PMID- 37466424 OWN - NLM STAT- MEDLINE DCOM- 20231229 LR - 20240226 IS - 2326-5205 (Electronic) IS - 2326-5191 (Linking) VI - 76 IP - 1 DP - 2024 Jan TI - Safety and Efficacy of Long-Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial. PG - 59-67 LID - 10.1002/art.42657 [doi] AB - OBJECTIVE: AURORA 2 evaluated the long-term 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-year AURORA 1 study. METHODS: Enrolled patients continued their double-blinded treatment of voclosporin or placebo randomly assigned in AURORA 1, in combination with mycophenolate mofetil and low-dose glucocorticoids. The primary objective was safety assessed with adverse events (AEs) and biochemical and hematological assessments. Efficacy was measured by renal response. RESULTS: 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-year period was -0.2 mL/min/1.73 m(2) (95% confidence interval [CI] -3.0 to 2.7) in the voclosporin group and -5.4 mL/min/1.73 m(2) (95% CI -8.4 to -2.3) 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 1.00-3.03). CONCLUSION: Data demonstrate the safety and efficacy of long-term voclosporin treatment over three years of follow-up in patients with LN. CI - (c) 2023 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology. FAU - Saxena, Amit AU - Saxena A AUID- ORCID: 0000-0003-0098-1083 AD - Division of Rheumatology, New York University School of Medicine, New York, New York. FAU - Ginzler, Ellen M AU - Ginzler EM AD - Department of Medicine, SUNY Downstate Health Sciences University, Brooklyn, New York. FAU - Gibson, Keisha AU - Gibson K AD - Department of Medicine, UNC Kidney Center, Chapel Hill, North Carolina. FAU - Satirapoj, Bancha AU - Satirapoj B AD - Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand. FAU - Santillan, Adolfina Elizabeth Zuta AU - Santillan AEZ AD - Instituto de Ginecologia y Reproduccion, Lima, Peru. FAU - Levchenko, Olena AU - Levchenko O AD - Odessa Regional Clinical Hospital, Oblast, Ukraine. FAU - Navarra, Sandra AU - Navarra S AD - Rheumatology Section, University of Santo Tomas, Manila and St Luke's Medical Center, Quezon City, Philippines. FAU - Atsumi, Tatsuya AU - Atsumi T AD - Department of Rheumatology, Endocrinology and Nephrology, Hokkaido University, Sapporo, Japan. FAU - Yasuda, Shinsuke AU - Yasuda S AUID- ORCID: 0000-0001-6171-2077 AD - Department of Rheumatology, Graduate School of Medical and Dental Medicine, Tokyo Medical and Dental University (TMDU), Tokyo, Japan. FAU - Chavez-Perez, Nilmo Noel AU - Chavez-Perez NN AD - Unidad de Reumatologia, Hospital General de Enfermedades, Instituto Guatemalteco de Seguridad Social, Guatemala City, Guatemala. FAU - Arriens, Cristina AU - Arriens C AUID- ORCID: 0000-0002-9546-1664 AD - Department of Arthritis & Clinical Immunology, Rheumatology, Oklahoma Medical Research Foundation and Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City. FAU - Parikh, Samir V AU - Parikh SV AUID- ORCID: 0000-0001-7023-525X AD - Department of Nephrology, The Ohio State University Wexner Medical Center, Columbus. FAU - Caster, Dawn J AU - Caster DJ AD - Department of Medicine, Division of Nephrology and Hypertension, University of Louisville School of Medicine, Louisville, Kentucky. FAU - Birardi, Vanessa AU - Birardi V AUID- ORCID: 0000-0002-5429-7546 AD - Medical Affairs, Aurinia Pharmaceuticals, Edmonton, Alberta, Canada. FAU - Randhawa, Simrat AU - Randhawa S AUID- ORCID: 0000-0002-5668-2843 AD - Dianthus Therapeutics, Waltham, Massachusetts. FAU - Lisk, Laura AU - Lisk L AD - Clinical Development, Aurinia Pharmaceuticals, Edmonton, Alberta, Canada. FAU - Huizinga, Robert B AU - Huizinga RB AD - Reformation Consulting Services, North Saanich, British Columbia, Canada; Research and Development, Aurinia Pharmaceuticals, Edmonton, Alberta, Canada. FAU - Teng, Y K Onno AU - Teng YKO AD - Center for Expertise on Lupus-, Vasculitis- and Complement-mediated Systemic Autoimmune Diseases, Department of Nephrology, Leiden University Medical Centre, Leiden, The Netherlands. LA - eng GR - Aurinia Pharmaceuticals Inc./ PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230915 PL - United States TA - Arthritis Rheumatol JT - Arthritis & rheumatology (Hoboken, N.J.) JID - 101623795 RN - 2PN063X6B1 (voclosporin) RN - 0 (Immunosuppressive Agents) RN - 83HN0GTJ6D (Cyclosporine) RN - HU9DX48N0T (Mycophenolic Acid) SB - IM MH - Humans MH - *Lupus Nephritis/drug therapy MH - Immunosuppressive Agents MH - Cyclosporine/therapeutic use MH - Mycophenolic Acid/therapeutic use MH - Treatment Outcome EDAT- 2023/07/19 13:06 MHDA- 2023/12/29 06:42 CRDT- 2023/07/19 10:03 PHST- 2023/06/01 00:00 [revised] PHST- 2023/02/22 00:00 [received] PHST- 2023/06/13 00:00 [accepted] PHST- 2023/12/29 06:42 [medline] PHST- 2023/07/19 13:06 [pubmed] PHST- 2023/07/19 10:03 [entrez] AID - 10.1002/art.42657 [doi] PST - ppublish SO - Arthritis Rheumatol. 2024 Jan;76(1):59-67. doi: 10.1002/art.42657. Epub 2023 Sep 15.