Ingested IFN-α : Results of a pilot study in relapsing-remitting MS
To investigate whether ingested human recombinant interferon-alpha2a (IFN-alpha2a) was safe and whether treatment reduces the number of gadolinium-enhanced lesions on serial MRI in patients with active relapsing-remitting MS (RRMS). Entry criteria included clinically definite RRMS and one or more ga...
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Veröffentlicht in: | Neurology 2001-09, Vol.57 (5), p.845-852 |
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description | To investigate whether ingested human recombinant interferon-alpha2a (IFN-alpha2a) was safe and whether treatment reduces the number of gadolinium-enhanced lesions on serial MRI in patients with active relapsing-remitting MS (RRMS).
Entry criteria included clinically definite RRMS and one or more gadolinium-enhanced lesions on a screening MRI.
Of 80 patients screened, 33 were eligible and 30 patients were enrolled for treatment. Patients were randomized (10 per group) to placebo, 10,000 or 30,000 IU IFN-alpha2a ingested on alternate days for 9 months. They were examined clinically and with monthly cerebral MRI. Sample size projections were based on the assumption of a parenteral IFN-like effect, a 90% reduction of enhancing lesions evident within 1 month of the initiation of treatment in the active treatment groups sustained during the 9-month study as the primary outcome variable.
There was no significant effect on enhancing lesions. However, post hoc analysis suggested a possible treatment effect in the 10,000 IU group. By direct monthly comparison of placebo and 10,000 IU group in treatment month 5, there were 73% (p < 0.05) fewer enhancements in the 10,000 IU group than in the placebo group. There was a decrease of tumor necrosis factor-alpha protein secretion at months 4 and 5. Relapses and adverse events were not different among the treatment groups. Ingested IFN-alpha2a did not induce systemic anti-IFN-alpha antibodies.
This trial showed no benefit based on the primary outcome measure. Because changes were detected in immune response and post hoc analysis suggested that a smaller dose could have an effect, IFN-alpha may deserve further study. |
doi_str_mv | 10.1212/WNL.57.5.845 |
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Entry criteria included clinically definite RRMS and one or more gadolinium-enhanced lesions on a screening MRI.
Of 80 patients screened, 33 were eligible and 30 patients were enrolled for treatment. Patients were randomized (10 per group) to placebo, 10,000 or 30,000 IU IFN-alpha2a ingested on alternate days for 9 months. They were examined clinically and with monthly cerebral MRI. Sample size projections were based on the assumption of a parenteral IFN-like effect, a 90% reduction of enhancing lesions evident within 1 month of the initiation of treatment in the active treatment groups sustained during the 9-month study as the primary outcome variable.
There was no significant effect on enhancing lesions. However, post hoc analysis suggested a possible treatment effect in the 10,000 IU group. By direct monthly comparison of placebo and 10,000 IU group in treatment month 5, there were 73% (p < 0.05) fewer enhancements in the 10,000 IU group than in the placebo group. There was a decrease of tumor necrosis factor-alpha protein secretion at months 4 and 5. Relapses and adverse events were not different among the treatment groups. Ingested IFN-alpha2a did not induce systemic anti-IFN-alpha antibodies.
This trial showed no benefit based on the primary outcome measure. Because changes were detected in immune response and post hoc analysis suggested that a smaller dose could have an effect, IFN-alpha may deserve further study.</description><identifier>ISSN: 0028-3878</identifier><identifier>EISSN: 1526-632X</identifier><identifier>DOI: 10.1212/WNL.57.5.845</identifier><identifier>PMID: 11552015</identifier><identifier>CODEN: NEURAI</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Administration, Oral ; Adult ; Analysis of Variance ; Biological and medical sciences ; Brain - drug effects ; Brain - pathology ; Double-Blind Method ; Humans ; Immunologic Factors - administration & dosage ; Immunomodulators ; Interferon Type I - administration & dosage ; Magnetic Resonance Imaging ; Male ; Medical sciences ; Middle Aged ; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis ; Multiple Sclerosis, Relapsing-Remitting - blood ; Multiple Sclerosis, Relapsing-Remitting - drug therapy ; Multiple Sclerosis, Relapsing-Remitting - pathology ; Neurology ; Outcome Assessment (Health Care) ; Pharmacology. Drug treatments ; Pilot Projects ; Recombinant Proteins ; Tumor Necrosis Factor-alpha - metabolism</subject><ispartof>Neurology, 2001-09, Vol.57 (5), p.845-852</ispartof><rights>2002 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c274t-28664672cf53e5842d5e451badc0a7406ffa71aa5145fb1733bbcc0bcc6691bc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14068456$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11552015$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>BROD, S. A</creatorcontrib><creatorcontrib>LINDSEY, J. W</creatorcontrib><creatorcontrib>VRIESENDORP, F. S</creatorcontrib><creatorcontrib>AHN, C</creatorcontrib><creatorcontrib>HENNINGER, E</creatorcontrib><creatorcontrib>NARAYANA, P. A</creatorcontrib><creatorcontrib>WOLINSKY, J. S</creatorcontrib><title>Ingested IFN-α : Results of a pilot study in relapsing-remitting MS</title><title>Neurology</title><addtitle>Neurology</addtitle><description>To investigate whether ingested human recombinant interferon-alpha2a (IFN-alpha2a) was safe and whether treatment reduces the number of gadolinium-enhanced lesions on serial MRI in patients with active relapsing-remitting MS (RRMS).
Entry criteria included clinically definite RRMS and one or more gadolinium-enhanced lesions on a screening MRI.
Of 80 patients screened, 33 were eligible and 30 patients were enrolled for treatment. Patients were randomized (10 per group) to placebo, 10,000 or 30,000 IU IFN-alpha2a ingested on alternate days for 9 months. They were examined clinically and with monthly cerebral MRI. Sample size projections were based on the assumption of a parenteral IFN-like effect, a 90% reduction of enhancing lesions evident within 1 month of the initiation of treatment in the active treatment groups sustained during the 9-month study as the primary outcome variable.
There was no significant effect on enhancing lesions. However, post hoc analysis suggested a possible treatment effect in the 10,000 IU group. By direct monthly comparison of placebo and 10,000 IU group in treatment month 5, there were 73% (p < 0.05) fewer enhancements in the 10,000 IU group than in the placebo group. There was a decrease of tumor necrosis factor-alpha protein secretion at months 4 and 5. Relapses and adverse events were not different among the treatment groups. Ingested IFN-alpha2a did not induce systemic anti-IFN-alpha antibodies.
This trial showed no benefit based on the primary outcome measure. Because changes were detected in immune response and post hoc analysis suggested that a smaller dose could have an effect, IFN-alpha may deserve further study.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Analysis of Variance</subject><subject>Biological and medical sciences</subject><subject>Brain - drug effects</subject><subject>Brain - pathology</subject><subject>Double-Blind Method</subject><subject>Humans</subject><subject>Immunologic Factors - administration & dosage</subject><subject>Immunomodulators</subject><subject>Interferon Type I - administration & dosage</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</subject><subject>Multiple Sclerosis, Relapsing-Remitting - blood</subject><subject>Multiple Sclerosis, Relapsing-Remitting - drug therapy</subject><subject>Multiple Sclerosis, Relapsing-Remitting - pathology</subject><subject>Neurology</subject><subject>Outcome Assessment (Health Care)</subject><subject>Pharmacology. Drug treatments</subject><subject>Pilot Projects</subject><subject>Recombinant Proteins</subject><subject>Tumor Necrosis Factor-alpha - metabolism</subject><issn>0028-3878</issn><issn>1526-632X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkMtOwzAQRS0EoqWwY428gRUptpOxU3aoUKhUisRDsLMcx0ZBeWEni34WP8I3YdRIXYxmRnN0decidErJlDLKrt7XqymIKUzTBPbQmALjEY_Zxz4aE8LSKE5FOkJH3n8REo5idohGlAKwsI3R7bL-NL4zOV4u1tHvD77Gz8b3ZedxY7HCbVE2HfZdn29wUWNnStX6ov6MnKmKrgsTfnw5RgdWld6cDH2C3hZ3r_OHaPV0v5zfrCLNRNJFLOU84YJpC7GBNGE5mARopnJNlEgIt1YJqhTQBGxGRRxnmdYkFOczmul4gi62uq1rvvtgW1aF16YsVW2a3ksR_poxCgG83ILaNd47Y2Xrikq5jaRE_qcmQ2oShAQZUgv42aDbZ5XJd_AQUwDOB0B5rUrrVK0Lv-OC96DD4z_5hHQJ</recordid><startdate>20010911</startdate><enddate>20010911</enddate><creator>BROD, S. A</creator><creator>LINDSEY, J. W</creator><creator>VRIESENDORP, F. S</creator><creator>AHN, C</creator><creator>HENNINGER, E</creator><creator>NARAYANA, P. A</creator><creator>WOLINSKY, J. S</creator><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20010911</creationdate><title>Ingested IFN-α : Results of a pilot study in relapsing-remitting MS</title><author>BROD, S. A ; LINDSEY, J. W ; VRIESENDORP, F. S ; AHN, C ; HENNINGER, E ; NARAYANA, P. A ; WOLINSKY, J. S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c274t-28664672cf53e5842d5e451badc0a7406ffa71aa5145fb1733bbcc0bcc6691bc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Analysis of Variance</topic><topic>Biological and medical sciences</topic><topic>Brain - drug effects</topic><topic>Brain - pathology</topic><topic>Double-Blind Method</topic><topic>Humans</topic><topic>Immunologic Factors - administration & dosage</topic><topic>Immunomodulators</topic><topic>Interferon Type I - administration & dosage</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</topic><topic>Multiple Sclerosis, Relapsing-Remitting - blood</topic><topic>Multiple Sclerosis, Relapsing-Remitting - drug therapy</topic><topic>Multiple Sclerosis, Relapsing-Remitting - pathology</topic><topic>Neurology</topic><topic>Outcome Assessment (Health Care)</topic><topic>Pharmacology. Drug treatments</topic><topic>Pilot Projects</topic><topic>Recombinant Proteins</topic><topic>Tumor Necrosis Factor-alpha - metabolism</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>BROD, S. A</creatorcontrib><creatorcontrib>LINDSEY, J. W</creatorcontrib><creatorcontrib>VRIESENDORP, F. S</creatorcontrib><creatorcontrib>AHN, C</creatorcontrib><creatorcontrib>HENNINGER, E</creatorcontrib><creatorcontrib>NARAYANA, P. A</creatorcontrib><creatorcontrib>WOLINSKY, J. S</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>BROD, S. A</au><au>LINDSEY, J. W</au><au>VRIESENDORP, F. S</au><au>AHN, C</au><au>HENNINGER, E</au><au>NARAYANA, P. A</au><au>WOLINSKY, J. S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ingested IFN-α : Results of a pilot study in relapsing-remitting MS</atitle><jtitle>Neurology</jtitle><addtitle>Neurology</addtitle><date>2001-09-11</date><risdate>2001</risdate><volume>57</volume><issue>5</issue><spage>845</spage><epage>852</epage><pages>845-852</pages><issn>0028-3878</issn><eissn>1526-632X</eissn><coden>NEURAI</coden><abstract>To investigate whether ingested human recombinant interferon-alpha2a (IFN-alpha2a) was safe and whether treatment reduces the number of gadolinium-enhanced lesions on serial MRI in patients with active relapsing-remitting MS (RRMS).
Entry criteria included clinically definite RRMS and one or more gadolinium-enhanced lesions on a screening MRI.
Of 80 patients screened, 33 were eligible and 30 patients were enrolled for treatment. Patients were randomized (10 per group) to placebo, 10,000 or 30,000 IU IFN-alpha2a ingested on alternate days for 9 months. They were examined clinically and with monthly cerebral MRI. Sample size projections were based on the assumption of a parenteral IFN-like effect, a 90% reduction of enhancing lesions evident within 1 month of the initiation of treatment in the active treatment groups sustained during the 9-month study as the primary outcome variable.
There was no significant effect on enhancing lesions. However, post hoc analysis suggested a possible treatment effect in the 10,000 IU group. By direct monthly comparison of placebo and 10,000 IU group in treatment month 5, there were 73% (p < 0.05) fewer enhancements in the 10,000 IU group than in the placebo group. There was a decrease of tumor necrosis factor-alpha protein secretion at months 4 and 5. Relapses and adverse events were not different among the treatment groups. Ingested IFN-alpha2a did not induce systemic anti-IFN-alpha antibodies.
This trial showed no benefit based on the primary outcome measure. Because changes were detected in immune response and post hoc analysis suggested that a smaller dose could have an effect, IFN-alpha may deserve further study.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>11552015</pmid><doi>10.1212/WNL.57.5.845</doi><tpages>8</tpages></addata></record> |
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subjects | Administration, Oral Adult Analysis of Variance Biological and medical sciences Brain - drug effects Brain - pathology Double-Blind Method Humans Immunologic Factors - administration & dosage Immunomodulators Interferon Type I - administration & dosage Magnetic Resonance Imaging Male Medical sciences Middle Aged Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis Multiple Sclerosis, Relapsing-Remitting - blood Multiple Sclerosis, Relapsing-Remitting - drug therapy Multiple Sclerosis, Relapsing-Remitting - pathology Neurology Outcome Assessment (Health Care) Pharmacology. Drug treatments Pilot Projects Recombinant Proteins Tumor Necrosis Factor-alpha - metabolism |
title | Ingested IFN-α : Results of a pilot study in relapsing-remitting MS |
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