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    Home > Active Ingredient News > Immunology News > Phase 3 clinical trials reveal the efficacy and safety of the new drug Voclosporin for lupus nephritis

    Phase 3 clinical trials reveal the efficacy and safety of the new drug Voclosporin for lupus nephritis

    • Last Update: 2021-05-21
    • Source: Internet
    • Author: User
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    Lupus nephritis (LN) is one of the common secondary kidney diseases in my country.
    About 50% of patients with systemic lupus erythematosus will have renal involvement in clinical practice, and 20% of LN patients will develop end-stage renal disease within 10 years .

    Currently, there are fewer therapies for the treatment of LN, and the risk of adverse events is usually higher.

     Voclosporin is a calcineurin inhibitor, which can block IL-2 expression and T cell-mediated immune response, and stabilize renal podocytes.

    In January of this year, the FDA approved Voclosporin to be marketed in the United States and made relevant comments on it.

    On May 7, the internationally renowned journal "Lancet" published a clinical trial of Voclosporin, revealing that Voclosporin has good efficacy and safety.

     Study Design The AURORA-1 trial is a randomized, double-blind, multi-center, phase 3 clinical controlled trial involving 142 medical institutions in 27 countries.

    Enrolled patients need to have systemic lupus erythematosus and LN, and their kidney biopsy results within 2 years are stage III, IV or V (alone or in combination with stage II, III or IV).

     A total of 357 eligible patients were enrolled in the group and grouped according to a ratio of 1:1.
    The Voclosporin group took Voclosporin 2 times a day, 23.
    7 mg each time.

    In the first 2 days of the trial, both groups of patients will use glucocorticoids to suppress immunity.

    In addition, both groups of patients will take mycophenolate mofetil (2 times a day, 1g each time) and low-dose steroids.

     The primary endpoint of the trial was the number of people who achieved complete renal remission at week 52, and complete renal remission was defined as urine protein-creatinine ratio (UPCR) ≤ 0.
    5 mg/mg and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/ 1.
    73㎡ or eGFR value did not drop more than 20% compared to the baseline.

    At the same time, before the end of the main trial (Week 44-Week 52), patients must meet the following conditions to be included in the statistics.
    They have not used emergency medicines, and the equivalent amount of prednisone used within 3 days does not exceed 10 mg or within 7 days.
    Continuous use of glucocorticoids.

     The secondary endpoint is the number of days required for the patient’s UPCR to reach 0.
    5 mg/mg; the number of days required for a 50% decrease in UPCR compared to baseline and the number of people who have achieved complete renal remission at week 24, week 24 and 52 The number of people who achieved partial renal remission at week.

     In terms of safety, the trial examined the adverse events of the two groups of patients.

     The patient's baseline information is shown in the table below (Table 1).
    The primary and secondary endpoints of the study results can be seen in the table below (Table 2).

    As for safety, 162 (91%) patients in the Voclosporin group reported adverse events, compared with 158 (89%) in the control group.

    Among them, there were 37 cases (21%) of serious adverse events, compared with 83 cases (21%) in the control group.

    Among them, about 18 cases (10%) were severely infected in the Voclosprin group, and 20 cases (11%) in the control group.

    Treatment-related adverse reactions were reported by 8 patients (4%) in both groups.

    In addition, 1 case (<1%) death was reported in the Voclosporin group, and 5 cases (3%) in the control group.

    FDA evaluates Voclosporin as follows: ➤Compared with placebo, after 1 year of Voclosporin treatment in LN patients, more patients in the Voclosporin group had improved renal inflammation; ➤The efficacy of Voclosporin was not significantly different between men and women.
    ➤In terms of tolerability, the racial difference between Voclosporin between whites and Asians is not big; ➤Because there are fewer LN patients over 65 years old, there is insufficient research on this part of the population, so the efficacy of Voclosporin for the elderly remains to be For further research, more attention should be paid to these patients during clinical work.

      Summary From the experimental results, the combination of Voclosporin and mycophenolate mofetil and low-dose steroids is better than the combination of mycophenolate mofetil and low-dose steroids in patients with LN.

    From the evaluation of the FDA, Voclosporin alone is also effective for LN patients.

    In short, Voclosporin is a medicine that deserves the attention of nephrologists and rheumatologists.

    References 1.
    Brad H Rovin, YK onno Teng, Ellen M Ginzler, at el.
    Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial Lancet.
    May 7, 2021.
    2.
    US food and drug administration.
    Novel Drug Approvals for 2021.
    April 23, 2021.
    3.
    Aurinia.
    FDA Approves Aurinia Pharmaceuticals' LUPKYNIS (voclosporin) for Adult Patients with Active Lupus Nephritis.
    Jan 23, 2021.
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