| Abstract: |
BACKGROUND: Teclistamab is the first-in-class B cell maturation × cluster of differentiation 3 T cell bispecific antibody approved in the United States for relapsed or refractory multiple myeloma (MM). During the first year following US Food and Drug Administration approval, many institutions initiated teclistamab step-up dosing (SUD) in hospital settings. OBJECTIVE: To describe patient characteristics, length of hospital stay (LOS) during SUD, and real-world incidence and management of cytokine release syndrome (CRS) among patients with MM who initiated teclistamab in US hospital settings. METHODS: This retrospective observational study used the Premier Healthcare Database and included patients (≥18 years) with confirmed MM who received at least 1 teclistamab administration in a hospital setting between November 1, 2022, and September 21, 2023. We descriptively analyzed characteristics across all patients included as well as SUD patterns, LOS (defined as the time between admission to discharge), and CRS in those who completed SUD. CRS was identified using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes and a symptom- and treatment-based algorithm (the Keating algorithm). RESULTS: A total of 413 patients were included. The median age (range) of the patients was 69 (32-89) years, 47.5% of patients were aged at least 70 years, and 69.7% had Medicare insurance. Most patients were male (56.4%), White (63.4%), and non-Hispanic (86.0%); 24.2% were Black. Most patients were treated in urban hospitals (96.4%), with 86.7% in teaching hospitals and 90.8% in hospitals with at least 300 beds. At the index hospital encounter, 47.9% of patients presented with anemia, 40.0% with peripheral neuropathy, and 35.8% with renal impairment/failure. Among 302 patients who completed SUD as of the data cutoff, 91.4% completed SUD in a single inpatient admission with a mean LOS of 8.7 days, after omitting extreme outliers; most patients had a 2-day (36.1%) or 3-day (31.1%) interval between SUD doses. CRS, per ICD-10-CM codes, was observed in 31.8% of patients (24.2% grade 1, 4.6% grade 2, and 1.0% grade 3). Per the Keating algorithm, 28.5% of patients experienced CRS-related symptoms, including fever (15.2%) and hypotension (10.3%); most of the events were classified as mild. Most patients with a complete SUD period had documented dexamethasone (97.0%) and acetaminophen (93.7%), 78.5% received diphenhydramine, and 29.8% received tocilizumab at any time during the SUD period. CONCLUSIONS: This large, national, real-world study of patients with MM treated with teclistamab confirmed that early initiators of teclistamab were older adults from diverse racial groups with substantial comorbidities. Despite these factors, most patients were able to safely complete SUD following label-described schedules with manageable CRS events. This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine |
