What is the efficacy of budesonide extended-release capsules (Kinpeygo) in the treatment of IgA nephropathy?

Budesonide sustained-release capsules (Kinpeygo) have certain efficacy in the treatment of IgA nephropathy.

Budesonide is a glucocorticoid commonly used to treat inflammation and immune responses. In IgA nephropathy, inflammation and immune responses are abnormally active, so budesonide can reduce the release of inflammatory mediators and allergic substances by suppressing immune responses and reducing antibody synthesis, thereby improving the symptoms and condition of IgA nephropathy.

Dosage form and specifications

Capsules, specification is 4mg*120 tablets.

Budesonide extended-release capsules

are corticosteroids indicated for the reduction of proteinuria in adult patients with primary immunoglobulin A nephropathy (IgA) who are at risk for rapid disease progression.

Budesonide sustained-release capsules (Kinpeygo) for the treatment of IgA nephropathy

Some clinical studies have shown that budesonide sustained-release capsules can reduce urinary protein levels in patients with IgA nephropathy and keep their renal function relatively stable. Budesonide extended-release capsules reduced urinary protein levels by 24.4%, while patients who did not take the drug increased urinary protein levels by 2.7%. At the same time, the renal function of IgA nephropathy patients who took budesonide sustained-release capsules remained relatively stable, while the renal function of patients who did not take this drug showed a downward trend.

In a multicenter, randomized, double-blind, placebo-controlled, two-part trial, the efficacy and safety of budesonide extended-release capsules versus placebo for 9 months were studied.

In Part A, 199 patients with IgAN were treated with desonide extended-release capsules or placebo for 9 months and then observed for an additional 3 months. At nine months, UPCR was reduced by 27% in the desonide extended-release capsule group compared with placebo, and the eGFR preservation benefit corresponded to a difference of 3.87 ml/min/1.73m² compared with placebo. Desonide extended-release capsules were well tolerated, and most adverse events during treatment were mild to moderate and reversible.

Efficacy of budesonide extended-release capsules in reducing proteinuria in IgA nephropathy

In a phase 3, multi-center, randomized, double-blind, placebo-controlled trial, 13 patients in 20 countries around the world Two hospital-based clinical research sites recruited 364 eligible patients with primary IgA nephropathy and randomly assigned them to receive budesonide extended-release capsules (n=182) or matching placebo (n=182) for 9 months, followed by a 15-month observational follow-up period before the study drug was discontinued.

Compared with the placebo group, the therapeutic benefit of the budesonide sustained-release capsules group was statistically significant. The time-weighted average changes in the budesonide sustained-release capsules group and the placebo group were -2.47mL/min and -7.52mL/min per 173m², respectively.

The most commonly reported treatment-emergent complications during treatment with budesonide extended-release capsules are peripheral edema, hypertension, muscle cramps, and acne headache.

9-month treatment with budesonide extended-release capsules provided clinically relevant reductions in eGFR decline and durable reductions in proteinuria compared with placebo, supporting disease-modifying effects in patients with IgA nephropathy.

Dosage

The recommended dose of budesonide sustained-release capsules is 16 mg, taken once a day, at least 1 hour before meals in the morning. When discontinuing the drug, the dose should be reduced to 8 mg once daily for the last two weeks.

Summary

Budesonide sustained-release capsules can improve the symptoms and condition of IgA nephropathy to a certain extent, but it needs to be used under the guidance of a doctor, and attention should be paid to monitoring side effects.

References:

1. Barratt J, Lafayette R, Kristensen J, Stone A, Cattran D, Floege J, Tesar V, Trimarchi H, Zhang H, Eren N, Paliege A, Rovin BH; NefIgArd Trial Investigators. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2023 Feb;103(2):391-402. doi: 10.1016/j.kint.2022.09.017. Epub 2022 Oct 19. PMID: 36270561.

2. Lafayette R, Kristensen J, Stone A, Floege J, Tesař V, Trimarchi H, Zhang H, Eren N, Paliege A, Reich HN, Rovin BH, Barratt J; NefIgArd trial investigators. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomized phase 3 trial. Lancet. 2023 Sep 9;402(10405):859-870. doi: 10.1016/S0140-6736(23)01554-4. Epub 2023 Aug 14. Erratum in: Lancet. 2023 Sep 9;402(10405):850. PMID: 37591292.

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