SCM2022 Conference Intelligence Express Lupus Nephritis New Dawn - VOCLOSPORIN?

From April 6 to 10, 2022, the National Kidney Foundation Spring Clinical Meeting (SCM 2022) will be held in Boston as scheduled
.

At the meeting, the participating experts discussed the latest research analysis of Voclosporin, a new drug for lupus nephritis (LN).
These analysis results show that Voclosporin can not only improve the complete renal remission rate of patients, but also improve the level of corresponding biomarkers in patients and patient subjective scores
.

Improve biomarker levels A retrospective study of AURORA 1 found that Voclosporin can improve anti-dsDNA and C3 complement levels in patients, further confirming the efficacy of Voclosporin in LN patients
.

 The AURORA1 study (Phase 3 clinical trial reveals superior efficacy and safety of new lupus nephritis drug Voclosporin) is a phase 3 clinical trial evaluating LN patients receiving mycophenolate mofetil (MMF) and low-dose glucocorticoids Whether adding Voclosporin to LN could improve the complete renal remission rate in LN patients (40.
8% Vs.
22.
5%; OR = 2.
65; P < 0.
001)
.

 The primary endpoint of this retrospective study was total protein-to-creatinine ratio (UPCR), anti-dsDNA levels, and total protein-to-creatinine ratio (UPCR), anti-dsDNA levels, and low-dose glucocorticoids or without rescue medication from baseline to week 52.
Changes in C3 complement levels
.

 For patients on Voclosporin, regardless of whether complete renal remission was achieved at week 52, anti-dsDNA levels were decreased and C3 complement levels were increased
.

The changes were more pronounced in patients with high levels (>10IU/mL) of anti-dsDNA and low levels (<90mg/dL) of C3 complement
.

However, there were similar changes in the placebo group, and no statistical difference was reached between the two groups
.

 In conclusion, Voclosporin reduced anti-dsDNA levels and increased C3 complement levels
.

Although not statistically significant compared to the placebo group, the change was greater in the Voclosporin group
.

Finally, these trends persisted regardless of whether patients achieved complete renal remission¹
.

The Improved Patient Subjective Score The Lupus Impact Score (LIT) is a specific patient-reported outcome that includes a 10-item tool that measures the impact of systemic lupus erythematosus on a patient's life
.

The researchers analyzed through the AURORA 1 study that Voclosporin can improve LIT scores and reduce the impact of systemic lupus erythematosus on their lives
.

 Since LIT was developed by LupusPRO, its specific score calculation is performed by LupusPRO
.

The researchers mainly collected relevant information in the AURORA 1 study through SF-36 and LupusPRO
.

The higher the LIT score, the greater the negative impact of the disease on LN patients
.

Previous studies have shown that the smallest clinically important difference in LIT was -4, with <-4 improving the subjective health of patients
.

 In this study, investigators collected LIT levels at baseline, 12, 24, and 52 weeks, and again determined whether patients achieved complete renal remission at week 52
.

 Compared with patients with no change in baseline health, at weeks 12, 24, and 52, patients with worsening health resulted in a significant increase in LIT score (6.
6 to 8.
6), while improvement in health resulted in a significant decrease in LIT score (- 6.
0~-8.
3)
.

 At week 52, 31.
7% (n=113) of patients achieved complete renal remission, of which 64.
6% received Voclosprin
.

At baseline, LIT scores were similar regardless of whether patients eventually achieved complete renal remission
.

At week 52, LIT was significantly improved in patients with complete renal remission compared with patients who did not achieve complete renal remission, with a mean difference of -4.
7 (95% CI, -8.
2 to -1.
1; P = 0.
011)
.

 In general, if the patient can achieve complete renal remission, the patient's LIT score will be improved, and Vcolosprin can improve the complete renal remission rate.
Therefore, Vcolosprin can help improve the LIT score to a certain extent ²
.

 What is Voclosporin? Vcolosprin is an oral calcineurin inhibitor immunosuppressant
.

It is marketed in the United States in combination with immunosuppressive therapy to treat adults with active lupus nephritis
.

In addition, the researchers are also investigating whether Vcolosprin could benefit kidney transplant patients infected with Covid-19
.

Finally, the pharmacological effects of Vcolosprin are calcineurin inhibition, blocking various immune responses, and increasing renal podocyte integrity³
.

 Figure 1 Chemical structure of Vcolosprin References: 1.
National Kidney Foundation.
National Kidney Foundation 2022 Spring Clinical Meeting Abstracts.
6 The Efficacy of Voclosporin in LupusNephritis Is Independent of Changes in Anti-dsDNA and Complement at Week 52.
AJKD.
2022 April.
2 .
National Kidney Foundation.
National Kidney Foundation 2022 Spring Clinical Meeting Abstracts.
53ATTAINMENT OF COMPLETE RENAL RESPONSE RESULTS INSIGNIFICANT IMPROVEMENTS IN LUPUS IMPACT TRACKER IN THE AURORA 1 STUDY OF VOCLOSPORININ LUPUS NEPHRITIS AJKD.
2022 April.
3.
HeoYA.
Voclosporin: First Approval.
Drugs .
2021 Apr;81(5):605-610.