Gholizadeh Ghozloujeh Zohreh, Srinivasan Vinay, Al Jurdi Ayman, Abdipour Amir, Norouzi Sayna
Loma Linda University School of Medicine, CA, USA.
Cooper Medical School of Rowan University, Camden, NJ, USA.
J Investig Med High Impact Case Rep. 2024 Jan-Dec;12:23247096241260964. doi: 10.1177/23247096241260964.
Delayed-release (DR) budesonide received expedited approval from the US Food and Drug Administration (FDA) as a treatment for reducing proteinuria in individuals with primary IgA nephropathy (IgAN) who are at significant risk of disease progression. The approval was based on clinical trials primarily involving patients with an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m. However, the efficacy of DR budesonide in reducing kidney function decline, especially in patients with an eGFR less than 30 mL/min/1.73 m and proteinuria less than 1 g/d, remains unclear. We report the case of a 43-year-old man with a long-term history of hypertension and biopsy-proven IgAN who experienced a progressive increase in proteinuria and serum creatinine, along with a decline in eGFR to 28 mL/min/1.73 m despite maximal supportive management. Following therapy with DR budesonide, a decreasing trend in proteinuria and a stabilization of eGFR were observed in the recent measurements. While initial data suggested the effectiveness of DR budesonide primarily in patients with an eGFR over 30 mL/min/1.73 m, our case demonstrates the potential of DR budesonide for use in scenarios beyond its currently approved indications. This underscores the need for additional research on patients with advanced stages of chronic kidney disease.
缓释布地奈德已获得美国食品药品监督管理局（FDA）的加速批准，用于治疗原发性IgA肾病（IgAN）且有显著疾病进展风险的患者，以降低蛋白尿。该批准基于主要涉及估算肾小球滤过率（eGFR）大于30 mL/min/1.73 m²的患者的临床试验。然而，缓释布地奈德在减缓肾功能下降方面的疗效，尤其是在eGFR小于30 mL/min/1.73 m²且蛋白尿小于1 g/d的患者中，仍不明确。我们报告了一例43岁男性患者，有长期高血压病史，经活检证实为IgAN，尽管进行了最大程度的支持治疗，但蛋白尿和血清肌酐仍逐渐增加，eGFR降至28 mL/min/1.73 m²。在接受缓释布地奈德治疗后，近期测量显示蛋白尿呈下降趋势，eGFR稳定。虽然初始数据表明缓释布地奈德主要对eGFR超过30 mL/min/1.73 m²的患者有效，但我们的病例显示了缓释布地奈德在其目前批准适应症以外的情况下使用的潜力。这突出了对慢性肾病晚期患者进行更多研究的必要性。
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