Abstract：
Mogamulizumab is a humanized antibody targeting CC chemokine receptor 4 (CCR4). This post-marketing surveillance was conducted in Japan as a regulatory requirement from 2014 to 2020 to ensure the safety and effectiveness of mogamulizumab in patients with relapsed or refractory (r/r) CCR4-positive peripheral T-cell lymphoma (PTCL) or r/r cutaneous T-cell lymphoma (CTCL). Safety and effectiveness data were collected for up to 31 weeks after treatment initiation. A total of 142 patients were registered; safety was evaluated in 136 patients. The median number of doses was 8.0 (range, 1-18). The main reasons for treatment termination were insufficient response (22.1%) and adverse events (13.2%). The frequency of any grade adverse drug reaction was 57.4%, including skin disorders (26.5%), infections and immune system disorders (16.2%), and infusion-related reactions (13.2%). Graft-versus-host disease, grade 2, developed in one of two patients who underwent allogeneic-hematopoietic stem cell transplantation after receiving mogamulizumab. Effectiveness was evaluated in 131 patients (103 with PTCL; 28 with CTCL). The best overall response rate was 45.8% (PTCL, 47.6%; CTCL, 39.3%). At week 31, the survival rate was 69.0% (95% confidence interval, 59.8%-76.5%) [PTCL, 64.4% (54.0%-73.0%); CTCL, 90.5% (67.0%-97.5%)]. Safety and effectiveness were comparable between patients <70 and ≥ 70 years old and between those with relapsed and refractory disease. The safety and effectiveness of mogamulizumab for PTCL and CTCL in the real world were comparable with the data reported in previous clinical trials. Clinical Trial Registration.
摘要：
Mogamulizumab是靶向CC趋化因子受体4(CCR4)的人源化抗体。这项上市后监测是在2014年至2020年在日本作为监管要求进行的，以确保莫加穆利珠单抗在复发或难治性（r/r）CCR4阳性外周T细胞淋巴瘤（PTCL）或r/r皮肤T细胞淋巴瘤（CTCL）患者中的安全性和有效性。在治疗开始后31周内收集安全性和有效性数据。共有142名患者登记；对136名患者进行了安全性评估。剂量的中位数为8.0（范围，1-18).终止治疗的主要原因为应答不足(22.1%)和不良事件(13.2%)。任何级别的药物不良反应发生率为57.4%,包括皮肤病（26.5%），感染和免疫系统紊乱（16.2%），和输液相关反应（13.2%）。移植物抗宿主病,2级，在接受mogamulizumab后接受异基因造血干细胞移植的两名患者中的一名中发展。对131例患者（103例PTCL；28例CTCL）进行了有效性评估。最佳总有效率为45.8%(PTCL，47.6%;CTCL,39.3%）。在第31周，生存率为69.0％（95％置信区间，59.8%-76.5%)[PTCL，64.4%（54.0%-73.0%）；CTCL，90.5%（67.0%-97.5%）]。<70岁和≥70岁的患者以及复发和难治性疾病患者之间的安全性和有效性相当。在现实世界中，mogamulizumab用于PTCL和CTCL的安全性和有效性与先前临床试验中报告的数据相当。临床试验注册。
