Ladan Zand, MD: Evaluating Obinutuzumab in Primary FSGS and Further Research

Patients with refractory primary focal segmental glomerulosclerosis (FSGS) treated with obinutuzumab tolerated the therapy well and experienced significant reductions in proteinuria associated with an improvement in estimated glomerular filtration rate (eGFR) and serum albumin.

The new data are from the first 12 months of an open-label phase 2 trial presented at The American Society of Nephrology (ASN) Kidney Week 2024, held October 23- 26 in San Diego, California by Ladan Zand, MD, Associate Professor of Medicine at the Division of Nephrology and Hypertension at Mayo Clinic.

“[Patients with primary FSGS have] really no other good therapeutic options available for them, and they tend to have a progressive course and end up needing either dialysis or transplant, and... tend to have a really high rate of recurrence post kidney transplantation. So the options become really limited for these patients... The patients that we had in this study, on average, had failed at least 2 or 3 different immunosuppressants before they came to our study,” Zand told HCPLive.

Zand and colleagues evaluated 20 patients with FSGS with an average age of 43.5 years to receive 2 doses of 1-gram obinutuzumab 2 weeks apart, at baseline and 6 months. They found that participants treated with obinutuzumab had significant improvements in proteinuria, with average reductions from 10.7 g/d (interquartile range (IQR), 7.5-13.7) to 7.3 g/d (IQR, 4.0-10.3) at 6 months and 3.8 g/d (IQR, 1.5-8.6) after 12 months (P = .001). Overall, 8 patients (40%) reached complete remission or partial remission at 12 months, and none had relapsed disease. They also observed significant improvements in eGFR, serum albumin, cholesterol, and B-cell counts from baseline to 12 months.

“We really tried to include patients that we thought are the true phenotype of a primary FSGs... A lot of times in FSGS trials, they can be kind a mix of patients with genetic, secondary, primary but this, I think, was a kind of unique patient population that we were able to identify,” Zand said.

REFERENCE

Zand L, Greene EL, Cheungpasitporn W, et al. Single-Center, Phase 2, Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Immunosuppression-Resistant Primary FSGS, or Contraindication to High-Dose Corticosteroids. Presented at: ASN Kidney Week 2024.