Enteric Budesonide Treatment in IgA Nephropathy

ABSTRACT: Introduction TRF Budesonide was the first drug approved by regulatory authorities for the management of IgA nephropathy (IgAN), but is not available in many countries. Enteric coated budesonide (EC-budesonide) is widely available but there is a paucity of data in IgAN. Methods This was a prospective, single arm, multicentre (n = 6), study of EC-budesonide (IgANEF formulation, 9 mg BID) on adult (age ≥ 18 years) IgAN patients (n = 168) who were immunosuppressive naïve, on maximally tolerated supportive regimen. The primary outcome was % urine albumin creatinine ratio (UACR) reduction at 9 month. Secondary outcomes included eGFR change and proportion of patients achieving ≥30% and ≥50% UACR reduction at 9 month. A sub-group analysis was performed for outcomes grouped by baseline proteinuria severity [UACR < 800 vs > 800 mg/g creatinine] and kidney function [eGFR < 35 vs > 35 ml/min/1.73m²]. Results The mean age of the cohort was 36.1 ± 11.0 years with 97(57.1%) males. At 9 months (n=148), geometric mean UACR decreased 66.3% (from 1,732 to 583 mg/g, p<0.001). UACR response rates were 88.5% for ≥30% reduction and 75.7% for ≥50% reduction. Mean eGFR improved +5.0 mL/min/1.73 m² (p<0.001, n=137). The outcome was similar in subgroups of both UACR and eGFR. There was no serious adverse events reported requiring discontinuation. Conclusion In this prospective multicentre, single arm study of EC budesonide in IgA Nephropathy, the safety, proteinuria reduction and eGFR stabilization was encouraging. The drug has promising efficacy in regions where other approved drugs are unavailable.