Efficacy and safety of subcutaneous interferon beta-1a in relapsing–remitting multiple sclerosis: Further outcomes from the IMPROVE study

Abstract Background The IMPROVE study demonstrated that the fetal bovine serum (FBS)- and human serum albumin (HSA)-free formulation of subcutaneous (sc) interferon (IFN) beta-1a had beneficial effects on the numbers of combined unique active magnetic resonance imaging (MRI) lesions in relapsing–rem...

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Veröffentlicht in:Journal of the neurological sciences 2012-01, Vol.312 (1), p.97-101
Hauptverfasser: De Stefano, Nicola, Sormani, Maria Pia, Stubinski, Bettina, Blevins, Gregg, Drulovic, Jelena S, Issard, Delphine, Shotekov, Penko, Gasperini, Claudio
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container_end_page 101
container_issue 1
container_start_page 97
container_title Journal of the neurological sciences
container_volume 312
creator De Stefano, Nicola
Sormani, Maria Pia
Stubinski, Bettina
Blevins, Gregg
Drulovic, Jelena S
Issard, Delphine
Shotekov, Penko
Gasperini, Claudio
description Abstract Background The IMPROVE study demonstrated that the fetal bovine serum (FBS)- and human serum albumin (HSA)-free formulation of subcutaneous (sc) interferon (IFN) beta-1a had beneficial effects on the numbers of combined unique active magnetic resonance imaging (MRI) lesions in relapsing–remitting multiple sclerosis (RRMS). Here we report additional MRI endpoints (including post hoc analyses), and clinical efficacy, safety, and immunogenicity outcomes. Methods Patients with active RRMS were randomized (2:1) to IFN beta-1a, 44 mcg sc three times weekly (tiw) (n = 120), or placebo (n = 60), for 16 weeks (double-blind phase). All patients then received IFN beta-1a, 44 mcg sc tiw, for 24 weeks (rater-blind phase). Patients underwent MRI brain scans every 4 weeks. Results Compared with placebo, there was a 68% reduction in the mean cumulative number of new gadolinium-enhancing lesions with IFN beta-1a as early as week 4 ( p < 0.001), and a 53% reduction in the mean cumulative number of new T2 lesions as early as week 8 ( p = 0.025; post hoc analyses). During the 16-week double-blind phase, the relapse rate was 0.14 (95% confidence interval [CI] 0.09–0.23) with IFN beta-1a and 0.33 (95% CI 0.22–0.52) with placebo ( p = 0.010). Safety outcomes were consistent with those expected with IFN-beta treatment. Conclusions The FBS/HSA-free formulation of sc IFN beta-1a has a beneficial impact on MRI and efficacy outcomes as early as 4 weeks after treatment initiation in patients with RRMS and has a safety profile consistent with previous trials of sc IFN beta-1a.
doi_str_mv 10.1016/j.jns.2011.08.013
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Here we report additional MRI endpoints (including post hoc analyses), and clinical efficacy, safety, and immunogenicity outcomes. Methods Patients with active RRMS were randomized (2:1) to IFN beta-1a, 44 mcg sc three times weekly (tiw) (n = 120), or placebo (n = 60), for 16 weeks (double-blind phase). All patients then received IFN beta-1a, 44 mcg sc tiw, for 24 weeks (rater-blind phase). Patients underwent MRI brain scans every 4 weeks. Results Compared with placebo, there was a 68% reduction in the mean cumulative number of new gadolinium-enhancing lesions with IFN beta-1a as early as week 4 ( p &lt; 0.001), and a 53% reduction in the mean cumulative number of new T2 lesions as early as week 8 ( p = 0.025; post hoc analyses). During the 16-week double-blind phase, the relapse rate was 0.14 (95% confidence interval [CI] 0.09–0.23) with IFN beta-1a and 0.33 (95% CI 0.22–0.52) with placebo ( p = 0.010). Safety outcomes were consistent with those expected with IFN-beta treatment. Conclusions The FBS/HSA-free formulation of sc IFN beta-1a has a beneficial impact on MRI and efficacy outcomes as early as 4 weeks after treatment initiation in patients with RRMS and has a safety profile consistent with previous trials of sc IFN beta-1a.</description><identifier>ISSN: 0022-510X</identifier><identifier>EISSN: 1878-5883</identifier><identifier>DOI: 10.1016/j.jns.2011.08.013</identifier><identifier>CODEN: JNSCAG</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Biological and medical sciences ; Efficacy ; Interferon beta-1a ; Magnetic resonance imaging ; Medical sciences ; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis ; Neurology ; Randomized controlled trial ; Relapsing–remitting multiple sclerosis ; Safety</subject><ispartof>Journal of the neurological sciences, 2012-01, Vol.312 (1), p.97-101</ispartof><rights>Elsevier B.V.</rights><rights>2011 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c414t-9c206c82d6b15f25279e6007174885fc5d4786827a28d09951d06eeb201485933</citedby><cites>FETCH-LOGICAL-c414t-9c206c82d6b15f25279e6007174885fc5d4786827a28d09951d06eeb201485933</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0022510X11004916$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=25395624$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>De Stefano, Nicola</creatorcontrib><creatorcontrib>Sormani, Maria Pia</creatorcontrib><creatorcontrib>Stubinski, Bettina</creatorcontrib><creatorcontrib>Blevins, Gregg</creatorcontrib><creatorcontrib>Drulovic, Jelena S</creatorcontrib><creatorcontrib>Issard, Delphine</creatorcontrib><creatorcontrib>Shotekov, Penko</creatorcontrib><creatorcontrib>Gasperini, Claudio</creatorcontrib><title>Efficacy and safety of subcutaneous interferon beta-1a in relapsing–remitting multiple sclerosis: Further outcomes from the IMPROVE study</title><title>Journal of the neurological sciences</title><description>Abstract Background The IMPROVE study demonstrated that the fetal bovine serum (FBS)- and human serum albumin (HSA)-free formulation of subcutaneous (sc) interferon (IFN) beta-1a had beneficial effects on the numbers of combined unique active magnetic resonance imaging (MRI) lesions in relapsing–remitting multiple sclerosis (RRMS). Here we report additional MRI endpoints (including post hoc analyses), and clinical efficacy, safety, and immunogenicity outcomes. Methods Patients with active RRMS were randomized (2:1) to IFN beta-1a, 44 mcg sc three times weekly (tiw) (n = 120), or placebo (n = 60), for 16 weeks (double-blind phase). All patients then received IFN beta-1a, 44 mcg sc tiw, for 24 weeks (rater-blind phase). Patients underwent MRI brain scans every 4 weeks. Results Compared with placebo, there was a 68% reduction in the mean cumulative number of new gadolinium-enhancing lesions with IFN beta-1a as early as week 4 ( p &lt; 0.001), and a 53% reduction in the mean cumulative number of new T2 lesions as early as week 8 ( p = 0.025; post hoc analyses). During the 16-week double-blind phase, the relapse rate was 0.14 (95% confidence interval [CI] 0.09–0.23) with IFN beta-1a and 0.33 (95% CI 0.22–0.52) with placebo ( p = 0.010). Safety outcomes were consistent with those expected with IFN-beta treatment. Conclusions The FBS/HSA-free formulation of sc IFN beta-1a has a beneficial impact on MRI and efficacy outcomes as early as 4 weeks after treatment initiation in patients with RRMS and has a safety profile consistent with previous trials of sc IFN beta-1a.</description><subject>Biological and medical sciences</subject><subject>Efficacy</subject><subject>Interferon beta-1a</subject><subject>Magnetic resonance imaging</subject><subject>Medical sciences</subject><subject>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. 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Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</topic><topic>Neurology</topic><topic>Randomized controlled trial</topic><topic>Relapsing–remitting multiple sclerosis</topic><topic>Safety</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>De Stefano, Nicola</creatorcontrib><creatorcontrib>Sormani, Maria Pia</creatorcontrib><creatorcontrib>Stubinski, Bettina</creatorcontrib><creatorcontrib>Blevins, Gregg</creatorcontrib><creatorcontrib>Drulovic, Jelena S</creatorcontrib><creatorcontrib>Issard, Delphine</creatorcontrib><creatorcontrib>Shotekov, Penko</creatorcontrib><creatorcontrib>Gasperini, Claudio</creatorcontrib><collection>Pascal-Francis</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Journal of the neurological sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>De Stefano, Nicola</au><au>Sormani, Maria Pia</au><au>Stubinski, Bettina</au><au>Blevins, Gregg</au><au>Drulovic, Jelena S</au><au>Issard, Delphine</au><au>Shotekov, Penko</au><au>Gasperini, Claudio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of subcutaneous interferon beta-1a in relapsing–remitting multiple sclerosis: Further outcomes from the IMPROVE study</atitle><jtitle>Journal of the neurological sciences</jtitle><date>2012-01-15</date><risdate>2012</risdate><volume>312</volume><issue>1</issue><spage>97</spage><epage>101</epage><pages>97-101</pages><issn>0022-510X</issn><eissn>1878-5883</eissn><coden>JNSCAG</coden><abstract>Abstract Background The IMPROVE study demonstrated that the fetal bovine serum (FBS)- and human serum albumin (HSA)-free formulation of subcutaneous (sc) interferon (IFN) beta-1a had beneficial effects on the numbers of combined unique active magnetic resonance imaging (MRI) lesions in relapsing–remitting multiple sclerosis (RRMS). Here we report additional MRI endpoints (including post hoc analyses), and clinical efficacy, safety, and immunogenicity outcomes. Methods Patients with active RRMS were randomized (2:1) to IFN beta-1a, 44 mcg sc three times weekly (tiw) (n = 120), or placebo (n = 60), for 16 weeks (double-blind phase). All patients then received IFN beta-1a, 44 mcg sc tiw, for 24 weeks (rater-blind phase). Patients underwent MRI brain scans every 4 weeks. Results Compared with placebo, there was a 68% reduction in the mean cumulative number of new gadolinium-enhancing lesions with IFN beta-1a as early as week 4 ( p &lt; 0.001), and a 53% reduction in the mean cumulative number of new T2 lesions as early as week 8 ( p = 0.025; post hoc analyses). During the 16-week double-blind phase, the relapse rate was 0.14 (95% confidence interval [CI] 0.09–0.23) with IFN beta-1a and 0.33 (95% CI 0.22–0.52) with placebo ( p = 0.010). Safety outcomes were consistent with those expected with IFN-beta treatment. Conclusions The FBS/HSA-free formulation of sc IFN beta-1a has a beneficial impact on MRI and efficacy outcomes as early as 4 weeks after treatment initiation in patients with RRMS and has a safety profile consistent with previous trials of sc IFN beta-1a.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><doi>10.1016/j.jns.2011.08.013</doi><tpages>5</tpages></addata></record>
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subjects Biological and medical sciences
Efficacy
Interferon beta-1a
Magnetic resonance imaging
Medical sciences
Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis
Neurology
Randomized controlled trial
Relapsing–remitting multiple sclerosis
Safety
title Efficacy and safety of subcutaneous interferon beta-1a in relapsing–remitting multiple sclerosis: Further outcomes from the IMPROVE study
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