Inoue Nagamu, Kobayashi Kiyonori, Naganuma Makoto, Hirai Fumihito, Ozawa Morio, Arikan Dilek, Huang Bidan, Robinson Anne M, Thakkar Roopal B, Hibi Toshifumi
Center for Preventive Medicine, Keio University Hospital, Tokyo, Japan.
Department of Gastroenterology, Kitasato University Hospital, Kanagawa, Japan.
Intest Res. 2017 Jul;15(3):395-401. doi: 10.5217/ir.2017.15.3.395. Epub 2017 Jun 12.
BACKGROUND/AIMS: Intestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671).
Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments.
Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively.
This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.
背景/目的：肠道白塞病（BD）是一种免疫介导的炎症性疾病。我们对患者进行了随访，并通过从52周临床试验（NCT01243671）延续而来的100周研究，评估了阿达木单抗治疗肠道BD的安全性和有效性。
患者在第0周开始接受160mg阿达木单抗治疗，第2周为80mg，之后每隔一周40mg，直至研究结束。检查长期安全性和所有不良事件（AE）。使用综合疗效指数评估疗效，该指数结合了整体胃肠道症状和内镜评估，依据显著改善（MI）和完全缓解（CR）进行评估。
本研究纳入20例患者；15例患者接受阿达木单抗治疗直至研究结束。至第100周时AE的发生率为544.4事件/100人年，与至第52周时的发生率（560.4事件/100人年）相当。未观察到意外趋势，阿达木单抗耐受性良好。在第52周和第100周时，分别有60.0%和40.0%的患者表现出显著改善，分别有20.0%和15.0%的患者表现出完全缓解。
本报告证明了阿达木单抗在肠道BD患者中的两年安全性和有效性。接受长达两年阿达木单抗治疗的常规治疗难治性肠道BD患者的安全性结果与阿达木单抗已知情况相符，且该治疗导致临床和内镜下疾病活动持续降低。
