Amgen Ltd, 1 Uxbridge Business Park, Uxbridge, UB8 1DH, UK.
VLB Contractors Ltd, 17 Marling Way, Gravesend, DA12 4DW, UK.
Future Oncol. 2020 Mar;16(8):317-328. doi: 10.2217/fon-2019-0838. Epub 2020 Feb 13.
There is a growing body of data on real-world use of talimogene laherparepvec (T-VEC). We aimed to characterize real-world T-VEC use using a nationally representative German prescription database covering 60% of prescriptions reimbursed. A retrospective analysis was conducted using the German IMS LRx prescription database, analyzing patients aged ≥18 years with an initial T-VEC prescription at 10 plaque-forming units (PFU)/ml and ≥1 subsequent prescription at 10 PFU/ml. Median time on T-VEC treatment, patient characteristics and patterns of T-VEC use were described. Of 127 patients prescribed T-VEC, 72 patients (57%) met study criteria. About two-thirds of these patients initiated T-VEC in 2017. Median age at T-VEC initiation was 74 years (range: 44 to 91). Most prescriptions (88%) were dispensed from hospitals. At study end, 26 (36%) patients remained on T-VEC; 46 (64%) had ended treatment. Median duration of T-VEC treatment for all patients was 18.7 weeks (95% CI: 15.3-26.9) and was longer among those who initiated treatment in 2017 versus 2016 (26.7 vs 15.6 weeks, respectively). Median volume administered for the first 10 PFU/ml and second 10 PFU/ml was 4 ml; the volume decreased for subsequent administrations (2 ml by the eighth administration and 1 ml by the 16th administration). This real-world prescription database study showed that patients who initiated treatment in 2017 had a treatment duration in clinical practice that corresponded with the European Summary of Product Characteristics guideline of continuing T-VEC for ≥6 months. Additional long-term data linking drug use with clinical outcomes are needed.
越来越多的数据表明，塔利木单抗（T-VEC）在真实世界中的应用效果良好。本研究旨在利用覆盖德国 60%报销处方的全国代表性处方数据库，对 T-VEC 的真实应用情况进行分析。本研究使用德国 IMS LRx 处方数据库进行回顾性分析，纳入初始 T-VEC 处方剂量为 10 噬斑形成单位（PFU）/ml、至少有一次后续处方剂量为 10 PFU/ml 的年龄≥18 岁患者。描述患者的中位 T-VEC 治疗时间、患者特征和 T-VEC 使用模式。在 127 例接受 T-VEC 治疗的患者中，有 72 例（57%）符合研究标准。其中约三分之二的患者于 2017 年开始 T-VEC 治疗。T-VEC 治疗开始时的中位年龄为 74 岁（范围：44 岁至 91 岁）。大多数处方（88%）从医院开出。研究结束时，26 例（36%）患者仍在接受 T-VEC 治疗；46 例（64%）已结束治疗。所有患者的 T-VEC 治疗中位持续时间为 18.7 周（95%CI：15.3-26.9），2017 年开始治疗的患者治疗时间长于 2016 年（分别为 26.7 周和 15.6 周）。前 10 PFU/ml 和后 10 PFU/ml 的中位给药体积均为 4 ml；随后的给药体积减少（第 8 次给药减少 2 ml，第 16 次给药减少 1 ml）。这项真实世界的处方数据库研究表明，2017 年开始治疗的患者在临床实践中的治疗时间与欧洲产品特性摘要指南中持续使用 T-VEC 治疗≥6 个月的建议一致。需要进一步进行长期的药物使用与临床结果关联的数据研究。
