Incidence of skeletal-related events among multiple myeloma patients in the United States at oncology clinics: Observations from real-world data

Abstract

Skeletal-related events (SREs) are common bone complications in multiple myeloma (MM). However, there are few real-world reports of their incidence. In this study, a database of oncology electronic health records was linked to administrative claims data. Patients identified were aged ≥18 years and newly diagnosed with MM, had ≥1 clinic visit within 1 month of diagnosis, and ≥1 year of follow-up after diagnosis. The study period was January 1, 2011 to December 31, 2016. 343 patients were included, 35% of whom had a baseline history of any SRE. During a median follow-up of 25.7 months, 34% of patients experienced SREs after diagnosis. Median time to SRE was 167 days. Among patients experiencing an SRE, 68% had an SRE within the first year. The incidence rate of SREs at 1 year following MM diagnosis for patients with baseline history was 103/100 person-years (PY) versus 16/100PY for patients without baseline history. SRE incidence rates within 3 months of initiating a line of therapy increased with subsequent lines (line 1: 81/100PY, line 2: 118/100PY, line 3: 150/100PY). Risk of SREs was similar across different anti-MM regimens, including proteasome inhibitor-based regimens. These results highlight the importance of continued surveillance and management of MM-associated bone disease.

Bone complications in patients with multiple myeloma in five European countries: a retrospective patient chart review

“…We also found that approximately half of bone complications occurred before initiation of first-line treatment (over a mean duration of 2.3 months); however, some of these may have already been present at diagnosis. Results from other studies suggest that most bone complications occur within the first year after MM diagnosis [10,16]; for example, Kim et al reported that 68% of bone complications occurred during this period [16]. In a recent randomized controlled trial in patients with NDMM (N = 1718), 60% of first on-study bone complications were experienced during the initial 3 months and 81% during the initial 6 months of the study [10].…”

“…Consistent with our findings, Nash Smyth et al estimated that, among patients who experienced at least one bone complication, 50% had one, 26% had two and 24% had at least three bone complications [17]. Furthermore, a retrospective US database analysis by Kim et al (N = 343) found that the incidence of bone complications 1 year after MM diagnosis for patients with a prior history of bone complications was 103 per 100 person-years compared with 16 per 100 person-years for individuals with no prior history [16]. The incidence of bone lesions was not recorded throughout our study, so it was not possible to establish the extent to which new bone complications were associated with changes in the burden of myeloma bone disease.…”

“…Bone complications, also referred to as skeletal-related events, include pathologic fracture (PF), spinal cord compression (SCC), radiation to bone (RB) and surgery to bone (SB) [9,10]. They may lead to increased mortality in patients with MM [11][12][13], and contribute towards disability and reduced health-related quality of life [5,14], although individuals with bone complications may have more advanced disease [15,16]. Management of bone complications is also associated with considerable healthcare resource use [6,[17][18][19].…”

“…For example, in a recent phase III study of patients with newly diagnosed MM, 67% of patients enrolled in the study already presented with bone complications [10]. Despite the use of novel anti-myeloma agents and anti-resorptive agents, bone complications continue to occur within the first months of starting MM treatment [9,10] and throughout the disease course, including in patients without a prior history of bone complications [16,35].…”

Pathogenic Mechanisms of Myeloma Bone Disease and Possible Roles for NRF2

“…It leads to serious complications and/or skeletal-related events (SREs), which include fracture, compression of the spinal cord, hypercalcemia, and the need for further surgical treatment or radiation therapy. SREs not only decrease the quality of life as a result of pain, emotional distress, and treatment procedures, but also affect the survival of MM patients [6,[8][9][10]. Therefore, knowledge of myeloma bone lesions for further disease management is warranted.…”