Commentary
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Zand discussed interim 12-month findings from an open-label, phase 2 trial currently ongoing for patients with refractory primary focal segmental glomerulosclerosis.
Obinutuzumab was well-tolerated and significantly reduced proteinuria in patients with refractory primary focal segmental glomerulosclerosis (FSGS). Improvements were also associated with an improvement in estimated glomerular filtration rate (eGFR) and serum albumin.
These findings, from the first 12 months of an open-label phase 2 trial, were presented by Ladan Zand, MD, Associate Professor of Medicine at the Division of Nephrology and Hypertension at Mayo Clinic, at The American Society of Nephrology (ASN) Kidney Week 2024, held October 23- 26 in San Diego, California.
The trial enrolled 20 patients with FSGS with an average age of 43.5 years (standard deviation [SD], 17.5), 55% of which were male, to receive 2 doses of 1-gram obinutuzumab 2 weeks apart, at baseline and 6 months. Participants had an average systolic blood pressure (BP) of 132 mmHg (SD. 17.5), an average diastolic BP of 77.1 mmHg (SD, 9.5) and had disease refractory to an average of 2-3 therapies.
Zand and colleagues 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.
“There are patients that fail steroid therapy, and that can be a large portion of the patients that don't respond, and then you really don't know what's the next step for these patients. And I think obinutuzumab, for the most part in the study, was very well tolerated. So that can be an option for [these patients] that can also help improve their kidney function over time. So, I really think that it does change the landscape long term,” Zand told HCPLive.