Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo‐controlled trial in North East Asia
Aim This post hoc analysis evaluated the efficacy and safety of intravenous belimumab 10 mg/kg in the South Korean subgroup of patients with systemic lupus erythematosus (SLE) enrolled in the North East Asia (NEA) study (GSK Study BEL113750; NCT01345253). Methods NEA was a double‐blind, placebo‐cont...
Gespeichert in:
| Veröffentlicht in: | International journal of rheumatic diseases 2024-01, Vol.27 (1), p.e14997-n/a |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | n/a |
|---|---|
| container_issue | 1 |
| container_start_page | e14997 |
| container_title | International journal of rheumatic diseases |
| container_volume | 27 |
| creator | Suh, Chang‐Hee Lee, Yoonhee Yoo, Sang‐Bae Quasny, Holly Navarro Rojas, Aldo Amador Hammer, Anne Song, Yeong‐Wook Kang, Young Mo Cho, Chul‐Soo Park, Won Kwok, Seung‐Ki Lee, Seung‐Geun Chung, Won Tae Bae, Sang‐Cheol |
| description | Aim
This post hoc analysis evaluated the efficacy and safety of intravenous belimumab 10 mg/kg in the South Korean subgroup of patients with systemic lupus erythematosus (SLE) enrolled in the North East Asia (NEA) study (GSK Study BEL113750; NCT01345253).
Methods
NEA was a double‐blind, placebo‐controlled, randomized Phase 3 trial. Patients with active, autoantibody‐positive SLE were randomized 2:1 to belimumab or placebo plus standard therapy administered on Days 0, 14, and 28, and then every 28 days up to Week 48. The primary efficacy endpoint in this analysis was SLE Responder Index 4 (SRI‐4) response rate at Week 52, defined as the proportion of patients achieving a ≥4‐point reduction in Safety of Estrogens in Lupus Erythematosus National Assessment‐SLE Disease Activity Index (SELENA‐SLEDAI) score, no worsening ( |
| doi_str_mv | 10.1111/1756-185X.14997 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2905526675</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2905526675</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3387-f0c39868d55599dcfbec9e1c9764fd4087f8e9579c0f586d2fa647de7234ba7e3</originalsourceid><addsrcrecordid>eNqFkcFu1DAQhi0EoqVw5oZ85NBt400cx8dVtVDUFa0ESNyiiTNmjZw42A5VOPUReCyegyfBacpe64vt0T_f_JqfkNcsO2PpnDPByxWr-NczVkgpnpDjQ-Xp4V2wI_IihO9ZVrK8FM_JUV6xIqt4cUz-bLU2CtREoW9pAI1xok5T00cPP7F3Y6ANWtONHTSpSoGGsfnm3TjMsk9ujHt65TxCTweIBvsY6K1JxTCFiJ1R1I5DgqCf4h47iC7Mv947a7Gd57jEvNlDQJqfUp9suM78wvaUDhYUNu7v3W_lkp2lIXoDdjby0fk0ZQsh0k0w8JI802ADvnq4T8iXd9vPF5er3fX7Dxeb3UrleSVWOlO5rMqq5ZxL2SrdoJLIlBRlodu0FKErlFxIlWlele1aQ1mIFsU6LxoQmJ-Qtwt38O7HiCHWnQkKrYUe07Lqtcw4X5el4El6vkiVdyF41PXgTQd-qllWz_HVc0D1HFZ9H1_qePMAH5sO24P-f15JwBfBrbE4PcarNze7BfwPMxeq4g</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2905526675</pqid></control><display><type>article</type><title>Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo‐controlled trial in North East Asia</title><source>Wiley Journals</source><creator>Suh, Chang‐Hee ; Lee, Yoonhee ; Yoo, Sang‐Bae ; Quasny, Holly ; Navarro Rojas, Aldo Amador ; Hammer, Anne ; Song, Yeong‐Wook ; Kang, Young Mo ; Cho, Chul‐Soo ; Park, Won ; Kwok, Seung‐Ki ; Lee, Seung‐Geun ; Chung, Won Tae ; Bae, Sang‐Cheol</creator><creatorcontrib>Suh, Chang‐Hee ; Lee, Yoonhee ; Yoo, Sang‐Bae ; Quasny, Holly ; Navarro Rojas, Aldo Amador ; Hammer, Anne ; Song, Yeong‐Wook ; Kang, Young Mo ; Cho, Chul‐Soo ; Park, Won ; Kwok, Seung‐Ki ; Lee, Seung‐Geun ; Chung, Won Tae ; Bae, Sang‐Cheol</creatorcontrib><description>Aim
This post hoc analysis evaluated the efficacy and safety of intravenous belimumab 10 mg/kg in the South Korean subgroup of patients with systemic lupus erythematosus (SLE) enrolled in the North East Asia (NEA) study (GSK Study BEL113750; NCT01345253).
Methods
NEA was a double‐blind, placebo‐controlled, randomized Phase 3 trial. Patients with active, autoantibody‐positive SLE were randomized 2:1 to belimumab or placebo plus standard therapy administered on Days 0, 14, and 28, and then every 28 days up to Week 48. The primary efficacy endpoint in this analysis was SLE Responder Index 4 (SRI‐4) response rate at Week 52, defined as the proportion of patients achieving a ≥4‐point reduction in Safety of Estrogens in Lupus Erythematosus National Assessment‐SLE Disease Activity Index (SELENA‐SLEDAI) score, no worsening (<0.3 increase from baseline) in Physician Global Assessment, no new British Isles Lupus Assessment Group (BILAG) A domain and <2 new BILAG B domain scores.
Results
Among 100 South Korean patients enrolled in NEA, 54/66 (81.8%) belimumab‐ and 24/34 (70.6%) placebo‐treated patients completed the double‐blind phase. Significantly more belimumab‐ than placebo‐treated patients achieved SRI‐4 response at Week 52 (n = 35/66, 53.0% vs. n = 8/34, 23.5%; odds ratio [OR; 95% confidence interval (CI)]: 3.67 [1.45, 9.28]; p = .0061). The proportion of patients experiencing ≥1 adverse event was similar between groups (belimumab: n = 60/66, 90.9% vs. placebo: n = 31/34, 91.2%). No new safety signals emerged in this subgroup analysis.
Conclusion
Belimumab was efficacious for the treatment of SLE and well tolerated among the South Korean subgroup of patients from the NEA study.</description><identifier>ISSN: 1756-1841</identifier><identifier>EISSN: 1756-185X</identifier><identifier>DOI: 10.1111/1756-185X.14997</identifier><identifier>PMID: 38140854</identifier><language>eng</language><publisher>England</publisher><subject>belimumab ; efficacy ; safety ; South Korea ; systemic lupus erythematosus</subject><ispartof>International journal of rheumatic diseases, 2024-01, Vol.27 (1), p.e14997-n/a</ispartof><rights>2023 The Authors. published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.</rights><rights>2023 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3387-f0c39868d55599dcfbec9e1c9764fd4087f8e9579c0f586d2fa647de7234ba7e3</cites><orcidid>0000-0003-3903-2424 ; 0000-0003-4658-1093 ; 0000-0001-6156-393X ; 0000-0002-1585-1022 ; 0000-0002-1659-0004 ; 0000-0002-0004-8034 ; 0000-0002-5210-8182 ; 0000-0002-5205-3978 ; 0000-0002-5384-3437 ; 0000-0002-6142-8364 ; 0000-0002-7409-0729</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2F1756-185X.14997$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2F1756-185X.14997$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38140854$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Suh, Chang‐Hee</creatorcontrib><creatorcontrib>Lee, Yoonhee</creatorcontrib><creatorcontrib>Yoo, Sang‐Bae</creatorcontrib><creatorcontrib>Quasny, Holly</creatorcontrib><creatorcontrib>Navarro Rojas, Aldo Amador</creatorcontrib><creatorcontrib>Hammer, Anne</creatorcontrib><creatorcontrib>Song, Yeong‐Wook</creatorcontrib><creatorcontrib>Kang, Young Mo</creatorcontrib><creatorcontrib>Cho, Chul‐Soo</creatorcontrib><creatorcontrib>Park, Won</creatorcontrib><creatorcontrib>Kwok, Seung‐Ki</creatorcontrib><creatorcontrib>Lee, Seung‐Geun</creatorcontrib><creatorcontrib>Chung, Won Tae</creatorcontrib><creatorcontrib>Bae, Sang‐Cheol</creatorcontrib><title>Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo‐controlled trial in North East Asia</title><title>International journal of rheumatic diseases</title><addtitle>Int J Rheum Dis</addtitle><description>Aim
This post hoc analysis evaluated the efficacy and safety of intravenous belimumab 10 mg/kg in the South Korean subgroup of patients with systemic lupus erythematosus (SLE) enrolled in the North East Asia (NEA) study (GSK Study BEL113750; NCT01345253).
Methods
NEA was a double‐blind, placebo‐controlled, randomized Phase 3 trial. Patients with active, autoantibody‐positive SLE were randomized 2:1 to belimumab or placebo plus standard therapy administered on Days 0, 14, and 28, and then every 28 days up to Week 48. The primary efficacy endpoint in this analysis was SLE Responder Index 4 (SRI‐4) response rate at Week 52, defined as the proportion of patients achieving a ≥4‐point reduction in Safety of Estrogens in Lupus Erythematosus National Assessment‐SLE Disease Activity Index (SELENA‐SLEDAI) score, no worsening (<0.3 increase from baseline) in Physician Global Assessment, no new British Isles Lupus Assessment Group (BILAG) A domain and <2 new BILAG B domain scores.
Results
Among 100 South Korean patients enrolled in NEA, 54/66 (81.8%) belimumab‐ and 24/34 (70.6%) placebo‐treated patients completed the double‐blind phase. Significantly more belimumab‐ than placebo‐treated patients achieved SRI‐4 response at Week 52 (n = 35/66, 53.0% vs. n = 8/34, 23.5%; odds ratio [OR; 95% confidence interval (CI)]: 3.67 [1.45, 9.28]; p = .0061). The proportion of patients experiencing ≥1 adverse event was similar between groups (belimumab: n = 60/66, 90.9% vs. placebo: n = 31/34, 91.2%). No new safety signals emerged in this subgroup analysis.
Conclusion
Belimumab was efficacious for the treatment of SLE and well tolerated among the South Korean subgroup of patients from the NEA study.</description><subject>belimumab</subject><subject>efficacy</subject><subject>safety</subject><subject>South Korea</subject><subject>systemic lupus erythematosus</subject><issn>1756-1841</issn><issn>1756-185X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><recordid>eNqFkcFu1DAQhi0EoqVw5oZ85NBt400cx8dVtVDUFa0ESNyiiTNmjZw42A5VOPUReCyegyfBacpe64vt0T_f_JqfkNcsO2PpnDPByxWr-NczVkgpnpDjQ-Xp4V2wI_IihO9ZVrK8FM_JUV6xIqt4cUz-bLU2CtREoW9pAI1xok5T00cPP7F3Y6ANWtONHTSpSoGGsfnm3TjMsk9ujHt65TxCTweIBvsY6K1JxTCFiJ1R1I5DgqCf4h47iC7Mv947a7Gd57jEvNlDQJqfUp9suM78wvaUDhYUNu7v3W_lkp2lIXoDdjby0fk0ZQsh0k0w8JI802ADvnq4T8iXd9vPF5er3fX7Dxeb3UrleSVWOlO5rMqq5ZxL2SrdoJLIlBRlodu0FKErlFxIlWlele1aQ1mIFsU6LxoQmJ-Qtwt38O7HiCHWnQkKrYUe07Lqtcw4X5el4El6vkiVdyF41PXgTQd-qllWz_HVc0D1HFZ9H1_qePMAH5sO24P-f15JwBfBrbE4PcarNze7BfwPMxeq4g</recordid><startdate>202401</startdate><enddate>202401</enddate><creator>Suh, Chang‐Hee</creator><creator>Lee, Yoonhee</creator><creator>Yoo, Sang‐Bae</creator><creator>Quasny, Holly</creator><creator>Navarro Rojas, Aldo Amador</creator><creator>Hammer, Anne</creator><creator>Song, Yeong‐Wook</creator><creator>Kang, Young Mo</creator><creator>Cho, Chul‐Soo</creator><creator>Park, Won</creator><creator>Kwok, Seung‐Ki</creator><creator>Lee, Seung‐Geun</creator><creator>Chung, Won Tae</creator><creator>Bae, Sang‐Cheol</creator><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-3903-2424</orcidid><orcidid>https://orcid.org/0000-0003-4658-1093</orcidid><orcidid>https://orcid.org/0000-0001-6156-393X</orcidid><orcidid>https://orcid.org/0000-0002-1585-1022</orcidid><orcidid>https://orcid.org/0000-0002-1659-0004</orcidid><orcidid>https://orcid.org/0000-0002-0004-8034</orcidid><orcidid>https://orcid.org/0000-0002-5210-8182</orcidid><orcidid>https://orcid.org/0000-0002-5205-3978</orcidid><orcidid>https://orcid.org/0000-0002-5384-3437</orcidid><orcidid>https://orcid.org/0000-0002-6142-8364</orcidid><orcidid>https://orcid.org/0000-0002-7409-0729</orcidid></search><sort><creationdate>202401</creationdate><title>Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo‐controlled trial in North East Asia</title><author>Suh, Chang‐Hee ; Lee, Yoonhee ; Yoo, Sang‐Bae ; Quasny, Holly ; Navarro Rojas, Aldo Amador ; Hammer, Anne ; Song, Yeong‐Wook ; Kang, Young Mo ; Cho, Chul‐Soo ; Park, Won ; Kwok, Seung‐Ki ; Lee, Seung‐Geun ; Chung, Won Tae ; Bae, Sang‐Cheol</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3387-f0c39868d55599dcfbec9e1c9764fd4087f8e9579c0f586d2fa647de7234ba7e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>belimumab</topic><topic>efficacy</topic><topic>safety</topic><topic>South Korea</topic><topic>systemic lupus erythematosus</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Suh, Chang‐Hee</creatorcontrib><creatorcontrib>Lee, Yoonhee</creatorcontrib><creatorcontrib>Yoo, Sang‐Bae</creatorcontrib><creatorcontrib>Quasny, Holly</creatorcontrib><creatorcontrib>Navarro Rojas, Aldo Amador</creatorcontrib><creatorcontrib>Hammer, Anne</creatorcontrib><creatorcontrib>Song, Yeong‐Wook</creatorcontrib><creatorcontrib>Kang, Young Mo</creatorcontrib><creatorcontrib>Cho, Chul‐Soo</creatorcontrib><creatorcontrib>Park, Won</creatorcontrib><creatorcontrib>Kwok, Seung‐Ki</creatorcontrib><creatorcontrib>Lee, Seung‐Geun</creatorcontrib><creatorcontrib>Chung, Won Tae</creatorcontrib><creatorcontrib>Bae, Sang‐Cheol</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of rheumatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Suh, Chang‐Hee</au><au>Lee, Yoonhee</au><au>Yoo, Sang‐Bae</au><au>Quasny, Holly</au><au>Navarro Rojas, Aldo Amador</au><au>Hammer, Anne</au><au>Song, Yeong‐Wook</au><au>Kang, Young Mo</au><au>Cho, Chul‐Soo</au><au>Park, Won</au><au>Kwok, Seung‐Ki</au><au>Lee, Seung‐Geun</au><au>Chung, Won Tae</au><au>Bae, Sang‐Cheol</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo‐controlled trial in North East Asia</atitle><jtitle>International journal of rheumatic diseases</jtitle><addtitle>Int J Rheum Dis</addtitle><date>2024-01</date><risdate>2024</risdate><volume>27</volume><issue>1</issue><spage>e14997</spage><epage>n/a</epage><pages>e14997-n/a</pages><issn>1756-1841</issn><eissn>1756-185X</eissn><abstract>Aim
This post hoc analysis evaluated the efficacy and safety of intravenous belimumab 10 mg/kg in the South Korean subgroup of patients with systemic lupus erythematosus (SLE) enrolled in the North East Asia (NEA) study (GSK Study BEL113750; NCT01345253).
Methods
NEA was a double‐blind, placebo‐controlled, randomized Phase 3 trial. Patients with active, autoantibody‐positive SLE were randomized 2:1 to belimumab or placebo plus standard therapy administered on Days 0, 14, and 28, and then every 28 days up to Week 48. The primary efficacy endpoint in this analysis was SLE Responder Index 4 (SRI‐4) response rate at Week 52, defined as the proportion of patients achieving a ≥4‐point reduction in Safety of Estrogens in Lupus Erythematosus National Assessment‐SLE Disease Activity Index (SELENA‐SLEDAI) score, no worsening (<0.3 increase from baseline) in Physician Global Assessment, no new British Isles Lupus Assessment Group (BILAG) A domain and <2 new BILAG B domain scores.
Results
Among 100 South Korean patients enrolled in NEA, 54/66 (81.8%) belimumab‐ and 24/34 (70.6%) placebo‐treated patients completed the double‐blind phase. Significantly more belimumab‐ than placebo‐treated patients achieved SRI‐4 response at Week 52 (n = 35/66, 53.0% vs. n = 8/34, 23.5%; odds ratio [OR; 95% confidence interval (CI)]: 3.67 [1.45, 9.28]; p = .0061). The proportion of patients experiencing ≥1 adverse event was similar between groups (belimumab: n = 60/66, 90.9% vs. placebo: n = 31/34, 91.2%). No new safety signals emerged in this subgroup analysis.
Conclusion
Belimumab was efficacious for the treatment of SLE and well tolerated among the South Korean subgroup of patients from the NEA study.</abstract><cop>England</cop><pmid>38140854</pmid><doi>10.1111/1756-185X.14997</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-3903-2424</orcidid><orcidid>https://orcid.org/0000-0003-4658-1093</orcidid><orcidid>https://orcid.org/0000-0001-6156-393X</orcidid><orcidid>https://orcid.org/0000-0002-1585-1022</orcidid><orcidid>https://orcid.org/0000-0002-1659-0004</orcidid><orcidid>https://orcid.org/0000-0002-0004-8034</orcidid><orcidid>https://orcid.org/0000-0002-5210-8182</orcidid><orcidid>https://orcid.org/0000-0002-5205-3978</orcidid><orcidid>https://orcid.org/0000-0002-5384-3437</orcidid><orcidid>https://orcid.org/0000-0002-6142-8364</orcidid><orcidid>https://orcid.org/0000-0002-7409-0729</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1756-1841 |
| ispartof | International journal of rheumatic diseases, 2024-01, Vol.27 (1), p.e14997-n/a |
| issn | 1756-1841 1756-185X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2905526675 |
| source | Wiley Journals |
| subjects | belimumab efficacy safety South Korea systemic lupus erythematosus |
| title | Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo‐controlled trial in North East Asia |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-29T09%3A42%3A56IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20safety%20of%20intravenous%20belimumab%20in%20a%20subgroup%20of%20South%20Korean%20patients%20with%20systemic%20lupus%20erythematosus%20enrolled%20into%20a%20Phase%203,%20randomized,%20placebo%E2%80%90controlled%20trial%20in%20North%20East%20Asia&rft.jtitle=International%20journal%20of%20rheumatic%20diseases&rft.au=Suh,%20Chang%E2%80%90Hee&rft.date=2024-01&rft.volume=27&rft.issue=1&rft.spage=e14997&rft.epage=n/a&rft.pages=e14997-n/a&rft.issn=1756-1841&rft.eissn=1756-185X&rft_id=info:doi/10.1111/1756-185X.14997&rft_dat=%3Cproquest_cross%3E2905526675%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2905526675&rft_id=info:pmid/38140854&rfr_iscdi=true |