Retrospective analysis of rapid drug desensitization with biologic agents: A single center experience

IF 4.6 2区医学 Q2 ALLERGY Clinical and Translational Allergy Pub Date : 2024-10-21 DOI:10.1002/clt2.12397

Döne Gülçin Unutmaz Erkaya, Makbule Seda Bayrak Durmaz, Begüm Görgülü Akın, Sevim Bavbek

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Abstract

Background

Following the increased use of biological agents, a subset of patients experiences hypersensitivity reaction (HSR). We reported our experience with rapid drug desensitization (RDD) to nine biologics (rituximab, infliximab, cetuximab, trastuzumab, pertuzumab, nivolumab, brentuximab, tocilizumab and filgrastim) and identified risk factors for breakthrough reactions (BTRs).

Method

This was a retrospective review (2013–2022) of patients with immediate HSRs to biological agents. Initial HSRs were classified as grade 1, 2, or 3 in their severity. Skin prick tests (SPT)/intradermal tests (IDT) were performed using implicated agents. The phenotypes of HSRs were defined as Type I, cytokine-release syndrome (CRS), mixed reactions (cytokine-release + type I) based on history, clinical presentations and skin tests with implicated biologicals. A 12-step RDD protocol was used.

Results

The study comprised 45 patients (F/M: 31/14, median age: 55 (range: 20–69)). Majority of the patients reacted at the first infusion (n: 29/45, 64.4%). The majority of initial HSRs were grade 3 (n: 24/45, 53.3%) and grade 2 (n: 21/45, 46.6%); none were grade 1. Initial reactions were presented as type I (n: 20/45, 44.4%), CRS (n: 12/45, 26.6%) and mixed (n: 13/45, 28.8%). A total of 258 RDDs were performed and 98.4% of them were completed successfully. BTRs occurred in 36/258 (13.9%) infusions of RDDs. There was no significant association between the BTRs and age, drug cycle, SPT and IDT positivity, gender, comorbidities, or atopy.

Conclusion

In our experience, 98.4% of 258 RDDs to biologics were successfully completed; RDD was safe and effective for our population.

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生物制剂快速药物脱敏的回顾性分析：单中心经验。

背景：随着生物制剂使用的增加，一部分患者出现了超敏反应（HSR）。我们报告了对九种生物制剂（利妥昔单抗、英夫利昔单抗、西妥昔单抗、曲妥珠单抗、培妥珠单抗、尼伐单抗、布伦妥昔单抗、托珠单抗和菲格列汀）进行快速药物脱敏（RDD）的经验，并确定了突破性反应（BTR）的风险因素：这是一项回顾性研究（2013-2022 年），研究对象为使用生物制剂出现即刻 HSR 的患者。初始 HSR 的严重程度分为 1 级、2 级或 3 级。使用相关制剂进行皮肤点刺试验（SPT）/皮内试验（IDT）。根据病史、临床表现和使用相关生物制剂进行的皮试，将 HSR 的表型定义为 I 型、细胞因子释放综合征 (CRS)、混合反应（细胞因子释放 + I 型）。研究采用了 12 步 RDD 方案：研究共涉及 45 名患者（女/男：31/14，中位年龄：55（范围：20-69））。大多数患者在首次输液时出现反应（29/45，64.4%）。大多数初始 HSR 为 3 级（人数：24/45，53.3%）和 2 级（人数：21/45，46.6%）；无 1 级反应。初始反应分为 I 型（20/45，44.4%）、CRS（12/45，26.6%）和混合型（13/45，28.8%）。共进行了 258 次 RDD，其中 98.4% 顺利完成。在 36 次/258 次（13.9%）RDD 输液中出现了 BTR。BTR与年龄、用药周期、SPT和IDT阳性、性别、合并症或过敏症之间没有明显关联：根据我们的经验，在258例生物制剂RDD中，98.4%的患者成功完成了RDD；RDD对我们的人群来说是安全有效的。

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来源期刊

Clinical and Translational Allergy Immunology and Microbiology-Immunology

CiteScore

7.50

自引率

4.50%

发文量

117

审稿时长

12 weeks

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.