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50% of patients with systemic lupus (SLE) have kidney involvement, that is, lupus nephritis (LN)
.
About 10% of patients with LN will progress to end-stage renal disease (ESKD)
.
In recent years, clinical evidence about LN has continued to emerge, and new treatment methods have continued to come out.
However, how to organically combine the new and the old methods and the applicable population of the new methods need to be further studied
.
On November 4, 2021, at the Kidney Week 2021 conference, Professor Brad H.
Rovin from Ohio State University introduced the new method of LN treatment and put forward practical suggestions for the organic combination of the old and the new method
.
New drug listing Professor Brad H.
Rovin mainly introduced the current new therapies for LN, which are Voclosporin, Belimumab and Obinutuzumab
.
It must be clear that the US Food and Drug Administration (FDA) has approved Voclosporin and Belimumab for the treatment of LN
.
The combination of immunosuppressive drugs and Voclosporin or belimumab can give patients a better prognosis within 1-2 years (Figure 1)
.
Figure 1 Clinical data of Voclosporin and Belimumab Note: The data on the left is Belimumab, the red on the right is the data of Voclosporin, and the blue is the control group.
A large number of studies have shown that the decline in renal function is related to whether the patient has remission
.
The figure below shows that compared with patients with non-remission LN, patients with complete and partial remission have better long-term renal function retention (Figure 2)
.
Voclosporin and belimumab can effectively increase the rate of complete remission and partial remission, and improve the long-term prognosis of patients
.
Figure 2 The relationship between kidney function and remission in patients with LN.
Professor Brad H.
Rovin mainly explained two drugs that have been on the market.
The main content is how new therapies can be incorporated into the existing treatment system and the advantages and disadvantages of each drug
.
Does the marketing of the two new drugs, new therapies and new pathways, mean that we can apply the above two drugs to all patients with LN? Professor Brad H.
Rovin pointed out 5 points that may hinder patients from using these two drugs.
They are: 1.
Existing data does not indicate who has the advantage between Voclosporin and belimumab, or what kind of patients.
It is more suitable for Voclosporin, and Belimumab is better for other LN patients; 2.
There is no biomarker to remind physicians when to use or stop Voclosporin or Belimumab; 3.
There is no data to support these two Long-term safety of drugs; 4.
Expensive drugs, which will increase the economic burden of patients; 5.
Some patients only respond to immunosuppressive therapy
.
In order to avoid the above risks and drug disadvantages, Voclosporin and belimumab can be incorporated into the existing LN treatment process.
The flow chart is shown in the figure below (Figure 3)
.
Figure 3 Path diagram of the new treatment process for lupus nephritis.
Analysis of the advantages and disadvantages of drugs.
Professor Brad H.
Rovin briefly explained the advantages and disadvantages of the above two drugs to ensure that doctors can select drugs more specifically
.
01 Voclosporin The most significant advantage of Voclosporin is that it can reduce the dosage of glucocorticoids, which is extremely beneficial for some patients with LN
.
Specifically, Voclosprin combined with mycophenolate mofetil can quickly reduce the dosage of glucocorticoids, thereby reducing adverse reactions in patients
.
2 weeks before treatment, the dosage of glucocorticoid is 20-25mg/d, but at the 8th week, only 5mg/d is used, and after the 12th week, only 2.
5mg/d, but complete remission rate appears Or partial remission rate has nothing to do with glucocorticoid reduction
.
In addition, Voclosporin is extremely friendly to Asian patients and is easier to improve the patient's condition
.
Compared with standard therapy, the OR of the Voclosporin Asian group was 3.
7 (95% CI, 1.
5-9.
2)
.
The OR for white patients was 1.
7 (95% CI, 0.
8-3.
7)
.
Professor BradH.
Rovin believes that the efficacy of Voclosporin is significantly related to its mechanism
.
As a calcineurin inhibitor, it can block the expression of IL-2 and the immune response mediated by T cells, and stabilize kidney podocytes
.
02 Belimumab The effect of Belimumab is also very good, but it is significantly related to the staging of LN patients
.
Belimumab has a significant effect on patients of type 3 or 4, type 3+5 or type 4+5, but if the patient is pure type 5, the effect is not even as ideal as a placebo (Figure 4)
.
Figure 4 The relationship between the stage of patients with lupus nephritis and the efficacy of belimumab.
In addition, if the patient has a high level of proteinuria at baseline, the efficacy of belimumab may also be less than ideal (Figure 5)
.
Figure 5 The effect of baseline proteinuria on the efficacy of belimumab.
Further reading: Yimaitong has also reported related trials of Voclosporin before.
For details, please refer to the AURORA 1 trial and AURORA 2 trial
.
References: 1.
More Options and More to Come: Update on the Management of Lupus Nephritis.
2021Kidney Week virtual meeting.
Nov 04, 2021.
.
About 10% of patients with LN will progress to end-stage renal disease (ESKD)
.
In recent years, clinical evidence about LN has continued to emerge, and new treatment methods have continued to come out.
However, how to organically combine the new and the old methods and the applicable population of the new methods need to be further studied
.
On November 4, 2021, at the Kidney Week 2021 conference, Professor Brad H.
Rovin from Ohio State University introduced the new method of LN treatment and put forward practical suggestions for the organic combination of the old and the new method
.
New drug listing Professor Brad H.
Rovin mainly introduced the current new therapies for LN, which are Voclosporin, Belimumab and Obinutuzumab
.
It must be clear that the US Food and Drug Administration (FDA) has approved Voclosporin and Belimumab for the treatment of LN
.
The combination of immunosuppressive drugs and Voclosporin or belimumab can give patients a better prognosis within 1-2 years (Figure 1)
.
Figure 1 Clinical data of Voclosporin and Belimumab Note: The data on the left is Belimumab, the red on the right is the data of Voclosporin, and the blue is the control group.
A large number of studies have shown that the decline in renal function is related to whether the patient has remission
.
The figure below shows that compared with patients with non-remission LN, patients with complete and partial remission have better long-term renal function retention (Figure 2)
.
Voclosporin and belimumab can effectively increase the rate of complete remission and partial remission, and improve the long-term prognosis of patients
.
Figure 2 The relationship between kidney function and remission in patients with LN.
Professor Brad H.
Rovin mainly explained two drugs that have been on the market.
The main content is how new therapies can be incorporated into the existing treatment system and the advantages and disadvantages of each drug
.
Does the marketing of the two new drugs, new therapies and new pathways, mean that we can apply the above two drugs to all patients with LN? Professor Brad H.
Rovin pointed out 5 points that may hinder patients from using these two drugs.
They are: 1.
Existing data does not indicate who has the advantage between Voclosporin and belimumab, or what kind of patients.
It is more suitable for Voclosporin, and Belimumab is better for other LN patients; 2.
There is no biomarker to remind physicians when to use or stop Voclosporin or Belimumab; 3.
There is no data to support these two Long-term safety of drugs; 4.
Expensive drugs, which will increase the economic burden of patients; 5.
Some patients only respond to immunosuppressive therapy
.
In order to avoid the above risks and drug disadvantages, Voclosporin and belimumab can be incorporated into the existing LN treatment process.
The flow chart is shown in the figure below (Figure 3)
.
Figure 3 Path diagram of the new treatment process for lupus nephritis.
Analysis of the advantages and disadvantages of drugs.
Professor Brad H.
Rovin briefly explained the advantages and disadvantages of the above two drugs to ensure that doctors can select drugs more specifically
.
01 Voclosporin The most significant advantage of Voclosporin is that it can reduce the dosage of glucocorticoids, which is extremely beneficial for some patients with LN
.
Specifically, Voclosprin combined with mycophenolate mofetil can quickly reduce the dosage of glucocorticoids, thereby reducing adverse reactions in patients
.
2 weeks before treatment, the dosage of glucocorticoid is 20-25mg/d, but at the 8th week, only 5mg/d is used, and after the 12th week, only 2.
5mg/d, but complete remission rate appears Or partial remission rate has nothing to do with glucocorticoid reduction
.
In addition, Voclosporin is extremely friendly to Asian patients and is easier to improve the patient's condition
.
Compared with standard therapy, the OR of the Voclosporin Asian group was 3.
7 (95% CI, 1.
5-9.
2)
.
The OR for white patients was 1.
7 (95% CI, 0.
8-3.
7)
.
Professor BradH.
Rovin believes that the efficacy of Voclosporin is significantly related to its mechanism
.
As a calcineurin inhibitor, it can block the expression of IL-2 and the immune response mediated by T cells, and stabilize kidney podocytes
.
02 Belimumab The effect of Belimumab is also very good, but it is significantly related to the staging of LN patients
.
Belimumab has a significant effect on patients of type 3 or 4, type 3+5 or type 4+5, but if the patient is pure type 5, the effect is not even as ideal as a placebo (Figure 4)
.
Figure 4 The relationship between the stage of patients with lupus nephritis and the efficacy of belimumab.
In addition, if the patient has a high level of proteinuria at baseline, the efficacy of belimumab may also be less than ideal (Figure 5)
.
Figure 5 The effect of baseline proteinuria on the efficacy of belimumab.
Further reading: Yimaitong has also reported related trials of Voclosporin before.
For details, please refer to the AURORA 1 trial and AURORA 2 trial
.
References: 1.
More Options and More to Come: Update on the Management of Lupus Nephritis.
2021Kidney Week virtual meeting.
Nov 04, 2021.
