ASSOCIATION BETWEEN FIRST-LINE CD38-CONTAINING REGIMENS AND OVERALL SURVIVAL VS. REGIMENS WITHOUT ANTI-CD38 EXPOSURE IN JAPANESE PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA: A REAL-WORLD STUDY USING JAPAN MDV CLAIMS DATABASE
Author(s)
David Bin-Chia Wu, PhD1, Kittima Wattanakamolkul, PhD2, Cathy Kwang-Wei Wu, MBBS3, Siddartho Zeet Sarker, MSc4, Thomas Webb, MSc4, DaeYoung Yu, PhD5, Kenshi Suzuki, MD6.
1Market Access (Asia Pacific), Johnson & Johnson, Singapore, Singapore, 2Johnson & Johnson, Tokyo, Japan, 3Medical Affairs (Asia Pacific), Johnson & Johnson, Singapore, Singapore, 4Johnson & Johnson, Singapore, Singapore, 5Johnson & Johnson, Seoul, Korea, Republic of, 6Japanese Red Cross Medical Center, Tokyo, Japan.
1Market Access (Asia Pacific), Johnson & Johnson, Singapore, Singapore, 2Johnson & Johnson, Tokyo, Japan, 3Medical Affairs (Asia Pacific), Johnson & Johnson, Singapore, Singapore, 4Johnson & Johnson, Singapore, Singapore, 5Johnson & Johnson, Seoul, Korea, Republic of, 6Japanese Red Cross Medical Center, Tokyo, Japan.
OBJECTIVES: Multiple myeloma (MM) imposes substantial burden in Japan. Earlier access to innovative medicines may improve outcomes in newly diagnosed MM (NDMM). This study assessed overall survival (OS) among Japanese NDMM patients receiving first-line (1L) CD38-containing versus non-CD38 regimens.
METHODS: This retrospective study used Japan Medical Data Vision (MDV) claims database where patients with NDMM were identified between 1 January 2020 and 31 December 2022 and followed until 31 December 2025. The intervention group included patients receiving a 1L CD38-containing regimen, defined as any anti-CD38 monoclonal antibody-containing regimen (n=149). The control group included patients receiving 1L non-CD38 regimens without anti-CD38 exposure in any treatment line (n=856). Covariates for inverse probability of treatment weighting (IPTW) were selected based on hematologist input, literature, and claims data availability, including age, sex, modified Charlson Comorbidity Index (CCI) score, and chronic kidney disease. Stabilized IPTW was used to balance characteristics. OS was compared using stabilized IPTW Cox regression, a doubly robust Cox model with IPTW and covariate adjustment, and trimmed IPTW sensitivity analysis.
RESULTS: After weighting, characteristics were well balanced, with standardized mean differences of 0.037 for age, 0.004 for female sex, 0.005 for modified CCI score, and 0.003 for chronic kidney disease. Weighted Kaplan-Meier curves favored CD38-containing regimens, with absolute OS differences of 7.7%, 7.8%, 8.6%, 7.7%, and 9.6% at months 12, 24, 36, 48, and 60. Stabilized IPTW Cox regression showed improved OS with CD38-containing regimens (HR=0.63; 95% CI: 0.49-0.82; p=0.0006). Results were consistent in the doubly robust Cox model (adjusted HR=0.65; 95% CI: 0.50-0.84; p=0.001) and trimmed IPTW analysis (HR=0.63; 95% CI: 0.49-0.82; p=0.0005).
CONCLUSIONS: In this real-world Japanese NDMM cohort, 1L CD38-containing regimens were associated with improved OS versus non-CD38 regimens after robust adjustment. Findings support early access to innovative MM therapies in Japan.
METHODS: This retrospective study used Japan Medical Data Vision (MDV) claims database where patients with NDMM were identified between 1 January 2020 and 31 December 2022 and followed until 31 December 2025. The intervention group included patients receiving a 1L CD38-containing regimen, defined as any anti-CD38 monoclonal antibody-containing regimen (n=149). The control group included patients receiving 1L non-CD38 regimens without anti-CD38 exposure in any treatment line (n=856). Covariates for inverse probability of treatment weighting (IPTW) were selected based on hematologist input, literature, and claims data availability, including age, sex, modified Charlson Comorbidity Index (CCI) score, and chronic kidney disease. Stabilized IPTW was used to balance characteristics. OS was compared using stabilized IPTW Cox regression, a doubly robust Cox model with IPTW and covariate adjustment, and trimmed IPTW sensitivity analysis.
RESULTS: After weighting, characteristics were well balanced, with standardized mean differences of 0.037 for age, 0.004 for female sex, 0.005 for modified CCI score, and 0.003 for chronic kidney disease. Weighted Kaplan-Meier curves favored CD38-containing regimens, with absolute OS differences of 7.7%, 7.8%, 8.6%, 7.7%, and 9.6% at months 12, 24, 36, 48, and 60. Stabilized IPTW Cox regression showed improved OS with CD38-containing regimens (HR=0.63; 95% CI: 0.49-0.82; p=0.0006). Results were consistent in the doubly robust Cox model (adjusted HR=0.65; 95% CI: 0.50-0.84; p=0.001) and trimmed IPTW analysis (HR=0.63; 95% CI: 0.49-0.82; p=0.0005).
CONCLUSIONS: In this real-world Japanese NDMM cohort, 1L CD38-containing regimens were associated with improved OS versus non-CD38 regimens after robust adjustment. Findings support early access to innovative MM therapies in Japan.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO65
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology