Naifang®NEFECON® (Buddine Enterico Capsule) is currently the only IgA nephropathy to treat drugs that are completely approved in the FDA.Essence
NEFLGARD test results show that the Buddeeid enterico -capsule capsule can reduce the decline in renal function of 50%of patients with IGA nephrotic disease. In the Chinese population, renal dysfunction can reach 66%. It is expected that the disease is expectedThe time for progress to dialysis or kidney transplantation was delayed for 12.8 years.
But many people have questions, such as: Buddine enter the enteric -soluble capsule After using 1 course of treatment, it is necessaryContinue to use it?
Is the second course of the second course of treatment is also effective?
This years Annual Meeting of the American Kidney Society-American Kidney Week 2024 The Nefigard open label expansion (OLE) research releasedAs a result, the answer was revealed.
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Research content
This research is a follow -up extension of Nefigards research. After 326 cases completed the NEFLGARD trial, a total of 119 patients with IGA nephropathy entered OLE research.Among them, 45 of them (38%) have received 1 course of treatment Budi Nide enteric capsule, 74 cases (62%, the previous placebo groupPatients) have not been treated with Buditanid entericapuloum capsule .
The baseline characteristics of the patient are: the median estimation of the previous acceptance and unacceptable patient treatment of patients (EGFR) is 50.4 ml, respectively./min/1.73 ㎡ and 49.2 ml/min/1.73 ㎡; the median urine protein creatinine ratio (UPCR) is 1.28 g/g and 1.37 g/g, respectively.
In the OLE trial, they accepted together Buddine enter the intestinal capsule, the treatment time was 9 months, and the follow -up was 12 months.
02
Research Results
The results show that patients who accept Patients with the second treatment course of the Buddine enteric cytarium capsule are estimated to calculate the glomerular filtration rate (EGFR) and proteinThe benefits of urine are equivalent to the first treatment patients and have good tolerance.
For all 119 patients, the Budiid enteric -coated capsule was treated for 9 months, and it is estimated that the glomerular filtration rate (EGFR) decreased by 1.43 ml/min/1.73 m2 than the baseline.Essence
EGFR autopilular lines that have been accepted or not received in the past or not accepting Patthonic Capsules for patients to treat patients decreased by 1.28 ml/min/1.73m2, 1.53, respectively.ML /min/1.73m2, The changes in EGFR between the two groups are similar.
For all 119 patients, the Budi Nide enteric capsule was treated after 9 months of treatment.) 32%.
Further analysis shows that the previous acceptance or unpaid Pattadic enteric capsule in the treatment of patients urine protein creatinine ratio (UPCR) compared with the baselineThe decrease was 33%and 31%, and the decline was similar.
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Reaction
The overall tolerance of the drug is good, no new safety reports have occurred, special attention to bad events (AESI), the treatment of adverse events (Teae) and it of the treatment (TEAE) and itThe incidence of adverse events such as drug suspension is low.And patients who have previously accepted Pattonal intestinal capsules have lower incidence of adverse events or cause the incidence of drug discontinuation.
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Research conclusions
This OLE study confirmed the efficacy and safety of IgA nephropathy continued to use the Buditanid enteric -coated capsule in the second course of the second course of treatment, which provided evidence support for the long -term treatment strategy of IGA nephropathy.
Increased pathogenic IGA (semi-lactose defects IGA, GD-IgA1) is one of the important factors that lead to IGA nephropathy.Can reduce the treatment of the pathogenic IgA targeted treatment.
During the treatment, except proteinuria and EGFR, how can it be more directly and targeted at the efficacy of drugs and continuous medication?
At present, scholars believe that or can detect the pathogenic IgA (semi-lactose defect IgA1, GD-IgA1) level in the serum of patients with a basis for diagnosis and treatment.Patients with IgA nephropathy with a higher level of pathogenic IGA levels may require continuous long -term medication.
This is also consistent with the recommendations of the "Draft of KDIGO Iga Nephriliated and IgA Vasculitis Clinical Management Practice (Public Examination Draft)".
2024 new version guide: In terms of decreased proteinuria or EGFR stability, it is unlikely to cause continuous clinical reactions with a 9 -month treatment course. Many patients may need to needRepeat 9 months of Buddine enterose cytarbilid treatment cycle or reduce dose maintenance plan.
Professor Zhang Hong
Nai Fang® Global III Phase III
Research NEFLGARD Global Guidance
Member of the Committee
International IgA Nephrology Alliance China
collaborationGroup Chairman
Peking University First Hospital
Director of Neep -ups
In China, the group of patients with IgA nephropathy is large, and the age of onset is mild and the prognosis is not good. Almost all patients with IgA nephropathy are in itThere is a risk of progress in the end of life.
Therefore, clinically, the purpose of long -term protection of patients with patients should be delayed as possible to delay the time of patients entering dialysis or kidney transplantation as much as possible.
For a chronic, long -term, and self -immune -mediated primary glomerular disease such as IGA nephropathy, it still needs to be safe and effective long -term treatment plan.
The results of this OLE study confirmed the effect and safety of the second treatment of IgA nephrotic patients.Nephrine has provided evidence support for the treatment strategy for a long time, and brought new medication ideas to clinicians.
References:
1.neflgard Open-Label Extension: Effical and Safety in Patients WHO Complety e 2-yearPhase 3 trial ?. Presented at asn 2024.
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References:1. 2024ASN. ORAL PRESENTATION.
2.Effical and Safety of a Targeted-Release formation I n Patients withPrimary Iga Nephropathy (Nefigard): 2-year Results from a randomised Phase 3 trial.
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