Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn’s disease with prior loss of response to infliximab
Aliment Pharmacol Ther 2011; 33: 541–550 Summary Background Crohn’s disease (CD) is associated with impaired health‐related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti‐TNF agent infliximab...
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| Veröffentlicht in: | Alimentary pharmacology & therapeutics 2011-03, Vol.33 (5), p.541-550 |
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| container_title | Alimentary pharmacology & therapeutics |
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| creator | Feagan, B. G. Sandborn, W. J. Wolf, D. C. Coteur, G. Purcaru, O. Brabant, Y. Rutgeerts, P. J. |
| description | Aliment Pharmacol Ther 2011; 33: 541–550
Summary
Background Crohn’s disease (CD) is associated with impaired health‐related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti‐TNF agent infliximab (WELCOME study).
Aim To investigate the impact of certolizumab pegol administered q2w and q4w on work productivity and HRQoL in the WELCOME study.
Methods Patients with loss of response to infliximab received open‐label certolizumab pegol induction and were randomised to receive double‐blind maintenance treatment with certolizumab pegol 400 mg either q4w or q2w through week 24, with a final evaluation at week 26. Work productivity and HRQoL were assessed using the Work Productivity and Activity Impairment:CD questionnaire and Inflammatory Bowel Disease Questionnaire respectively.
Results Baseline HRQoL burden was representative of moderately to severely active CD. HRQoL, daily activity and work productivity improved in both treatment groups as early as week 6 and were maintained through week 26. Treatment benefits to HRQoL, daily activity and work productivity were similar between the certolizumab pegol q2w vs. q4w groups.
Conclusions Certolizumab pegol therapy results in meaningful improvements in work productivity, daily activities and HRQoL in patients with active CD who previously responded to but either lost response or could not tolerate infliximab (ClinicalTrials.gov number: NCT00308581). |
| doi_str_mv | 10.1111/j.1365-2036.2010.04568.x |
| format | Article |
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Summary
Background Crohn’s disease (CD) is associated with impaired health‐related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti‐TNF agent infliximab (WELCOME study).
Aim To investigate the impact of certolizumab pegol administered q2w and q4w on work productivity and HRQoL in the WELCOME study.
Methods Patients with loss of response to infliximab received open‐label certolizumab pegol induction and were randomised to receive double‐blind maintenance treatment with certolizumab pegol 400 mg either q4w or q2w through week 24, with a final evaluation at week 26. Work productivity and HRQoL were assessed using the Work Productivity and Activity Impairment:CD questionnaire and Inflammatory Bowel Disease Questionnaire respectively.
Results Baseline HRQoL burden was representative of moderately to severely active CD. HRQoL, daily activity and work productivity improved in both treatment groups as early as week 6 and were maintained through week 26. Treatment benefits to HRQoL, daily activity and work productivity were similar between the certolizumab pegol q2w vs. q4w groups.
Conclusions Certolizumab pegol therapy results in meaningful improvements in work productivity, daily activities and HRQoL in patients with active CD who previously responded to but either lost response or could not tolerate infliximab (ClinicalTrials.gov number: NCT00308581).</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/j.1365-2036.2010.04568.x</identifier><identifier>PMID: 21223344</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized ; Biological and medical sciences ; Certolizumab Pegol ; Crohn Disease - drug therapy ; Digestive system ; Double-Blind Method ; Drug Resistance ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Gastrointestinal Agents - therapeutic use ; Humans ; Immunoglobulin Fab Fragments - therapeutic use ; Immunologic Factors - therapeutic use ; Infliximab ; Male ; Medical sciences ; Middle Aged ; Other diseases. Semiology ; Pharmacology. Drug treatments ; Polyethylene Glycols - therapeutic use ; Quality of Life ; Severity of Illness Index ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Treatment Outcome</subject><ispartof>Alimentary pharmacology & therapeutics, 2011-03, Vol.33 (5), p.541-550</ispartof><rights>2011 Blackwell Publishing Ltd</rights><rights>2015 INIST-CNRS</rights><rights>2011 Blackwell Publishing Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4488-e62eef52f948a57290d534f3da43c5a78f628a2cb6e20d16fbe3a7c634de9b4d3</citedby><cites>FETCH-LOGICAL-c4488-e62eef52f948a57290d534f3da43c5a78f628a2cb6e20d16fbe3a7c634de9b4d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2036.2010.04568.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2036.2010.04568.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27903,27904,45553,45554,46387,46811</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23840110$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21223344$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Feagan, B. G.</creatorcontrib><creatorcontrib>Sandborn, W. J.</creatorcontrib><creatorcontrib>Wolf, D. C.</creatorcontrib><creatorcontrib>Coteur, G.</creatorcontrib><creatorcontrib>Purcaru, O.</creatorcontrib><creatorcontrib>Brabant, Y.</creatorcontrib><creatorcontrib>Rutgeerts, P. J.</creatorcontrib><title>Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn’s disease with prior loss of response to infliximab</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Aliment Pharmacol Ther 2011; 33: 541–550
Summary
Background Crohn’s disease (CD) is associated with impaired health‐related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti‐TNF agent infliximab (WELCOME study).
Aim To investigate the impact of certolizumab pegol administered q2w and q4w on work productivity and HRQoL in the WELCOME study.
Methods Patients with loss of response to infliximab received open‐label certolizumab pegol induction and were randomised to receive double‐blind maintenance treatment with certolizumab pegol 400 mg either q4w or q2w through week 24, with a final evaluation at week 26. Work productivity and HRQoL were assessed using the Work Productivity and Activity Impairment:CD questionnaire and Inflammatory Bowel Disease Questionnaire respectively.
Results Baseline HRQoL burden was representative of moderately to severely active CD. HRQoL, daily activity and work productivity improved in both treatment groups as early as week 6 and were maintained through week 26. Treatment benefits to HRQoL, daily activity and work productivity were similar between the certolizumab pegol q2w vs. q4w groups.
Conclusions Certolizumab pegol therapy results in meaningful improvements in work productivity, daily activities and HRQoL in patients with active CD who previously responded to but either lost response or could not tolerate infliximab (ClinicalTrials.gov number: NCT00308581).</description><subject>Adult</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Biological and medical sciences</subject><subject>Certolizumab Pegol</subject><subject>Crohn Disease - drug therapy</subject><subject>Digestive system</subject><subject>Double-Blind Method</subject><subject>Drug Resistance</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Gastrointestinal Agents - therapeutic use</subject><subject>Humans</subject><subject>Immunoglobulin Fab Fragments - therapeutic use</subject><subject>Immunologic Factors - therapeutic use</subject><subject>Infliximab</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Other diseases. Semiology</subject><subject>Pharmacology. Drug treatments</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Quality of Life</subject><subject>Severity of Illness Index</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Treatment Outcome</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkctu1DAUhi1ERYfCKyBvEKsMju04DhKLasRNqtQKlbXlOMeMR04c7KSdsuI1eABejCfBYYayrTe-nO8_F_8I4ZKsy7xe79YlE1VBCRNrSvIr4ZWQ6_0jtLoPPEYrQkVTUFmyU_Q0pR0hRNSEPkGntKSUMc5X6NdnPXShdwk6bLwbnNEeT9Fp_wa7fozhBnoYJuwGvAXtpy0O82RCDwnfunwzEKfg3fe51y0e4WvwCzrqyWXVkdFmcjeANzFsh98_fibc5XI6wSE6Rhci9iElHCyOkMYw5NgUciLr3d7lzM_QidU-wfPjfoa-vH93vflYXFx--LQ5vygM51IWICiArahtuNRVTRvSVYxb1mnOTKVraQWVmppWACVdKWwLTNdGMN5B0_KOnaFXh7x58G8zpEnlnzHgvR4gzElJXtO6EXWdSXkgTcydR7Aqz9HreKdKohaP1E4tVqjFCrV4pP56pPZZ-uJYZG576O6F_0zJwMsjoFO2w0Y9GJf-c0xyUpYkc28P3K3zcPfgBtT51fVyYn8AStyyXw</recordid><startdate>201103</startdate><enddate>201103</enddate><creator>Feagan, B. G.</creator><creator>Sandborn, W. J.</creator><creator>Wolf, D. C.</creator><creator>Coteur, G.</creator><creator>Purcaru, O.</creator><creator>Brabant, Y.</creator><creator>Rutgeerts, P. J.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</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>201103</creationdate><title>Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn’s disease with prior loss of response to infliximab</title><author>Feagan, B. G. ; Sandborn, W. J. ; Wolf, D. C. ; Coteur, G. ; Purcaru, O. ; Brabant, Y. ; Rutgeerts, P. J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4488-e62eef52f948a57290d534f3da43c5a78f628a2cb6e20d16fbe3a7c634de9b4d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Biological and medical sciences</topic><topic>Certolizumab Pegol</topic><topic>Crohn Disease - drug therapy</topic><topic>Digestive system</topic><topic>Double-Blind Method</topic><topic>Drug Resistance</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Gastrointestinal Agents - therapeutic use</topic><topic>Humans</topic><topic>Immunoglobulin Fab Fragments - therapeutic use</topic><topic>Immunologic Factors - therapeutic use</topic><topic>Infliximab</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Other diseases. Semiology</topic><topic>Pharmacology. Drug treatments</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Quality of Life</topic><topic>Severity of Illness Index</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Feagan, B. G.</creatorcontrib><creatorcontrib>Sandborn, W. J.</creatorcontrib><creatorcontrib>Wolf, D. C.</creatorcontrib><creatorcontrib>Coteur, G.</creatorcontrib><creatorcontrib>Purcaru, O.</creatorcontrib><creatorcontrib>Brabant, Y.</creatorcontrib><creatorcontrib>Rutgeerts, P. J.</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>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Feagan, B. G.</au><au>Sandborn, W. J.</au><au>Wolf, D. C.</au><au>Coteur, G.</au><au>Purcaru, O.</au><au>Brabant, Y.</au><au>Rutgeerts, P. J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn’s disease with prior loss of response to infliximab</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2011-03</date><risdate>2011</risdate><volume>33</volume><issue>5</issue><spage>541</spage><epage>550</epage><pages>541-550</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Aliment Pharmacol Ther 2011; 33: 541–550
Summary
Background Crohn’s disease (CD) is associated with impaired health‐related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti‐TNF agent infliximab (WELCOME study).
Aim To investigate the impact of certolizumab pegol administered q2w and q4w on work productivity and HRQoL in the WELCOME study.
Methods Patients with loss of response to infliximab received open‐label certolizumab pegol induction and were randomised to receive double‐blind maintenance treatment with certolizumab pegol 400 mg either q4w or q2w through week 24, with a final evaluation at week 26. Work productivity and HRQoL were assessed using the Work Productivity and Activity Impairment:CD questionnaire and Inflammatory Bowel Disease Questionnaire respectively.
Results Baseline HRQoL burden was representative of moderately to severely active CD. HRQoL, daily activity and work productivity improved in both treatment groups as early as week 6 and were maintained through week 26. Treatment benefits to HRQoL, daily activity and work productivity were similar between the certolizumab pegol q2w vs. q4w groups.
Conclusions Certolizumab pegol therapy results in meaningful improvements in work productivity, daily activities and HRQoL in patients with active CD who previously responded to but either lost response or could not tolerate infliximab (ClinicalTrials.gov number: NCT00308581).</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21223344</pmid><doi>10.1111/j.1365-2036.2010.04568.x</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Biological and medical sciences Certolizumab Pegol Crohn Disease - drug therapy Digestive system Double-Blind Method Drug Resistance Female Gastroenterology. Liver. Pancreas. Abdomen Gastrointestinal Agents - therapeutic use Humans Immunoglobulin Fab Fragments - therapeutic use Immunologic Factors - therapeutic use Infliximab Male Medical sciences Middle Aged Other diseases. Semiology Pharmacology. Drug treatments Polyethylene Glycols - therapeutic use Quality of Life Severity of Illness Index Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Treatment Outcome |
| title | Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn’s disease with prior loss of response to infliximab |
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