Drug-specific risk and characteristics of lupus and vasculitis-like events in patients with rheumatoid arthritis treated with TNFi: results from BSRBR-RA

ObjectiveTo compare the risk of lupus-like events (LLEs) and vasculitis-like events (VLEs) in tumour necrosis factor-α inhibitor (TNFi)-treated patients with rheumatoid arthritis (RA) to those receiving non-biological disease-modifying antirheumatic drugs (nbDMARDs).MethodsPatients were recruited to...

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Published in:Rheumatic & musculoskeletal diseases open 2017-01, Vol.3 (1), p.e000314-e000314
Main Authors: Jani, Meghna, Dixon, William G, Kersley-Fleet, Lianne, Bruce, Ian N, Chinoy, Hector, Barton, Anne, Lunt, Mark, Watson, Kath, Symmons, Deborah P, Hyrich, Kimme L
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container_title Rheumatic & musculoskeletal diseases open
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creator Jani, Meghna
Dixon, William G
Kersley-Fleet, Lianne
Bruce, Ian N
Chinoy, Hector
Barton, Anne
Lunt, Mark
Watson, Kath
Symmons, Deborah P
Hyrich, Kimme L
description ObjectiveTo compare the risk of lupus-like events (LLEs) and vasculitis-like events (VLEs) in tumour necrosis factor-α inhibitor (TNFi)-treated patients with rheumatoid arthritis (RA) to those receiving non-biological disease-modifying antirheumatic drugs (nbDMARDs).MethodsPatients were recruited to the British Society for Rheumatology Biologics Register—RA, a national prospective cohort study. Two cohorts recruited between 2001 and 2015: (1) patients starting first TNFi (adalimumab, etanercept, infliximab and certolizumab) (n=12 937) and (2) biological-naïve comparison cohort receiving nbDMARDs (n=3673). The risk of an event was compared between the two cohorts using Cox proportional-hazard models, adjusted using propensity scores. Rates of LLE/VLE were compared between TNFi and nbDMARD patients.ResultsThe crude incidence rates for LLEs were: TNFi 10/10 000 patient-years (pyrs) (95% CI 8 to 13) and nbDMARD 2/10 000 pyrs (95% CI 1 to 6); for VLEs: TNFi 15/10 000 pyrs (95% CI 12 to 19) and nbDMARD 7/10 000 pyrs (95% CI 4 to 12). The risk of both events was highest in the first year of TNFi treatment. After adjusting for differences in baseline characteristics, there was no difference in risk of LLEs (adjHR 1.86; 95% CI 0.52 to 6.58) or VLEs (adjHR 1.27; 95% CI 0.40 to 4.04) for TNFi compared to nbDMARD-treated patients. Infliximab conferred the highest overall risk, followed by etanercept, although 95% CIs overlapped following adjustment.ConclusionsIn one of the largest biological registers, the absolute risk of both events is low. The addition of TNFi to nbDMARD does not alter the risk of either event in patients with RA selected for TNFi. This is the first study to assess the risk of these outcomes in a prospective, observational cohort.
doi_str_mv 10.1136/rmdopen-2016-000314
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Two cohorts recruited between 2001 and 2015: (1) patients starting first TNFi (adalimumab, etanercept, infliximab and certolizumab) (n=12 937) and (2) biological-naïve comparison cohort receiving nbDMARDs (n=3673). The risk of an event was compared between the two cohorts using Cox proportional-hazard models, adjusted using propensity scores. Rates of LLE/VLE were compared between TNFi and nbDMARD patients.ResultsThe crude incidence rates for LLEs were: TNFi 10/10 000 patient-years (pyrs) (95% CI 8 to 13) and nbDMARD 2/10 000 pyrs (95% CI 1 to 6); for VLEs: TNFi 15/10 000 pyrs (95% CI 12 to 19) and nbDMARD 7/10 000 pyrs (95% CI 4 to 12). The risk of both events was highest in the first year of TNFi treatment. After adjusting for differences in baseline characteristics, there was no difference in risk of LLEs (adjHR 1.86; 95% CI 0.52 to 6.58) or VLEs (adjHR 1.27; 95% CI 0.40 to 4.04) for TNFi compared to nbDMARD-treated patients. Infliximab conferred the highest overall risk, followed by etanercept, although 95% CIs overlapped following adjustment.ConclusionsIn one of the largest biological registers, the absolute risk of both events is low. The addition of TNFi to nbDMARD does not alter the risk of either event in patients with RA selected for TNFi. This is the first study to assess the risk of these outcomes in a prospective, observational cohort.</description><identifier>ISSN: 2056-5933</identifier><identifier>EISSN: 2056-5933</identifier><identifier>DOI: 10.1136/rmdopen-2016-000314</identifier><identifier>PMID: 28123776</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Epidemiology</subject><ispartof>Rheumatic &amp; musculoskeletal diseases open, 2017-01, Vol.3 (1), p.e000314-e000314</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Copyright: 2017 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-1dbce9f56a757bfab75efc3ee54f4898c0eb4037bc267a8400ab746d62014e8f3</citedby><cites>FETCH-LOGICAL-b472t-1dbce9f56a757bfab75efc3ee54f4898c0eb4037bc267a8400ab746d62014e8f3</cites><orcidid>0000-0002-8625-1200 ; 0000-0002-1487-277X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/1859392443/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/1859392443?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,315,733,786,790,891,25783,27582,27583,27957,27958,37047,37048,44625,53827,53829,75483</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28123776$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jani, Meghna</creatorcontrib><creatorcontrib>Dixon, William G</creatorcontrib><creatorcontrib>Kersley-Fleet, Lianne</creatorcontrib><creatorcontrib>Bruce, Ian N</creatorcontrib><creatorcontrib>Chinoy, Hector</creatorcontrib><creatorcontrib>Barton, Anne</creatorcontrib><creatorcontrib>Lunt, Mark</creatorcontrib><creatorcontrib>Watson, Kath</creatorcontrib><creatorcontrib>Symmons, Deborah P</creatorcontrib><creatorcontrib>Hyrich, Kimme L</creatorcontrib><creatorcontrib>BSRBR-RA</creatorcontrib><creatorcontrib>BSRBR-RA Control Centre Consortium</creatorcontrib><title>Drug-specific risk and characteristics of lupus and vasculitis-like events in patients with rheumatoid arthritis treated with TNFi: results from BSRBR-RA</title><title>Rheumatic &amp; musculoskeletal diseases open</title><addtitle>RMD Open</addtitle><description>ObjectiveTo compare the risk of lupus-like events (LLEs) and vasculitis-like events (VLEs) in tumour necrosis factor-α inhibitor (TNFi)-treated patients with rheumatoid arthritis (RA) to those receiving non-biological disease-modifying antirheumatic drugs (nbDMARDs).MethodsPatients were recruited to the British Society for Rheumatology Biologics Register—RA, a national prospective cohort study. Two cohorts recruited between 2001 and 2015: (1) patients starting first TNFi (adalimumab, etanercept, infliximab and certolizumab) (n=12 937) and (2) biological-naïve comparison cohort receiving nbDMARDs (n=3673). The risk of an event was compared between the two cohorts using Cox proportional-hazard models, adjusted using propensity scores. Rates of LLE/VLE were compared between TNFi and nbDMARD patients.ResultsThe crude incidence rates for LLEs were: TNFi 10/10 000 patient-years (pyrs) (95% CI 8 to 13) and nbDMARD 2/10 000 pyrs (95% CI 1 to 6); for VLEs: TNFi 15/10 000 pyrs (95% CI 12 to 19) and nbDMARD 7/10 000 pyrs (95% CI 4 to 12). The risk of both events was highest in the first year of TNFi treatment. After adjusting for differences in baseline characteristics, there was no difference in risk of LLEs (adjHR 1.86; 95% CI 0.52 to 6.58) or VLEs (adjHR 1.27; 95% CI 0.40 to 4.04) for TNFi compared to nbDMARD-treated patients. Infliximab conferred the highest overall risk, followed by etanercept, although 95% CIs overlapped following adjustment.ConclusionsIn one of the largest biological registers, the absolute risk of both events is low. The addition of TNFi to nbDMARD does not alter the risk of either event in patients with RA selected for TNFi. 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musculoskeletal diseases open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jani, Meghna</au><au>Dixon, William G</au><au>Kersley-Fleet, Lianne</au><au>Bruce, Ian N</au><au>Chinoy, Hector</au><au>Barton, Anne</au><au>Lunt, Mark</au><au>Watson, Kath</au><au>Symmons, Deborah P</au><au>Hyrich, Kimme L</au><aucorp>BSRBR-RA</aucorp><aucorp>BSRBR-RA Control Centre Consortium</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Drug-specific risk and characteristics of lupus and vasculitis-like events in patients with rheumatoid arthritis treated with TNFi: results from BSRBR-RA</atitle><jtitle>Rheumatic &amp; musculoskeletal diseases open</jtitle><addtitle>RMD Open</addtitle><date>2017-01-01</date><risdate>2017</risdate><volume>3</volume><issue>1</issue><spage>e000314</spage><epage>e000314</epage><pages>e000314-e000314</pages><issn>2056-5933</issn><eissn>2056-5933</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>Member details available below</notes><abstract>ObjectiveTo compare the risk of lupus-like events (LLEs) and vasculitis-like events (VLEs) in tumour necrosis factor-α inhibitor (TNFi)-treated patients with rheumatoid arthritis (RA) to those receiving non-biological disease-modifying antirheumatic drugs (nbDMARDs).MethodsPatients were recruited to the British Society for Rheumatology Biologics Register—RA, a national prospective cohort study. Two cohorts recruited between 2001 and 2015: (1) patients starting first TNFi (adalimumab, etanercept, infliximab and certolizumab) (n=12 937) and (2) biological-naïve comparison cohort receiving nbDMARDs (n=3673). The risk of an event was compared between the two cohorts using Cox proportional-hazard models, adjusted using propensity scores. Rates of LLE/VLE were compared between TNFi and nbDMARD patients.ResultsThe crude incidence rates for LLEs were: TNFi 10/10 000 patient-years (pyrs) (95% CI 8 to 13) and nbDMARD 2/10 000 pyrs (95% CI 1 to 6); for VLEs: TNFi 15/10 000 pyrs (95% CI 12 to 19) and nbDMARD 7/10 000 pyrs (95% CI 4 to 12). The risk of both events was highest in the first year of TNFi treatment. After adjusting for differences in baseline characteristics, there was no difference in risk of LLEs (adjHR 1.86; 95% CI 0.52 to 6.58) or VLEs (adjHR 1.27; 95% CI 0.40 to 4.04) for TNFi compared to nbDMARD-treated patients. Infliximab conferred the highest overall risk, followed by etanercept, although 95% CIs overlapped following adjustment.ConclusionsIn one of the largest biological registers, the absolute risk of both events is low. The addition of TNFi to nbDMARD does not alter the risk of either event in patients with RA selected for TNFi. This is the first study to assess the risk of these outcomes in a prospective, observational cohort.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>28123776</pmid><doi>10.1136/rmdopen-2016-000314</doi><orcidid>https://orcid.org/0000-0002-8625-1200</orcidid><orcidid>https://orcid.org/0000-0002-1487-277X</orcidid><oa>free_for_read</oa></addata></record>
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title Drug-specific risk and characteristics of lupus and vasculitis-like events in patients with rheumatoid arthritis treated with TNFi: results from BSRBR-RA
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