Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial
To report 5-year efficacy and safety in rheumatoid arthritis (RA) patients with active disease treated with tocilizumab. LITHE was a 2-year, randomised, placebo-controlled study of tocilizumab in RA patients (ClinicalTrials.gov, NCT00106535), with an additional 3-year, open-label extension. Patients...
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| Veröffentlicht in: | Clinical and experimental rheumatology 2016-07, Vol.34 (4), p.625-633 |
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| container_title | Clinical and experimental rheumatology |
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| creator | Kremer, Joel M Blanco, Ricardo Halland, Anne-Marie Brzosko, Marek Burgos-Vargas, Ruben Mela, Christopher M Rowell, Lucy Fleischmann, Roy M |
| description | To report 5-year efficacy and safety in rheumatoid arthritis (RA) patients with active disease treated with tocilizumab.
LITHE was a 2-year, randomised, placebo-controlled study of tocilizumab in RA patients (ClinicalTrials.gov, NCT00106535), with an additional 3-year, open-label extension. Patients were randomly assigned to tocilizumab (4 or 8 mg/kg IV) or placebo every 4 weeks + methotrexate. They could receive rescue with tocilizumab from week 16; after week 52, patients could switch to open-label tocilizumab 8 mg/kg. Radiographs were analysed by randomized treatment using the Genant-modified Total Sharp Score (GmTSS). Patients with at least baseline, week 104 and post-week 104 radiographs were included. Clinical and safety data were pooled for all patients who received ≥1 dose of tocilizumab; results are presented from the first tocilizumab dose.
1,149 patients were included with 4,380 patient-years of exposure; 34% received 5 years of treatment. Mean 5-year change in GmTSS revealed greater inhibition of radiographic progression in tocilizumab patients than placebo patients (1.34 vs. 3.02), with the greatest annualised progression rate in year 1. Overall, 53% of tocilizumab and 35% of placebo patients experienced no progression (GmTSS ≤0). Clinical benefit was maintained - determined by ACR response, DAS28-ESR |
| format | Article |
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LITHE was a 2-year, randomised, placebo-controlled study of tocilizumab in RA patients (ClinicalTrials.gov, NCT00106535), with an additional 3-year, open-label extension. Patients were randomly assigned to tocilizumab (4 or 8 mg/kg IV) or placebo every 4 weeks + methotrexate. They could receive rescue with tocilizumab from week 16; after week 52, patients could switch to open-label tocilizumab 8 mg/kg. Radiographs were analysed by randomized treatment using the Genant-modified Total Sharp Score (GmTSS). Patients with at least baseline, week 104 and post-week 104 radiographs were included. Clinical and safety data were pooled for all patients who received ≥1 dose of tocilizumab; results are presented from the first tocilizumab dose.
1,149 patients were included with 4,380 patient-years of exposure; 34% received 5 years of treatment. Mean 5-year change in GmTSS revealed greater inhibition of radiographic progression in tocilizumab patients than placebo patients (1.34 vs. 3.02), with the greatest annualised progression rate in year 1. Overall, 53% of tocilizumab and 35% of placebo patients experienced no progression (GmTSS ≤0). Clinical benefit was maintained - determined by ACR response, DAS28-ESR <2.6, EULAR good/moderate response and Boolean remission - as was physical function. The safety profile over 5 years was similar to that over 2 years.
Over 5 years, tocilizumab + MTX inhibited radiographic progression and maintained improvements in signs and symptoms and physical function in MTX-inadequate responders with active disease; no new safety signals occurred.</description><identifier>ISSN: 0392-856X</identifier><identifier>PMID: 27087059</identifier><language>eng</language><publisher>Italy</publisher><subject>Antibodies, Monoclonal, Humanized - adverse effects ; Antibodies, Monoclonal, Humanized - therapeutic use ; Antirheumatic Agents - adverse effects ; Antirheumatic Agents - therapeutic use ; Arthritis, Rheumatoid - diagnostic imaging ; Arthritis, Rheumatoid - drug therapy ; Arthrography ; Blood Sedimentation ; Disability Evaluation ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Joints - drug effects ; Joints - pathology ; Male ; Methotrexate - therapeutic use ; Middle Aged ; Remission Induction ; Time Factors ; Treatment Outcome</subject><ispartof>Clinical and experimental rheumatology, 2016-07, Vol.34 (4), p.625-633</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27087059$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kremer, Joel M</creatorcontrib><creatorcontrib>Blanco, Ricardo</creatorcontrib><creatorcontrib>Halland, Anne-Marie</creatorcontrib><creatorcontrib>Brzosko, Marek</creatorcontrib><creatorcontrib>Burgos-Vargas, Ruben</creatorcontrib><creatorcontrib>Mela, Christopher M</creatorcontrib><creatorcontrib>Rowell, Lucy</creatorcontrib><creatorcontrib>Fleischmann, Roy M</creatorcontrib><title>Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial</title><title>Clinical and experimental rheumatology</title><addtitle>Clin Exp Rheumatol</addtitle><description>To report 5-year efficacy and safety in rheumatoid arthritis (RA) patients with active disease treated with tocilizumab.
LITHE was a 2-year, randomised, placebo-controlled study of tocilizumab in RA patients (ClinicalTrials.gov, NCT00106535), with an additional 3-year, open-label extension. Patients were randomly assigned to tocilizumab (4 or 8 mg/kg IV) or placebo every 4 weeks + methotrexate. They could receive rescue with tocilizumab from week 16; after week 52, patients could switch to open-label tocilizumab 8 mg/kg. Radiographs were analysed by randomized treatment using the Genant-modified Total Sharp Score (GmTSS). Patients with at least baseline, week 104 and post-week 104 radiographs were included. Clinical and safety data were pooled for all patients who received ≥1 dose of tocilizumab; results are presented from the first tocilizumab dose.
1,149 patients were included with 4,380 patient-years of exposure; 34% received 5 years of treatment. Mean 5-year change in GmTSS revealed greater inhibition of radiographic progression in tocilizumab patients than placebo patients (1.34 vs. 3.02), with the greatest annualised progression rate in year 1. Overall, 53% of tocilizumab and 35% of placebo patients experienced no progression (GmTSS ≤0). Clinical benefit was maintained - determined by ACR response, DAS28-ESR <2.6, EULAR good/moderate response and Boolean remission - as was physical function. The safety profile over 5 years was similar to that over 2 years.
Over 5 years, tocilizumab + MTX inhibited radiographic progression and maintained improvements in signs and symptoms and physical function in MTX-inadequate responders with active disease; no new safety signals occurred.</description><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Arthritis, Rheumatoid - diagnostic imaging</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Arthrography</subject><subject>Blood Sedimentation</subject><subject>Disability Evaluation</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Humans</subject><subject>Joints - drug effects</subject><subject>Joints - pathology</subject><subject>Male</subject><subject>Methotrexate - therapeutic use</subject><subject>Middle Aged</subject><subject>Remission Induction</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0392-856X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kMtKxEAQRbNQnHH0F6SWbgL9yKOzlMEXDLhRcBcqScVpycvuChI_wa-2HcdFcTfnVt1bJ9Fa6ELFJs1eV9G59-9CqCzN8rNopXJhcpEW6-h729nB1tgBtW3QegEcGvDYEi_Qox04DDUwT8AjpLAQOg92gAnZ0sAePi3vwe1p7pFH2wA63jvL1gM7Qg7eA8FjbTv7Fajq147gwqGxtz4A7Cx2F9Fpi52ny6Nuope72-ftQ7x7un_c3uziN6Vzjo1qVa4bkolodSO1qpNcUS3rEL4VMkmllAINUWZEJUJJklVCEmXRBB9pvYmu__ZObvyYyXMZQtTUdTjQOPtSGpGbwqSpDOjVEZ2rnppycrZHt5T__9M_zNxtqg</recordid><startdate>20160701</startdate><enddate>20160701</enddate><creator>Kremer, Joel M</creator><creator>Blanco, Ricardo</creator><creator>Halland, Anne-Marie</creator><creator>Brzosko, Marek</creator><creator>Burgos-Vargas, Ruben</creator><creator>Mela, Christopher M</creator><creator>Rowell, Lucy</creator><creator>Fleischmann, Roy M</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>20160701</creationdate><title>Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial</title><author>Kremer, Joel M ; Blanco, Ricardo ; Halland, Anne-Marie ; Brzosko, Marek ; Burgos-Vargas, Ruben ; Mela, Christopher M ; Rowell, Lucy ; Fleischmann, Roy M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g237t-82f273de140f3d132c472ec1ccacf01451110a8ee680b0059e1b4e1a19d273e33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Antibodies, Monoclonal, Humanized - adverse effects</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis, Rheumatoid - diagnostic imaging</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthrography</topic><topic>Blood Sedimentation</topic><topic>Disability Evaluation</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Humans</topic><topic>Joints - drug effects</topic><topic>Joints - pathology</topic><topic>Male</topic><topic>Methotrexate - therapeutic use</topic><topic>Middle Aged</topic><topic>Remission Induction</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kremer, Joel M</creatorcontrib><creatorcontrib>Blanco, Ricardo</creatorcontrib><creatorcontrib>Halland, Anne-Marie</creatorcontrib><creatorcontrib>Brzosko, Marek</creatorcontrib><creatorcontrib>Burgos-Vargas, Ruben</creatorcontrib><creatorcontrib>Mela, Christopher M</creatorcontrib><creatorcontrib>Rowell, Lucy</creatorcontrib><creatorcontrib>Fleischmann, Roy M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical and experimental rheumatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kremer, Joel M</au><au>Blanco, Ricardo</au><au>Halland, Anne-Marie</au><au>Brzosko, Marek</au><au>Burgos-Vargas, Ruben</au><au>Mela, Christopher M</au><au>Rowell, Lucy</au><au>Fleischmann, Roy M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial</atitle><jtitle>Clinical and experimental rheumatology</jtitle><addtitle>Clin Exp Rheumatol</addtitle><date>2016-07-01</date><risdate>2016</risdate><volume>34</volume><issue>4</issue><spage>625</spage><epage>633</epage><pages>625-633</pages><issn>0392-856X</issn><abstract>To report 5-year efficacy and safety in rheumatoid arthritis (RA) patients with active disease treated with tocilizumab.
LITHE was a 2-year, randomised, placebo-controlled study of tocilizumab in RA patients (ClinicalTrials.gov, NCT00106535), with an additional 3-year, open-label extension. Patients were randomly assigned to tocilizumab (4 or 8 mg/kg IV) or placebo every 4 weeks + methotrexate. They could receive rescue with tocilizumab from week 16; after week 52, patients could switch to open-label tocilizumab 8 mg/kg. Radiographs were analysed by randomized treatment using the Genant-modified Total Sharp Score (GmTSS). Patients with at least baseline, week 104 and post-week 104 radiographs were included. Clinical and safety data were pooled for all patients who received ≥1 dose of tocilizumab; results are presented from the first tocilizumab dose.
1,149 patients were included with 4,380 patient-years of exposure; 34% received 5 years of treatment. Mean 5-year change in GmTSS revealed greater inhibition of radiographic progression in tocilizumab patients than placebo patients (1.34 vs. 3.02), with the greatest annualised progression rate in year 1. Overall, 53% of tocilizumab and 35% of placebo patients experienced no progression (GmTSS ≤0). Clinical benefit was maintained - determined by ACR response, DAS28-ESR <2.6, EULAR good/moderate response and Boolean remission - as was physical function. The safety profile over 5 years was similar to that over 2 years.
Over 5 years, tocilizumab + MTX inhibited radiographic progression and maintained improvements in signs and symptoms and physical function in MTX-inadequate responders with active disease; no new safety signals occurred.</abstract><cop>Italy</cop><pmid>27087059</pmid><tpages>9</tpages></addata></record> |
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| subjects | Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Antirheumatic Agents - adverse effects Antirheumatic Agents - therapeutic use Arthritis, Rheumatoid - diagnostic imaging Arthritis, Rheumatoid - drug therapy Arthrography Blood Sedimentation Disability Evaluation Double-Blind Method Drug Therapy, Combination Female Humans Joints - drug effects Joints - pathology Male Methotrexate - therapeutic use Middle Aged Remission Induction Time Factors Treatment Outcome |
| title | Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial |
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