Carfilzomib’s Real-World Safety Outcomes in Korea: Target Trial Emulation Study Using Electronic Health Records

Author:

Jang Ha Young,Lee Hyun Kyung,Kim Chae Jeong,Yoon Sung-SooORCID,Kim In-WhaORCID,Oh Jung Mi

Abstract

Carfilzomib is a promising anticancer drug for relapsed/refractory multiple myeloma (RRMM). However, real-world evidence has only investigated the cardiovascular safety of carfilzomib, and there is a high demand for thorough safety evaluations. We aimed to comprehensively evaluate the risk of adverse events associated with carfilzomib in Korean patients with RRMM. We followed up with 138 matched patients with RRMM (69 KRd (carfilzomib, lenalidomide, and dexamethasone) and 69 Rd (lenalidomide and dexamethasone) users). A total of 12 adverse events were evaluated. More than 75% of adverse events occurred during the early cycle (1–6 cycles), and the incidence rate showed a tendency to decrease in the later cycle (7–12 and 13–18 cycles). Severities of most adverse events were evaluated as grade 1-2. The KRd regimen were related with significantly increased risks of dyspnea (adjusted HR (aHR) 2.27, 95% confidence interval (CI) 1.24–4.16), muscle spasm (aHR 5.12, 95% CI 1.05–24.9) and thrombocytopenia (aHR 1.84, 95% CI 1.10–3.06). Although the severities were low, carfilzomib has many side effects in treating RRMM; hence, findings on the patterns of its adverse events could lead to both effective and safe use of KRd therapy in real-world settings.

Funder

Ministry of Food and Drug Safety

Publisher

MDPI AG

Subject

Health, Toxicology and Mutagenesis,Public Health, Environmental and Occupational Health

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