Real-World Safety and Health Care Resource Utilization of Teclistamab Under an Outpatient Model for Step-Up Dosing Administration

Abstract

Purpose: 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.

Methods: 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.

Results: 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%).

Conclusion: Outcomes of this study support outpatient administration as a safe and feasible option for teclistamab SUD to potentially reduce HRU and improve patient experiences.

FIG 1.

Patient attrition. BCMA, B-cell maturation antigen; SUD, step-up dosing. ^aBaseline demographic and clinical characteristics were evaluated for all patients (N = 65) and the patients who initiated teclistamab in an outpatient setting (N = 58), respectively (Table 1). ^bSUD patterns and safety outcomes in subgroups with versus without BCMA exposure were analyzed for all patients who completed SUD regardless of the administration site (N = 59, including two patients who completed SUD in an inpatient setting). ^cSafety and health care resource utilization outcomes were analyzed for patients who completed SUD with ≥1 SUD dose in an outpatient setting (N = 57).

FIG 2.

Time between teclistamab administration and patient checkout during SUD and for subsequent treatment doses. Number of teclistamab doses during the SUD = 161. Number of teclistamab treatment doses = 412. SUD, step-up dosing.