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Predictors of British Isles Lupus Assessment Group-based outcomes in patients with systemic lupus erythematosus: Analysis from the Systemic Lupus International Collaborating Clinics Inception Cohort

Background We aimed to identify factors associated with a significant reduction in SLE disease activity over 12 months assessed by the BILAG Index. Methods In an international SLE cohort, we studied patients from their ‘inception enrolment’ visit. We also defined an ‘active disease’ cohort of patien...

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Published in:Lupus 2023-08, Vol.32 (9), p.1043-1055
Main Authors: David, Trixy, Su, Li, Cheng, Yafeng, Gordon, Caroline, Parker, Benjamin, Isenberg, David, Reynolds, John A, Bruce, Ian N
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container_issue 9
container_start_page 1043
container_title Lupus
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creator David, Trixy
Su, Li
Cheng, Yafeng
Gordon, Caroline
Parker, Benjamin
Isenberg, David
Reynolds, John A
Bruce, Ian N
description Background We aimed to identify factors associated with a significant reduction in SLE disease activity over 12 months assessed by the BILAG Index. Methods In an international SLE cohort, we studied patients from their ‘inception enrolment’ visit. We also defined an ‘active disease’ cohort of patients who had active disease similar to that needed for enrolment into clinical trials. Outcomes at 12 months were; Major Clinical Response (MCR: reduction to classic BILAG C in all domains, steroid dose of ≤7.5 mg and SLEDAI ≤ 4) and ‘Improvement’ (reduction to ≤1B score in previously active organs; no new BILAG A/B; stable or reduced steroid dose; no increase in SLEDAI). Univariate and multivariate logistic regression with Least Absolute Shrinkage and Selection Operator (LASSO) and cross-validation in randomly split samples were used to build prediction models. Results ‘Inception enrolment’ (n = 1492) and ‘active disease’ (n = 924) patients were studied. Models for MCR performed well (ROC AUC = .777 and .732 in the inception enrolment and active disease cohorts, respectively). Models for Improvement performed poorly (ROC AUC = .574 in the active disease cohort). MCR in both cohorts was associated with anti-malarial use and inversely associated with active disease at baseline (BILAG or SLEDAI) scores, BILAG haematological A/B scores, higher steroid dose and immunosuppressive use. Conclusion Baseline predictors of response in SLE can help identify patients in clinic who are less likely to respond to standard therapy. They are also important as stratification factors when designing clinical trials in order to better standardize overall usual care response rates.
doi_str_mv 10.1177/09612033231183273
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Methods In an international SLE cohort, we studied patients from their ‘inception enrolment’ visit. We also defined an ‘active disease’ cohort of patients who had active disease similar to that needed for enrolment into clinical trials. Outcomes at 12 months were; Major Clinical Response (MCR: reduction to classic BILAG C in all domains, steroid dose of ≤7.5 mg and SLEDAI ≤ 4) and ‘Improvement’ (reduction to ≤1B score in previously active organs; no new BILAG A/B; stable or reduced steroid dose; no increase in SLEDAI). Univariate and multivariate logistic regression with Least Absolute Shrinkage and Selection Operator (LASSO) and cross-validation in randomly split samples were used to build prediction models. Results ‘Inception enrolment’ (n = 1492) and ‘active disease’ (n = 924) patients were studied. Models for MCR performed well (ROC AUC = .777 and .732 in the inception enrolment and active disease cohorts, respectively). Models for Improvement performed poorly (ROC AUC = .574 in the active disease cohort). MCR in both cohorts was associated with anti-malarial use and inversely associated with active disease at baseline (BILAG or SLEDAI) scores, BILAG haematological A/B scores, higher steroid dose and immunosuppressive use. Conclusion Baseline predictors of response in SLE can help identify patients in clinic who are less likely to respond to standard therapy. They are also important as stratification factors when designing clinical trials in order to better standardize overall usual care response rates.</description><identifier>ISSN: 0961-2033</identifier><identifier>EISSN: 1477-0962</identifier><identifier>DOI: 10.1177/09612033231183273</identifier><identifier>PMID: 37463793</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Atrophy ; Clinical trials ; Lupus ; Prediction models ; Steroids ; Systemic lupus erythematosus</subject><ispartof>Lupus, 2023-08, Vol.32 (9), p.1043-1055</ispartof><rights>The Author(s) 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c363t-98dd29c55bd5373c5b13581c0918c81abf10d2d76ebec114d7b87cf34a3b6eb33</cites><orcidid>0000-0002-1244-6443 ; 0000-0002-8962-4404 ; 0000-0001-9514-2455 ; 0000-0003-3047-500X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37463793$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>David, Trixy</creatorcontrib><creatorcontrib>Su, Li</creatorcontrib><creatorcontrib>Cheng, Yafeng</creatorcontrib><creatorcontrib>Gordon, Caroline</creatorcontrib><creatorcontrib>Parker, Benjamin</creatorcontrib><creatorcontrib>Isenberg, David</creatorcontrib><creatorcontrib>Reynolds, John A</creatorcontrib><creatorcontrib>Bruce, Ian N</creatorcontrib><creatorcontrib>MASTERPLANS Consortium</creatorcontrib><creatorcontrib>International Collaborating Clinics Consortium</creatorcontrib><creatorcontrib>on behalf of The Systemic Lupus International Collaborating Clinics Consortium</creatorcontrib><title>Predictors of British Isles Lupus Assessment Group-based outcomes in patients with systemic lupus erythematosus: Analysis from the Systemic Lupus International Collaborating Clinics Inception Cohort</title><title>Lupus</title><addtitle>Lupus</addtitle><description>Background We aimed to identify factors associated with a significant reduction in SLE disease activity over 12 months assessed by the BILAG Index. Methods In an international SLE cohort, we studied patients from their ‘inception enrolment’ visit. We also defined an ‘active disease’ cohort of patients who had active disease similar to that needed for enrolment into clinical trials. Outcomes at 12 months were; Major Clinical Response (MCR: reduction to classic BILAG C in all domains, steroid dose of ≤7.5 mg and SLEDAI ≤ 4) and ‘Improvement’ (reduction to ≤1B score in previously active organs; no new BILAG A/B; stable or reduced steroid dose; no increase in SLEDAI). Univariate and multivariate logistic regression with Least Absolute Shrinkage and Selection Operator (LASSO) and cross-validation in randomly split samples were used to build prediction models. Results ‘Inception enrolment’ (n = 1492) and ‘active disease’ (n = 924) patients were studied. Models for MCR performed well (ROC AUC = .777 and .732 in the inception enrolment and active disease cohorts, respectively). Models for Improvement performed poorly (ROC AUC = .574 in the active disease cohort). MCR in both cohorts was associated with anti-malarial use and inversely associated with active disease at baseline (BILAG or SLEDAI) scores, BILAG haematological A/B scores, higher steroid dose and immunosuppressive use. Conclusion Baseline predictors of response in SLE can help identify patients in clinic who are less likely to respond to standard therapy. They are also important as stratification factors when designing clinical trials in order to better standardize overall usual care response rates.</description><subject>Atrophy</subject><subject>Clinical trials</subject><subject>Lupus</subject><subject>Prediction models</subject><subject>Steroids</subject><subject>Systemic lupus erythematosus</subject><issn>0961-2033</issn><issn>1477-0962</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp1kUFv1DAQhS1ERbcLP4ALssSll5Q4k8QJt2VFy0orFQk4R4496bpK4uBxhPYP9nfhsC1IIE6W_b73ZqzH2GuRXgkh5bu0LkWWAmQgRAWZhGdsJXIpkyhkz9lq0ZMFOGcXRPdpmoKoyxfsHGRegqxhxR4-ezRWB-eJu45_8DZYOvAd9Uh8P08z8Q0REg04Bn7j3TwlrSI03M1BuyFSduSTCjbqxH_YcOB0pICD1bz_5Ud_DAccVHA003u-GVV_JEu8827gUeFfnvjTvN0Y0I8x0UWSb13fq9b5eB_v-La3o9ULo3FaiKgfnA8v2VmnesJXj-eafbv--HX7Kdnf3uy2m32ioYSQ1JUxWa2LojUFSNBFK6CohE5rUelKqLYTqcmMLLFFLURuZFtJ3UGuoI1vAGt2ecqdvPs-I4VmsKQxrjiim6nJKqgl1FAUEX37F3rv5vivfqFymcmijCWsmThR2jsij10zeTsof2xE2iwlN_-UHD1vHpPndkDz2_HUagSuTgCpO_wz9v-JPwEGS7Q9</recordid><startdate>20230801</startdate><enddate>20230801</enddate><creator>David, Trixy</creator><creator>Su, Li</creator><creator>Cheng, Yafeng</creator><creator>Gordon, Caroline</creator><creator>Parker, Benjamin</creator><creator>Isenberg, David</creator><creator>Reynolds, John A</creator><creator>Bruce, Ian N</creator><general>SAGE Publications</general><general>Sage Publications Ltd</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-1244-6443</orcidid><orcidid>https://orcid.org/0000-0002-8962-4404</orcidid><orcidid>https://orcid.org/0000-0001-9514-2455</orcidid><orcidid>https://orcid.org/0000-0003-3047-500X</orcidid></search><sort><creationdate>20230801</creationdate><title>Predictors of British Isles Lupus Assessment Group-based outcomes in patients with systemic lupus erythematosus: Analysis from the Systemic Lupus International Collaborating Clinics Inception Cohort</title><author>David, Trixy ; Su, Li ; Cheng, Yafeng ; Gordon, Caroline ; Parker, Benjamin ; Isenberg, David ; Reynolds, John A ; Bruce, Ian N</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c363t-98dd29c55bd5373c5b13581c0918c81abf10d2d76ebec114d7b87cf34a3b6eb33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Atrophy</topic><topic>Clinical trials</topic><topic>Lupus</topic><topic>Prediction models</topic><topic>Steroids</topic><topic>Systemic lupus erythematosus</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>David, Trixy</creatorcontrib><creatorcontrib>Su, Li</creatorcontrib><creatorcontrib>Cheng, Yafeng</creatorcontrib><creatorcontrib>Gordon, Caroline</creatorcontrib><creatorcontrib>Parker, Benjamin</creatorcontrib><creatorcontrib>Isenberg, David</creatorcontrib><creatorcontrib>Reynolds, John A</creatorcontrib><creatorcontrib>Bruce, Ian N</creatorcontrib><creatorcontrib>MASTERPLANS Consortium</creatorcontrib><creatorcontrib>International Collaborating Clinics Consortium</creatorcontrib><creatorcontrib>on behalf of The Systemic Lupus International Collaborating Clinics Consortium</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Lupus</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>David, Trixy</au><au>Su, Li</au><au>Cheng, Yafeng</au><au>Gordon, Caroline</au><au>Parker, Benjamin</au><au>Isenberg, David</au><au>Reynolds, John A</au><au>Bruce, Ian N</au><aucorp>MASTERPLANS Consortium</aucorp><aucorp>International Collaborating Clinics Consortium</aucorp><aucorp>on behalf of The Systemic Lupus International Collaborating Clinics Consortium</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Predictors of British Isles Lupus Assessment Group-based outcomes in patients with systemic lupus erythematosus: Analysis from the Systemic Lupus International Collaborating Clinics Inception Cohort</atitle><jtitle>Lupus</jtitle><addtitle>Lupus</addtitle><date>2023-08-01</date><risdate>2023</risdate><volume>32</volume><issue>9</issue><spage>1043</spage><epage>1055</epage><pages>1043-1055</pages><issn>0961-2033</issn><eissn>1477-0962</eissn><abstract>Background We aimed to identify factors associated with a significant reduction in SLE disease activity over 12 months assessed by the BILAG Index. 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Models for Improvement performed poorly (ROC AUC = .574 in the active disease cohort). MCR in both cohorts was associated with anti-malarial use and inversely associated with active disease at baseline (BILAG or SLEDAI) scores, BILAG haematological A/B scores, higher steroid dose and immunosuppressive use. Conclusion Baseline predictors of response in SLE can help identify patients in clinic who are less likely to respond to standard therapy. They are also important as stratification factors when designing clinical trials in order to better standardize overall usual care response rates.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>37463793</pmid><doi>10.1177/09612033231183273</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-1244-6443</orcidid><orcidid>https://orcid.org/0000-0002-8962-4404</orcidid><orcidid>https://orcid.org/0000-0001-9514-2455</orcidid><orcidid>https://orcid.org/0000-0003-3047-500X</orcidid><oa>free_for_read</oa></addata></record>
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source SAGE:Jisc Collections:SAGE Journals Read and Publish 2023-2024:2025 extension (reading list)
subjects Atrophy
Clinical trials
Lupus
Prediction models
Steroids
Systemic lupus erythematosus
title Predictors of British Isles Lupus Assessment Group-based outcomes in patients with systemic lupus erythematosus: Analysis from the Systemic Lupus International Collaborating Clinics Inception Cohort
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