INSERM U1160, EMiLy, Institut de Recherche Saint-Louis, Université de Paris Cité, Paris, France.
Gastroenterology Department, AP-HP, Hôpital Saint-Louis/Lariboisière, Paris, France.
Scand J Gastroenterol. 2024 May;59(5):553-560. doi: 10.1080/00365521.2024.2316765. Epub 2024 Feb 14.
Hypersensitivity reactions (HSR) to the administration of infliximab (IFX) in Inflammatory Bowel Diseases (IBD) patients are not rare and usually lead to drug discontinuation. We report data on safety and effectiveness of desensitization to IFX in patients with previous HSR.
We conducted a retrospective monocentric observational study. Patients for whom a desensitization protocol to IFX was realized after a previous HSR were included. Anti-drug antibodies (ADA) and IFX trough levels at both inclusion and six months after desensitization were collected. Clinical outcomes, including recurrence of HSR were evaluated.
From 2005 to 2020, 27 patients (Crohn's Disease: 26 (96%) were included). Desensitization after HSR was performed after a median time of 10.4 months (2.9-33.1). Nineteen (70%) patients received immunosuppressants at time of desensitization. Eight (30%) patients presented HSR at first ( = 2), second ( = 4) or third ( = 2) IFX perfusion after desensitization. None led to intensive care unit transfer or death. Thirteen (48%) had clinical response at 6 months and 8 (29%) were still under IFX treatment two years after desensitization. IFX trough levels and ADA were available for 14 patients at time of desensitization. Most patients (12 out of 14) had ADA at a high level. At 6 months, among the 7 patients with long term response to IFX, 4 presented a decrease of ADA titers and 2 had a significant trough level of IFX.
IFX desensitization in patients with IBD is a safe therapeutic alternative and represents a potential option for patients refractory to multiple biologics. Hypersensitivity reactions to the administration of infliximab is frequent. Occurrence of hypersensitivity reaction, either immediate or delayed, usually leads to permanent drug discontinuation. Infliximab desensitization is well tolerated with no hypersensitivity reaction recurrence in 70% of patients. Clinical success at 6 months was of 48% and around a third of patients remained under infliximab therapy two years after desensitization. Antidrug antibodies decreased and infliximab trough levels increased in these patients showing the impact of desensitization on immunogenicity. Infliximab desensitization represents a potential option for patients refractory to multiple biologics who presented hypersensitivity reaction to the drug.
英夫利昔单抗（IFX）在炎症性肠病（IBD）患者中的给药引起的超敏反应（HSR）并不罕见，通常导致药物停药。我们报告了先前对 HSR 患者进行 IFX 脱敏治疗的安全性和有效性数据。
我们进行了一项回顾性单中心观察性研究。纳入了先前 HSR 后接受 IFX 脱敏方案的患者。在纳入和脱敏后 6 个月时收集了抗药物抗体（ADA）和 IFX 谷浓度。评估了临床结局，包括 HSR 的复发。
2005 年至 2020 年，共纳入 27 例患者（克罗恩病：26 例（96%））。HSR 后脱敏的中位时间为 10.4 个月（2.9-33.1）。19 例（70%）患者在脱敏时接受免疫抑制剂治疗。8 例（30%）患者在脱敏后首次（ = 2）、第二次（ = 4）或第三次（ = 2）IFX 灌注时出现 HSR。均未导致转入重症监护病房或死亡。13 例（48%）患者在 6 个月时具有临床反应，8 例（29%）在脱敏后两年仍接受 IFX 治疗。14 例患者在脱敏时可获得 IFX 谷浓度和 ADA。大多数患者（14 例中有 12 例）ADA 水平较高。在对 IFX 长期反应的 7 例患者中，ADA 滴度降低 4 例，IFX 谷浓度显著升高 2 例。
IBD 患者的 IFX 脱敏治疗是一种安全的治疗选择，是对多种生物制剂耐药的患者的潜在选择。英夫利昔单抗给药引起的超敏反应很常见。立即或延迟发生的超敏反应通常导致药物永久停药。IFX 脱敏治疗耐受性良好，70%的患者无 HSR 复发。6 个月时的临床成功率为 48%，约三分之一的患者在脱敏后两年仍接受 IFX 治疗。这些患者的 ADA 减少，IFX 谷浓度增加，表明脱敏治疗对免疫原性有影响。对药物有超敏反应且对多种生物制剂耐药的患者，IFX 脱敏治疗是一种潜在的选择。
