Rituximab in IgA Nephropathy: The RITA Multicenter Randomized Trial
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Yan Ouyang1, Hong Ren1, Weiming Wang2
1Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Rationale & Objective:
B-cell dysregulation contributes to IgA nephropathy (IgAN). Rituximab (RTX) targets CD20-positive B cells, but its efficacy in adults with IgAN receiving stable renin-angiotensin system inhibitor (RASI) therapy remains uncertain. This study sought to evaluate the efficacy and safety of RTX combined with RASI therapy compared with RASI therapy alone.
Study Design:
Multicenter, randomized, controlled trial.
Setting & Participants:
Chinese adults with biopsy-proven IgAN across 10 centers, with 24-hour urine total protein (UTP) >1 g/day despite ≥3 months RASI therapy, and blood pressure <130/80 mmHg.
Interventions:
RTX plus RASI versus RASI alone for 12 months OUTCOMES: Primary: 24-hour UTP change at month 12. Secondary continuous: changes in 24-hour UTP at month 6 and in eGFR and serum Gd-IgA1 at month 12. Secondary categorical: ≥50% reduction in 24-hour UTP at months 6 and 12, ≥50% eGFR decline or doubling of serum creatinine, and ESKD.
Safety:
adverse events, serious adverse events, and infections. Exploratory analyses examined outcomes through month 24.
Results:
Among the 106 participants randomized (53 per group), 24-hour UTP change at 12 months was similar between groups (adjusted GMR, 1.05; 95% CI, 0.80-1.36). Median change of 24-hour UTP was -0.21 g/day for RTX and -0.26 g/day for RASI. No statistically significant differences were observed in eGFR (adjusted mean difference, 3.80 mL/min/1.73 m2; 95% CI, -0.47 to 8.06), Gd-IgA1 (adjusted GMR, 1.04; 95% CI, 0.87-1.24), or the proportion achieving a ≥50% reduction in 24-hour UTP (15.1% vs 20.8%). Adverse events occurred at similar rates between two groups; no events of ≥50% eGFR decline, doubling of serum creatinine, or ESKD occurred during the 12-month treatment period. These findings were consistent with analyses that included outcome data through month 24.
Limitations:
The follow-up period was relatively short, and only Asian patients were enrolled.
Conclusions:
No additional reduction in proteinuria or preservation of kidney function was observed with the addition of RTX to optimized RASI-based therapy in patients with IgAN.
Funding:
Grants from government (National Key Research and Development Program, Major International [Regional] Joint Research Program of China, National Natural Science Foundation of China, National Facility for Translational Medicine [Shanghai], Shanghai 'Rising Stars of Medical Talent' Youth Development Program), academic (Shanghai Shenkang Hospital Development Center), and non-profit (International Society of Nephrology) sources.
