Sandahl Tyler B, Soefje Scott A, Fonseca Rafael, Ailawadhi Sikander, Parrondo Ricardo, Lin Dee, Wu Bingcao, Calay Ediz S, Silvert Eli, Kim Nina, Carpenter Corinne, Wagner Tyler E, Fowler Jessica, Hester Laura, Rangarajan Nivedita, Murugadoss Karthik, Marshall Alexander, Stoy Patrick, Gifkins Dina, Lin Yi, Kumar Shaji
Mayo Clinic, Rochester, MN.
Mayo Clinic, Phoenix, AZ.
JCO Oncol Pract. 2025 May;21(5):702-709. doi: 10.1200/OP-24-00489. Epub 2024 Dec 20.
Teclistamab is initiated with a step-up dosing (SUD) schedule to mitigate the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Early teclistamab users commonly received SUD in a hospital setting. This study aimed to evaluate safety and health care resource utilization (HRU) in real-world patients with multiple myeloma who initiated teclistamab SUD in an outpatient setting.
This was a retrospective study using Mayo Clinic's electronic medical records from October 26, 2022, to October 31, 2023. Patient characteristics were summarized for all patients treated with teclistamab and separately for patients who started SUD outpatient. SUD pattern, safety, HRU, and post-SUD dosing schedule were described in patients with complete SUD.
At data cutoff, 65 patients received ≥1 teclistamab dose, including 58 patients who initiated SUD outpatient (median age, 69.2 years; male, 63.8%; White, 89.7%). Among 57 patients who completed SUD in an outpatient setting, all received premedications on the days of teclistamab administrations per label recommendation; 18 (31.6%) developed CRS (13 grade 1, four grade 2, and one grade 4) and two developed ICANS (one each with grade 2 and 4). All CRS and ICANS resolved with supportive care and all patients continued treatment. Eighteen patients were admitted to the hospital for CRS treatment, with a median CRS-related hospital stay of 2 days per admission. Most (60%) doses during SUD required <1 hour clinic time between administration and checkout. Post-SUD, clinic time for treatment doses decreased to <30 minutes for most doses (82%).
Outcomes of this study support outpatient administration as a safe and feasible option for teclistamab SUD to potentially reduce HRU and improve patient experiences.
替雷利珠单抗采用逐步递增剂量（SUD）方案起始给药，以降低细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）的风险。早期使用替雷利珠单抗的患者通常在医院环境中接受SUD。本研究旨在评估在门诊环境中起始替雷利珠单抗SUD的真实世界多发性骨髓瘤患者的安全性和医疗资源利用（HRU）情况。
这是一项回顾性研究，使用梅奥诊所2022年10月26日至2023年10月31日的电子病历。总结了所有接受替雷利珠单抗治疗的患者的特征，并分别总结了门诊起始SUD的患者的特征。对完成SUD的患者的SUD模式、安全性、HRU和SUD后给药方案进行了描述。
在数据截止时，65例患者接受了≥1剂替雷利珠单抗，其中58例患者在门诊起始SUD（中位年龄69.2岁；男性占63.8%；白人占89.7%）。在57例在门诊完成SUD的患者中，所有患者均按照标签建议在替雷利珠单抗给药当天接受了预处理；18例（31.6%）发生CRS（13例1级，4例2级，1例4级），2例发生ICANS（1例2级，1例4级）。所有CRS和ICANS均通过支持治疗得到缓解，所有患者均继续治疗。18例患者因CRS治疗入院，每次入院与CRS相关的住院时间中位数为2天。SUD期间，大多数（60%）剂量在给药和结账之间所需的门诊时间<1小时。SUD后，大多数剂量（82%）的治疗剂量门诊时间减少至<30分钟。
本研究结果支持门诊给药作为替雷利珠单抗SUD的一种安全可行的选择，可能会降低HRU并改善患者体验。
