Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks
Objective: To evaluate the continued safety and durability of clinical response in patients with ankylosing spondylitis receiving etanercept. Methods: 277 patients who had participated in a previous randomised, double blind, placebo controlled 24 week trial were eligible to continue in this open lab...
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| Veröffentlicht in: | Annals of the rheumatic diseases 2005-11, Vol.64 (11), p.1557-1562 |
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| container_title | Annals of the rheumatic diseases |
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| creator | Davis, J C van der Heijde, D M Braun, J Dougados, M Cush, J Clegg, D Inman, R D Kivitz, A Zhou, L Solinger, A Tsuji, W |
| description | Objective: To evaluate the continued safety and durability of clinical response in patients with ankylosing spondylitis receiving etanercept. Methods: 277 patients who had participated in a previous randomised, double blind, placebo controlled 24 week trial were eligible to continue in this open label extension study. All patients who enrolled in the open label extension (n = 257) received subcutaneous etanercept 25 mg twice weekly for up to 72 weeks, for a combined 96 weeks of cumulative trial and open label experience. For the patients who had received etanercept for 24 weeks in the double blind trial, this represented almost 2 years of continuous etanercept treatment. Results: Patients continuing etanercept treatment had a sustained response for almost 2 years, with 74% achieving an ASsessments in Ankylosing Spondylitis 20% (ASAS 20) response after 96 weeks of etanercept treatment. Patients who had received placebo in the preceding double blind trial had similar responses, with 70% of patients attaining an ASAS 20 response after 24 weeks of etanercept treatment and 78% achieving an ASAS 20 response after 72 weeks. Improved spinal mobility was seen in both groups. Etanercept was well tolerated in patients treated for up to 96 weeks. Conclusion: The subcutaneous administration of twice weekly doses of etanercept provided sustained durability of response in the improvement of signs and symptoms of ankylosing spondylitis for nearly 2 years. |
| doi_str_mv | 10.1136/ard.2004.035105 |
| format | Article |
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Methods: 277 patients who had participated in a previous randomised, double blind, placebo controlled 24 week trial were eligible to continue in this open label extension study. All patients who enrolled in the open label extension (n = 257) received subcutaneous etanercept 25 mg twice weekly for up to 72 weeks, for a combined 96 weeks of cumulative trial and open label experience. For the patients who had received etanercept for 24 weeks in the double blind trial, this represented almost 2 years of continuous etanercept treatment. Results: Patients continuing etanercept treatment had a sustained response for almost 2 years, with 74% achieving an ASsessments in Ankylosing Spondylitis 20% (ASAS 20) response after 96 weeks of etanercept treatment. Patients who had received placebo in the preceding double blind trial had similar responses, with 70% of patients attaining an ASAS 20 response after 24 weeks of etanercept treatment and 78% achieving an ASAS 20 response after 72 weeks. Improved spinal mobility was seen in both groups. Etanercept was well tolerated in patients treated for up to 96 weeks. Conclusion: The subcutaneous administration of twice weekly doses of etanercept provided sustained durability of response in the improvement of signs and symptoms of ankylosing spondylitis for nearly 2 years.</description><identifier>ISSN: 0003-4967</identifier><identifier>EISSN: 1468-2060</identifier><identifier>DOI: 10.1136/ard.2004.035105</identifier><identifier>PMID: 15843448</identifier><identifier>CODEN: ARDIAO</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><subject>Adolescent ; Adult ; Aged ; ankylosing spondylitis ; Antirheumatic Agents - adverse effects ; Antirheumatic Agents - therapeutic use ; ASAS ; ASsessment in Ankylosing Spondylitis ; BASDAI ; BASFI ; Bath Ankylosing Spondylitis Disease Activity Index ; Bath Ankylosing Spondylitis Function Index ; Biological and medical sciences ; C reactive protein ; Clinical trials ; CRP ; Diseases of the osteoarticular system ; Double-Blind Method ; Drug Administration Schedule ; Etanercept ; Extended Report ; Female ; Follow-Up Studies ; Humans ; Immunoglobulin G - adverse effects ; Immunoglobulin G - therapeutic use ; Immunomodulators ; Inflammation ; Inflammatory bowel disease ; Inflammatory joint diseases ; Injections, Subcutaneous ; Male ; Medical sciences ; Middle Aged ; Pain ; Pharmacology. Drug treatments ; PPD ; purified protein derivative ; randomised clinical trial ; Randomized Controlled Trials as Topic ; Range of Motion, Articular ; RCT ; receptors ; Receptors, Tumor Necrosis Factor - therapeutic use ; Rheumatoid arthritis ; Severity of Illness Index ; Spine - physiopathology ; Spondylitis, Ankylosing - drug therapy ; Spondylitis, Ankylosing - physiopathology ; Studies ; subcutaneous ; TNFR-Fc fusion protein ; Treatment Outcome ; tumour necrosis factor</subject><ispartof>Annals of the rheumatic diseases, 2005-11, Vol.64 (11), p.1557-1562</ispartof><rights>Copyright 2005 by Annals of the Rheumatic Diseases</rights><rights>2005 INIST-CNRS</rights><rights>Copyright: 2005 Copyright 2005 by Annals of the Rheumatic Diseases</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b588t-45cd68f3dac40d8e66f2d37ddbed12e20217bad18679904403a2b5a64d2339853</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1755272/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1755272/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17234410$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15843448$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Davis, J C</creatorcontrib><creatorcontrib>van der Heijde, D M</creatorcontrib><creatorcontrib>Braun, J</creatorcontrib><creatorcontrib>Dougados, M</creatorcontrib><creatorcontrib>Cush, J</creatorcontrib><creatorcontrib>Clegg, D</creatorcontrib><creatorcontrib>Inman, R D</creatorcontrib><creatorcontrib>Kivitz, A</creatorcontrib><creatorcontrib>Zhou, L</creatorcontrib><creatorcontrib>Solinger, A</creatorcontrib><creatorcontrib>Tsuji, W</creatorcontrib><title>Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks</title><title>Annals of the rheumatic diseases</title><addtitle>Ann Rheum Dis</addtitle><description>Objective: To evaluate the continued safety and durability of clinical response in patients with ankylosing spondylitis receiving etanercept. Methods: 277 patients who had participated in a previous randomised, double blind, placebo controlled 24 week trial were eligible to continue in this open label extension study. All patients who enrolled in the open label extension (n = 257) received subcutaneous etanercept 25 mg twice weekly for up to 72 weeks, for a combined 96 weeks of cumulative trial and open label experience. For the patients who had received etanercept for 24 weeks in the double blind trial, this represented almost 2 years of continuous etanercept treatment. Results: Patients continuing etanercept treatment had a sustained response for almost 2 years, with 74% achieving an ASsessments in Ankylosing Spondylitis 20% (ASAS 20) response after 96 weeks of etanercept treatment. Patients who had received placebo in the preceding double blind trial had similar responses, with 70% of patients attaining an ASAS 20 response after 24 weeks of etanercept treatment and 78% achieving an ASAS 20 response after 72 weeks. Improved spinal mobility was seen in both groups. Etanercept was well tolerated in patients treated for up to 96 weeks. Conclusion: The subcutaneous administration of twice weekly doses of etanercept provided sustained durability of response in the improvement of signs and symptoms of ankylosing spondylitis for nearly 2 years.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>ankylosing spondylitis</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>ASAS</subject><subject>ASsessment in Ankylosing Spondylitis</subject><subject>BASDAI</subject><subject>BASFI</subject><subject>Bath Ankylosing Spondylitis Disease Activity Index</subject><subject>Bath Ankylosing Spondylitis Function Index</subject><subject>Biological and medical sciences</subject><subject>C reactive protein</subject><subject>Clinical trials</subject><subject>CRP</subject><subject>Diseases of the osteoarticular system</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Etanercept</subject><subject>Extended Report</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Immunoglobulin G - adverse effects</subject><subject>Immunoglobulin G - therapeutic use</subject><subject>Immunomodulators</subject><subject>Inflammation</subject><subject>Inflammatory bowel disease</subject><subject>Inflammatory joint diseases</subject><subject>Injections, Subcutaneous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pain</subject><subject>Pharmacology. Drug treatments</subject><subject>PPD</subject><subject>purified protein derivative</subject><subject>randomised clinical trial</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Range of Motion, Articular</subject><subject>RCT</subject><subject>receptors</subject><subject>Receptors, Tumor Necrosis Factor - therapeutic use</subject><subject>Rheumatoid arthritis</subject><subject>Severity of Illness Index</subject><subject>Spine - physiopathology</subject><subject>Spondylitis, Ankylosing - drug therapy</subject><subject>Spondylitis, Ankylosing - physiopathology</subject><subject>Studies</subject><subject>subcutaneous</subject><subject>TNFR-Fc fusion protein</subject><subject>Treatment Outcome</subject><subject>tumour necrosis factor</subject><issn>0003-4967</issn><issn>1468-2060</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqF0c9rFDEUB_Agil2rZ28yIHoozDa_k7kIdtvVQlHw18FLyEwyNbuzyZpkqvvfmzLL1nrxFJL3yeM9vgA8R3COEOGnOpo5hpDOIWEIsgdghiiXNYYcPgQzCCGpacPFEXiS0qpcoUTyMThCTFJCqZyB75_HlLXz1lRmjLp1g8u7SntT5TDYw0PoK5u1t7Gz21w5X8R6N4Tk_HWVtsGbXWEuVX2IVcOrX9au01PwqNdDss_25zH4urz4snhfX318d7l4e1W3TMpcU9YZLntidEehkZbzHhsijGmtQdhiiJFotUGSi6aBlEKiccs0pwYT0khGjsGbqe92bDfWdNbnqAe1jW6j404F7dT9inc_1HW4UUgwhgUuDV7vG8Twc7Qpq41LnR2GsnAYk-KSN5jJpsCX_8BVGKMvy5VeQjQCSyaKOp1UF0NK0faHURBUt6mpkpq6TU1NqZUfL_7e4M7vYyrg1R7o1Omhj9p3Lt25sgSlCBZXT86lbH8f6jquFRdEMPXh20KdLT8tzyFaqrPiTybfblb_nfIPO0C9Gw</recordid><startdate>20051101</startdate><enddate>20051101</enddate><creator>Davis, J C</creator><creator>van der Heijde, D M</creator><creator>Braun, J</creator><creator>Dougados, M</creator><creator>Cush, J</creator><creator>Clegg, D</creator><creator>Inman, R D</creator><creator>Kivitz, A</creator><creator>Zhou, L</creator><creator>Solinger, A</creator><creator>Tsuji, W</creator><general>BMJ Publishing Group Ltd and European League Against Rheumatism</general><general>BMJ</general><general>BMJ Publishing Group LTD</general><scope>BSCLL</scope><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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20051101</creationdate><title>Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks</title><author>Davis, J C ; van der Heijde, D M ; Braun, J ; Dougados, M ; Cush, J ; Clegg, D ; Inman, R D ; Kivitz, A ; Zhou, L ; Solinger, A ; Tsuji, W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b588t-45cd68f3dac40d8e66f2d37ddbed12e20217bad18679904403a2b5a64d2339853</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>ankylosing spondylitis</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>ASAS</topic><topic>ASsessment in Ankylosing Spondylitis</topic><topic>BASDAI</topic><topic>BASFI</topic><topic>Bath Ankylosing Spondylitis Disease Activity Index</topic><topic>Bath Ankylosing Spondylitis Function Index</topic><topic>Biological and medical sciences</topic><topic>C reactive protein</topic><topic>Clinical trials</topic><topic>CRP</topic><topic>Diseases of the osteoarticular system</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Etanercept</topic><topic>Extended Report</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Immunoglobulin G - adverse effects</topic><topic>Immunoglobulin G - therapeutic use</topic><topic>Immunomodulators</topic><topic>Inflammation</topic><topic>Inflammatory bowel disease</topic><topic>Inflammatory joint diseases</topic><topic>Injections, Subcutaneous</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pain</topic><topic>Pharmacology. Drug treatments</topic><topic>PPD</topic><topic>purified protein derivative</topic><topic>randomised clinical trial</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Range of Motion, Articular</topic><topic>RCT</topic><topic>receptors</topic><topic>Receptors, Tumor Necrosis Factor - therapeutic use</topic><topic>Rheumatoid arthritis</topic><topic>Severity of Illness Index</topic><topic>Spine - physiopathology</topic><topic>Spondylitis, Ankylosing - drug therapy</topic><topic>Spondylitis, Ankylosing - physiopathology</topic><topic>Studies</topic><topic>subcutaneous</topic><topic>TNFR-Fc fusion protein</topic><topic>Treatment Outcome</topic><topic>tumour necrosis factor</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Davis, J C</creatorcontrib><creatorcontrib>van der Heijde, D M</creatorcontrib><creatorcontrib>Braun, J</creatorcontrib><creatorcontrib>Dougados, M</creatorcontrib><creatorcontrib>Cush, J</creatorcontrib><creatorcontrib>Clegg, D</creatorcontrib><creatorcontrib>Inman, R D</creatorcontrib><creatorcontrib>Kivitz, A</creatorcontrib><creatorcontrib>Zhou, L</creatorcontrib><creatorcontrib>Solinger, A</creatorcontrib><creatorcontrib>Tsuji, W</creatorcontrib><collection>Istex</collection><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>ProQuest Central (Corporate)</collection><collection>Health Medical collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science 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)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>ProQuest Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest Science Journals</collection><collection>Biological Science 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><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Annals of the rheumatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Davis, J C</au><au>van der Heijde, D M</au><au>Braun, J</au><au>Dougados, M</au><au>Cush, J</au><au>Clegg, D</au><au>Inman, R D</au><au>Kivitz, A</au><au>Zhou, L</au><au>Solinger, A</au><au>Tsuji, W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks</atitle><jtitle>Annals of the rheumatic diseases</jtitle><addtitle>Ann Rheum Dis</addtitle><date>2005-11-01</date><risdate>2005</risdate><volume>64</volume><issue>11</issue><spage>1557</spage><epage>1562</epage><pages>1557-1562</pages><issn>0003-4967</issn><eissn>1468-2060</eissn><coden>ARDIAO</coden><abstract>Objective: To evaluate the continued safety and durability of clinical response in patients with ankylosing spondylitis receiving etanercept. Methods: 277 patients who had participated in a previous randomised, double blind, placebo controlled 24 week trial were eligible to continue in this open label extension study. All patients who enrolled in the open label extension (n = 257) received subcutaneous etanercept 25 mg twice weekly for up to 72 weeks, for a combined 96 weeks of cumulative trial and open label experience. For the patients who had received etanercept for 24 weeks in the double blind trial, this represented almost 2 years of continuous etanercept treatment. Results: Patients continuing etanercept treatment had a sustained response for almost 2 years, with 74% achieving an ASsessments in Ankylosing Spondylitis 20% (ASAS 20) response after 96 weeks of etanercept treatment. Patients who had received placebo in the preceding double blind trial had similar responses, with 70% of patients attaining an ASAS 20 response after 24 weeks of etanercept treatment and 78% achieving an ASAS 20 response after 72 weeks. Improved spinal mobility was seen in both groups. Etanercept was well tolerated in patients treated for up to 96 weeks. Conclusion: The subcutaneous administration of twice weekly doses of etanercept provided sustained durability of response in the improvement of signs and symptoms of ankylosing spondylitis for nearly 2 years.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and European League Against Rheumatism</pub><pmid>15843448</pmid><doi>10.1136/ard.2004.035105</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged ankylosing spondylitis Antirheumatic Agents - adverse effects Antirheumatic Agents - therapeutic use ASAS ASsessment in Ankylosing Spondylitis BASDAI BASFI Bath Ankylosing Spondylitis Disease Activity Index Bath Ankylosing Spondylitis Function Index Biological and medical sciences C reactive protein Clinical trials CRP Diseases of the osteoarticular system Double-Blind Method Drug Administration Schedule Etanercept Extended Report Female Follow-Up Studies Humans Immunoglobulin G - adverse effects Immunoglobulin G - therapeutic use Immunomodulators Inflammation Inflammatory bowel disease Inflammatory joint diseases Injections, Subcutaneous Male Medical sciences Middle Aged Pain Pharmacology. Drug treatments PPD purified protein derivative randomised clinical trial Randomized Controlled Trials as Topic Range of Motion, Articular RCT receptors Receptors, Tumor Necrosis Factor - therapeutic use Rheumatoid arthritis Severity of Illness Index Spine - physiopathology Spondylitis, Ankylosing - drug therapy Spondylitis, Ankylosing - physiopathology Studies subcutaneous TNFR-Fc fusion protein Treatment Outcome tumour necrosis factor |
| title | Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks |
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