Bressler Brian, Bethel Kevin P, Kleef Ralf, Reynolds Sophie L, Sutcliffe Simon, Mullins David W, Gunn Hal
Gastrointestinal Research Institute (GIRI), Vancouver, BC, Canada V6Z 2K5.
Freeport Family Wellness Center, P.O. Box F41325, Freeport, Bahamas.
Gastroenterol Res Pract. 2015;2015:231243. doi: 10.1155/2015/231243. Epub 2015 May 12.
We investigated the mechanism of action, safety, and efficacy of the Site-Specific Immunomodulator (SSI) QBECO, a novel immunotherapy for Crohn's disease (CD). Using human monocytic THP-1 cells, we demonstrate that SSI QBECO (derived from the common colon bacteria E. coli) activates macrophages to an M1 phenotype (associated with enhanced capacity to eliminate bacteria and activate innate immune responses). We assessed SSI QBECO in a compassionate use protocol of ten adult patients with active CD. Patients with moderate to severe clinical symptoms receiving conventional CD treatments and/or complementary therapies were included, except patients receiving anti-TNF medications. SSI QBECO was self-administered subcutaneously every second day, for a minimum of 2.5 months and a maximum of 11 months. All 10 patients reported improvement of symptoms while on the SSI QBECO treatment. Seven patients reported full resolution of clinical symptoms during a course of SSI QBECO of at least three months. Three patients have experienced ongoing sustained clinical remission after discontinuing all medications, including SSI treatment. The longest case of clinical remission is still ongoing (>4 years). No serious severe adverse clinical events were reported. Collectively, we conclude that treatment with the immunoactive SSI QBECO was well tolerated and effective for treatment of Crohn's disease in this case series.
我们研究了位点特异性免疫调节剂（SSI）QBECO（一种用于治疗克罗恩病（CD）的新型免疫疗法）的作用机制、安全性和疗效。我们使用人单核细胞THP-1细胞证明，SSI QBECO（源自常见的结肠细菌大肠杆菌）可将巨噬细胞激活为M1表型（与增强的清除细菌能力和激活先天免疫反应相关）。我们在一项针对10名成年活动性CD患者的同情用药方案中评估了SSI QBECO。纳入了接受传统CD治疗和/或辅助治疗且有中度至重度临床症状的患者，但接受抗TNF药物治疗的患者除外。SSI QBECO每两天皮下自我给药一次，最短2.5个月，最长11个月。所有10名患者在接受SSI QBECO治疗期间均报告症状有所改善。7名患者在至少三个月的SSI QBECO疗程中报告临床症状完全缓解。3名患者在停用所有药物（包括SSI治疗）后持续处于临床缓解状态。临床缓解最长的病例仍在持续（>4年）。未报告严重的不良临床事件。总体而言，我们得出结论，在这个病例系列中，免疫活性SSI QBECO治疗耐受性良好且对克罗恩病治疗有效。
