| アブストラクト | Background: Although anti-CD38 monoclonal antibody-based regimens are standard care for newly diagnosed multiple myeloma (NDMM), direct comparative efficacy and comprehensive real-world safety data remain scarce. Methods: We conducted a systematic review and Bayesian network meta-analysis (NMA) of randomized controlled trials (RCTs). Efficacy was assessed using hazard ratios (HRs) for progression-free survival and odds ratios (ORs) for response rates, with treatment rankings evaluated by Surface Under the Cumulative Ranking (SUCRA) values. Separately, adverse event reports for daratumumab, bortezomib, lenalidomide, and dexamethasone (D_VRd) regimens were extracted from the US FDA Adverse Event Reporting System (FAERS) (Q1 2015-Q2 2025). Statistical analyses were performed using R (4.3.3) and STATA (16.0). Results: The NMA included 33 RCTs. For the primary efficacy endpoints, compared to the standard bortezomib, lenalidomide, and dexamethasone (VRd) regimen, both D_VRd (OR = 3.21, 95% CI: 2.46-4.26; HR = 0.48, 95% CI: 0.38-0.63) and isatuximab plus VRd (Isa_VRd) (OR = 1.71, 95% CI: 1.25-2.32; HR = 0.66, 95% CI: 0.51-0.85) regimens demonstrated superior efficacy. Subsequent pharmacovigilance analysis of D_VRd identified 11,714 FAERS reports, yielding 197 significant adverse drug event signals (64 unlabeled). These signals primarily affected elderly males and showed a bimodal distribution pattern. Conclusions: Combination regimens containing anti-CD38 monoclonal antibodies demonstrate superiority in achieving deep remission and survival benefits, with D_VRd and Isa_VRd regimens showing particularly outstanding performance. However, efficacy and safety profiles vary across different combination regimens. Real-world data analysis further indicates that the D_VRd regimen carries several safety risk signals that remain underappreciated and exhibits a bimodal time distribution pattern. These findings provide new evidence to guide clinical decision-making and risk-stratified monitoring. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2026/1/28 |
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| 投稿者 | Liu, Yanjun; Zhang, Ying; Yang, Wenhui; Du, Haoyan; Sun, Shijie; Li, Zuojing; Zong, Dongsheng |
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| 組織名 | School of Clinical Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016,;China.;National Medical Products Administration, Beijing 100037, China.;School of Medical Devices, Shenyang Pharmaceutical University, Shenyang 110016, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41599619/ |
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