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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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 < 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>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25395624$$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 < 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. Leukoencephalitis</subject><subject>Neurology</subject><subject>Randomized controlled trial</subject><subject>Relapsing–remitting multiple sclerosis</subject><subject>Safety</subject><issn>0022-510X</issn><issn>1878-5883</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><recordid>eNp9kU-L1TAUxYso-Bz9AO6yEVetN2nTpgqCDG90YGTEf7gLeemNprbpMzcV3s69S7-hn8Q83uDChatcLufccH6nKB5yqDjw9slYjYEqAZxXoCrg9a1iw1WnSqlUfbvYAAhRSg6f7hb3iEYAaJXqN8XPrXPeGntgJgyMjMN0YItjtO7smkzAZSXmQ8LoMC6B7TCZkpu8YhEnsycfPv_-8Svi7FPKM5vXKfn9hIzslB3k6Sm7WGP6gpEta7LLjMRcXGaWV-zy9Zu31x-3jNI6HO4Xd5yZCB_cvGfFh4vt-_NX5dX1y8vzF1elbXiTyt4KaK0SQ7vj0gkpuh5bgI53jVLSWTk0nWqV6IxQA_S95AO0iLsMp1Gyr-uz4vHp7j4u31akpGdPFqfpFFf3XIHsVNdlJT8pbU5CEZ3eRz-beNAc9JG7HnXmro_cNSiduWfPo5vrhqyZXDTBevprFLLuZSuarHt20mGO-t1j1GQ9BouDj2iTHhb_31-e_-O2kw-5yekrHpDGZY0hM9Rck9Cg3x37P9bPOUDT87b-AwSArwk</recordid><startdate>20120115</startdate><enddate>20120115</enddate><creator>De Stefano, Nicola</creator><creator>Sormani, Maria Pia</creator><creator>Stubinski, Bettina</creator><creator>Blevins, Gregg</creator><creator>Drulovic, Jelena S</creator><creator>Issard, Delphine</creator><creator>Shotekov, Penko</creator><creator>Gasperini, Claudio</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope></search><sort><creationdate>20120115</creationdate><title>Efficacy and safety of subcutaneous interferon beta-1a in relapsing–remitting multiple sclerosis: Further outcomes from the IMPROVE study</title><author>De Stefano, Nicola ; Sormani, Maria Pia ; Stubinski, Bettina ; Blevins, Gregg ; Drulovic, Jelena S ; Issard, Delphine ; Shotekov, Penko ; Gasperini, Claudio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c414t-9c206c82d6b15f25279e6007174885fc5d4786827a28d09951d06eeb201485933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Biological and medical sciences</topic><topic>Efficacy</topic><topic>Interferon beta-1a</topic><topic>Magnetic resonance imaging</topic><topic>Medical sciences</topic><topic>Multiple sclerosis and variants. 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 < 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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