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Published on: May 22, 2020
Clinical Response and Pattern of B cell Suppression with Single Low Dose Rituximab in Nephrology
Jacob George1, Sunu Alex1, E T Arun Thomas1
1Department of Nephrology, Government Medical College Thiruvananthapuram, Thiruvananthapuram, Kerala, India.
Insights
Low-dose rituximab effectively depletes CD19 B cells in kidney disease patients, leading to sustained remission in many with steroid-dependent nephrotic syndrome. Further research is needed to confirm its role in preventing relapses and rejection.
Area of Science:
- Nephrology
- Immunology
- Pharmacology
Background:
- Lack of established rituximab dosing guidelines in nephrology.
- Current dosing often extrapolated from lymphoproliferative disorder treatments.
- No clear targets for CD19 B cell levels for rituximab administration.
Purpose of the Study:
- To evaluate the efficacy of a low-dose rituximab regimen in nephrology patients.
- To assess the impact of rituximab on CD19 B cell depletion and clinical outcomes.
- To explore rituximab's role in steroid-dependent nephrotic syndrome (SDNS), frequently relapsing nephrotic syndrome (FRNS), and membranous nephropathy (MN).
Main Methods:
- Administered 100 mg rituximab to 42 adult patients with SDNS, FRNS, MN, or high-risk kidney transplants.
- Monitored CD19 B cell counts and clinical status at multiple time points up to 1 year.
- Adjusted subsequent rituximab doses based on CD19 B cell reconstitution and clinical response.
Main Results:
- Significant reduction in CD19 B cell percentage observed at 30, 90, and 180 days post-treatment (P≤0.001).
- 95.2% of patients achieved CD19 B cell suppression below 1% at 30 days.
- High remission rates (96.7% at day 30, 70% at 1 year) in SDNS/FRNS patients, with reduced steroid requirements.
- CD19 B cell percentage at 90 days correlated with relapse risk (OR 1.42, P=0.001).
Conclusions:
- Low-dose rituximab effectively depletes CD19 B cells for up to 90 days.
- Sustained remission achieved in a majority of SDNS/FRNS patients.
- Further investigation is warranted for rituximab's efficacy in preventing relapses and managing MN and transplant rejection.
Background:
There is no consensus regarding dose and frequency of rituximab in nephrology with extrapolation of doses used in treating lymphoproliferative disorders. There are no guidelines on targeting initial and subsequent doses on the basis of CD19+ B cells.
Methods:
Initially, 100 mg rituximab was given to 42 adults with steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS), idiopathic membranous nephropathy (MN), and high-immunologic-risk kidney transplantation. Absolute and percentage levels of CD19 B cells and clinical status were assessed at baseline, days 30, 90, and 180, and at 1 year. Subsequent doses of rituximab were on the basis of CD19 B cell reconstitution and clinical response.
Results:
CD19 B cell percentage decreased from 16.3 ± 7.6 to 0.3 ± 0.3 (P≤0.001), 1.9 ± 1.7 (P≤0.001), and 4.0 ± 4.5 (P=0.005) by 30, 90, and 180 days, respectively. Suppression of CD19 B cell count below 1% at days 30, 90, and 180 was seen in 40 of 42 (95.2%), 18 of 42 (42.9%), and 7 of 42 (16.7%) patients, respectively. Of 30 with SDNS and FRNS followed up for 1 year, 29 (96.7%) went into remission at day 30. Remission was sustained in 23 (76.6%) at day 180 and 21 (70%) at 1 year. There was a significant decrease (P<0.001) in the dose of steroids needed to maintain remission at 180 days after rituximab (0.27 ± 0.02 mg/kg to 0.02 ± 0.00 mg/kg). CD19 B cell percentage at 90 days correlated with relapse (P=0.001; odds ratio 1.42; 95% confidence interval, 1.25 to 2.57). Eighteen (60%) required an additional dose. Of five with MN, four achieved remission by 6 months, which was sustained in three by 1 year. Of the seven kidney transplant recipients, two had antibody-mediated rejections, although CD19 B cells were suppressed even at 1 year.
Conclusions:
Low-dose rituximab induces sustained depletion of CD19 B cells for up to 90 days. Its role in preventing relapses in SDNS, FRNS, MN, and rejection needs further study.
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