Service de Gastroentérologie, Université de Paris, APHP, Hôpital Saint-Louis, Paris, France.
Service de Biochimie, Université de Paris, APHP, Hôpital Necker, Paris, France.
J Crohns Colitis. 2021 May 4;15(5):742-748. doi: 10.1093/ecco-jcc/jjaa231.
Hydrocortisone premedication reduces the risk of antibodies to infliximab [ATIs] formation in patients receiving infliximab [IFX] therapy for inflammatory bowel disease [IBD].
We aimed to determine the safety of hydrocortisone premedication withdrawal in IBD patients with sustained clinical response on maintenance therapy with IFX.
We performed an observational prospective pharmacoclinical study in a tertiary referral centre, including all consecutive IBD outpatients with no previous IFX infusion reaction and in clinical remission on maintenance IFX [alone or in combination therapy] for at least 6 months. This cohort was followed for 1 year after discontinuation of hydrocortisone premedication.
Among the 268 IBD outpatients, 95 patients met the inclusion criteria [mean age 38 years; 64% male; 80% Crohn's disease; 45% combination therapy]. The median IFX duration was 5 years [0.54-14] with a mean infused dose of 533 mg [200-1000] and a mean interval duration of 7.9 weeks [4-10]. None of the patients developed permanent ATIs or infusion-related reaction at 1 year. Four patients developed transient ATIs without loss of clinical response. There was no significant variation of infliximab serum trough levels [5.5 µg/mL vs 5.9 µg/mL] measured at the time of the three IFX infusions before and after hydrocortisone withdrawal. Loss of response rate to IFX was 18% at 1 year.
Hydrocortisone discontinuation is safe in IBD patients with sustained clinical remission on maintenance therapy with IFX. Our data suggest that routine premedication with hydrocortisone is unnecessary in patients in prolonged remission under IFX maintenance therapy.
氢化可的松预处理可降低接受英夫利昔单抗（IFX）治疗炎症性肠病（IBD）的患者产生针对英夫利昔单抗的抗体（ATIs）的风险。
我们旨在确定在维持 IFX 治疗下持续临床缓解的 IBD 患者停用氢化可的松预处理的安全性。
我们在一家三级转诊中心进行了一项观察性前瞻性药代动力学研究，纳入所有连续的 IBD 门诊患者，这些患者无先前 IFX 输注反应，并且在维持 IFX[单独或联合治疗]至少 6 个月后处于临床缓解期。在停用氢化可的松预处理后，该队列随访了 1 年。
在 268 名 IBD 门诊患者中，95 名患者符合纳入标准[平均年龄 38 岁；64%为男性；80%为克罗恩病；45%为联合治疗]。IFX 治疗的中位时间为 5 年[0.54-14]，平均输注剂量为 533mg[200-1000]，平均间隔时间为 7.9 周[4-10]。在 1 年时，没有患者发生永久性 ATIs 或输注相关反应。有 4 名患者发生了短暂的 ATIs，但没有失去临床反应。在停用氢化可的松前后的三次 IFX 输注时测量的英夫利昔单抗血清谷浓度[5.5μg/mL 比 5.9μg/mL]没有显著变化。在 1 年时，IFX 应答丧失率为 18%。
在维持 IFX 治疗下持续临床缓解的 IBD 患者中，停用氢化可的松是安全的。我们的数据表明，在接受 IFX 维持治疗的长期缓解患者中，常规使用氢化可的松预处理是不必要的。
