Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

开始日期2024-03-20

申办/合作机构

Bayer AG

[+3]

NCT05688436

/ RecruitingN/A

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

开始日期2021-09-24

申办/合作机构

Biogen, Inc.

NCT04967430

/ Unknown status临床3期IIT

TOGETHER-Toronto: A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter, Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19

Interferon (IFN) lambda is one of the fundamental responses of the innate immune system. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming it safety and tolerability. It is particularly attractive for consideration in the use of acute respiratory illness due to the high expression of the lambda receptor in lung epithelia. We propose to evaluate peginterferon-lambda in ambulatory patients with mild to moderate COVID-19.

开始日期2021-08-27

申办/合作机构

University Health Network

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104

项与聚乙二醇干扰素β-1a 相关的文献（医药）

2025-02-01·Multiple Sclerosis and Related Disorders

Efficacy and safety of disease-modifying therapies in pediatric-onset multiple sclerosis: A systematic review of clinical trials and observational studies

Review

作者: Moćko, Paweł ; Brzostek, Tomasz ; Śladowska, Katarzyna ; Kawalec, Paweł

OBJECTIVE:

This study aimed to review the efficacy and safety profile of disease-modifying therapies (DMTs) in patients with relapsing pediatric-onset multiple sclerosis (POMS).

METHODS:

A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Published randomized controlled trials (RCTs), nonrandomized studies with a control group, large single-arm studies, and ongoing (unpublished) studies investigating the use of approved and unapproved DMTs in POMS were included. Eligible published studies were identified in MEDLINE (via PubMed), EMBASE, and the Cochrane Library, and unpublished studies were identified in a clinical trials registry (www.

CLINICALTRIALS:

gov).

RESULTS:

A total of 13 published studies were included in the systematic review: 4 RCTs, 3 observational studies with a control group, and 6 large single-arm studies. The following DMTs for the treatment of POMS were evaluated in the included studies: interferon beta-1a, interferon beta-1b, teriflunomide, dimethyl fumarate, fingolimod, natalizumab, glatiramer acetate, and ocrelizumab. All DMTs were shown to be effective in reducing relapse rates, preventing disability progression, and reducing disease activity in MRI in patients with POMS. DMTs that are considered highly effective in adults with multiple sclerosis (natalizumab, fingolimod) were also shown to be more effective than interferon beta-1a in POMS. A total of 9 ongoing (unpublished) studies were identified, including 5 RCTs. The following drugs were evaluated: ozanimod, fingolimod, peginterferon beta-1a, ocrelizumab, ofatumumab, siponimod, alemtuzumab, and natalizumab.

CONCLUSION:

The number of DMTs approved for the treatment of POMS is limited, and some of the available DMTs are used off-label. The available evidence from published studies of varying reliability supports the efficacy of DMTs in POMS. However, well-designed, long-term RCTs in the pediatric population are needed. The results of ongoing studies may fill the existing gap in clinical evidence, possibly leading to the approval of more highly effective DMTs for patients with POMS.

2024-10-01·Multiple Sclerosis and Related Disorders

Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients: A phase 3, randomized, non-inferiority clinical trial (PEGINTEGRITY)

Article

作者: Saeidi, Morteza ; Ghiasian, Masoud ; Baghbanian, Seyed Mohammad ; Abolfazli, Roya ; Ayromlou, Hormoz ; Ghalyanchi Langroodi, Hamidreza ; Asadollahzadeh, Elnaz ; Shaygannejad, Vahid ; Beladi Moghadam, Nahid ; Ashtari, Fereshteh ; Sabzvari, Araz ; Kafi, Hamidreza ; Azimi Saeen, Amirreza

BACKGROUND:

Multiple sclerosis (MS) is a prevalent, disabling, inflammatory, neurodegenerative disease that typically manifests during a highly productive stage of life. Interferon beta-1a was among the first approved disease-modifying therapies for MS and remains among the first-line treatment options. Pegylation of the interferon beta-1a molecule prolongs its half-life while maintaining its efficacy and safety profile. In PEGINTEGRITY study, we aimed to compare peginterferon beta-1a with interferon beta-1a in terms of efficacy and safety in relapsing-remitting multiple sclerosis (RRMS) patients.

METHODS:

This study was a randomized, active-controlled, parallel-group, multi-center Phase 3 trial conducted in Iran in participants with RRMS. Participants received 125 µg of subcutaneous peginterferon beta-1a every two weeks or 30 µg of intramuscular interferon beta-1a once a week for up to 96 weeks. The primary outcome was the non-inferiority of peginterferon beta-1a to interferon beta-1a in reducing annualized relapse rate (ARR). Other outcomes included the number of patients with 12-week confirmed disability progression, the number of new or newly-enlarging T2 hyperintense lesions, the number of gadolinium-enhancing lesions, the number of new T1 hypointense lesions, the volume of new or newly-enlarging T2 hyperintense lesions, changes in brain volume, immunogenicity, and safety assessments.

RESULTS:

A total of 168 patients who met the eligibility criteria were enrolled and assigned to two arms of the study, each consisting of 84 participants. Totally, 41 participants (24 patients in the peginterferon beta-1a group and 17 patients in the interferon beta-1a group) were withdrawn from the study. The withdrawn patients were included in the per-protocol analysis for the period of time they were in the study. In 96 weeks, in the per-protocol population, the ARR was 0.05 in the peginterferon beta-1a group versus 0.11 in the interferon beta-1a group, which does not reflect a statistically significant difference (p=0.09; 95 % CI, 0.18-1.14). Considering the upper limit of the one-sided 95 % CI of the rate ratio of peginterferon beta-1a compared to interferon beta-1a, as well as the non-inferiority margin, it can be concluded that the primary outcome was met. The results were also comparable for other efficacy and safety outcomes.

CONCLUSION:

The results demonstrate the non-inferiority of peginterferon beta-1a to interferon beta-1a with similar efficacy in 96-week ARR in RRMS patients. Both arms were also comparable in other efficacy outcomes and safety profiles with no statistically significant differences. These findings support considering peginterferon beta-1a as a safe and efficient option in patients with RRMS. This study was registered on Iranian Registry of Clinical Trials (IRCT201612306135N8) and clinicaltrials.gov (NCT05242133).

2024-04-01·Multiple Sclerosis Journal-Experimental Translational and Clinical

Safety and clinical effectiveness of peginterferon beta-1a for relapsing multiple sclerosis in a real-world setting: Final results from the Plegridy Observational Program

Article

作者: Kumar, Achint ; Belviso, Nicholas ; Nelles, Gereon ; Koster, Thijs ; Salvetti, Marco ; Castro-Borrero, Wanda ; Wray, Sibyl ; Vignos, Megan

Background:

Interferon beta-1a remains an important treatment option for multiple sclerosis, particularly when safety or tolerability concerns may outweigh the benefits of higher-efficacy disease-modifying therapies. The five-year phase 4 Plegridy Observational Program (POP) study (NCT02230969) collected data on real-world safety and effectiveness of Plegridy® (peginterferon beta-1a) treatment in patients with relapsing multiple sclerosis.

Objective:

To explore the real-world safety and effectiveness of peginterferon beta-1a in patients with relapsing multiple sclerosis, including factors influencing treatment discontinuation.

Methods:

Data were collected prospectively from patients ≥ 18 years old with relapsing multiple sclerosis for overall population analysis and for subpopulations including newly/previously diagnosed patients, age, and experience with peginterferon beta-1a. Outcome measures included annualized relapse rates, adverse events, and predictors of time to treatment discontinuation.

Results:

Mean (SD) treatment duration in the overall population ( N = 1172) was 896.0 (733.15) days. Incidence of adverse events was higher in new than experienced users (79.4% vs. 57.0%). New users were more likely than experienced users to discontinue (hazard ratio = 1.60; P < 0.0001). The adjusted annualized relapse rate was 0.09, and at the end of 5 years, 77.1% of patients were relapse-free.

Conclusions:

Peginterferon beta-1a is an effective therapy for managing relapsing multiple sclerosis. The identification of predictors of discontinuation can help inform strategies to enhance treatment persistence.

项与聚乙二醇干扰素β-1a 相关的新闻（医药）

2025-07-23

·细胞基因治疗前沿

20亿美元！又一MNC加码对美投资，强势扩大ASO产能

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。2025年7月21日，Biogen公司宣布计划在其位于北卡罗来纳州三角研究园（RTP）的现有生产基地额外投资20亿美元，旨在推动该公司后期临床管线的“持续发展”。自1995年破土动工以来，Biogen在RTP的生产基地在为全球数百万患者提供公司创新疗法产品线和产品组合方面发挥了至关重要的作用。迄今为止，Biogen已在其北卡罗来纳州的生产基地投资约100亿美元，其中近年来投资超过30亿美元。未来几年，Biogen计划继续在位于RTP的两个园区内投资“多种生产模式和工厂”。这些投资将包括进一步扩展反义寡核苷酸（ASO）的能力和基础设施，建立临床和商业多平台灌装与包装能力，并继续通过更先进的自动化和人工智能技术实现生产技术和控制的现代化。Biogen公司制药运营和技术主管Nicole Murphy表示：“我们长期致力于制造业创新、投资以及与三角研究园社区的合作，对此我们深感自豪。我们在美国的制造足迹在渤健的历史和成功中发挥了关键作用，并推动了对美国以及全球患者、家庭和社区产生影响的治疗方案的发展。通过此次投资，我们将现代化并扩展我们的制造能力，以支持我们的研发管线并提供可靠的患者供应，同时继续支持北卡罗来纳州的熟练且敬业的生命科学人才群体。”北卡罗来纳州的RTP是Biogen最大的生产基地所在地，是Biogen许多临床和商业产品的主要供应来源，目前渤健在该园区现有设施中生产Avonex、Plegridy、Tysabri 和 Qalsody 等药物。作为该州最大的生物技术雇主和五大生物制药雇主之一，Biogen在其威克县和达勒姆县的园区拥有超过1,500名制造和技术员工以及超过400名熟练的合同工。Biogen生产的90%以上的创新商业药物在美国进行生产和质量控制测试。位于威克县的Biogen生物园区（图源：公司官网）Biogen在北卡罗来纳州的制造业务包括多个模式的七家生产工厂。Biogen 现有的七家工厂中有四家构成了公司的 RTP Pharma 园区，分别用于反义寡核苷酸生产、肠外填充、口服固体剂量和基因治疗生产。RTP Pharma 是 Biogen 许多临床和商业产品的主要供应来源，包括治疗多发性硬化症、脊髓性肌萎缩症、肌萎缩侧索硬化症 (ALS) 和阿尔茨海默病的药物。渤健的另外三个现有工厂构成了其RTP Bio园区，专注于灵活批量生产、小规模生产和大规模生产。RTP生物园区生产一系列临床和商业化生物制品，用于治疗多发性硬化症、阿尔茨海默病和红斑狼疮等疾病，同时也支持寡核苷酸类药物的生产。由于需求不断增长，Biogen 多次扩建 RTP Bio，以适应对新制造技术和更大规模工厂的投资。第八家最先进的工厂目前正在建设中，预计将于2025年下半年投入运营。位于达勒姆县的Biogen制药园区（图源：公司官网）除了最先进的制造设施外，公司在北卡罗来纳州的园区还包括复杂的质量控制实验室，以确保所生产药品的安全性、有效性和纯度。渤健生产的超过90%的创新药物在美国进行制造和质量控制检测。今年3月，渤健宣布计划将其位于马萨诸塞州剑桥市的总部运营从三栋建筑整合至一栋建筑—Kendall Common，75 Broadway。Biogen 已签署一份为期15年的租约，租用位于Kendall Common的约580,000平方英尺的办公和研发空间，计划将其研发和技术运营团队以及全球和北美商业组织整合到一个位于同一地点的创新中心，从而将公司业务集中在Kendall Square。总结近几个月来，MNC纷纷宣布在美国重大投资计划。对美国制造和研发做出最大投资承诺的生物制药公司是强生公司，该公司承诺在四年内投资550亿美元。其他生物制药公司也做出了投资承诺，包括罗氏公司（五年内投资 500 亿美元）、百时美施贵宝公司（五年内投资 400 亿美元）、礼来公司（投资 270 亿美元，加上自 2020 年以来已投入的230亿美元）、诺华公司（五年内投资 230 亿美元）、阿斯利康公司（到2026年底投资35亿美元，到2030年将在美国投资500亿美元）、安进公司（在俄亥俄州新奥尔巴尼投资9亿美元扩建工厂）以及赛默飞世尔科技公司（四年内投资 20 亿美元）。默沙东也在3月宣布，将在北卡罗来纳州开设一家生产四价HPV疫苗的工厂。默沙东计划在原有工厂的基础上进行扩建，预计追加投资10亿美元。目标产能覆盖全球需求30%。默沙东表示，这间工厂工厂始建于2004年，目前已拥有1000多名员工，去年生产7000多万剂疫苗，包括预防水痘、麻疹、风疹等多种疫苗产品。同时，默沙东计划到2028年，在美投资80亿美元。再生元制药与CDMO巨头富士胶片Diosynth达成合作，宣布了一项为期10年、价值超过30亿美元的制造供应协议，旨在提供美国生物制剂的生产。参考资料：公司公告-END-扫码参与报名

寡核苷酸核酸药物

2025-05-05

·梅斯医学

双手越来越无力，肌肉慢慢萎缩，真正的“元凶”藏得太深了！

26岁的王先生（化名）是一位程序员，平时性格温和、思维敏捷。两年前，他开始出现一些“莫名其妙”的症状：先是右手食指无力，敲键盘时经常敲不准，后来连水杯也握不稳。起初他以为是工作太累、颈椎出了问题。休息、按摩、贴膏药，怎么也不见好，反而逐渐加重。第一次就诊是在他出现右手腕明显下垂后，检查提示右桡神经功能受损，但并无外伤史或压迫因素。当时被当作单纯的“周围神经病”处理。但半年后，他左手也出现了类似无力，接着右上臂也开始变得“提不起来”，同时手部肌肉逐渐萎缩。奇怪的是，整个过程中他从未出现麻木或感觉障碍。多次求医，MRI、颈椎CT、血液检查结果都未能明确诊断，肌电图提示多发性运动神经传导阻滞，医生怀疑是某种罕见的神经疾病。直到一次神经科会诊中，有经验的专家敏锐察觉到其肌无力分布“跳跃性”和“不对称性”的特点，并进一步完善电生理检查，发现其非嵌压部位存在典型的运动传导阻滞，而感觉神经传导正常，结合症状进展缓慢、无感觉障碍，最终高度怀疑多灶性运动神经病（MMN），随后完善抗GM1抗体检测，结果阳性。什么是多灶性运动神经病多灶性运动神经病（multifocal motor neuropathy, MMN），是一种自身免疫相关的多发单神经病变。该病起病隐匿、进展缓慢，早期上肢神经受累多见，表现为不对称性肢体远端为主的无力、萎缩，无客观感觉障碍，随病情进展最终可导致肌肉无力萎缩而致残。临床表现多灶性运动神经病（MMN）可发生于任何年龄。起病通常隐匿，病程呈缓慢进展或阶段性加重，可出现较长时间的稳定期。临床表现以多发性单神经病为特征。早期多见于单侧上肢一根或多根神经受累，表现为相应神经支配区域的肌肉无力，主要累及远端肌群，可伴有痉挛或束颤。肌无力的分布通常不对称，可见同一肢体内不同神经受累程度不同，或双侧肢体、上下肢之间存在差异，甚至同一神经支配区域内不同肌肉的无力程度亦可不同。随着病情进展，患者可出现肌肉萎缩。病程较长者可累及多个肢体多根神经，不对称性可能减弱，呈类似多发性周围神经病的分布。部分患者可主诉轻微感觉异常，但通常无明显客观感觉障碍，病程后期个别患者可出现轻度感觉神经受累。脑神经一般不受累。部分无明显无力的肢体腱反射可正常甚至活跃，临床检查无上运动神经元受累体征。诊断诊断依靠临床表现、神经系统查体、实验室检查、神经电生理和神经影像学检测。隐袭起病，缓慢或阶段性进展的双侧肢体远端不对称无力萎缩患者，结合神经系统查体发现至少有2根神经受累，早期上肢受累多见，表现为不对称性肢体无力，随病情发展可出现肌肉萎缩，无客观的感觉异常体征。运动神经传导测定，在非嵌压部位，至少2根神经或1根神经的两个节段出现运动神经部分传导阻滞，相应部位的感觉神经传导正常。血清或脑脊液GM1抗体阳性，IVIG治疗有效等均可支持诊断。治疗静脉注射免疫球蛋白（IVIG）是MMN的一线治疗。多项研究表明，IVIG可改善肌无力和生活质量，可能延缓轴索变性。初始推荐剂量为0.4 g/kg/d，连续5天，部分患者1周内可见疗效，但维持时间一般为1个月左右。有效者可根据个体情况进行间断维持治疗。皮下注射免疫球蛋白在国外已有应用，疗效与静脉注射相当。免疫抑制剂的疗效尚不明确。对于IVIG无效或无法使用者，可尝试环磷酰胺（2–3 mg/kg/d），部分患者有效，亦可用于减少IVIG用量，需密切监测不良反应。其他药物如干扰素β-1a、硫唑嘌呤、环孢素仅见于小样本或个案报道，疗效有限。糖皮质激素可能加重病情，不推荐常规使用。血浆置换在个别患者中可能有效，但亦可能导致症状恶化，不建议常规采用。参考资料：[1]郝嫣霞,陈海,笪宇威,等.多灶性运动神经病临床特点分析[J].北京医学,2018,40(05):410-412+416+492.DOI:10.15932/j.0253-9713.2018.05.009.[2]Corbo M, Quattrini A, Latov N, et al.Localization of GM1 and Gal (beta1-3) Gal NAc antigenic determinants in peripheral nerve[J].Neurology, 1993, 43:809-814.[3]王银霞，吴荷花,张国华,等.急性运动轴索性神经病与急性炎性脱髓鞘性多神经病的比较研究[J].北京医学，2017,39:1142-1145.来源 | 梅斯医学编辑 | wanny神经系统罕见病交流群↓点击下方“阅读原文”，下载梅斯医学APP吧！

2025-03-31

·Pharma CMC

创新药 “爆发” 获批！今日85个上市申请获NMPA批准

刚刚，NMPA发布2025年03月31日药品批准证明文件送达信息，本批次共有85个受理号获批，均为上市申请，其中多款创新药获批：此前，NMPA公告过的：宜昌东阳光长江药业的艾考磷布韦片获批上市，用于与磷酸萘坦司韦胶囊联用，治疗初治或干扰素经治的基因1、2、3、6型成人慢性丙型肝炎病毒（HCV）感染，可合并或不合并代偿性肝硬化。江西科睿药业申报的玛舒拉沙韦片获批上市，用于既往健康的12岁及以上青少年和成人单纯性甲型和乙型流感患者的治疗，不包括存在流感相关并发症高风险的患者。恒瑞医药的硫酸艾玛昔替尼片获批上市，用于治疗对一种或多种TNF抑制剂疗效不佳或不耐受的活动性强直性脊柱炎成人患者。此外，参天制药的他氟噻吗滴眼液获批上市，推测适应症为：用于降低开角型青光眼或高眼压症成年患者的眼压（IOP），用于对局部单独使用β-受体阻滞剂或前列腺素衍生物疗效不佳而需要联合治疗的患者。他氟噻吗滴眼液是不含防腐剂的0.0015%他氟前列素和0.5%马来酸噻吗洛尔固定剂量复方滴眼液，含有两种对房水动力学有不同作用机制的有效成分，每日滴眼1次即可达到与联合用药相同的有效性和安全性。罗氏的奥瑞利珠单抗注射液（罗可适®）获批上市，每六个月静脉输注一次给药，用于治疗成人复发型多发性硬化症（RMS，包括临床孤立综合征、复发缓解型多发性硬化和活动性继发进展型多发性硬化）和成人原发进展型多发性硬化症（PPMS）。奥瑞利珠单抗是罗氏开发的靶向CD20阳性B细胞的单抗药物。针对复发型多发性硬化症（RMS）的两项随机、双盲、双模拟、阳性药物对照III期临床试验OPERA I和OPERA II结果显示，与干扰素β-1a治疗相比，奥瑞利珠单抗可以显著降低患者的年复发率（ARR）及致残比例（12周确认残疾进展CDP的患者比例）。优时比的罗泽利昔珠单抗注射液获批上市，用于治疗重症肌无力（gMG）。公开资料显示，罗泽利昔珠单抗是一款靶向人类胎儿Fc受体（FcRn）的单克隆抗体，此前已在美国、欧盟、日本等地区获批用于治疗全身性重症肌无力成人患者。百时美施贵宝旗下两款肿瘤免疫治疗药物——欧狄沃（纳武利尤单抗注射液）与逸沃(伊匹木单抗注射液）的联合疗法获批新适应症，用于不可切除或晚期肝细胞（HCC）成人患者的一线治疗，这是中国首个且目前唯一获批的肝细胞癌一线双免疫联合疗法。此次获批基于I期CheckMate-9DW研究，该研究在全球范围内首次证实免疫治疗方案用于肝细胞癌一线治疗，疗效可显著优于两种既往标准治疗药物(仑伐替尼或索拉非尼）。有关研究数据证实：双免方案不仅缓解率高，而且一旦起效，缓解持续时间（DOR）和总生存期（OS）都显著延长。完整批件信息如下：

上市批准临床3期临床2期

100 项与聚乙二醇干扰素β-1a 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10483	聚乙二醇干扰素β-1a	L03AB13	DB09122

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
多发性硬化症	美国	Biogen, Inc.	2014-08-15
复发-缓解型多发性硬化	欧盟	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	冰岛	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	列支敦士登	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	挪威	Biogen Netherlands BV	2014-07-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
流感样症状	临床3期	美国	Biogen, Inc.	2013-11-01
复发性多发性硬化	临床3期	美国	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	比利时	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	保加利亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	加拿大	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	智利	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	哥伦比亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	克罗地亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	捷克	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	爱沙尼亚	Biogen, Inc.	2009-06-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2023)	N/A	多发性硬化症	247	Interferon beta-1a	糧窪遞膚夢繭遞遞鏇膚(願顧範積糧艱鹹觸鬱鹽) = comparable between exposed children and controls during the observation period 鬱選夢壓衊構繭願觸鹹 (願衊鬱齋範鹽製構鑰壓 ) 更多	积极	2023-09-30
NCT03870763 (CTgov)	临床3期	复发-缓解型多发性硬化	11	Dimethyl Fumarate (Dimethyl Fumarate 240 mg)	餘蓋齋鹹鬱築築鹽襯襯(築鑰壓網選鹽鏇衊艱壓) = 艱願構簾壓網觸鹽構糧襯窪廠鑰艱繭築繭鏇製 (齋構衊簾壓鏇繭膚遞襯, 鏇願餘製襯製鑰選衊鹹 ~ 鑰窪蓋蓋壓範鹽廠觸衊) 更多	-	2023-05-16
				Peginterferon Beta-1a (Peginterferon Beta-1a 125 µg)	餘蓋齋鹹鬱築築鹽襯襯(築鑰壓網選鹽鏇衊艱壓) = 糧夢簾艱膚製網壓鑰窪襯窪廠鑰艱繭築繭鏇製 (齋構衊簾壓鏇繭膚遞襯, 簾鹽製簾願繭鑰鑰廠廠 ~ 願廠憲鬱範鬱醖網網淵) 更多
German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2022)	N/A	多发性硬化症	70	Interferon-beta 1a exposure during pregnancy	鑰淵鑰膚齋獵觸糧壓鏇(鹽顧壓簾膚遞遞選願壓) = 願鑰廠鹽簾窪繭鑰選廠膚憲鏇糧積齋淵衊繭獵 (願獵繭壓願憲鏇積醖淵 )	积极	2022-10-12
IMSE 6 (ECTRIMS2021)	N/A	-	393	Peginterferon beta-1a	鑰構選選鏇鹽襯餘艱構(鹹網餘繭鹹夢餘範遞製) = General disorders and administration site were also the most common for non-serious AEs (68%) 獵窪網範鏇夢積廠範構 (簾範夢艱壓鏇糧網蓋選 ) 更多	积极	2021-10-12
Plegridy Observational Program (ECTRIMS2021)	N/A	复发性多发性硬化	1,208	Peginterferon beta-1a	範繭膚遞獵鏇餘顧觸鏇(積夢衊壓廠製夢繭壓積) = 鑰簾鬱衊獵鹽顧齋夢淵鏇構衊鬱憲遞顧構製壓 (繭鏇膚襯憲蓋觸繭膚餘 ) 更多	积极	2021-10-12
				Placebo	範繭膚遞獵鏇餘顧觸鏇(積夢衊壓廠製夢繭壓積) = 願鹽餘醖範襯淵構醖膚鏇構衊鬱憲遞顧構製壓 (繭鏇膚襯憲蓋觸繭膚餘 ) 更多
NARCOMS (ECTRIMS2020)	N/A	复发性多发性硬化	-	Intramuscular interferon beta-1a	網憲築繭鬱艱齋餘簾憲(選壓鹹憲醖鹽夢淵遞憲) = 構壓簾淵蓋襯餘醖淵蓋範構製繭夢膚鏇壓糧願 (蓋醖構鹽積糧觸齋衊鑰 ) 更多	积极	2020-12-07
				Peginterferon beta-1a	網憲築繭鬱艱齋餘簾憲(選壓鹹憲醖鹽夢淵遞憲) = 願鬱憲襯夢壓齋築構膚範構製繭夢膚鏇壓糧願 (蓋醖構鹽積糧觸齋衊鑰 ) 更多
PLEGRIDY Observational Program (ECTRIMS2020)	临床4期	复发性多发性硬化	1,208	peginterferon beta-1a (Newly diagnosed patients)	網衊鏇獵選構醖壓鏇膚(觸艱鬱齋選鑰獵鬱蓋壓) = 鏇醖齋築齋蓋糧獵餘淵築觸願範鹹選鹹膚獵憲 (鏇獵壓構鏇築積餘獵願 ) 更多	-	2020-12-07
				peginterferon beta-1a (Non-newly diagnosed patients)	網衊鏇獵選構醖壓鏇膚(觸艱鬱齋選鑰獵鬱蓋壓) = 鏇襯願壓衊範餘築製簾築觸願範鹹選鹹膚獵憲 (鏇獵壓構鏇築積餘獵願 ) 更多
IMSE 6 (ECTRIMS2020)	N/A	-	364	Peginterferon beta-1a	壓鑰壓製淵鬱艱齋構願(衊積壓憲遞範鏇糧衊鹹) = A total number of 18 adverse events (6 serious) were reported to Swedish Medical Product Agency. 襯廠窪獵壓膚蓋積獵鬱 (蓋窪糧齋淵鹹鹽簾鬱壓 )	-	2020-12-07
MS PATHS (ECTRIMS2020)	N/A	-	817	Peginterferon beta-1a	簾淵簾糧膚蓋繭窪願願(範網積淵築鑰夢顧選壓) = 鏇窪鏇醖鹹鑰餘淵選鏇繭積廠襯壓繭遞鹹觸憲 (夢廠獵顧遞夢醖鹽獵繭 ) 更多	积极	2020-12-07
				Intramuscular interferon beta-1a	簾淵簾糧膚蓋繭窪願願(範網積淵築鑰夢顧選壓) = 鬱壓蓋築積齋鹽獵廠鏇繭積廠襯壓繭遞鹹觸憲 (夢廠獵顧遞夢醖鹽獵繭 ) 更多
ECTRIMS2020	N/A	-	-	Peginterferon beta-1a	襯鹹範獵淵鑰醖膚鹽糧(遞餘鑰膚蓋獵齋憲遞窪): ARR ratio = 1.18 (95% CI, 0.72 ~ 1.94), P-Value = 0.5047 更多	-	2020-12-07
				Non-pegylated interferons