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250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study
The aim of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial was to compare the efficacy, safety, and tolerability of 250 microg or 500 microg interferon beta-1b with glatiramer acetate for treating relapsing-remitting multiple sclerosis. Between November, 2003, and June, 2005, 2...
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| Published in: | Lancet neurology 2009-10, Vol.8 (10), p.889-897 |
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| container_title | Lancet neurology |
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| creator | O'Connor, Paul Filippi, Massimo Arnason, Barry Comi, Giancarlo Cook, Stuart Goodin, Douglas Hartung, Hans-Peter Jeffery, Douglas Kappos, Ludwig Boateng, Francis Filippov, Vitali Groth, Maria Knappertz, Volker Kraus, Christian Sandbrink, Rupert Pohl, Christoph Bogumil, Timon O'Connor, P Filippi, M Arnason, B Cook, S Goodin, D Hartung, H-P Harung, H-P Kappos, L Jeffery, D Comi, G |
| description | The aim of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial was to compare the efficacy, safety, and tolerability of 250 microg or 500 microg interferon beta-1b with glatiramer acetate for treating relapsing-remitting multiple sclerosis.
Between November, 2003, and June, 2005, 2447 patients with relapsing-remitting multiple sclerosis were screened and 2244 patients were enrolled in this prospective, multicentre, randomised trial. Patients were randomly assigned 2:2:1 by block randomisation with regional stratification to receive one of two doses of interferon beta-1b (250 microg or 500 microg) subcutaneously every other day or 20 mg glatiramer acetate subcutaneously every day. The primary outcome was relapse risk, defined as new or recurrent neurological symptoms separated by at least 30 days from the preceding event and that lasted at least 24 h. Secondary outcomes were progression on the expanded disability status scale (EDSS) and change in T1-hypointense lesion volume. Clinical outcomes were assessed quarterly for 2.0-3.5 years; MRI was done at screening and annually thereafter. Analysis was by per protocol. This study is registered, number NCT00099502.
We found no differences in relapse risk, EDSS progression, T1-hypointense lesion volume, or normalised brain volume among treatment groups. Flu-like symptoms were more common in patients treated with interferon beta-1b (p |
| doi_str_mv | 10.1016/S1474-4422(09)70226-1 |
| format | article |
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Between November, 2003, and June, 2005, 2447 patients with relapsing-remitting multiple sclerosis were screened and 2244 patients were enrolled in this prospective, multicentre, randomised trial. Patients were randomly assigned 2:2:1 by block randomisation with regional stratification to receive one of two doses of interferon beta-1b (250 microg or 500 microg) subcutaneously every other day or 20 mg glatiramer acetate subcutaneously every day. The primary outcome was relapse risk, defined as new or recurrent neurological symptoms separated by at least 30 days from the preceding event and that lasted at least 24 h. Secondary outcomes were progression on the expanded disability status scale (EDSS) and change in T1-hypointense lesion volume. Clinical outcomes were assessed quarterly for 2.0-3.5 years; MRI was done at screening and annually thereafter. Analysis was by per protocol. This study is registered, number NCT00099502.
We found no differences in relapse risk, EDSS progression, T1-hypointense lesion volume, or normalised brain volume among treatment groups. Flu-like symptoms were more common in patients treated with interferon beta-1b (p<0.0001), whereas injection-site reactions were more common in patients treated with glatiramer acetate (p=0.0005). Patient attrition rates were 17% (153 of 888) on 250 microg interferon beta-1b, 26% (227 of 887) on 500 microg interferon beta-1b, and 21% (93 of 445) for glatiramer acetate.
500 microg interferon beta-1b was not more effective than the standard 250 microg dose, and both doses had similar clinical effects to glatiramer acetate. Although interferon beta-1b and glatiramer acetate had different adverse event profiles, the overall tolerability to both drugs was similar.
Bayer HealthCare Pharmaceuticals.</description><identifier>EISSN: 1474-4465</identifier><identifier>DOI: 10.1016/S1474-4422(09)70226-1</identifier><identifier>PMID: 19729344</identifier><language>eng</language><publisher>England</publisher><subject>Adolescent ; Adult ; Brain - drug effects ; Brain - pathology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Glatiramer Acetate ; Humans ; Immunologic Factors - therapeutic use ; Interferon beta-1b ; Interferon-beta - administration & dosage ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting - drug therapy ; Multiple Sclerosis, Relapsing-Remitting - pathology ; Peptides - therapeutic use ; Young Adult</subject><ispartof>Lancet neurology, 2009-10, Vol.8 (10), p.889-897</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19729344$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>O'Connor, Paul</creatorcontrib><creatorcontrib>Filippi, Massimo</creatorcontrib><creatorcontrib>Arnason, Barry</creatorcontrib><creatorcontrib>Comi, Giancarlo</creatorcontrib><creatorcontrib>Cook, Stuart</creatorcontrib><creatorcontrib>Goodin, Douglas</creatorcontrib><creatorcontrib>Hartung, Hans-Peter</creatorcontrib><creatorcontrib>Jeffery, Douglas</creatorcontrib><creatorcontrib>Kappos, Ludwig</creatorcontrib><creatorcontrib>Boateng, Francis</creatorcontrib><creatorcontrib>Filippov, Vitali</creatorcontrib><creatorcontrib>Groth, Maria</creatorcontrib><creatorcontrib>Knappertz, Volker</creatorcontrib><creatorcontrib>Kraus, Christian</creatorcontrib><creatorcontrib>Sandbrink, Rupert</creatorcontrib><creatorcontrib>Pohl, Christoph</creatorcontrib><creatorcontrib>Bogumil, Timon</creatorcontrib><creatorcontrib>O'Connor, P</creatorcontrib><creatorcontrib>Filippi, M</creatorcontrib><creatorcontrib>Arnason, B</creatorcontrib><creatorcontrib>Cook, S</creatorcontrib><creatorcontrib>Goodin, D</creatorcontrib><creatorcontrib>Hartung, H-P</creatorcontrib><creatorcontrib>Harung, H-P</creatorcontrib><creatorcontrib>Kappos, L</creatorcontrib><creatorcontrib>Jeffery, D</creatorcontrib><creatorcontrib>Comi, G</creatorcontrib><creatorcontrib>BEYOND Study Group</creatorcontrib><title>250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study</title><title>Lancet neurology</title><addtitle>Lancet Neurol</addtitle><description>The aim of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial was to compare the efficacy, safety, and tolerability of 250 microg or 500 microg interferon beta-1b with glatiramer acetate for treating relapsing-remitting multiple sclerosis.
Between November, 2003, and June, 2005, 2447 patients with relapsing-remitting multiple sclerosis were screened and 2244 patients were enrolled in this prospective, multicentre, randomised trial. Patients were randomly assigned 2:2:1 by block randomisation with regional stratification to receive one of two doses of interferon beta-1b (250 microg or 500 microg) subcutaneously every other day or 20 mg glatiramer acetate subcutaneously every day. The primary outcome was relapse risk, defined as new or recurrent neurological symptoms separated by at least 30 days from the preceding event and that lasted at least 24 h. Secondary outcomes were progression on the expanded disability status scale (EDSS) and change in T1-hypointense lesion volume. Clinical outcomes were assessed quarterly for 2.0-3.5 years; MRI was done at screening and annually thereafter. Analysis was by per protocol. This study is registered, number NCT00099502.
We found no differences in relapse risk, EDSS progression, T1-hypointense lesion volume, or normalised brain volume among treatment groups. Flu-like symptoms were more common in patients treated with interferon beta-1b (p<0.0001), whereas injection-site reactions were more common in patients treated with glatiramer acetate (p=0.0005). Patient attrition rates were 17% (153 of 888) on 250 microg interferon beta-1b, 26% (227 of 887) on 500 microg interferon beta-1b, and 21% (93 of 445) for glatiramer acetate.
500 microg interferon beta-1b was not more effective than the standard 250 microg dose, and both doses had similar clinical effects to glatiramer acetate. Although interferon beta-1b and glatiramer acetate had different adverse event profiles, the overall tolerability to both drugs was similar.
Bayer HealthCare Pharmaceuticals.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Brain - drug effects</subject><subject>Brain - pathology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Glatiramer Acetate</subject><subject>Humans</subject><subject>Immunologic Factors - therapeutic use</subject><subject>Interferon beta-1b</subject><subject>Interferon-beta - administration & dosage</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multiple Sclerosis, Relapsing-Remitting - drug therapy</subject><subject>Multiple Sclerosis, Relapsing-Remitting - pathology</subject><subject>Peptides - therapeutic use</subject><subject>Young Adult</subject><issn>1474-4465</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><recordid>eNo9kFtLAzEQhYMgtlZ_gpInUehqrpuNb1K8QcEH-75ks7MlsjeTbKG_xz9qoNWnOTN853AYhK4ouaeE5g-fVCiRCcHYLdF3ijCWZ_QEzY_nXM7QeQhfhDAqCnqGZlQrprkQc_TDJMGds37Y4sFjSf4310fwDfihxxVEk9EK78CHKWCWmC3etiY6bzrw2NgEREgW7KE1Y3D9NvPQuRiTwt3URje2gINtU15w4REbPCY1go1uB0vsTV8PnQtQLw-4hT765IhTvb9Ap41pA1we5wJtXp43q7ds_fH6vnpaZ6MUItOG6VoWTUOAc010VdOqUFLWuVCmMFUBnAqmBLOFZY01NudKNVzLvCgaoSu-QDeH2NTse4IQy1TIQtuaHoYplLnKJeVcJvD6CE5VB3U5etcZvy__vsp_AR5Qeqo</recordid><startdate>200910</startdate><enddate>200910</enddate><creator>O'Connor, Paul</creator><creator>Filippi, Massimo</creator><creator>Arnason, Barry</creator><creator>Comi, Giancarlo</creator><creator>Cook, Stuart</creator><creator>Goodin, Douglas</creator><creator>Hartung, Hans-Peter</creator><creator>Jeffery, Douglas</creator><creator>Kappos, Ludwig</creator><creator>Boateng, Francis</creator><creator>Filippov, Vitali</creator><creator>Groth, Maria</creator><creator>Knappertz, Volker</creator><creator>Kraus, Christian</creator><creator>Sandbrink, Rupert</creator><creator>Pohl, Christoph</creator><creator>Bogumil, Timon</creator><creator>O'Connor, P</creator><creator>Filippi, M</creator><creator>Arnason, B</creator><creator>Cook, S</creator><creator>Goodin, D</creator><creator>Hartung, H-P</creator><creator>Harung, H-P</creator><creator>Kappos, L</creator><creator>Jeffery, D</creator><creator>Comi, G</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>200910</creationdate><title>250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study</title><author>O'Connor, Paul ; 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Between November, 2003, and June, 2005, 2447 patients with relapsing-remitting multiple sclerosis were screened and 2244 patients were enrolled in this prospective, multicentre, randomised trial. Patients were randomly assigned 2:2:1 by block randomisation with regional stratification to receive one of two doses of interferon beta-1b (250 microg or 500 microg) subcutaneously every other day or 20 mg glatiramer acetate subcutaneously every day. The primary outcome was relapse risk, defined as new or recurrent neurological symptoms separated by at least 30 days from the preceding event and that lasted at least 24 h. Secondary outcomes were progression on the expanded disability status scale (EDSS) and change in T1-hypointense lesion volume. Clinical outcomes were assessed quarterly for 2.0-3.5 years; MRI was done at screening and annually thereafter. Analysis was by per protocol. This study is registered, number NCT00099502.
We found no differences in relapse risk, EDSS progression, T1-hypointense lesion volume, or normalised brain volume among treatment groups. Flu-like symptoms were more common in patients treated with interferon beta-1b (p<0.0001), whereas injection-site reactions were more common in patients treated with glatiramer acetate (p=0.0005). Patient attrition rates were 17% (153 of 888) on 250 microg interferon beta-1b, 26% (227 of 887) on 500 microg interferon beta-1b, and 21% (93 of 445) for glatiramer acetate.
500 microg interferon beta-1b was not more effective than the standard 250 microg dose, and both doses had similar clinical effects to glatiramer acetate. Although interferon beta-1b and glatiramer acetate had different adverse event profiles, the overall tolerability to both drugs was similar.
Bayer HealthCare Pharmaceuticals.</abstract><cop>England</cop><pmid>19729344</pmid><doi>10.1016/S1474-4422(09)70226-1</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | EISSN: 1474-4465 |
| ispartof | Lancet neurology, 2009-10, Vol.8 (10), p.889-897 |
| issn | 1474-4465 |
| language | eng |
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| source | ScienceDirect Freedom Collection 2022-2024 |
| subjects | Adolescent Adult Brain - drug effects Brain - pathology Dose-Response Relationship, Drug Double-Blind Method Female Glatiramer Acetate Humans Immunologic Factors - therapeutic use Interferon beta-1b Interferon-beta - administration & dosage Magnetic Resonance Imaging Male Middle Aged Multiple Sclerosis, Relapsing-Remitting - drug therapy Multiple Sclerosis, Relapsing-Remitting - pathology Peptides - therapeutic use Young Adult |
| title | 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study |
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