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Interferons and Multiple Sclerosis: Lessons from 25 Years of Clinical and Real-World Experience with Intramuscular Interferon Beta-1a (Avonex)
CNS Drugs ( IF 6 ) Pub Date : 2021-07-06 , DOI: 10.1007/s40263-021-00822-z
Stanley L Cohan 1 , Barry A Hendin 2 , Anthony T Reder 3 , Kyle Smoot 1 , Robin Avila 4 , Jason P Mendoza 4 , Bianca Weinstock-Guttman 5
Affiliation  

Recombinant interferon (IFN) β-1b was approved by the US Food and Drug Administration as the first disease-modifying therapy (DMT) for multiple sclerosis (MS) in 1993. Since that time, clinical trials and real-world observational studies have demonstrated the effectiveness of IFN therapies. The pivotal intramuscular IFN β-1a phase III trial published in 1996 was the first to demonstrate that a DMT could reduce accumulation of sustained disability in MS. Patient adherence to treatment is higher with intramuscular IFN β-1a, given once weekly, than with subcutaneous formulations requiring multiple injections per week. Moreover, subcutaneous IFN β-1a is associated with an increased incidence of injection-site reactions and neutralizing antibodies compared with intramuscular administration. In recent years, revisions to MS diagnostic criteria have improved clinicians’ ability to identify patients with MS and have promoted the use of magnetic resonance imaging (MRI) for diagnosis and disease monitoring. MRI studies show that treatment with IFN β-1a, relative to placebo, reduces T2 and gadolinium-enhancing lesions and gray matter atrophy. Since the approval of intramuscular IFN β-1a, a number of high-efficacy therapies have been approved for MS, though the benefit of these high-efficacy therapies should be balanced against the increased risk of serious adverse events associated with their long-term use. For some subpopulations of patients, including pregnant women, the safety profile of IFN β formulations may provide a particular benefit. In addition, the antiviral properties of IFNs may indicate potential therapeutic opportunities for IFN β in reducing the risk of viral infections such as COVID-19.



中文翻译:

干扰素和多发性硬化症:肌内干扰素 Beta-1a (Avonex) 25 年临床和实际经验的教训

重组干扰素 (IFN) β-1b 于 1993 年被美国食品和药物管理局批准为第一种治疗多发性硬化症 (MS) 的疾病改善疗法 (DMT)。从那时起,临床试验和真实世界的观察研究证明干扰素治疗的有效性。1996 年发表的关键性肌内 IFN β-1a III 期试验首次证明 DMT 可以减少 MS 中持续残疾的累积。与每周需要多次注射的皮下制剂相比,每周一次肌肉注射 IFN β-1a 的患者对治疗的依从性更高。此外,与肌肉注射相比,皮下注射 IFN β-1a 与注射部位反应和中和抗体的发生率增加有关。最近几年,MS 诊断标准的修订提高了临床医生识别 MS 患者的能力,并促进了磁共振成像 (MRI) 在诊断和疾病监测中的应用。MRI 研究表明,与安慰剂相比,用 IFN β-1a 治疗可减少 T2 和钆增强病变以及灰质萎缩。自从批准肌内 IFN β-1a 以来,许多高效疗法已被批准用于 MS,但应权衡这些高效疗法的益处与与其长期使用相关的严重不良事件风险的增加. 对于某些患者亚群,包括孕妇,IFN β 制剂的安全性可能会带来特别的好处。此外,

更新日期:2021-07-06
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