Ianalumab

点击“蓝字”关注我们 编者按：2型糖尿病（T2DM）是全球范围内最常见的糖尿病类型，其发病率呈逐年上升趋势，对人类健康构成了严重威胁。高甘油三酯血症（HTG）作为一种常见的脂质代谢异常疾病，与多种心血管疾病和代谢综合征密切相关。近年来，越来越多的研究表明，高甘油三酯血症可能是2型糖尿病的一个风险因素。近期，一项发表在Front Endocrinol (Lausanne)的题为“Hypertriglyceridemia is a dose-dependent risk factor for type 2 diabetes mellitus: a systematic review and meta-analysis”的系统综述与荟萃分析，深入探讨了HTG与T2DM之间的关系，为临床预防和治疗提供参考依据。 研究背景 2021年，全球超过5.3亿成年人患有糖尿病，预计到2045年将增至7.83亿，给医疗系统带来诸多挑战，如医疗成本上升、并发症风险增加等。其中，T2DM占比超90%。T2DM由遗传、环境和生活方式因素（如不良饮食、缺乏运动、肥胖）引起，约80%可通过调节风险因素预防。 HTG是代谢综合征的重要组成部分，与心血管疾病、胰腺炎等密切相关，也是T2DM的潜在可调节风险因素。甘油三酯相关指标，如甘油三酯-葡萄糖指数（TyG）、甘油三酯与高密度脂蛋白胆固醇比值（TG/HDL-C），已被证实与T2DM风险增加相关，但甘油三酯在T2DM发生中的剂量依赖性作用尚待全面评估。 基于此，本研究旨在在系统评估HTG对T2DM发生的剂量依赖性效应，为临床医生更好评估风险并实施干预。 研究方法 本研究为系统综述与荟萃分析，遵循PRISMA指南和Cochrane手册建议，采用布达佩斯塞梅尔韦斯大学的教育-研究模式。2023年11月9日，对MEDLINE、Embase和CENTRAL三个数据库进行系统检索，探究成年人群中不同甘油三酯水平（暴露情况）与T2DM发生（关注结果）的关系。 资格标准与定义 01 人群（P）：基线时无糖尿病的成年患者。 暴露（E）：不同水平的甘油三酯（TG）及甘油三酯相关指标（如TyG指数、TG/HDL-C比值、HTGW表型）。HTG定义为>1.7 mmol/L（>150 mg/dl），TyG指数计算公式为ln [空腹甘油三酯（mg/dl）×空腹血糖（mg/dl）/2]。HTGW表型分为四组：(1) 正常TG和正常腰围（对照组）；(2) 高TG和正常腰围（HTNW）；(3) 正常TG和高腰围（NTGW）；(4) 高TG和高腰围（HTGW）。 结果（O）：发展为T2DM或糖尿病前期。T2DM诊断标准主要为空腹血糖≥7.0 mmol/L（126 mg/dl）和/或HbA1c≥6.5%，特殊情况在偏倚风险评估中考虑。 研究类型：涵盖所有出版年份和语言的研究，排除会议摘要、综述、病例报告和病例系列。 数据分析 02 采用随机效应模型计算合并风险比（HR）、比值比（OR）和均数差（MD），并报告对应的95%置信区间（CI）。并通过森林图总结，用τ2和I2统计量描述研究间异质性，研究数量≥8时，报告预测区间。通过漏斗图和Egger检验或Harbord检验评估发表偏差，探索潜在异常值发表。所有统计分析使用R软件及相关软件包进行。 研究结果 从三个数据库共检索到31 098篇文章，经筛选及参考文献核查，最终纳入145项研究。其中，101项研究符合定量荟萃分析条件；其余44项因研究人群重叠、统计数据不足或缺乏可合并的效应量，仅纳入系统综述进行定性分析。 TG 01 首先，研究分析了基线有无HTG（TG>1.7 mmol/L或≥150 mg/dL）对T2DM的影响。8项队列研究结果显示，基线时患有HTG的个体在随访期间发展为T2DM的风险高出1.5倍以上（HR: 1.73，95%CI：1.31~2.29）。为进一步探讨甘油三酯（TG）水平的剂量依赖性影响，研究还增加了两个亚组分析：TG1.7~2.3 mmol/L vs. <1.7 mmol/L；TG>2.3 mmol/L vs. <1.7 mmol/L。结果显示，与TG<1.7 mmol/L相比，TG1.7~2.3 mmol/L发生糖尿病的风险高出约1.5倍（HR: 1.42，95%CI：1.13~1.79）；而TG水平更高（>2.3 mmol/L）者患糖尿病的风险更高（HR: 1.84，95%CI：1.18~2.87）（图1）。 图1.不同基线糖尿病组的并发症风险比 其次，研究发现，基线时糖尿病患者的平均TG水平比非糖尿病者高出约0.46 mmol/L（MD：0.46 mmol/L，95%CI：0.41~0.52）。在随访期间进展为糖尿病前期的个体，其基线TG水平虽低于最终发展为T2DM者，但仍显著高于未发病人群，平均升高0.31 mmol/L（95%CI：0.06~0.56）。亚组分析显示，女性的TG升高幅度略大于男性（女性MD：0.50 mmol/L，95%CI：0.37~0.64；男性MD：0.45 mmol/L，95%CI：0.32~0.58）。因此，6项研究的剂量-反应分析表明，TG每升高50 mg/dL（≈0.56 mmol/L），T2DM发病风险增加8%（HR：1.08，95%CI：1.04~1.13）。此外，将TG按标准差增量进行分析的结果也一致支持：甘油三酯水平升高是T2DM的独立风险因素。 高甘油三酯腰部表型 02 在评估HTGW表型时，研究发现：腰围升高但甘油三酯（TG）水平正常者（NTGW表型）糖尿病风险显著增加（女性：HR=2.86，95%CI：1.59~5.14；男性：HR=3.31，95%CI：1.51~7.27）；TG升高但腰围正常者（HTNW表型）风险亦有所上升，但置信区间较宽，统计学意义有限（女性：HR=2.30，95%CI：0.66~7.95；男性：HR=1.82，95%CI：0.95~3.48）；TG与腰围均升高者（HTGW表型）表现出最高的风险趋势，男女T2DM风险均增加逾3.5倍，但由于置信区间过宽且包含无效值（女性：HR=3.54，95%CI：0.52~23.94；男性：HR=3.51，95%CI：0.59~20.84），结果未达统计学显著性（图2）。 图2. 在不同高甘油三酯腰部表型中糖尿病发病风险比 TG/HDL-C 03 在评估TG/HDL-C时。结果显示，处于TG/HDL-C最高四分位数（Q4）的参与者，其糖尿病发病风险显著高于最低四分位数（Q1）者（HR=2.17，95%CI：1.53~3.09），这一正向关联在性别亚组中均保持一致：女性（HR=1.91，95% CI：1.08~3.38）和男性（HR=1.65，95%CI：1.16~2.35）均表现出显著升高的风险（图3）。此外，基线时已确诊糖尿病患者的TG/HDL-C比值亦显著高于非糖尿病人群（MD=0.65，95%CI：0.20~1.10）。进一步剂量-反应分析表明，TG/HDL-C比值每增加1个单位，糖尿病发病风险上升14%（HR=1.14，95%CI：1.00~1.31），提示该指标具有连续性风险预测价值。 图3. 在不同TG/HDL-C中糖尿病发病风险比 TyG 04 在分析TyG指数时，研究观察到与TG/HDL-C比值相似的结果。人群中TyG指数处于最高四分位数（Q4）的个体，其2型糖尿病（T2DM）发病风险是最低四分位数（Q1）者的3倍以上（HR=3.25，95%CI：1.91~5.52），这一效应量高于TG/HDL-C比值所反映的风险（图4）。基线TyG指数在后续发展为T2DM者与未发病者之间存在显著差异，平均差值为0.30（95%CI：0.21~0.40）。进一步分析显示，TyG指数每增加1个标准差（SD），T2DM发病风险显著升高36%（HR=1.36，95%CI：1.15~1.60）。而当以绝对单位增量评估时（每增加1个单位），风险比为HR=1.91（95%CI：0.61~5.98）。 图4. 在不同TyG中糖尿病发病的风险比 结语 本研究首次系统证实：甘油三酯（TG）水平及其衍生指标（如TyG指数、TG/HDL-C比值和HTGW表型）与2型糖尿病（T2DM）风险呈显著剂量依赖性关联。升高的TG不仅反映代谢紊乱，更通过脂毒性、炎症和胰岛素抵抗等机制直接推动T2DM发生。这些指标成本低、易获取，可作为早期筛查和风险分层的实用工具。尤其在腰围增大合并高TG人群中，T2DM风险显著升高，女性尤为突出。未来应加强生活方式干预，并探索新型降TG疗法，将这些标志物纳入糖尿病预防策略，助力精准防控。 参考文献：1.Havelda L, et al. Front Endocrinol (Lausanne). 2025 Nov 5;16:1710007.  声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。 最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！ （来源：《国际糖尿病》编辑部） 版权声明 版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

Positive results from ianalumab pivotal Phase III trial in ITP patients previously treated with corticosteroids to be presented as late-breakerScemblix data across clinical and real-world settings offer new evidence informing CML care amid evolving patient needs 96-week pelabresib Phase III data represent longest follow-up of first-line myelofibrosis patients in randomized combination trialKisqali NATALEE and MONALEESA data add to evidence of long-term benefits for early and metastatic breast cancer patients Basel, November 25, 2025 – Novartis will present data from over 70 abstracts, including investigator-initiated trials at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition and 2025 San Antonio Breast Cancer Symposium® (SABCS). Featured among these latest advances in hematology and oncology are 11 oral presentations, with the Phase III VAYHIT2 trial for ianalumab in immune thrombocytopenia (ITP) accepted as a late-breaker abstract.“For decades, Novartis has redefined the future of hematology and oncology, and we’re building on that foundation with compelling new data presented at ASH and SABCS,” said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. “These data underscore how we seek to set new standards for transformative care, with the aim of turning cutting-edge innovation into meaningful impact for patients.”Key highlights of data accepted by ASH include: Abstract Title Abstract Number/ Presentation Details Ianalumab (VAY736)Primary results from VAYHIT2, a randomized, double-blind, Phase 3 trial of ianalumab plus eltrombopag versus placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatmentAbstract #LBA-2Oral PresentationDecember 9, 7:45 – 8:00 am ETSecondary analysis results from VAYHIT3, a Phase 2 study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapyAbstract #844Oral PresentationDecember 8, 3:30 – 3:45 pm ETScemblix® (asciminib)Asciminib (ASC) demonstrates continued improvement in patient-reported outcomes (PROs) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST week 96 analysisAbstract #1997Poster PresentationDecember 6, 5:30 – 7:30 pm ETImproved long-term tolerability with asciminib (ASC) vs investigator-selected (IS) tyrosine kinase inhibitors (TKIs) in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Week 96 exploratory analysis of the phase 3 ASC4FIRST trialAbstract #5549Poster PresentationDecember 8, 6:00 – 8:00 pm ETAsciminib (ASC) in chronic myeloid leukemia in chronic Phase (CML-CP): Efficacy and safety results of the Phase 2 ASC2ESCALATE trial in the cohort of patients (pts) with 1 prior tyrosine kinase inhibitor (TKI)Abstract #906Oral PresentationDecember 8, 4:00 – 4:15 pm ETA comparison of real-world outcomes of asciminib versus ATP-competitive tyrosine kinase inhibitors as second-line treatment in patients with chronic myeloid leukemia in chronic phaseAbstract #724Oral PresentationDecember 7, 5:15 – 5:30 pm ETPelabresib (DAK539)Durable efficacy and long-term safety with pelabresib plus ruxolitinib in JAK Inhibitor–Naive myelofibrosis: 96-week Results from the Phase III MANIFEST-2 studyAbstract #910Oral PresentationDecember 8, 3:30 – 3:45pm ETRapcabtagene autoleucel (YTB323)Rapcabtagene autoleucel (YTB323) for patients with first line high-risk large B-cell lymphoma: phase II interim resultsAbstract #670Oral PresentationDecember 7, 5:15 – 5:30 pm ETFabhalta® (iptacopan)Oral iptacopan monotherapy demonstrates clinically meaningful hemoglobin increases in patients with paroxysmal nocturnal hemoglobinuria with baseline hemoglobin levels 10 to <12 g/dL on anti-C5 therapy: Subgroup analysis of the APPULSE-PNH Phase 3b trialAbstract #4981Poster PresentationDecember 8, 6:00 – 8:00 pm ETLong-term safety and efficacy of iptacopan in patients with paroxysmal nocturnal hemoglobinuria: 4- and 5-year follow-up of patients from phase 2 studies who entered the roll-over extension programAbstract #3198Poster PresentationDecember 7, 6:00 – 8:00 pm ETThe 2-year efficacy and safety of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria with a history of aplastic anemia on concomitant immunosuppressive therapy who entered the roll-over extension programAbstract #4978Poster PresentationDecember 8, 6:00 – 8:00 pm ET Key highlights of data accepted by SABCS include: Kisqali® (ribociclib)Pooled analysis of patients (pts) treated with 1st-line (1L) ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) studies: long-term progression-free survival (PFS)Abstract # PD5-10Poster Spotlight PresentationDecember 11, 8:09 – 8:12 am CSTFive-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC)Abstract # PS3-09-08Poster PresentationDecember 11, 12:30 – 2:00 pm CSTProgression-free survival (PFS) and overall survival (OS) results from the phase 3 MONALEESA-3 trial of postmenopausal patients with hormone receptor–positive (HR+)/HER2-negative (HER2−) advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL): A subgroup analysis of patients with invasive lobular carcinoma (ILC) Abstract # PS1-10-27 Poster PresentationDecember 10, 12:30 – 2:00 pm CSTRibociclib drug-drug interaction and concomitant medication management in early and advanced breast cancer patientsAbstract # PS3-09-15Poster PresentationDecember 11, 12:30 – 2:00 pm CSTReal-world patient (pt) and caregiver experiences with breast cancer (BC) risk of recurrence (ROR) in the US: Results of an Online Survey and Social Media Analysis Abstract # PS1-04-17Poster PresentationDecember 10, 12:30 – 2:00 pm CSTRepower: a real-world noninterventional study of outcomes and experiences in patients with hormone receptor-positive (HR+)/human epidermal growth fact receptor 2-negative (HER2−) early breast cancer (EBC) treated with an adjuvant cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) plus endocrine therapy (ET) Abstract # PS3-08-27Poster PresentationDecember 11, 12:30 – 2:00 pm CST Product InformationFor full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.Novartis in hematologyOur legacy in hematology runs deep, shaped by over 25 years of progress, partnerships and a commitment to keep asking questions, challenging norms and striving for better answers in a uniquely complex field. In the past two decades, we have delivered more than 10 medicines across more than 15 blood cancers and serious blood disorders including leading the era of targeted therapies in cancer and bringing the first CAR-T therapy to patients. Innovation in hematology has brought significant progress, yet patients and clinicians continue to face persistent challenges. We’re forging the future of hematology, powered by our foundation in scientific discovery to deliver meaningful change for patients with unmet needs.Novartis in breast cancer For over 30 years, Novartis has been at the forefront of driving scientific advancements for individuals affected by breast cancer and enhancing clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease. 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Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. # # # Novartis Media RelationsE-mail: media.relations@novartis.comNovartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com