Treatment of rheumatoid arthritis with certolizumab pegol: Results from PROACTIVE, a non-interventional study in the UK and Ireland

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dc.contributor.authorKumar, Namita
dc.contributor.authorNaz, Sophia
dc.contributor.authorQuinn, Mark
dc.contributor.authorRyan, John
dc.contributor.authorKumke, Thomas
dc.contributor.authorSheeran, Tom
dc.contributor.funderUCB Pharmaen
dc.date.accessioned2019-11-25T10:40:11Z
dc.date.available2019-11-25T10:40:11Z
dc.date.issued2018-08-03
dc.description.abstractThe objective of this non-interventional study was to investigate the long-term safety and effectiveness of certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) in the UK and Ireland. Methods: Patients were prescribed CZP at their physicians’ discretion and followed during routine clinical practice for up to 88 weeks. DAS28(ESR) response (defined as at least a 1.2-point reduction from baseline) was measured in the full analysis set (FAS) at week 12, and patients were categorized by week 12 responder status in all subsequent analyses. The primary outcome was DAS28(ESR) response at week 78. Secondary outcomes included change from baseline in DAS28(ESR), HAQ-DI, and RADAI scores at week 78, and EULAR response at week 78. Adverse drug reactions (ADRs) were recorded for all patients who received at least one dose of CZP. Results: A total of 149 patients were enrolled, of whom 111 (74.5%) formed the FAS. At week 12, 80 patients (72.1%) were DAS28(ESR) responders and 31 (27.9%) non-responders. Compared to non-responders, a greater proportion of week 12 responders had a DAS28(ESR) response at week 78 (43.8% versus 22.6%). Improvements in DAS28(ESR), HAQ-DI, and RADAI scores were also greater on average among week 12 responders, as was the proportion of patients meeting EULAR criteria. Overall, 9 patients (6.1%) experienced 13 ADRs during the study. Conclusion: These data demonstrate the safety and effectiveness of CZP in adult patients with RA treated during routine clinical practice in the UK and Ireland.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationKumar, N., Naz, S., Quinn, M., Ryan, J., Kumke, T. and Sheeran, T., 2018. Treatment of rheumatoid arthritis with certolizumab pegol: results from PROACTIVE, a non-interventional study in the UK and Ireland. Advances in therapy, 35(9), (12pp). DOI:10.1007/s12325-018-0758-1en
dc.identifier.doi10.1007/s12325-018-0758-1en
dc.identifier.eissn1865-8652
dc.identifier.endpage1437en
dc.identifier.issn0741-238X
dc.identifier.issued9en
dc.identifier.journaltitleAdvances in Therapyen
dc.identifier.startpage1426en
dc.identifier.urihttps://hdl.handle.net/10468/9213
dc.identifier.volume35en
dc.language.isoenen
dc.publisherSpringer Healthcareen
dc.relation.urihttps://link.springer.com/article/10.1007%2Fs12325-018-0758-1
dc.rights© The Author(s) 2018en
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectAnti-TNFen
dc.subjectArthritisen
dc.subjectCertolizumab pegolen
dc.subjectDAS28en
dc.subjectDMARDs (biologic)en
dc.subjectRheumatoid arthritisen
dc.subjectRheumatologyen
dc.titleTreatment of rheumatoid arthritis with certolizumab pegol: Results from PROACTIVE, a non-interventional study in the UK and Irelanden
dc.typeArticle (peer-reviewed)en
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