We have treated 69 patients with steroid refractory acute graft versus host disease (SR-aGvHD), with an anti-CD26 monoclonal antibody (Begelomab): 28 patients in two prospective studies (EudraCT No. 2007-005809-21; EudraCT No. 2012-001353-19), and 41 patients on a compassionate use study. The median age of patients was 42 and 44 years; the severity of GvHD was as follows: grade II in 8 patients, grade III in 33, and grade IV in 28 patients. There were no adverse events directly attributable to the antibody. Day 28 response was 75% in the prospective studies and 61% in the compassionate use patients, with complete response rates of 11 and 12%. Response for grade III GvHD was 83 and 73% in the two groups; response in grade IV GvHD was 66 and 56% in the two groups. Non relapse mortality (NRM) at 6 months was 28 and 38%. Overall there were 64, 56, 68% responses for skin, liver, and gut stage 3–4 GvHD. The overall survival at 1 year was 50% for the prospective studies and 33% for the compassionate use patients. In conclusion, Begelomab induces over 60% responses in SR-aGvHD, including patients with severe gut and liver GvHD, having failed one or more lines of treatment.

我们已经用抗CD26单克隆抗体（Begelomab）治疗了69例患有类固醇难治性急性移植物抗宿主病（SR-aGvHD）的患者：两项前瞻性研究（EudraCT No. 2007-005809-21; EudraCT No. 2012）中的28名患者-001353-19），以及41位患者进行同情使用研究。患者的中位年龄为42岁和44岁；GvHD的严重程度如下：II级8例，III级33例，IV级28例。没有直接归因于抗体的不良事件。在前瞻性研究中，第28天的缓解率为75％，富有同情心的患者为61％，完全缓解率为11和12％。两组对III级GvHD的反应分别为83％和73％。两组IVv GvHD的缓解率分别为66％和56％。6个月时的非复发死亡率为28％和38％。总体上有64，56 68％的皮肤，肝脏和肠道3–4 GvHD反应。前瞻性研究在1年时的总生存率为50％，有同情心的患者为33％。总之，Begelomab在SR-aGvHD中诱导60％以上的反应，包括严重的肠道和肝脏GvHD患者，但一线或多线治疗均无效。