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Objective <p>To evaluate the real-world clinical efficacy and safety of Nefecon, a targeted-release formulation of budesonide, in patients with IgA nephropathy (IgAN).</p> Methods <p>Retrospective cohort analysis of 40 biopsy-confirmed IgAN patients receiving Nefecon 16&#xa0;mg/day. Primary endpoint: change in proteinuria at 9&#xa0;months. Secondary endpoints: eGFR trajectory, remission rates, and safety.</p> Results <p>At 9&#xa0;months, proteinuria decreased from 2.24 ± 1.64 to 0.69 ± 0.59&#xa0;g/day (60.2% reduction; <i>p</i> &lt; 0.001), with 85% and 72.5% of patients achieving ≥ 30% and ≥ 50% reductions, respectively. Mean eGFR improved from 49.5 ± 22.6 to 53.6 ± 27.6&#xa0;mL/min/1.73&#xa0;m<sup>2</sup> (+ 6.6%; <i>p</i> &lt; 0.05). The overall remission rate was 90.0% (complete remission 27.5%, partial remission 62.5%). Subgroup analysis revealed enhanced responses in patients with heavy baseline proteinuria (≥ 3&#xa0;g/day), and biopsy-to-treatment intervals &lt; 4&#xa0;years. Notably, combination therapy with immuno-suppressants (35% of cohort) demonstrated superior proteinuria reduction (71.4% vs 66.7%; <i>p</i> = 0.007) and eGFR improvement (9.3% vs 8.0%; <i>p</i> &lt; 0.001) compared to Nefecon monotherapy despite greater baseline histologic chronicity. Safety was favorable: Cushingoid facies and acne each occurred in 17.5%, menstrual disorders in 33.3% of females; no severe adverse events or treatment discontinuations occurred.</p> Conclusion <p>In real-world practice, Nefecon demonstrates significant efficacy in reducing proteinuria, improving renal function, and achieving high remission rates in IgAN patients over 9&#xa0;months, with a favorable safety profile. Subgroup analyses highlight that baseline renal function, proteinuria severity, biopsy interval, and combination with immuno-suppressants may influence treatment response. Larger prospective studies are needed to validate these findings.</p>

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Nefecon in IgA nephropathy: real-world renal efficacy, safety profile, and treatment response from a 9-month retrospective cohort analysis

  • 期刊论文

  • 发表日期：

    2026年1月4日

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  • Yanyan Zhang,
  • Yingying Lin,
  • Wei Wang,
  • Guishen Li,
  • Shasha Chen

摘要

Objective

To evaluate the real-world clinical efficacy and safety of Nefecon, a targeted-release formulation of budesonide, in patients with IgA nephropathy (IgAN).

Methods

Retrospective cohort analysis of 40 biopsy-confirmed IgAN patients receiving Nefecon 16 mg/day. Primary endpoint: change in proteinuria at 9 months. Secondary endpoints: eGFR trajectory, remission rates, and safety.

Results

At 9 months, proteinuria decreased from 2.24 ± 1.64 to 0.69 ± 0.59 g/day (60.2% reduction; p < 0.001), with 85% and 72.5% of patients achieving ≥ 30% and ≥ 50% reductions, respectively. Mean eGFR improved from 49.5 ± 22.6 to 53.6 ± 27.6 mL/min/1.73 m2 (+ 6.6%; p < 0.05). The overall remission rate was 90.0% (complete remission 27.5%, partial remission 62.5%). Subgroup analysis revealed enhanced responses in patients with heavy baseline proteinuria (≥ 3 g/day), and biopsy-to-treatment intervals < 4 years. Notably, combination therapy with immuno-suppressants (35% of cohort) demonstrated superior proteinuria reduction (71.4% vs 66.7%; p = 0.007) and eGFR improvement (9.3% vs 8.0%; p < 0.001) compared to Nefecon monotherapy despite greater baseline histologic chronicity. Safety was favorable: Cushingoid facies and acne each occurred in 17.5%, menstrual disorders in 33.3% of females; no severe adverse events or treatment discontinuations occurred.

Conclusion

In real-world practice, Nefecon demonstrates significant efficacy in reducing proteinuria, improving renal function, and achieving high remission rates in IgAN patients over 9 months, with a favorable safety profile. Subgroup analyses highlight that baseline renal function, proteinuria severity, biopsy interval, and combination with immuno-suppressants may influence treatment response. Larger prospective studies are needed to validate these findings.