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At the EULAR virtual conference in 2021, the poster with the abstract number POS0681 showed that patients with lupus nephritis (LN) treated with Voclosporin maintained a "significant" reduction in proteinuria after 2 years (Figure 1), and glomerular filtration The average rate is stable
.
These findings represent the first interim data of the phase 3 AURORA 1 study expansion reported earlier, which together with the phase 2 AURA-LV trial showed that compared with mycophenolate mofetil and low-dose steroid monotherapy, the standard of care On the basis of combined Voclosporin treatment for 1 year, the renal response rate of LN patients was significantly increased and proteinuria decreased
.
Amit Saxena, MD, New York University Langone Health Center said, “For decades, LN has lacked specialized, safe, and effective treatment options.
This is a clinical challenge that doctors and patients have been facing
.
Based on stage 2 and stage 3 Voclosporin in the kidney The results of the response are better than the results of standard care treatment.
Voclosporin has recently been approved by the FDA
.
However, to date, the long-term efficacy and safety of Voclosporin have not been evaluated for more than 1 year
.
"For the analysis of voclosporin in the AURORA 1 study after 2 years For the impact of the included patients, Saxena et al.
conducted the AURORA 2 study
.
This is a two-year blinded, controlled extension study, which is still in progress
.
Participants who complete the AURORA 1 study are eligible to continue their randomized treatment, which is 23.
7 mg Voclosporin or placebo twice daily in combination with 1 g mycophenolate mofetil and low-dose oral steroids
.
116 patients in the Voclosporin group and 100 patients in the placebo group participated in this extension study
.
In the interim analysis, 73 patients in the Voclosporin group and 51 patients in the placebo group received 2 years of treatment
.
The researchers assessed the subjects' urine protein-creatinine ratio and estimated glomerular filtration rate (eGFR)-from the first year of the AURORA 2 study, which is 2 years after the initial treatment of AURORA 1
.
The results showed that before the overall treatment (at baseline of AURORA 1), among the participants who entered the extended phase, the average urine protein-creatinine ratio of the Voclosporin group was 3.
94 mg/mg and that of the placebo group was 3.
87 mg/mg
.
At the time of the interim analysis, the least squares mean change in the urine protein-creatinine ratio of Voclosporin-treated patients from baseline to the second year was -3.
1mg/mg, and that of the placebo group was -2.
1mg/mg
.
At the same time, before the overall treatment (at baseline of AURORA 1), the average eGFR of the Voclosporin group was 79.
6 mL/min, and that of the placebo group was 78.
9 mL/min
.
In terms of eGFR, the average eGFR of patients in the Voclosporin group was 79 mL/min, while the eGFR of patients in the placebo group was 82.
9 mL/min
.
The researchers noticed that in the first 4 weeks of AURORA 1 treatment, the average eGFR decreased slightly in the early stage, and then remained stable during the first and second years
.
In addition, compared with placebo, patients who continued to use voclosporin for more than 1 year did not experience unexpected new adverse events
.
Expert opinion Saxena said, “The AURORA 2 extended study provides data on the longest period of treatment of LN with voclosporin to date
.
This study evaluated patients for up to 104 days of treatment—from AURORA 1 for one year to AURORA 2.
It lasted for one year
.
The
results showed that the proteinuria of the patients in the voclosporin treatment group maintained a meaningful reduction, the average eGFR did not change, and there were no unexpected adverse events for two years of treatment
.
These data are of great significance and strengthen the clinical value and clinical value of voclosporin for up to 2 years.
Security
.
"
.
These findings represent the first interim data of the phase 3 AURORA 1 study expansion reported earlier, which together with the phase 2 AURA-LV trial showed that compared with mycophenolate mofetil and low-dose steroid monotherapy, the standard of care On the basis of combined Voclosporin treatment for 1 year, the renal response rate of LN patients was significantly increased and proteinuria decreased
.
Amit Saxena, MD, New York University Langone Health Center said, “For decades, LN has lacked specialized, safe, and effective treatment options.
This is a clinical challenge that doctors and patients have been facing
.
Based on stage 2 and stage 3 Voclosporin in the kidney The results of the response are better than the results of standard care treatment.
Voclosporin has recently been approved by the FDA
.
However, to date, the long-term efficacy and safety of Voclosporin have not been evaluated for more than 1 year
.
"For the analysis of voclosporin in the AURORA 1 study after 2 years For the impact of the included patients, Saxena et al.
conducted the AURORA 2 study
.
This is a two-year blinded, controlled extension study, which is still in progress
.
Participants who complete the AURORA 1 study are eligible to continue their randomized treatment, which is 23.
7 mg Voclosporin or placebo twice daily in combination with 1 g mycophenolate mofetil and low-dose oral steroids
.
116 patients in the Voclosporin group and 100 patients in the placebo group participated in this extension study
.
In the interim analysis, 73 patients in the Voclosporin group and 51 patients in the placebo group received 2 years of treatment
.
The researchers assessed the subjects' urine protein-creatinine ratio and estimated glomerular filtration rate (eGFR)-from the first year of the AURORA 2 study, which is 2 years after the initial treatment of AURORA 1
.
The results showed that before the overall treatment (at baseline of AURORA 1), among the participants who entered the extended phase, the average urine protein-creatinine ratio of the Voclosporin group was 3.
94 mg/mg and that of the placebo group was 3.
87 mg/mg
.
At the time of the interim analysis, the least squares mean change in the urine protein-creatinine ratio of Voclosporin-treated patients from baseline to the second year was -3.
1mg/mg, and that of the placebo group was -2.
1mg/mg
.
At the same time, before the overall treatment (at baseline of AURORA 1), the average eGFR of the Voclosporin group was 79.
6 mL/min, and that of the placebo group was 78.
9 mL/min
.
In terms of eGFR, the average eGFR of patients in the Voclosporin group was 79 mL/min, while the eGFR of patients in the placebo group was 82.
9 mL/min
.
The researchers noticed that in the first 4 weeks of AURORA 1 treatment, the average eGFR decreased slightly in the early stage, and then remained stable during the first and second years
.
In addition, compared with placebo, patients who continued to use voclosporin for more than 1 year did not experience unexpected new adverse events
.
Expert opinion Saxena said, “The AURORA 2 extended study provides data on the longest period of treatment of LN with voclosporin to date
.
This study evaluated patients for up to 104 days of treatment—from AURORA 1 for one year to AURORA 2.
It lasted for one year
.
The
results showed that the proteinuria of the patients in the voclosporin treatment group maintained a meaningful reduction, the average eGFR did not change, and there were no unexpected adverse events for two years of treatment
.
These data are of great significance and strengthen the clinical value and clinical value of voclosporin for up to 2 years.
Security
.
"
