弥合差距:妊娠期间杜匹单抗治疗特应性皮炎

IF 8 2区 医学 Q1 DERMATOLOGY
Christian Vestergaard, Mette Deleuran
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引用次数: 0

摘要

在这一期的JEADV中,两篇论文解决了以前未被满足的需求-为妊娠期间使用dupilumab治疗特应性皮炎(AD)提供证据。特应性皮炎影响所有年龄和性别的个体,并在大约5-10%的病例中持续到成年。这些病例通常需要对有生育能力和怀孕期间的妇女进行积极治疗然而,患有中度至重度ad的女性,或者患有其他需要全身治疗的疾病的女性,经常处于治疗的不确定状态。由于安全性数据有限,医生通常建议在怀孕前和怀孕期间停止全身治疗,以避免对胎儿造成任何风险。2019年,欧洲特应性皮炎工作组发表了一份关于治疗患有AD.2的孕妇、孕妇和哺乳期妇女的立场声明。当时,关于怀孕期间局部和全身治疗的证据严重缺乏。大多数关于全身免疫抑制剂的建议是从其他患者群体,特别是器官移植接受者和结缔组织疾病妇女的数据中推断出来的。值得注意的是,尚无证据表明dupilumab用于妊娠AD患者的安全性。从那时起,几次德尔菲练习试图完善这些指导方针,尽管共识通常仅限于已经使用的治疗方法——最值得注意的是环孢素。在第一篇论文中,Preuss等人利用了美国的协作网络TriNetX,该网络提供了多达1.1亿份电子健康记录的实时访问从这个庞大的数据集中,他们确定了293名在怀孕期间暴露于dupilumab的妇女。值得注意的是,该研究没有发现不良妊娠结局的风险增加。事实上,数据表明,暴露于dupilumab的妇女早产风险降低。第二篇论文由S. Gregoriou等人发表,对已发表的怀孕期间使用杜匹单抗的病例报告进行了系统回顾作者确定了14份出版物,包括61例怀孕和2例母乳喂养。虽然有28名妇女在得知自己怀孕后停用了杜匹单抗,但在妊娠的一些最关键时期,胎儿已经接触到了杜匹单抗。即便如此,该研究在审查的病例中没有报告不良妊娠结果。总之,这两项研究为皮肤科医生治疗妊娠期中度至重度AD患者提供了可靠的证据。研究结果表明,dupilumab不会增加不良妊娠结局的风险,甚至可能带来一些益处。根据本期《JEADV》提供的数据,考虑在患有中度至重度、不受控制ad的患者中继续使用杜匹单抗可能是合理的,尤其是在伴有合并症(如哮喘)的孕妇中。Vestergaard曾在辉瑞、诺华、LEO Pharma、艾伯维、赛诺菲、默沙杜和皮埃尔法伯(Pierre Fabre)的顾问委员会任职/获得荣誉/赠款;Mette Deleuran曾担任辉瑞(Pfizer)、诺华(Novartis)、利奥制药(LEO Pharma)、艾伯维(Abbvie)、赛诺菲(Sanofi)、默沙明(MSD)、Almirall、皮埃尔法伯(Pierre Fabre)、Kymab、Numab、Eli Lily、Regeneron、Union Therapeutics和Incyte的顾问委员会成员/获得荣誉/资助。Mette Deleuran获得了AbbVie、Eli Lilly、LEO Pharma、Incyte、La Roche Posay、NUMAB Therapeutics AG、Pierre Fabre、Pfizer、Regeneron Pharmaceuticals, Inc.、Sanofi Genzyme、Union Therapeutics、Mustela、Almirall和Kymab的研究支持、差旅支持、演讲奖金和/或咨询/顾问委员会协议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Bridging the gap: Treatment of atopic dermatitis with dupilumab during pregnancy

In this issue of the JEADV, two papers address a previously unmet need—providing evidence for the use of dupilumab in the treatment of atopic dermatitis (AD) during pregnancy.

Atopic dermatitis affects individuals of all ages and sexes and persists into adulthood in approximately 5–10% of cases. These cases often require active treatment in women of childbearing potential and during pregnancy.1 However, women with moderate to severe AD—or with other conditions requiring systemic treatment—have frequently been left in a therapeutic limbo. Due to limited safety data, physicians often advise stopping systemic treatment before and during pregnancy to avoid any risk to the fetus.

In 2019, the European Task Force on Atopic Dermatitis published a position statement on treating conceiving, pregnant and lactating women with AD.2 At that time, there was a significant lack of evidence regarding both topical and systemic treatments during pregnancy. Most recommendations for systemic immunosuppressants were extrapolated from data on other patient populations, particularly organ transplant recipients and women with connective tissue diseases. Notably, there was no available evidence on the safety of dupilumab use in pregnant AD patients. Since then, several Delphi exercises have attempted to refine these guidelines, though consensus has generally been limited to treatments already in use—most notably, cyclosporine.3

In the first paper, Preuss et al.4 utilize the US-based collaborative network TriNetX, which provides real-time access to up to 110 million electronic health records.4 From this vast dataset, they identified 293 women who had been exposed to dupilumab during pregnancy. Remarkably, the study found no increased risk of adverse pregnancy outcomes. In fact, the data suggested a reduced risk of preterm labour among dupilumab-exposed women.

The second paper, by S. Gregoriou et al.5 presents a systematic review of published case reports involving dupilumab use during pregnancy.5 The authors identified 14 publications, encompassing 61 pregnancies and 2 cases of breastfeeding. While 28 of the women discontinued dupilumab upon learning they were pregnant, fetal exposure had already occurred during some of the most critical periods of gestation. Even so, the study reported no adverse pregnancy outcomes among the cases reviewed.

Together, these two studies offer reassuring evidence for dermatologists managing moderate to severe AD in pregnant patients. The findings suggest that dupilumab does not increase the risk of adverse pregnancy outcomes and may even offer some benefits. Based on the data presented in this issue of the JEADV, it may be reasonable to consider continuing dupilumab in selected patients with moderate to severe, uncontrolled AD—especially when associated with comorbidities such as asthma—who become pregnant.

Christian Vestergaard has served on advisory boards/received honoraria/received grants from Pfizer, Novartis, LEO Pharma, Abbvie, Sanofi, MSD and Pierre Fabre; Mette Deleuran has served on advisory boards/received honoraria/received grants from Pfizer, Novartis, LEO Pharma, Abbvie, Sanofi, MSD, Almirall, Pierre Fabre, Kymab, Numab, Eli Lily, Regeneron, Union Therapeutics and Incyte. Mette Deleuran has received research support, travel support, honoraria for lecturing and/or consulting/advisory board agreements from AbbVie, Eli Lilly, LEO Pharma, Incyte, La Roche Posay, NUMAB Therapeutics AG, Pierre Fabre, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Union Therapeutics, Mustela, Almirall and Kymab.

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来源期刊
CiteScore
10.70
自引率
8.70%
发文量
874
审稿时长
3-6 weeks
期刊介绍: The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV). The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology. The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.
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