(24) Evaluating The Burden of Peripheral Neuropathy in Multiple Myeloma Using Two Real-World Data Sources from the United States

Publication Number: 698

Background: Peripheral neuropathy (PN) is frequently diagnosed among patients with multiple myeloma (MM), and may result from the underlying disease or treatment. Timely and effective management of PN is essential to minimizing the severity and maintaining therapeutic efficacy in treatment-emergent PN. Clinical trials or small observational studies outside of the United States or Europe have reported high rates of treatment-related PN in bortezomib- and thalidomide-based regimens, but generalizable information on PN in patients with MM in the US is lacking.

Objectives: To evaluate the 30-day incidence of PN among newly diagnosed patients with MM and among those initiating a bortezomib- or thalidomide-containing regimen.

Methods: Patients were identified between January 2013 and September 2020 in IQVIA PharMetrics® Plus and between January 2008 and October 2020 in Optum Claims. Newly diagnosed patients with MM were identified in two US real world data sources using a MM diagnosis [index event] for the first time in a patient’s medical history, a second MM diagnostic code between 30 and 90 days post-index, and ≥1 procedure code for bone marrow aspirate, biopsy, or interpretation OR procedure codes for at least two distinct diagnostic tests 90 days before or after the index event. Patients with MM initiating a bortezomib- or thalidomide-containing regimen were identified based on a pharmacy code for bortezomib or thalidomide for the first time in the medical record [index event], and the same criteria for the newly diagnosed cohort occurring at most 365 days before the index event. Thirty-day incidence rates were calculated per 1,000 patient-years and are presented with 95% confidence intervals (CI) based on the Fisher’s exact test.

Results: Among newly diagnosed patients with MM, the 30-day incidence of PN was 319.2 (95% CI: 280.7 - 361.5) in the IQVIA PharMetrics® Plus database (N=13,697) and 365.4 (95% CI: 324.5 - 410.0) per 1,000 patient-years in the Optum Claims database (N=15,161). Higher rates of PN were observed among males compared with females and among individuals with type 2 diabetes compared to those without. The incidence of PN in bortezomib-exposed patients was 367.7 (95% CI: 316.2 - 425.1) in IQVIA PharMetrics® Plus (N=8,862) and 349.4 (95% CI: 294.8 - 411.1) in Optum Claims (N=8,130). For patients exposed to thalidomide, the incidence of PN was 857.1 (95% CI: 442.9 - 1497.0) in IQVIA PharMetrics® Plus (N=287) and 321.4 (95% CI: 147.0 - 610.2) in Optum Claims (N=484).

Conclusions: This study describes a high burden of PN (~ >30%) both after MM diagnosis as well as after initiation of treatment for MM and elucidates the need for enhanced surveillance and identification of neuroprotective strategies.