{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T01:08:18Z","timestamp":1791248898883,"version":"4.1.0"},"reference-count":25,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2022,4,14]],"date-time":"2022-04-14T00:00:00Z","timestamp":1649894400000},"content-version":"unspecified","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"GSK"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2021,12,14]]},"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To evaluate the long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus (SLE) in China.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this phase 3, open-label extension period, eligible completers of study BEL113750 (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01345253\">NCT01345253<\/jats:ext-link>) received intravenous belimumab 10\u2009mg\/kg monthly for \u22646 years. The primary endpoint was safety. Secondary endpoints included the SLE Responder Index (SRI)-4 response rate, severe SLE flares and changes in prednisone use. Analyses were based on observed data from the first dose of belimumab through to study end.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of the 424 patients who received belimumab, 215 (50.7%) completed the study, 208 (49.1%) withdrew and 1 patient died. Overall, 359\/424 (84.7%) patients had adverse events (AEs), and 96\/424 (22.6%) had serious AEs. 26\/424 (6.1%) patients discontinued study treatment\/withdrew from the study due to AEs. Postinfusion systemic reaction rate was 1.5 events\/100 patient-years. Herpes zoster infection rate was 3.0 events\/100 patient-years, of which 0.4 events\/100 patient-years were serious events. One papillary thyroid cancer and one vaginal cancer were reported in year 0\u20131 and year 3\u20134, respectively. There were no completed suicides\/suicide attempts and no reports of serious depression. The proportion of SRI-4 responders increased progressively (year 1, week 24: 190\/346 (54.9%); year 5, week 48: 66\/82 (80.5%)). Severe flares were experienced by 55\/396 (13.9%) patients. For 335 patients with baseline prednisone-equivalent dose &gt;7.5\u2009mg\/day, the number of patients with a dose reduction to \u22647.5\u2009mg\/day increased over time (year 1, week 24: 30\/333 (9.0%); year 5, week 48: 36\/67 (53.7%)).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Favourable safety profile and disease control appeared to be maintained in patients with SLE in China for \u22646 years, consistent with previous belimumab studies.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2021-001669","type":"journal-article","created":{"date-parts":[[2022,4,15]],"date-time":"2022-04-15T11:15:31Z","timestamp":1650021331000},"page":"e001669","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":18,"title":["Phase 3, long-term, open-label extension period of safety and efficacy of belimumab in patients with systemic lupus erythematosus in China, for up to 6 years"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct01345253","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01345253","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01597622","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01345253","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3484-4319","authenticated-orcid":false,"given":"Fengchun","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7961-6427","authenticated-orcid":false,"given":"Jie","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, The Second Affiliated Hospital, Harbin Medical University, Nangang District, Harbin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guochun","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingjun","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, The First Affiliated Hospital of Soochow University, Suzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yin","family":"Su","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology, Peking University People\u2019s Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jieruo","family":"Gu","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xingfu","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2480-5674","authenticated-orcid":false,"given":"Damon","family":"Bass","sequence":"additional","affiliation":[{"name":"Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5763-5603","authenticated-orcid":false,"given":"Myron","family":"Chu","sequence":"additional","affiliation":[{"name":"Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Curtis","sequence":"additional","affiliation":[{"name":"Biostatistics, GlaxoSmithKline, Brentford, Middlesex, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1056-3400","authenticated-orcid":false,"given":"Kathleen","family":"DeRose","sequence":"additional","affiliation":[{"name":"Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, 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USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8356-0457","authenticated-orcid":false,"given":"David A","family":"Roth","sequence":"additional","affiliation":[{"name":"Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,4,15]]},"reference":[{"key":"2025090313504171000_8.1.e001669.1","doi-asserted-by":"crossref","DOI":"10.3390\/antib5010002","article-title":"Autoantibodies in SLE: specificities, isotypes and receptors","volume":"5","author":"Dema","year":"2016","journal-title":"Antibodies"},{"key":"2025090313504171000_8.1.e001669.2","first-page":"330","article-title":"Manifestations of systemic lupus 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Prescribing information, 2019. Available: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125370s064,761043s007lbl.pdf [Accessed Jan 2020]."},{"key":"2025090313504171000_8.1.e001669.13","unstructured":"GSK . Benlysta summary of product characteristics. Available: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/benlysta-epar-product-information_en.pdf [Accessed Mar 2020]."},{"key":"2025090313504171000_8.1.e001669.14","unstructured":"PMDA . Benlysta report on deliberation results. Available: https:\/\/www.pmda.go.jp\/files\/000233737.pdf [Accessed Mar 2020]."},{"key":"2025090313504171000_8.1.e001669.15","unstructured":"GSK . Benlysta, the world\u2019s first biologic therapy for the treatment of systemic lupus erythematosus (SLE), now approved in mainland China, 2019. Available: https:\/\/www.gsk-china.com\/en-gb\/media\/press-releases\/2019\/benlysta-the-world-s-first-biologic-therapy-for-the-treatment-of-systemic-lupus-erythematosus-sle-now-approved-in-mainland-china\/ [Accessed Feb 2020]."},{"key":"2025090313504171000_8.1.e001669.16","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2017-211631"},{"key":"2025090313504171000_8.1.e001669.17","doi-asserted-by":"publisher","DOI":"10.1002\/art.30613"},{"key":"2025090313504171000_8.1.e001669.18","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)61354-2"},{"key":"2025090313504171000_8.1.e001669.19","doi-asserted-by":"crossref","first-page":"868","DOI":"10.1002\/art.40439","article-title":"Long-Term safety and efficacy of belimumab in patients with systemic lupus erythematosus: a continuation of a Seventy-Six-Week phase III parent study in the United States","volume":"70","author":"Furie","year":"2018","journal-title":"Arthritis Rheumatol"},{"key":"2025090313504171000_8.1.e001669.20","doi-asserted-by":"publisher","DOI":"10.1177\/0961203315625119"},{"key":"2025090313504171000_8.1.e001669.21","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2021-001629"},{"key":"2025090313504171000_8.1.e001669.22","doi-asserted-by":"crossref","first-page":"1125","DOI":"10.1002\/art.40861","article-title":"Safety and efficacy of belimumab plus standard therapy for up to thirteen years in patients with systemic lupus erythematosus","volume":"71","author":"Wallace","year":"2019","journal-title":"Arthritis Rheumatol"},{"key":"2025090313504171000_8.1.e001669.23","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.121368"},{"key":"2025090313504171000_8.1.e001669.24","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1093\/rheumatology\/kez279","article-title":"Long-Term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a phase III study extension","volume":"59","author":"van Vollenhoven","year":"2020","journal-title":"Rheumatology"},{"key":"2025090313504171000_8.1.e001669.25","doi-asserted-by":"publisher","DOI":"10.1007\/s12026-012-8345-z"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2021-001669","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T20:50:47Z","timestamp":1756932647000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2021-001669"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4]]},"references-count":25,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,4,15]]},"published-print":{"date-parts":[[2022,4]]}},"alternative-id":["10.1136\/rmdopen-2021-001669"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2021-001669","relation":{},"ISSN":["2056-5933"],"issn-type":[{"value":"2056-5933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4]]}}}