is a monoclonal antibody approved for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged ≥12 years. Large, double-blind, randomized, placebo-controlled trials showed its efficacy and safety in adolescents. However, real-life data are few. The aim of this monocentric retrospective observational study (December 2020-November 2021) was to assess the effectiveness and safety of dupilumab in AD adolescents treated for at least 24 weeks. For each patient demographic features, clinical data and adverse events (AEs) were collected. Eczema Area and Severity Index (EASI), Numerical Rating Scale (NRS) for pruritus (P-NRS) and for sleep disturbances (S-NRS), and Children Dermatology Life Quality Index (cDLQI) were assessed at baseline, week (W)4, W16, and W24. Twenty-seven patients (18 males; 15.23 ± 3.54 years) were enrolled. Dupilumab was administered subcutaneously at dosage of 600 mg induction dose, followed by 300 mg every 2 weeks in 14 (51.85%) patients with a weight ≥60 kg, while 13 (48.15%) patients with a weight <60 kg were treated with dupilumab 200 mg every 2 weeks after a loading dose of 400 mg. The mean EASI score at baseline was 26.96 ± 4.93 and significantly reduced to 3.74 ± 3.47 at W16 (<0.001), and to 3.4 ± 5.04 at W24 (p < 0.001). P-NRS (9.14 ± 0.94 at baseline vs. 2.33 ± 4.93 at W16 [p < 0.001], and 1.45 ± 2.35 at W24 [p < 0.001]), S-NRS (7.88 ± 1.64 at baseline vs. 0.92 ± 1.35 at W16 [p < 0.001], and 1.66 ± 2.84 at W24 [p < 0.0001]) and cDLQI (26.62 ± 4.45 vs. 2.18 ± 3.51 at baseline vs. 2.18 ± 3.51 at W16 [p < 0.001], and 3.4 ± 5.02 at W24 [p < 0.001]) showed a statistically significative improvement as well. Injection-site reaction (5/27; 18.52%), conjunctivitis (2/27; 7.41%), and asthenia (2/27; 7.41%) were the main AEs collected. This study seems to confirm the efficacy and safety of dupilumab in adolescents with moderate-to-severe AD also in real-life setting.
度普利尤单抗是一种单克隆抗体，已获批用于治疗 12 岁及以上中重度特应性皮炎（AD）患者。大型、双盲、随机、安慰剂对照试验显示了其在青少年中的疗效和安全性。然而，真实世界的数据很少。本单中心回顾性观察研究（2020 年 12 月至 2021 年 11 月）旨在评估至少接受 24 周治疗的 AD 青少年患者使用度普利尤单抗的有效性和安全性。每位患者均收集人口统计学特征、临床数据和不良反应（AE）。在基线、第 4 周（W4）、第 16 周（W16）和第 24 周（W24）评估湿疹面积和严重程度指数（EASI）、瘙痒数字评分量表（P-NRS）、睡眠障碍数字评分量表（S-NRS）和儿童皮肤病生活质量指数（cDLQI）。共纳入 27 例患者（18 名男性；15.23±3.54 岁）。14 名（51.85%）体重≥60kg 的患者接受了 600mg 诱导剂量的皮下注射，随后每 2 周给予 300mg；而 13 名（48.15%）体重<60kg 的患者在给予 400mg 负荷剂量后，每 2 周给予 200mg 度普利尤单抗。基线时 EASI 评分均值为 26.96±4.93，在 W16 时显著降低至 3.74±3.47（<0.001），在 W24 时进一步降低至 3.4±5.04（p<0.001）。P-NRS（基线时 9.14±0.94 与 W16 时 2.33±4.93[ p<0.001]，W24 时 1.45±2.35[p<0.001]）、S-NRS（基线时 7.88±1.64 与 W16 时 0.92±1.35[ p<0.001]，W24 时 1.66±2.84[p<0.0001]）和 cDLQI（基线时 26.62±4.45 与 W16 时 2.18±3.51[ p<0.001]，W16 时 2.18±3.51[ p<0.001]，W24 时 3.4±5.02[p<0.001]）均显示出统计学显著改善。收集到的主要 AE 包括注射部位反应（27 例中有 5 例；18.52%）、结膜炎（27 例中有 2 例；7.41%）和乏力（27 例中有 2 例；7.41%）。本研究似乎证实了度普利尤单抗在真实世界环境中对中重度 AD 青少年的疗效和安全性。
