PMID- 36039949
OWN - NLM
STAT- MEDLINE
DCOM- 20230628
LR  - 20230628
IS  - 2151-4658 (Electronic)
IS  - 2151-464X (Linking)
VI  - 75
IP  - 7
DP  - 2023 Jul
TI  - Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis 
      of Clinical Trials in Lupus Nephritis.
PG  - 1399-1408
LID - 10.1002/acr.25007 [doi]
AB  - OBJECTIVE: This integrated analysis evaluates the efficacy and safety of 
      voclosporin, a novel calcineurin inhibitor, at 23.7 mg twice daily in combination 
      with mycophenolate mofetil (MMF) and oral glucocorticoids in lupus nephritis (LN) 
      using pooled data from two large phase II and phase III clinical trials. The 
      purpose was to expand the pool of patients for safety analyses and to increase 
      power for efficacy analyses in patient subpopulations. METHODS: Aurinia Urinary 
      Protein Reduction in Active Lupus with Voclosporin (AURA-LV) (phase II) and 
      Aurinia Renal Response in Active Lupus With Voclosporin (AURORA 1) (phase III) 
      were randomized, placebo-controlled, double-blind trials with similar designs and 
      end points comparing voclosporin to control in combination with MMF and oral 
      glucocorticoids for the treatment of LN. The primary efficacy outcome of the 
      integrated analysis was complete renal response (CRR) at approximately one year 
      (Week 48 data from AURA-LV and Week 52 from AURORA 1). Safety was assessed 
      throughout the trials. RESULTS: Overall, 534 patients (268 voclosporin; 266 
      control) were included in the integrated analysis. Significantly more patients 
      achieved a CRR at one year in the voclosporin group than in the control group 
      (43.7% vs. 23.3%; OR 2.76; 95% CI 1.88, 4.05 P < 0.0001). The incidence of 
      adverse events (AEs) was similar (91.4% voclosporin; 87.2% control). Most AEs 
      were mild to moderate in severity; the most commonly reported AEs were classified 
      as infections and infestations (62.2% voclosporin; 54.9% control) and 
      gastrointestinal disorders (45.3% voclosporin; 35.3% placebo). No new or 
      unexpected safety signals were detected. CONCLUSIONS: This integrated analysis 
      demonstrates the efficacy and safety of voclosporin in the treatment of LN across 
      the diverse racial and ethnic groups studied.
CI  - (c) 2022 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC 
      on behalf of American College of Rheumatology.
FAU - Arriens, Cristina
AU  - Arriens C
AUID- ORCID: 0000-0002-9546-1664
AD  - Oklahoma Medical Research Foundation and University of Oklahoma Health Sciences 
      Center, Oklahoma City.
FAU - Teng, Y K Onno
AU  - Teng YKO
AUID- ORCID: 0000-0001-9920-2195
AD  - Leiden University Medical Centre, Leiden, The Netherlands.
FAU - Ginzler, Ellen M
AU  - Ginzler EM
AD  - SUNY Downstate Health Sciences University, Brooklyn, New York.
FAU - Parikh, Samir V
AU  - Parikh SV
AD  - The Ohio State University Wexner Medical Center, Columbus.
FAU - Askanase, Anca D
AU  - Askanase AD
AUID- ORCID: 0000-0003-4597-5023
AD  - Columbia University Lupus Center, New York, New York.
FAU - Saxena, Amit
AU  - Saxena A
AUID- ORCID: 0000-0003-0098-1083
AD  - New York University School of Medicine, New York.
FAU - Gibson, Keisha
AU  - Gibson K
AUID- ORCID: 0000-0003-4702-8150
AD  - University of North Carolina Kidney Center, Chapel Hill.
FAU - Caster, Dawn J
AU  - Caster DJ
AD  - University of Louisville School of Medicine, Louisville, Kentucky.
FAU - Atsumi, Tatsuya
AU  - Atsumi T
AD  - Hokkaido University, Sapporo, Japan.
FAU - Lisk, Laura
AU  - Lisk L
AD  - Aurinia Pharmaceuticals Inc., Victoria, British Columbia, Canada.
FAU - Randhawa, Simrat
AU  - Randhawa S
AUID- ORCID: 0000-0002-5668-2843
AD  - Aurinia Pharmaceuticals Inc., Victoria, British Columbia, Canada.
FAU - Gluck, Rashieda
AU  - Gluck R
AD  - Aurinia Pharmaceuticals Inc., Victoria, British Columbia, Canada.
FAU - Solomons, Neil
AU  - Solomons N
AD  - Aurinia Pharmaceuticals Inc., Victoria, British Columbia, Canada.
FAU - Huizinga, Robert B
AU  - Huizinga RB
AUID- ORCID: 0000-0001-8703-7655
AD  - Aurinia Pharmaceuticals Inc., Victoria, British Columbia, Canada.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230212
PL  - United States
TA  - Arthritis Care Res (Hoboken)
JT  - Arthritis care & research
JID - 101518086
RN  - 0 (Glucocorticoids)
RN  - 0 (Immunosuppressive Agents)
RN  - HU9DX48N0T (Mycophenolic Acid)
RN  - 2PN063X6B1 (voclosporin)
SB  - IM
MH  - Humans
MH  - Glucocorticoids/therapeutic use
MH  - *Immunosuppressive Agents/adverse effects
MH  - *Lupus Nephritis/diagnosis/drug therapy
MH  - Mycophenolic Acid/therapeutic use
MH  - Treatment Outcome
MH  - Clinical Trials as Topic
EDAT- 2022/08/31 06:00
MHDA- 2023/06/28 06:42
CRDT- 2022/08/30 07:23
PHST- 2022/07/26 00:00 [revised]
PHST- 2022/02/11 00:00 [received]
PHST- 2022/08/25 00:00 [accepted]
PHST- 2023/06/28 06:42 [medline]
PHST- 2022/08/31 06:00 [pubmed]
PHST- 2022/08/30 07:23 [entrez]
AID - 10.1002/acr.25007 [doi]
PST - ppublish
SO  - Arthritis Care Res (Hoboken). 2023 Jul;75(7):1399-1408. doi: 10.1002/acr.25007. 
      Epub 2023 Feb 12.