International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis

Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years. Study hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original drug Rebif®.

开始日期2015-02-12

申办/合作机构

Biocad CJSC

100 项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的临床结果

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100 项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的转化医学

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100 项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的专利（医药）

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项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的文献（医药）

2023-02-01·Multiple Sclerosis and Related Disorders

Interferon β1a treatment does not influence serum Epstein-Barr virus antibodies in patients with multiple sclerosis

Letter

作者: Rød, Brit Ellen ; Kvistad, Silje Stokke ; Lie, Ingrid Anne ; Holmøy, Trygve ; Wergeland, Stig ; Torkildsen, Øivind ; Myhr, Kjell-Morten

There is increasing evidence of Epstein-Barr virus (EBV) being conditional in multiple sclerosis (MS) pathogenesis and influential for disease activity. Interferon-beta (IFNβ) is a cytokine with antiviral effects used to treat MS, in which a possible antiviral effect against EBV has been questioned. In this study, we investigated the effect of IFNβ-1a treatment on serum EBV antibody levels in 84 patients with relapsing-remitting MS. In the 18 months following IFNβ-1a treatment initiation, there were no significant associations between treatment and serum levels of Epstein-Barr nuclear antigen 1 (EBNA-1) immunoglobulin (Ig) G, early antigen (EA) IgG, viral capsid antigen (VCA) IgG or VCA IgM. The findings suggest that IFNβ-1a treatment does not influence the humoral response to EBV in patients with MS.

2022-12-01·BMC Anesthesiology4区 · 医学

Migraine, interferon β1a and siponimod immunomodulator therapies

4区 · 医学

ArticleOA

作者: Bornemann-Cimenti, Helmar ; Dahaba, Ashraf A

AbstractBackgroundAutoimmunity seems to play a great role in the pathogenesis of migraine headache pain. There is far more evidence that interferon can exacerbate migraines. We report a case where remission of severe comorbid migraine attacks happened with the start of interferon β1a (Merck, Netherlands) immunomodulation therapy. Therapy for multiple sclerosis was decided according to the severity of the debilitating comorbid migraine headache pain rather than the evolution of multiple sclerosis the far more serious disease.Case presentationA 63-years old patient suffered for 30-years from migraine headache of severe disability assessment scale (MIDAS) Grade-IV = 27. He also suffered for 25-years from optic-sensory relapsing remitting multiple sclerosis (RRMS). Subcutaneous interferon β1a 44-µg immunomodulation therapy for 4-years resulted in multiple sclerosis complete remission. The start of interferon β1a therapy for multiple sclerosis seemed to help resolving the comorbid migraine attacks. The visual aura premonitory symptom preceding migraine headache would end up with a feeling of post visual aura clearer field of vision and a feeling of wellbeing. As the patient developed secondary progressive multiple sclerosis (SPMS), oral siponimod 2 mg (Novartis, Ireland), currently the only available therapy for SPMS, replaced his interferon therapy. This was associated with a relapse of migraine severe attacks. Reverting back to interferon therapy was again associated with migraine headache remission.ConclusionsInterferon β1a might be an efficic therapy for “autoimmune migraine”. With numerous immunomodulators currently available for other systemic autoimmune diseases associated with comorbid migraine; examining the effect of these immunomodulatory therapies on comorbid migraine headache could be beneficial in finding a specific immunomodulator therapy for “autoimmune migraine”.

2022-01-01·PharmacoEconomics3区 · 医学

The Potential Cost-Effectiveness of a Cell-Based Bioelectronic Implantable Device Delivering Interferon-β1a Therapy Versus Injectable Interferon-β1a Treatment in Relapsing–Remitting Multiple Sclerosis

3区 · 医学

Article

作者: Visser, Laurenske A ; Escudero, Encarna ; Redekop, William Ken ; Uyl-de Groot, Carin A ; Delgado Simao, Claudia ; Folcher, Marc ; Gutierrez Arechederra, Biotza

BACKGROUNDCurrent first-line disease-modifying therapies (DMT) for multiple sclerosis (MS) patients are injectable or oral treatments. The Optogenerapy consortium is developing a novel bioelectronic cell-based implant for controlled release of beta-interferon (IFNβ1a) protein into the body. The current study estimated the potential cost effectiveness of the Optogenerapy implant (hereafter: Optoferon) compared with injectable IFNβ1a (Avonex).METHODSA Markov model simulating the costs and effects of Optoferon compared with injectable 30 mg IFNβ1a over a 9-year time horizon from a Dutch societal perspective. Costs were reported in 2019 Euros and discounted at a 4% annual rate; health effects were discounted at a 1.5% annual rate. The cohort consisted of 35-year-old, relapsing-remitting MS patients with mild disability. The device is implanted in a daycare setting, and is replaced every 3 years. In the base-case analysis, we assumed equal input parameters for Optoferon and Avonex regarding disability progression, health effects, adverse event probabilities, and acquisition costs. We assumed reduced annual relapse rates and withdrawal rates for Optoferon compared with Avonex. Sensitivity, scenario, value of information, and headroom analysis were performed.RESULTSOptoferon was the dominant strategy with cost reductions (- €26,966) and health gains (0.45 quality-adjusted life-years gained). A main driver of cost differences are the acquisition costs of Optoferon being 2.5 times less than the costs of Avonex. The incremental cost-effectiveness ratio was most sensitive to variations in the annual acquisition costs of Avonex, the annual withdrawal rate of Avonex and Optoferon, and the disability progression of Avonex.CONCLUSIONInnovative technology such as the Optoferon implant may be a cost-effective therapy for patients with MS. The novel implantable mode of therapeutic protein administration has the potential to become a new mode of treatment administration for MS patients and in other disease areas. However, trials are needed to establish safety and effectiveness.

100 项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB07	DB00060

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适应症	国家/地区	公司	日期
多发性硬化症	俄罗斯	Biocad Medical, Inc.	2017-01-01

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适应症	最高研发状态	国家/地区	公司	日期
复发-缓解型多发性硬化	药物发现	俄罗斯	Biocad CJSC	2015-02-12

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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


NCT02727907 (CTgov)	临床2/3期	复发-缓解型多发性硬化	163	BCD-033 (interferon beta 1a) (BCD-033)	醖簾窪餘願餘遞醖顧構(襯獵製獵鹹選艱範憲壓) = 簾淵顧餘願鹽築膚製廠簾選鏇淵鑰獵範餘艱鬱 (鹽淵獵獵簾淵顧獵壓醖, 繭製簾鏇鹽顧廠繭鏇糧 ~ 選繭憲齋膚鑰醖選淵構) 更多	-	2023-02-17
				Rebif (interferon beta 1a) (Rebif)	醖簾窪餘願餘遞醖顧構(襯獵製獵鹹選艱範憲壓) = 製選積艱廠觸鹹鏇鑰鹹簾選鏇淵鑰獵範餘艱鬱 (鹽淵獵獵簾淵顧獵壓醖, 積夢網鑰廠願構齋襯鹹 ~ 蓋積繭衊鹹鏇積夢膚範) 更多