Anne R. Schlösser, Lotte Bult, John C. Thelen, Alberta A. H. J. Thiadens, Renske Schappin, Tamar E. C. Nijsten, Johannes C. C. M. in 't Veen, Gerrit J. Braunstahl, DirkJan Hijnen
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引用次数: 0
Abstract
Background
Dupilumab has been shown to be an effective treatment in moderate-to-severe atopic dermatitis (AD) and severe asthma (SA). However, comparative real-world analyses of adverse events (AE), particularly dupilumab-associated ocular surface disease (DAOSD), are lacking.
Objective
This is the first real-world study to provide insight into the prevalence of AEs associated with dupilumab in AD compared with SA. Secondary objectives were to assess the prevalence, onset and therapeutic strategies of DAOSD and evaluate dupilumab discontinuation rates.
Methods
Data from two daily practice registries including AD and SA patients receiving dupilumab treatment were analyzed. Adverse events, including DAOSD, were evaluated.
Results
In total, 322 AD and 148 SA patients were included. Headaches (23.6%), injection site reactions (10.1%), and influenza-like symptoms (13.5%) were more prevalent in SA patients. Interestingly, ocular AEs were significantly more prevalent in AD patients (62.1%, p < 0.001), including conjunctivitis (17.1%, p = 0.004). 88% AD and 47% SA patients with ocular AEs received one or more ophthalmic treatment(s). Additionally, 20% of AD and 17.6% of SA patients discontinued dupilumab treatment due to ocular AEs, while only 65% of these AD and none of these SA patients were referred to an ophthalmologist.
Conclusion
The higher incidence of DAOSD in AD patients compared with SA patients in this real-world study highlights the importance of physician awareness, especially when prescribing dupilumab to AD patients. Conversely, the findings of this study help alleviate potential concerns about ocular AEs in patients with SA who do not have comorbid AD. Furthermore, the effective management of most ocular AEs with ophthalmic treatments suggests favorable tolerability of dupilumab in daily practice, and multidisciplinary collaboration is essential to proactively manage ocular AEs before discontinuing dupilumab.
背景 杜匹单抗已被证明是治疗中重度特应性皮炎(AD)和重症哮喘(SA)的有效药物。然而,目前还缺乏对不良事件(AE),尤其是杜匹单抗相关眼表疾病(DAOSD)的真实世界对比分析。 目的 这是第一项真实世界研究,旨在深入了解与杜比单抗相关的不良反应在 AD 和 SA 中的发生率。次要目标是评估DAOSD的患病率、发病率和治疗策略,并评估杜必鲁单抗的停药率。 方法 分析了来自两个日常实践登记处的数据,包括接受杜比单抗治疗的 AD 和 SA 患者。对包括DAOSD在内的不良事件进行了评估。 结果 共纳入 322 例 AD 和 148 例 SA 患者。在SA患者中,头痛(23.6%)、注射部位反应(10.1%)和流感样症状(13.5%)更为普遍。有趣的是,眼部 AEs 在 AD 患者中的发生率明显更高(62.1%,p < 0.001),包括结膜炎(17.1%,p = 0.004)。88%的 AD 和 47% 的 SA 眼部 AE 患者接受了一种或多种眼科治疗。此外,20%的AD和17.6%的SA患者因眼部AE停止了dupilumab治疗,而这些AD患者中只有65%被转诊到眼科医生处,SA患者中没有人被转诊到眼科医生处。 结论 在这项真实世界研究中,AD 患者的 DAOSD 发生率高于 SA 患者,这凸显了医生意识的重要性,尤其是在为 AD 患者开具杜比单抗处方时。相反,本研究的结果有助于减轻不合并 AD 的 SA 患者对眼部 AEs 的潜在担忧。此外,眼科治疗能有效控制大多数眼部 AEs,这表明杜比单抗在日常治疗中具有良好的耐受性,多学科合作对于在停用杜比单抗前积极控制眼部 AEs 至关重要。
期刊介绍:
Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience.
Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.