{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T14:06:44Z","timestamp":1784642804726,"version":"3.55.0"},"reference-count":11,"publisher":"SAGE Publications","issue":"14","license":[{"start":{"date-parts":[[2016,7,11]],"date-time":"2016-07-11T00:00:00Z","timestamp":1468195200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Lupus"],"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Tabalumab is a monoclonal antibody that neutralizes membrane and soluble B-cell activating factor. Two 52-week, randomized, double-blind, placebo controlled phase 3 trials evaluated the safety and efficacy of tabalumab in systemic lupus erythematosus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients with moderate to severe active systemic lupus erythematosus (without severe active lupus nephritis) were randomly assigned 1:1:1 to receive tabalumab (120 mg subcutaneously every 2 or 4 weeks) or placebo for 52 weeks. Serum creatinine concentration, estimated glomerular filtration rate, urine protein\/creatinine ratio, renal flares and renal adverse events were determined monthly. Data were analyzed for the intent-to-treat population and for intent-to-treat patients with baseline urine protein\/creatinine ratio &gt;20\u2009mg\/mmol (intent-to-treat plus urine protein\/creatinine ratio).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The trials enrolled 2262 patients. At baseline, demographics, systemic lupus erythematosus disease activity, serum creatinine concentration, estimated glomerular filtration rate and urine protein\/creatinine ratio were similar among the treatment arms (with the exception of disease duration). In the intent-to-treat and intent-to-treat plus urine protein\/creatinine ratio populations, there were no differences between the arms in the baseline-to-endpoint change in serum creatinine concentration, glomerular filtration rate, urine protein\/creatinine ratio, or renal flare rates. Tabalumab resulted in a significant B-cell reduction and decreased immunoglobulin G levels at both doses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Compared to placebo, tabalumab did not significantly affect the serum creatinine concentration, glomerular filtration rate, urine protein\/creatinine ratio, or renal flare rates over 1 year in intent-to-treat or intent-to-treat plus urine protein\/creatinine ratio patients. There were no significant renal safety signals. ClinicalTrials.gov identifiers: NCT01205438 and NCT01196091 Lupus (2016) 25, 1597\u20131601.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0961203316650734","type":"journal-article","created":{"date-parts":[[2016,5,24]],"date-time":"2016-05-24T21:51:48Z","timestamp":1464126708000},"page":"1597-1601","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":27,"title":["The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials"],"prefix":"10.1177","volume":"25","author":[{"given":"B H","family":"Rovin","sequence":"first","affiliation":[{"name":"Department of Internal Medicine at their respective institutions, Ohio State University, Columbus, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M A","family":"Dooley","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine at their respective institutions, University of North Carolina, Chapel Hill, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J","family":"Radhakrishnan","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine at their respective institutions, Columbia University, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E M","family":"Ginzler","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine at their respective institutions, SUNY Downstate, Brooklyn, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T D","family":"Forrester","sequence":"additional","affiliation":[{"name":"Eli Lilly & Company, Indianapolis, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P W","family":"Anderson","sequence":"additional","affiliation":[{"name":"Eli Lilly & Company, Indianapolis, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2016,7,11]]},"reference":[{"key":"bibr1-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1084\/jem.189.11.1747"},{"key":"bibr2-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1002\/art.11354"},{"key":"bibr3-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1002\/art.23678"},{"key":"bibr4-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)61354-2"},{"key":"bibr5-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1002\/art.30613"},{"key":"bibr6-0961203316650734","first-page":"121","volume":"7","author":"Manetta J","year":"2014","journal-title":"J Inflamm Res"},{"key":"bibr7-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207653"},{"key":"bibr8-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207654"},{"key":"bibr9-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051135"},{"key":"bibr10-0961203316650734","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-130-6-199903160-00002"},{"key":"bibr11-0961203316650734","doi-asserted-by":"publisher","DOI":"10.1177\/0961203312465781"}],"container-title":["Lupus"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0961203316650734","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0961203316650734","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0961203316650734","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T23:17:05Z","timestamp":1777677425000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0961203316650734"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,7,11]]},"references-count":11,"journal-issue":{"issue":"14","published-print":{"date-parts":[[2016,12]]}},"alternative-id":["10.1177\/0961203316650734"],"URL":"https:\/\/doi.org\/10.1177\/0961203316650734","relation":{},"ISSN":["0961-2033","1477-0962"],"issn-type":[{"value":"0961-2033","type":"print"},{"value":"1477-0962","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,7,11]]}}}