MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study
We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing–remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with...
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| Veröffentlicht in: | Journal of neurology 2013-04, Vol.260 (4), p.1136-1146 |
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| creator | Comi, Giancarlo Cook, Stuart D. Giovannoni, Gavin Rammohan, Kottil Rieckmann, Peter Sørensen, Per Soelberg Vermersch, Patrick Hamlett, Anthony C. Viglietta, Vissia Greenberg, Steven J. |
| description | We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing–remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with RRMS were randomized 1:1:1 to annual short-course therapy with cladribine tablets cumulative dose 3.5 or 5.25 mg/kg or placebo. MRI endpoints included mean number of T1 gadolinium-enhancing (Gd+), active T2 and combined unique (CU) lesions/patient/scan. MRI-measured disease activity was significantly reduced in both cladribine tablets groups versus placebo. The proportion of patients with no active lesions at study end was: T1 Gd+ lesions: 86.8 and 91.0 versus 48.3 % (
p
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| doi_str_mv | 10.1007/s00415-012-6775-0 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1348488839</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2936974381</sourcerecordid><originalsourceid>FETCH-LOGICAL-c405t-36109088992ea1e9ffffa61b6982dbe3ed9e526ffa5d5b467b7a4e6cc8b58e823</originalsourceid><addsrcrecordid>eNp1kMtKAzEUhoMotlYfwI0E3LgZzX0ySyleChWl1IWrMJczdspcapJB-vamTBURzCYh5zv_ST6Ezim5poTEN44QQWVEKItUHIfDARpTwVlEhUwO0ZhwQSLJpRihE-fWhBAdCsdoxDhTXMR8jF6eFjPc9T7vGnD4s_IrnNdpYausagH7NKvBO1x2Fjd97atNDdjlNdjOVQ5XLfYrwNP57WK2fMPO98X2FB2Vae3gbL9P0Ov93XL6GM2fH2bT23mUCyJ9xBUlCdE6SRikFJIyrFTRTCWaFRlwKBKQTIVLWchMqDiLUwEqz3UmNWjGJ-hqyN3Y7qMH501TuRzqOm2h652hXGihteZJQC__oOuut214XaCYCPq04oGiA5WHzzkLpdnYqknt1lBidrrNoNsE3ux0GxJ6LvbJfdZA8dPx7TcAbABcKLXvYH-N_jf1C1URiZQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1324012863</pqid></control><display><type>article</type><title>MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Comi, Giancarlo ; Cook, Stuart D. ; Giovannoni, Gavin ; Rammohan, Kottil ; Rieckmann, Peter ; Sørensen, Per Soelberg ; Vermersch, Patrick ; Hamlett, Anthony C. ; Viglietta, Vissia ; Greenberg, Steven J.</creator><creatorcontrib>Comi, Giancarlo ; Cook, Stuart D. ; Giovannoni, Gavin ; Rammohan, Kottil ; Rieckmann, Peter ; Sørensen, Per Soelberg ; Vermersch, Patrick ; Hamlett, Anthony C. ; Viglietta, Vissia ; Greenberg, Steven J.</creatorcontrib><description>We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing–remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with RRMS were randomized 1:1:1 to annual short-course therapy with cladribine tablets cumulative dose 3.5 or 5.25 mg/kg or placebo. MRI endpoints included mean number of T1 gadolinium-enhancing (Gd+), active T2 and combined unique (CU) lesions/patient/scan. MRI-measured disease activity was significantly reduced in both cladribine tablets groups versus placebo. The proportion of patients with no active lesions at study end was: T1 Gd+ lesions: 86.8 and 91.0 versus 48.3 % (
p
< 0.001); active T2 lesions: 61.7 and 62.5 versus 28.4 % (
p
< 0.001); CU lesions: 59.6 and 60.7 versus 26.1 % (
p
< 0.001). Clinically meaningful and significant reductions in active lesion counts and increases in proportions of active lesion-free patients were achieved consistently in cladribine tablet groups when data were stratified by baseline disease characteristics. For example, the percentage of patients who remained lesion-free over the study was significantly greater in cladribine tablet groups than in the placebo group for all lesion types regardless of relapse category at baseline (
p
< 0.001 for all analyses of patients with ≤1 or 2 relapses;
p
≤ 0.022 for analyses of patients with ≥3 relapses). MRI-measured disease activity was greatly reduced by both doses of cladribine tablets, with consistent effect across clinically relevant patient populations. These findings add to our scientific understanding of the neurological impact of this therapeutic modality in patients with RRMS.</description><identifier>ISSN: 0340-5354</identifier><identifier>EISSN: 1432-1459</identifier><identifier>DOI: 10.1007/s00415-012-6775-0</identifier><identifier>PMID: 23263473</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer-Verlag</publisher><subject>Analysis of Variance ; Brain - drug effects ; Brain - pathology ; Cladribine - therapeutic use ; Clinical trials ; Dentistry ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug dosages ; Female ; Follow-Up Studies ; Gadolinium ; Humans ; Immunosuppressive Agents - therapeutic use ; Magnetic Resonance Imaging ; Male ; Medicine ; Medicine & Public Health ; Multiple sclerosis ; Multiple Sclerosis - drug therapy ; Multiple Sclerosis - pathology ; Neurology ; Neuroradiology ; Neurosciences ; Original Communication ; Patients ; Secondary Prevention ; Severity of Illness Index ; Tablets - therapeutic use ; Treatment Outcome</subject><ispartof>Journal of neurology, 2013-04, Vol.260 (4), p.1136-1146</ispartof><rights>Springer-Verlag Berlin Heidelberg 2012</rights><rights>Springer-Verlag Berlin Heidelberg 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c405t-36109088992ea1e9ffffa61b6982dbe3ed9e526ffa5d5b467b7a4e6cc8b58e823</citedby><cites>FETCH-LOGICAL-c405t-36109088992ea1e9ffffa61b6982dbe3ed9e526ffa5d5b467b7a4e6cc8b58e823</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00415-012-6775-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00415-012-6775-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27902,27903,41466,42535,51296</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23263473$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Comi, Giancarlo</creatorcontrib><creatorcontrib>Cook, Stuart D.</creatorcontrib><creatorcontrib>Giovannoni, Gavin</creatorcontrib><creatorcontrib>Rammohan, Kottil</creatorcontrib><creatorcontrib>Rieckmann, Peter</creatorcontrib><creatorcontrib>Sørensen, Per Soelberg</creatorcontrib><creatorcontrib>Vermersch, Patrick</creatorcontrib><creatorcontrib>Hamlett, Anthony C.</creatorcontrib><creatorcontrib>Viglietta, Vissia</creatorcontrib><creatorcontrib>Greenberg, Steven J.</creatorcontrib><title>MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study</title><title>Journal of neurology</title><addtitle>J Neurol</addtitle><addtitle>J Neurol</addtitle><description>We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing–remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with RRMS were randomized 1:1:1 to annual short-course therapy with cladribine tablets cumulative dose 3.5 or 5.25 mg/kg or placebo. MRI endpoints included mean number of T1 gadolinium-enhancing (Gd+), active T2 and combined unique (CU) lesions/patient/scan. MRI-measured disease activity was significantly reduced in both cladribine tablets groups versus placebo. The proportion of patients with no active lesions at study end was: T1 Gd+ lesions: 86.8 and 91.0 versus 48.3 % (
p
< 0.001); active T2 lesions: 61.7 and 62.5 versus 28.4 % (
p
< 0.001); CU lesions: 59.6 and 60.7 versus 26.1 % (
p
< 0.001). Clinically meaningful and significant reductions in active lesion counts and increases in proportions of active lesion-free patients were achieved consistently in cladribine tablet groups when data were stratified by baseline disease characteristics. For example, the percentage of patients who remained lesion-free over the study was significantly greater in cladribine tablet groups than in the placebo group for all lesion types regardless of relapse category at baseline (
p
< 0.001 for all analyses of patients with ≤1 or 2 relapses;
p
≤ 0.022 for analyses of patients with ≥3 relapses). MRI-measured disease activity was greatly reduced by both doses of cladribine tablets, with consistent effect across clinically relevant patient populations. These findings add to our scientific understanding of the neurological impact of this therapeutic modality in patients with RRMS.</description><subject>Analysis of Variance</subject><subject>Brain - drug effects</subject><subject>Brain - pathology</subject><subject>Cladribine - therapeutic use</subject><subject>Clinical trials</subject><subject>Dentistry</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug dosages</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gadolinium</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Multiple sclerosis</subject><subject>Multiple Sclerosis - drug therapy</subject><subject>Multiple Sclerosis - pathology</subject><subject>Neurology</subject><subject>Neuroradiology</subject><subject>Neurosciences</subject><subject>Original Communication</subject><subject>Patients</subject><subject>Secondary Prevention</subject><subject>Severity of Illness Index</subject><subject>Tablets - therapeutic use</subject><subject>Treatment Outcome</subject><issn>0340-5354</issn><issn>1432-1459</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kMtKAzEUhoMotlYfwI0E3LgZzX0ySyleChWl1IWrMJczdspcapJB-vamTBURzCYh5zv_ST6Ezim5poTEN44QQWVEKItUHIfDARpTwVlEhUwO0ZhwQSLJpRihE-fWhBAdCsdoxDhTXMR8jF6eFjPc9T7vGnD4s_IrnNdpYausagH7NKvBO1x2Fjd97atNDdjlNdjOVQ5XLfYrwNP57WK2fMPO98X2FB2Vae3gbL9P0Ov93XL6GM2fH2bT23mUCyJ9xBUlCdE6SRikFJIyrFTRTCWaFRlwKBKQTIVLWchMqDiLUwEqz3UmNWjGJ-hqyN3Y7qMH501TuRzqOm2h652hXGihteZJQC__oOuut214XaCYCPq04oGiA5WHzzkLpdnYqknt1lBidrrNoNsE3ux0GxJ6LvbJfdZA8dPx7TcAbABcKLXvYH-N_jf1C1URiZQ</recordid><startdate>20130401</startdate><enddate>20130401</enddate><creator>Comi, Giancarlo</creator><creator>Cook, Stuart D.</creator><creator>Giovannoni, Gavin</creator><creator>Rammohan, Kottil</creator><creator>Rieckmann, Peter</creator><creator>Sørensen, Per Soelberg</creator><creator>Vermersch, Patrick</creator><creator>Hamlett, Anthony C.</creator><creator>Viglietta, Vissia</creator><creator>Greenberg, Steven J.</creator><general>Springer-Verlag</general><general>Springer Nature B.V</general><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>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20130401</creationdate><title>MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study</title><author>Comi, Giancarlo ; Cook, Stuart D. ; Giovannoni, Gavin ; Rammohan, Kottil ; Rieckmann, Peter ; Sørensen, Per Soelberg ; Vermersch, Patrick ; Hamlett, Anthony C. ; Viglietta, Vissia ; Greenberg, Steven J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c405t-36109088992ea1e9ffffa61b6982dbe3ed9e526ffa5d5b467b7a4e6cc8b58e823</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Analysis of Variance</topic><topic>Brain - drug effects</topic><topic>Brain - pathology</topic><topic>Cladribine - therapeutic use</topic><topic>Clinical trials</topic><topic>Dentistry</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug dosages</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gadolinium</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Multiple sclerosis</topic><topic>Multiple Sclerosis - drug therapy</topic><topic>Multiple Sclerosis - pathology</topic><topic>Neurology</topic><topic>Neuroradiology</topic><topic>Neurosciences</topic><topic>Original Communication</topic><topic>Patients</topic><topic>Secondary Prevention</topic><topic>Severity of Illness Index</topic><topic>Tablets - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Comi, Giancarlo</creatorcontrib><creatorcontrib>Cook, Stuart D.</creatorcontrib><creatorcontrib>Giovannoni, Gavin</creatorcontrib><creatorcontrib>Rammohan, Kottil</creatorcontrib><creatorcontrib>Rieckmann, Peter</creatorcontrib><creatorcontrib>Sørensen, Per Soelberg</creatorcontrib><creatorcontrib>Vermersch, Patrick</creatorcontrib><creatorcontrib>Hamlett, Anthony C.</creatorcontrib><creatorcontrib>Viglietta, Vissia</creatorcontrib><creatorcontrib>Greenberg, Steven J.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Journal of neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Comi, Giancarlo</au><au>Cook, Stuart D.</au><au>Giovannoni, Gavin</au><au>Rammohan, Kottil</au><au>Rieckmann, Peter</au><au>Sørensen, Per Soelberg</au><au>Vermersch, Patrick</au><au>Hamlett, Anthony C.</au><au>Viglietta, Vissia</au><au>Greenberg, Steven J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study</atitle><jtitle>Journal of neurology</jtitle><stitle>J Neurol</stitle><addtitle>J Neurol</addtitle><date>2013-04-01</date><risdate>2013</risdate><volume>260</volume><issue>4</issue><spage>1136</spage><epage>1146</epage><pages>1136-1146</pages><issn>0340-5354</issn><eissn>1432-1459</eissn><abstract>We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing–remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with RRMS were randomized 1:1:1 to annual short-course therapy with cladribine tablets cumulative dose 3.5 or 5.25 mg/kg or placebo. MRI endpoints included mean number of T1 gadolinium-enhancing (Gd+), active T2 and combined unique (CU) lesions/patient/scan. MRI-measured disease activity was significantly reduced in both cladribine tablets groups versus placebo. The proportion of patients with no active lesions at study end was: T1 Gd+ lesions: 86.8 and 91.0 versus 48.3 % (
p
< 0.001); active T2 lesions: 61.7 and 62.5 versus 28.4 % (
p
< 0.001); CU lesions: 59.6 and 60.7 versus 26.1 % (
p
< 0.001). Clinically meaningful and significant reductions in active lesion counts and increases in proportions of active lesion-free patients were achieved consistently in cladribine tablet groups when data were stratified by baseline disease characteristics. For example, the percentage of patients who remained lesion-free over the study was significantly greater in cladribine tablet groups than in the placebo group for all lesion types regardless of relapse category at baseline (
p
< 0.001 for all analyses of patients with ≤1 or 2 relapses;
p
≤ 0.022 for analyses of patients with ≥3 relapses). MRI-measured disease activity was greatly reduced by both doses of cladribine tablets, with consistent effect across clinically relevant patient populations. These findings add to our scientific understanding of the neurological impact of this therapeutic modality in patients with RRMS.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer-Verlag</pub><pmid>23263473</pmid><doi>10.1007/s00415-012-6775-0</doi><tpages>11</tpages></addata></record> |
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| subjects | Analysis of Variance Brain - drug effects Brain - pathology Cladribine - therapeutic use Clinical trials Dentistry Dose-Response Relationship, Drug Double-Blind Method Drug dosages Female Follow-Up Studies Gadolinium Humans Immunosuppressive Agents - therapeutic use Magnetic Resonance Imaging Male Medicine Medicine & Public Health Multiple sclerosis Multiple Sclerosis - drug therapy Multiple Sclerosis - pathology Neurology Neuroradiology Neurosciences Original Communication Patients Secondary Prevention Severity of Illness Index Tablets - therapeutic use Treatment Outcome |
| title | MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study |
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