Kampa Katia Cristina, Morsoletto Daphne Benatti Gonçalves, Loures Marcela Rocha, Pissaia Alcindo, Nones Rodrigo Bremer, Ivantes Cláudia Alexandra Pontes
Departamento de Gastroenterologia, Hepatologia e Transplante Hepático, Nossa Senhora das Graças Hospital, Curitiba, PR, Brasil.
Arq Gastroenterol. 2017 Dec;54(4):333-337. doi: 10.1590/S0004-2803.201700000-41. Epub 2017 Sep 21.
Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases. In such pathologies, there is an increased production of alpha tumor necrosis factor (TNF-α). Patients, in whom the conventional immunosuppressant treatment fails, require the use of immunobiological therapy, such as anti-TNF-α, a monoclonal antibody. Infliximab is an anti-TNF-α drug, a chimerical immunoglobulin, with a murine component, which is responsible for the generation of immunogenicity against the drug and formation of anti-TNF-α antibodies. The presence of anti-drug antibodies may be responsible for adverse events and reduction of the drug's effectiveness. Patients with inflammatory bowel diseases undergoing therapy with biological medication, such as infliximab, can relapse overtime and this may not be translated into clinical symptoms. Thus, there is a need for a method to evaluate the efficacy of the drug, through the measurement of serum infliximab levels, as well as antibodies research.
This study aimed to measure serum infliximab levels and anti-infliximab antibodies in patients with inflammatory bowel diseases post-induction phase and during maintenance therapy, and describe the therapeutic modifications that took place based on the serum levels results.
It was a retrospective study, that included forty-five patients, with a total of 63 samples of infliximab measurement.
Twenty-one patients had an adequate infliximab serum level, 31 had subtherapeutic levels and 11 had supratherapeutic levels. Seven patients had their medication suspended due to therapeutic failure or high levels of antibodies to infliximab.
In conclusion, only a third of the patients had adequate infliximab levels and 36% presented with subtherapeutic levels at the end of the induction phase. Therapy optimization occurred based in about 46% of the samples results, demonstrating the importance of having this tool to help the clinical handling of patients with inflammatory bowel diseases ongoing biologic therapy.
克罗恩病和溃疡性结肠炎是慢性炎症性肠病。在这类病症中，α肿瘤坏死因子（TNF-α）的产生会增加。传统免疫抑制剂治疗失败的患者需要使用免疫生物疗法，如抗TNF-α单克隆抗体。英夫利昔单抗是一种抗TNF-α药物，是一种嵌合免疫球蛋白，含有鼠源成分，该成分会引发针对该药物的免疫原性并形成抗TNF-α抗体。抗药物抗体的存在可能导致不良事件并降低药物疗效。接受生物药物（如英夫利昔单抗）治疗的炎症性肠病患者可能会随时间推移复发，而这可能不会转化为临床症状。因此，需要一种通过测量血清英夫利昔单抗水平以及进行抗体研究来评估药物疗效的方法。
本研究旨在测量炎症性肠病患者诱导期后及维持治疗期间的血清英夫利昔单抗水平和抗英夫利昔单抗抗体，并根据血清水平结果描述所进行的治疗调整。
这是一项回顾性研究，纳入了45名患者，共63份英夫利昔单抗测量样本。
21名患者的英夫利昔单抗血清水平充足，31名患者的水平低于治疗剂量，11名患者的水平高于治疗剂量。7名患者因治疗失败或抗英夫利昔单抗抗体水平高而停药。
总之，只有三分之一的患者英夫利昔单抗水平充足，在诱导期结束时36%的患者水平低于治疗剂量。约46%的样本结果促使了治疗优化，这表明拥有该工具对于帮助临床处理正在接受生物治疗的炎症性肠病患者具有重要意义。
