ArticleDrug design, development and therapy2026
Obinutuzumab as a Rescue and Maintenance Strategy in Children with Difficult-to-Treat Nephrotic Syndrome After Rituximab-Based Treatment Failure or Intolerance: A Preliminary Single-Center Real-World Retrospective Study.
Article in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Purpose: This preliminary study aimed to describe the effectiveness and safety of obinutuzumab as a rescue and maintenance anti-CD20 strategy in children with difficult-to-treat nephrotic syndrome after failure or intolerance of rituximab-based multi-target immunosuppression. Patients and Methods: This exploratory single-center retrospective real-world study included consecutive children who received obinutuzumab between April 2024 and January 2025. Nine patients were included in the safety set, and eight who completed treatment and had follow-up data comprised the efficacy set. The primary outcome was 12-month relapse-free survival. Secondary outcomes included annualized relapse rate, peripheral B-cell depletion, glucocorticoid-free status, reduction or discontinuation of background immunosuppression, and safety. Results: Median follow-up in the efficacy set was 1.24 years (IQR 1.01-1.67). No relapses occurred after obinutuzumab in this small efficacy set, corresponding to an observed 12-month relapse-free proportion of 8/8 (100%; exact 95% CI 63.1-100) and reducing the annualized relapse rate from 2.50 to 0 episodes/person-year. All eight efficacy-set patients achieved complete peripheral B-cell depletion and remained depleted at 6 months. At last follow-up, seven had discontinued both glucocorticoids and all non-obinutuzumab immunosuppressants, while one had discontinued glucocorticoids with a reduced dose of mycophenolate mofetil. In the safety set, one child developed severe anaphylactic shock during the first infusion; infectious events were limited to CTCAE grade 1-2 events. Conclusion: In this exploratory, hypothesis-generating study, obinutuzumab was associated with a favorable relapse profile, sustained peripheral B-cell depletion, and reduction of background immunosuppression in a highly selected pediatric population. Larger prospective studies are required to confirm these preliminary observations and define long-term safety.
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