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妊娠期葡萄膜炎患者接受培塞利珠单抗治疗的疗效和安全性。关于妊娠期葡萄膜炎应用免疫抑制和生物治疗药物的管理建议。

Efficacy and safety of certolizumab pegol in pregnant women with uveitis. Recommendations on the management with immunosuppressive and biologic therapies in uveitis during pregnancy.

机构信息

Rheumatology and Ophthalmology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.

Clinic Institute of Ophthalmology (ICOF), Hospital Clinic of Barcelona, Spain.

出版信息

Clin Exp Rheumatol. 2021 Jan-Feb;39(1):105-114. doi: 10.55563/clinexprheumatol/j9ysbm. Epub 2020 Oct 9.

DOI:10.55563/clinexprheumatol/j9ysbm
PMID:33124565
Abstract

OBJECTIVES

Clinicians often face the challenge of providing effective and safe therapy for pregnant women with uveitis. Certolizumab pegol (CZP) differs from other anti-TNFα agents due to its limited placental transfer. In this study we assessed the efficacy of CZP in pregnant women with uveitis. We also provided information on outcomes of pregnant women and neonates exposed to CZP.

METHODS

We carried out a multicentre study of women with uveitis who received CZP during pregnancy and their neonates. The main visual outcomes were visual acuity (VA), intraocular inflammation and corticosteroid-sparing effect. Pregnancy outcomes, maternal and neonatal infections and congenital malformations were also assessed.

RESULTS

We studied 14 women (23 affected eyes); mean age of 34.3±5.5 years. The underlying diseases were spondyloarthritis (n=7), idiopathic (n=2), and Vogt-Koyanagi-Harada, rheumatoid arthritis, juvenile idiopathic arthritis, punctate inner choroidopathy and Behçet's disease (1 each). The patterns of ocular involvement were anterior (n=10), posterior (n=2), intermediate (n=1), panuveitis (n=1). Cystoid macular oedema was present in one patient (1 eye). Uveitis was bilateral in nine cases and chronic in seven patients. CZP was started before getting pregnant in ten patients and after conceiving in four. All patients achieved or maintained ocular remission throughout pregnancy. Fifteen healthy infants were born. Only one woman presented a mild infection during pregnancy. Neither infections nor malformations were observed in neonates after a follow-up of 6 months. Six infants were breastfed and all of them received scheduled vaccinations without complications.

CONCLUSIONS

Certolizumab pegol is effective and safe in women with uveitis during pregnancy.

摘要

目的

临床医生在为患有葡萄膜炎的孕妇提供有效和安全的治疗时常面临挑战。由于其胎盘转移有限,培塞利珠单抗(CZP)与其他抗 TNFα 药物不同。在这项研究中,我们评估了 CZP 治疗葡萄膜炎孕妇的疗效。我们还提供了接触 CZP 的孕妇和新生儿结局的信息。

方法

我们对怀孕期间接受 CZP 治疗的葡萄膜炎女性及其新生儿进行了一项多中心研究。主要视觉结局是视力(VA)、眼内炎症和皮质类固醇节省效应。还评估了妊娠结局、母婴和新生儿感染以及先天性畸形。

结果

我们研究了 14 名(23 只受累眼)女性;平均年龄为 34.3±5.5 岁。基础疾病为脊柱关节炎(n=7)、特发性(n=2)、Vogt-Koyanagi-Harada、类风湿关节炎、幼年特发性关节炎、点状内层脉络膜病变和贝切特病(各 1 例)。眼部受累模式为前葡萄膜炎(n=10)、后葡萄膜炎(n=2)、中间葡萄膜炎(n=1)、全葡萄膜炎(n=1)。1 例(1 只眼)存在黄斑囊样水肿。9 例为双侧葡萄膜炎,7 例为慢性葡萄膜炎。10 例患者在怀孕前开始使用 CZP,4 例患者在怀孕后开始使用。所有患者在整个怀孕期间均达到或维持眼部缓解。15 名健康婴儿出生。仅 1 名女性在怀孕期间出现轻度感染。在随访 6 个月后,新生儿未出现感染或畸形。6 名婴儿接受母乳喂养,所有婴儿均接受了预定的疫苗接种,无并发症。

结论

培塞利珠单抗在妊娠期间对患有葡萄膜炎的女性是有效且安全的。

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