Application of SLE-DAS to assess subcutaneous belimumab efficacy in a cohort of systemic lupus erythematosus patients
To assess the efficacy of subcutaneous (sc) belimumab (BLM) by the application of SLE-DAS in a monocentric SLE cohort. We evaluated SLE patients treated with sc BLM from March 2019. Disease activity has been assessed by SLEDAI-2k, SLE-DAS and PGA (Physician Global Assessment) in all the established...
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Veröffentlicht in: | Clinical and experimental rheumatology 2024-07, Vol.42 (7), p.1491 |
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creator | Ceccarelli, Fulvia Picciariello, Licia Natalucci, Francesco Moretti, Valeria Spinelli, Francesca Romana Alessandri, Cristiano Conti, Fabrizio |
description | To assess the efficacy of subcutaneous (sc) belimumab (BLM) by the application of SLE-DAS in a monocentric SLE cohort.
We evaluated SLE patients treated with sc BLM from March 2019. Disease activity has been assessed by SLEDAI-2k, SLE-DAS and PGA (Physician Global Assessment) in all the established time-points [baseline (T0), after 1 (T1), 3 (T3), 6 (T6) and 12 (T12) months]. Furthermore, we applied and compared the achievement of remission according to SLE-DAS values (SLEDAS ≤2.08 + PDN ≤5mg/daily) and DORIS definition (clinical SLEDAI- 2k=0 + PGA |
doi_str_mv | 10.55563/clinexprheumatol/l5976o |
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We evaluated SLE patients treated with sc BLM from March 2019. Disease activity has been assessed by SLEDAI-2k, SLE-DAS and PGA (Physician Global Assessment) in all the established time-points [baseline (T0), after 1 (T1), 3 (T3), 6 (T6) and 12 (T12) months]. Furthermore, we applied and compared the achievement of remission according to SLE-DAS values (SLEDAS ≤2.08 + PDN ≤5mg/daily) and DORIS definition (clinical SLEDAI- 2k=0 + PGA<0.5 + antimalarial treatment, PDN≤5mg/daily, stable immunosuppressive treatment).
We enrolled 86 patients [M/F 5/81, median age 48 years (IQR 17.5), median disease duration 166 months (IQR 216)]. At baseline, median values of SLEDA-2k and SLE-DAS were 6 (IQR 4) and 5.77 (IQR 4.33), respectively, and they significantly correlated (r=0.719, CI 95% 0.586-0.815, p<0.0001). Median duration of treatment was 14 months (IQR 20). We found a significant reduction of SLEDAI-2k and SLE-DAS already at T1, maintained in the subsequent time-points (p<0.0001). At T12, a remission state was achieved by 60.4% of patients according to SLE-DAS definition and by 62.3% according to the DORIS definition. Both definitions of remission have demonstrated an agreement of 84%, with a Cohen's kappa equal to 0.6.
In this study we applied SLE-DAS to assess the efficacy of sc BLM, by analysing its over-time changes and by comparing its performance with SLEDAI-2k. Indeed, our results suggest the usefulness of this new activity index in a real-life setting.</description><identifier>ISSN: 0392-856X</identifier><identifier>ISSN: 1593-098X</identifier><identifier>EISSN: 1593-098X</identifier><identifier>DOI: 10.55563/clinexprheumatol/l5976o</identifier><identifier>PMID: 38819948</identifier><language>eng</language><publisher>Italy</publisher><ispartof>Clinical and experimental rheumatology, 2024-07, Vol.42 (7), p.1491</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></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/38819948$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ceccarelli, Fulvia</creatorcontrib><creatorcontrib>Picciariello, Licia</creatorcontrib><creatorcontrib>Natalucci, Francesco</creatorcontrib><creatorcontrib>Moretti, Valeria</creatorcontrib><creatorcontrib>Spinelli, Francesca Romana</creatorcontrib><creatorcontrib>Alessandri, Cristiano</creatorcontrib><creatorcontrib>Conti, Fabrizio</creatorcontrib><title>Application of SLE-DAS to assess subcutaneous belimumab efficacy in a cohort of systemic lupus erythematosus patients</title><title>Clinical and experimental rheumatology</title><addtitle>Clin Exp Rheumatol</addtitle><description>To assess the efficacy of subcutaneous (sc) belimumab (BLM) by the application of SLE-DAS in a monocentric SLE cohort.
We evaluated SLE patients treated with sc BLM from March 2019. Disease activity has been assessed by SLEDAI-2k, SLE-DAS and PGA (Physician Global Assessment) in all the established time-points [baseline (T0), after 1 (T1), 3 (T3), 6 (T6) and 12 (T12) months]. Furthermore, we applied and compared the achievement of remission according to SLE-DAS values (SLEDAS ≤2.08 + PDN ≤5mg/daily) and DORIS definition (clinical SLEDAI- 2k=0 + PGA<0.5 + antimalarial treatment, PDN≤5mg/daily, stable immunosuppressive treatment).
We enrolled 86 patients [M/F 5/81, median age 48 years (IQR 17.5), median disease duration 166 months (IQR 216)]. At baseline, median values of SLEDA-2k and SLE-DAS were 6 (IQR 4) and 5.77 (IQR 4.33), respectively, and they significantly correlated (r=0.719, CI 95% 0.586-0.815, p<0.0001). Median duration of treatment was 14 months (IQR 20). We found a significant reduction of SLEDAI-2k and SLE-DAS already at T1, maintained in the subsequent time-points (p<0.0001). At T12, a remission state was achieved by 60.4% of patients according to SLE-DAS definition and by 62.3% according to the DORIS definition. Both definitions of remission have demonstrated an agreement of 84%, with a Cohen's kappa equal to 0.6.
In this study we applied SLE-DAS to assess the efficacy of sc BLM, by analysing its over-time changes and by comparing its performance with SLEDAI-2k. Indeed, our results suggest the usefulness of this new activity index in a real-life setting.</description><issn>0392-856X</issn><issn>1593-098X</issn><issn>1593-098X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpdkE1PwzAMhiMEYmPwF1COXMrSpkmT4zTGhzSJw0DarUpTVytKm1KnEvv3dGxw4GRZ8uPXfgihMbsXQkg-t65u4avrdzA0Jng3d0Jn0p-RaSw0j5hW23MyZVwnkRJyOyFXiB-MJVLI7JJMuFKx1qmakmHRda62JtS-pb6im_UqelhsaPDUIAIixaGwQzAt-AFpAa5uxsiCQlWNmN3TuqWGWr_zfTgswD0GaGpL3dCNAPT7sIPDjTh23ZgDbcBrclEZh3BzqjPy_rh6Wz5H69enl-ViHdlYsxDFvDCsLJkpksyUCjKruE0157FMIauSVLFCC5uwkoPKbMJVbEttRJkZw6Qq-IzcHfd2vf8cAEPe1GjBueM7OWeSp5KxUemMqOOo7T1iD1Xe9XVj-n0es_xHev5fen6UPqK3p5ShaKD8A38t82-l9IcZ</recordid><startdate>20240701</startdate><enddate>20240701</enddate><creator>Ceccarelli, Fulvia</creator><creator>Picciariello, Licia</creator><creator>Natalucci, Francesco</creator><creator>Moretti, Valeria</creator><creator>Spinelli, Francesca Romana</creator><creator>Alessandri, Cristiano</creator><creator>Conti, Fabrizio</creator><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20240701</creationdate><title>Application of SLE-DAS to assess subcutaneous belimumab efficacy in a cohort of systemic lupus erythematosus patients</title><author>Ceccarelli, Fulvia ; Picciariello, Licia ; Natalucci, Francesco ; Moretti, Valeria ; Spinelli, Francesca Romana ; Alessandri, Cristiano ; Conti, Fabrizio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c190t-13ba0dd0ab27ad8e7c83c4933164e7f2480b95c20d3e87c2381cd9a5d7aa068b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ceccarelli, Fulvia</creatorcontrib><creatorcontrib>Picciariello, Licia</creatorcontrib><creatorcontrib>Natalucci, Francesco</creatorcontrib><creatorcontrib>Moretti, Valeria</creatorcontrib><creatorcontrib>Spinelli, Francesca Romana</creatorcontrib><creatorcontrib>Alessandri, Cristiano</creatorcontrib><creatorcontrib>Conti, Fabrizio</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical and experimental rheumatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ceccarelli, Fulvia</au><au>Picciariello, Licia</au><au>Natalucci, Francesco</au><au>Moretti, Valeria</au><au>Spinelli, Francesca Romana</au><au>Alessandri, Cristiano</au><au>Conti, Fabrizio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Application of SLE-DAS to assess subcutaneous belimumab efficacy in a cohort of systemic lupus erythematosus patients</atitle><jtitle>Clinical and experimental rheumatology</jtitle><addtitle>Clin Exp Rheumatol</addtitle><date>2024-07-01</date><risdate>2024</risdate><volume>42</volume><issue>7</issue><spage>1491</spage><pages>1491-</pages><issn>0392-856X</issn><issn>1593-098X</issn><eissn>1593-098X</eissn><abstract>To assess the efficacy of subcutaneous (sc) belimumab (BLM) by the application of SLE-DAS in a monocentric SLE cohort.
We evaluated SLE patients treated with sc BLM from March 2019. Disease activity has been assessed by SLEDAI-2k, SLE-DAS and PGA (Physician Global Assessment) in all the established time-points [baseline (T0), after 1 (T1), 3 (T3), 6 (T6) and 12 (T12) months]. Furthermore, we applied and compared the achievement of remission according to SLE-DAS values (SLEDAS ≤2.08 + PDN ≤5mg/daily) and DORIS definition (clinical SLEDAI- 2k=0 + PGA<0.5 + antimalarial treatment, PDN≤5mg/daily, stable immunosuppressive treatment).
We enrolled 86 patients [M/F 5/81, median age 48 years (IQR 17.5), median disease duration 166 months (IQR 216)]. At baseline, median values of SLEDA-2k and SLE-DAS were 6 (IQR 4) and 5.77 (IQR 4.33), respectively, and they significantly correlated (r=0.719, CI 95% 0.586-0.815, p<0.0001). Median duration of treatment was 14 months (IQR 20). We found a significant reduction of SLEDAI-2k and SLE-DAS already at T1, maintained in the subsequent time-points (p<0.0001). At T12, a remission state was achieved by 60.4% of patients according to SLE-DAS definition and by 62.3% according to the DORIS definition. Both definitions of remission have demonstrated an agreement of 84%, with a Cohen's kappa equal to 0.6.
In this study we applied SLE-DAS to assess the efficacy of sc BLM, by analysing its over-time changes and by comparing its performance with SLEDAI-2k. Indeed, our results suggest the usefulness of this new activity index in a real-life setting.</abstract><cop>Italy</cop><pmid>38819948</pmid><doi>10.55563/clinexprheumatol/l5976o</doi></addata></record> |
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title | Application of SLE-DAS to assess subcutaneous belimumab efficacy in a cohort of systemic lupus erythematosus patients |
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