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18岁以下银屑病患者的生物制剂:来自中国银屑病真实世界证据研究组的真实世界证据

Biologics for psoriasis patients under 18 years of age: Real-world evidence from the Chinese psoriasis real world evidence research group.

作者信息

Zheng Yu-Xin, Ye Li-Ran, Yan Bing-Xi, Chen Si-Qi, Cai Sui-Qing, Man Xiao-Yong

机构信息

Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

出版信息

Front Med (Lausanne). 2022 Sep 7;9:1009991. doi: 10.3389/fmed.2022.1009991. eCollection 2022.

Abstract

BACKGROUND

Treatment for pediatric psoriasis is challenging because of the lack of real-world evidence, especially for biological therapies.

OBJECTIVES

This study evaluated the efficacy and safety of biologics in children with psoriasis based on real-world evidence.

METHODS

Pediatric psoriasis patients aged <18 years who were treated with biologics in our hospital (2020-2022) were prospectively analyzed. Patients treated with adalimumab, secukinumab, or ixekizumab were followed up for at least 16 weeks, and 22 of 38 patients completed the 52-week observation period. Dermatologist raters were blinded to ensure the reliability of the PASI, BSA, and PGA score assessments. PASI 75 or PGA 0/1 at week 12 represented an efficient indicator.

RESULTS

Thirty-eight patients (20 males and 18 females; median age, 12.6 ± 4.1 years) were enrolled, and none were lost to follow-up. All participants were diagnosed with psoriasis, including plaque psoriasis ( = 36), nail psoriasis ( = 1), and pustular psoriasis ( = 1). Within 12 weeks, all patients achieved scores above PASI 75 and PGA 0/1. The average time to reach PASI 75 was 4.3 ± 2.0, 3.2 ± 1.8, and 2.4 ± 0.4 weeks in patients using adalimumab, secukinumab, and ixekizumab, respectively, and, 27.2% (3/11), 86.4% (19/22), and 75.0% (3/4) of these patients achieved PASI 100 at week 12, respectively. Moreover, 18 of 20 patients with plaque psoriasis maintained ≥PASI 75 after 52 weeks. The most commonly reported adverse effect was upper respiratory tract infection, and no severe adverse effects were reported.

CONCLUSIONS

Our real-world data demonstrated the safety and effectiveness of adalimumab, secukinumab, and ixekizumab in children with psoriasis.

摘要

背景

由于缺乏真实世界证据,儿童银屑病的治疗具有挑战性,尤其是生物疗法方面。

目的

本研究基于真实世界证据评估生物制剂对儿童银屑病的疗效和安全性。

方法

对2020年至2022年在我院接受生物制剂治疗的18岁以下儿童银屑病患者进行前瞻性分析。接受阿达木单抗、司库奇尤单抗或依奇珠单抗治疗的患者随访至少16周,38例患者中有22例完成了52周观察期。皮肤科评估人员不知情以确保银屑病面积和严重程度指数(PASI)、体表面积(BSA)和医师全面评估(PGA)评分评估的可靠性。第12周时达到PASI 75或PGA 0/1代表有效指标。

结果

纳入38例患者(20例男性和18例女性;中位年龄12.6±4.1岁),无一例失访。所有参与者均被诊断为银屑病,包括斑块状银屑病(n = 36)、甲银屑病(n = 1)和脓疱型银屑病(n = 1)。12周内,所有患者PASI评分均高于75且PGA为0/1。使用阿达木单抗、司库奇尤单抗和依奇珠单抗的患者达到PASI 75的平均时间分别为4.3±2.0周、3.2±1.8周和2.4±0.4周,这些患者中分别有27.2%(3/11)、86.4%(19/22)和75.0%(3/4)在第12周时达到PASI 100。此外,20例斑块状银屑病患者中有18例在52周后维持PASI≥75。最常报告的不良反应是上呼吸道感染,未报告严重不良反应。

结论

我们的真实世界数据证明了阿达木单抗、司库奇尤单抗和依奇珠单抗对儿童银屑病的安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0fb/9490006/bf018d02805e/fmed-09-1009991-g0001.jpg

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