{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T21:02:41Z","timestamp":1791838961109,"version":"4.3.4"},"reference-count":25,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,9,15]],"date-time":"2023-09-15T00:00:00Z","timestamp":1694736000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>AURORA 2 evaluated the long\u2010term safety, tolerability, and efficacy of voclosporin compared to placebo in patients with lupus nephritis (LN) receiving an additional two years of treatment following completion of the one\u2010year AURORA 1 study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Enrolled patients continued their double\u2010blinded treatment of voclosporin or placebo randomly assigned in AURORA 1, in combination with mycophenolate mofetil and low\u2010dose glucocorticoids. The primary objective was safety assessed with adverse events (AEs) and biochemical and hematological assessments. Efficacy was measured by renal response.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 216 patients enrolled in AURORA 2. Treatment was well tolerated with 86.1% completing the study and no unexpected safety signals. AEs occurred in 86% and 80% of patients in the voclosporin and control groups, respectively, with an AE profile similar to that seen in AURORA 1, albeit with reduced frequency. Investigator reported AEs of both glomerular filtration rate (GFR) decrease and hypertension occurred more frequently in the voclosporin than the control group (10.3% vs 5.0%, and 8.6% vs 7.0%, respectively). Mean corrected estimated GFR (eGFR) was within the normal range and stable in both treatment groups. eGFR slope over the two\u2010year period was \u22120.2 mL\/min\/1.73 m<jats:sup>2<\/jats:sup> (95% confidence interval [CI] \u22123.0 to 2.7) in the voclosporin group and \u22125.4 mL\/min\/1.73 m<jats:sup>2<\/jats:sup> (95% CI \u22128.4 to \u22122.3) in the control group. Improved proteinuria persisted across three years of treatment, leading to more frequent complete renal responses in patients treated with voclosporin (50.9% vs 39.0%; odds ratio 1.74; 95% CI 1.00\u20133.03).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Data demonstrate the safety and efficacy of long\u2010term voclosporin treatment over three years of follow\u2010up in patients with LN.<\/jats:p><jats:p><jats:boxed-text content-type=\"graphic\" position=\"anchor\"><jats:graphic xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" mimetype=\"image\/png\" position=\"anchor\" specific-use=\"enlarged-web-image\" xlink:href=\"graphic\/art42657-toc-0001-m.png\"><jats:alt-text>image<\/jats:alt-text><\/jats:graphic><\/jats:boxed-text><\/jats:p><\/jats:sec>","DOI":"10.1002\/art.42657","type":"journal-article","created":{"date-parts":[[2023,7,19]],"date-time":"2023-07-19T09:59:26Z","timestamp":1689760766000},"page":"59-67","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":127,"title":["Safety and Efficacy of <scp>Long\u2010Term<\/scp> Voclosporin Treatment for Lupus Nephritis in the Phase 3 <scp>AURORA<\/scp> 2 Clinical Trial"],"prefix":"10.1002","volume":"76","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0098-1083","authenticated-orcid":false,"given":"Amit","family":"Saxena","sequence":"first","affiliation":[{"name":"Division of Rheumatology New York University School of Medicine  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen M.","family":"Ginzler","sequence":"additional","affiliation":[{"name":"Department of Medicine SUNY Downstate Health Sciences University  Brooklyn New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keisha","family":"Gibson","sequence":"additional","affiliation":[{"name":"Department of Medicine UNC Kidney Center  Chapel Hill North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bancha","family":"Satirapoj","sequence":"additional","affiliation":[{"name":"Department of Medicine Phramongkutklao Hospital  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adolfina Elizabeth Zuta","family":"Santill\u00e1n","sequence":"additional","affiliation":[{"name":"Instituto de Ginecolog\u00eda y Reproducci\u00f3n  Lima Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olena","family":"Levchenko","sequence":"additional","affiliation":[{"name":"Odessa Regional Clinical Hospital  Oblast Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Navarra","sequence":"additional","affiliation":[{"name":"Rheumatology Section, University of Santo Tomas, Manila and St Luke's Medical Center  Quezon City Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuya","family":"Atsumi","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Endocrinology and Nephrology Hokkaido University  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6171-2077","authenticated-orcid":false,"given":"Shinsuke","family":"Yasuda","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Graduate School of Medical and Dental Medicine Tokyo Medical and Dental University (TMDU)  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nilmo Noel","family":"Chavez\u2010Perez","sequence":"additional","affiliation":[{"name":"Unidad de Reumatolog\u00eda, Hospital General de Enfermedades Instituto Guatemalteco de Seguridad Social  Guatemala City Guatemala"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9546-1664","authenticated-orcid":false,"given":"Cristina","family":"Arriens","sequence":"additional","affiliation":[{"name":"Department of Arthritis &amp; Clinical Immunology, Rheumatology, Oklahoma Medical Research Foundation and Department of Medicine University of Oklahoma Health Sciences Center  Oklahoma City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7023-525X","authenticated-orcid":false,"given":"Samir V.","family":"Parikh","sequence":"additional","affiliation":[{"name":"Department of Nephrology The Ohio State University Wexner Medical Center  Columbus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawn J.","family":"Caster","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Nephrology and Hypertension University of Louisville School of Medicine  Louisville Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5429-7546","authenticated-orcid":false,"given":"Vanessa","family":"Birardi","sequence":"additional","affiliation":[{"name":"Medical Affairs Aurinia Pharmaceuticals  Edmonton Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5668-2843","authenticated-orcid":false,"given":"Simrat","family":"Randhawa","sequence":"additional","affiliation":[{"name":"Dianthus Therapeutics  Waltham Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Lisk","sequence":"additional","affiliation":[{"name":"Clinical Development Aurinia Pharmaceuticals  Edmonton Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert B.","family":"Huizinga","sequence":"additional","affiliation":[{"name":"Reformation Consulting Services, North Saanich, British Columbia, Canada; 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