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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100 项与聚乙二醇干扰素β-1a 相关的专利（医药）

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101

项与聚乙二醇干扰素β-1a 相关的文献（医药）

2025-09-03·Neurodegenerative Disease Management

Outcomes of older patients with multiple sclerosis treated with interferon beta-1a or peginterferon beta-1a in MS PATHS

Article

作者: Belviso, Nick ; Zhovtis Ryerson, Lana ; Hua, Le H. ; Vignos, Megan ; Hersh, Carrie M.

BACKGROUND:

The peak prevalence of multiple sclerosis (MS) is shifting to older patients. Using real-world data, we describe outcomes among older (≥60 years) and younger patients treated with interferon beta-1a or no disease-modifying therapy (no-DMT).

METHODS:

Assessments over 24 months included annualized relapse rates (ARRs), patient-reported disability outcomes, and MS Performance Test (MSPT) outcomes.

RESULTS:

The study included 767 interferon-treated and 2783 no-DMT patients. ARR over 24 months was lower for the older and younger interferon-treated patients than the no-DMT patients. Mean change in Patient-Determined Disease Steps (PDDS) from baseline-24 months was -0.13 (1.08) in older interferon-treated patients vs 0.20 (1.30) in older no-DMT patients.

CONCLUSION:

Over 24 months ARR remained low and disability progression was stable for interferon-treated patients aged ≥ 60 years.

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: Brzostek, Tomasz ; Moćko, Paweł ; 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 ; Kafi, Hamidreza ; Ashtari, Fereshteh ; Sabzvari, Araz ; 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).

项与聚乙二醇干扰素β-1a 相关的新闻（医药）

2025-08-29

·EINPresswire

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

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！

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

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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


NCT03870763 (CTgov)	临床3期	复发-缓解型多发性硬化	11	Dimethyl Fumarate (Dimethyl Fumarate 240 mg)	夢衊鹽夢廠廠淵構廠膚(艱顧簾夢積憲積夢製衊) = 餘齋襯顧網願餘獵選淵襯膚遞餘鹽廠廠糧遞顧 (構選顧憲醖齋遞觸蓋壓, 夢鏇襯製鏇簾夢衊醖獵 ~ 鑰繭夢鑰遞膚鑰壓蓋願) 更多	-	2023-05-16
				Peginterferon Beta-1a (Peginterferon Beta-1a 125 µg)	夢衊鹽夢廠廠淵構廠膚(艱顧簾夢積憲積夢製衊) = 窪壓築鬱鹽構醖醖鏇鏇襯膚遞餘鹽廠廠糧遞顧 (構選顧憲醖齋遞觸蓋壓, 膚觸顧積壓憲獵夢醖壓 ~ 蓋醖餘衊觸顧鏇鬱壓獵) 更多
ECTRIMS2021	N/A	-	393	Peginterferon beta-1a	積齋獵簾選顧醖鏇顧糧(積蓋窪齋齋憲鏇衊廠廠) = General disorders and administration site were also the most common for non-serious AEs (68%) 遞淵構積鏇鹽鑰襯廠製 (襯醖網鑰範積艱廠鬱顧 ) 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	蓋襯繭艱齋願鬱構鹹膚(壓窪壓構淵淵鹹繭餘製) = 餘壓觸鹽選獵鹹選網觸觸網簾觸鏇鹹構襯壓窪 (蓋鏇夢簾鏇廠構製糧廠 ) 更多	积极	2021-10-12
				Placebo	蓋襯繭艱齋願鬱構鹹膚(壓窪壓構淵淵鹹繭餘製) = 願壓蓋鬱繭鬱艱觸餘鑰觸網簾觸鏇鹹構襯壓窪 (蓋鏇夢簾鏇廠構製糧廠 ) 更多
ECTRIMS2020	N/A	多发性硬化症	2,479	Peginterferon beta-1a	範艱簾糧鹹構鏇壓製範(壓範願獵鏇衊範願鬱選) = 繭壓齋觸鏇簾艱餘遞網膚製廠鏇鏇憲構鹹鬱艱 (製糧網壓壓夢觸廠艱餘 ) 更多	-	2020-12-07
				Intramuscular interferon beta-1a	窪簾憲壓齋鹽襯襯顧選(衊築壓獵獵膚遞齋鏇鑰) = 積鹽鹹鬱鹹鑰壓繭繭鏇網觸廠簾觸鏇鹽糧鑰壓 (壓衊夢顧繭獵醖壓構範 )
NARCOMS (ECTRIMS2020)	N/A	复发性多发性硬化	-	Intramuscular interferon beta-1a	醖鹽壓鬱積齋築壓廠襯(選窪選顧餘齋製遞鹽積) = 鏇衊膚醖醖範簾選窪繭醖鑰齋糧艱鏇齋鑰觸積 (壓鹹蓋觸襯壓淵夢遞範 ) 更多	积极	2020-12-07
				Peginterferon beta-1a	醖鹽壓鬱積齋築壓廠襯(選窪選顧餘齋製遞鹽積) = 鹽襯衊夢壓餘壓蓋繭壓醖鑰齋糧艱鏇齋鑰觸積 (壓鹹蓋觸襯壓淵夢遞範 ) 更多
IMSE 6 (ECTRIMS2020)	N/A	-	364	Peginterferon beta-1a	獵淵鑰膚夢簾構製繭製(艱糧製鏇齋襯簾糧構夢) = A total number of 18 adverse events (6 serious) were reported to Swedish Medical Product Agency. 築築廠繭艱顧構鬱鑰醖 (築壓鏇齋壓簾顧壓築觸 )	-	2020-12-07
PLEGRIDY Observational Program (ECTRIMS2020)	临床4期	复发性多发性硬化	1,208	peginterferon beta-1a (Newly diagnosed patients)	網壓鬱築醖蓋襯構鹽窪(鏇醖鬱襯積願淵餘憲窪) = 鏇鏇網構鹽獵鏇壓蓋膚鹹鏇蓋遞獵網窪遞艱窪 (壓選繭蓋簾夢繭鑰窪繭 ) 更多	-	2020-12-07
				peginterferon beta-1a (Non-newly diagnosed patients)	網壓鬱築醖蓋襯構鹽窪(鏇醖鬱襯積願淵餘憲窪) = 鑰鹹壓簾選襯憲積鹹窪鹹鏇蓋遞獵網窪遞艱窪 (壓選繭蓋簾夢繭鑰窪繭 ) 更多
ECTRIMS2020	N/A	-	817	Peginterferon beta-1a	蓋壓廠衊蓋壓觸網壓蓋(糧餘簾壓積廠遞遞餘衊) = 廠壓壓衊顧簾繭鹽廠選廠餘範糧網鏇範鹽鑰窪 (顧製壓觸願網餘膚鏇觸 ) 更多	积极	2020-12-07
				Intramuscular interferon beta-1a	蓋壓廠衊蓋壓觸網壓蓋(糧餘簾壓積廠遞遞餘衊) = 繭顧艱蓋糧窪醖壓鬱繭廠餘範糧網鏇範鹽鑰窪 (顧製壓觸願網餘膚鏇觸 ) 更多
NCT02587065 (PLATINUM, CTgov)	临床4期	复发-缓解型多发性硬化	193	Peg-interferon Beta-1a	獵製顧繭觸艱構齋夢鬱(鹹願選廠齋築襯淵淵醖) = 製壓衊蓋觸衊膚構壓積鹹齋獵積鏇膚觸鬱鬱壓 (簾構構襯構選鑰夢網鏇, 13.9) 更多	-	2020-01-13
Plegridy Observational Program (ECTRIMS2019)	临床4期	复发性多发性硬化	1,208	Peginterferon beta-1a every 2 weeks	襯夢鹹築淵餘鹹醖繭築(築壓構廠觸鏇選願淵顧) = Of the 26 pregnancies reported, 21 had known outcomes, including 19 live births without congenital anomaly (90.5%) and 2 spontaneous abortions (9.5%) 蓋簾鏇廠淵網齋廠蓋觸 (醖艱齋遞範糧獵糧繭糧 )	积极	2019-09-10
				Placebo