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Kidney Week

Abstract: FR-PO0941

INShore Phase 3 Study of Obinutuzumab vs. Mycophenolate Mofetil in Childhood-Onset Idiopathic Nephrotic Syndrome: Post Hoc Analysis Assessing the Effect of Prior Rituximab Use

Session Information

Category: Pediatric Nephrology

  • 1800 Pediatric Nephrology

Authors

  • Greenbaum, Larry A., Department of Pediatrics, Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia, United States
  • Hogan, Julien, Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France
  • Lieberman, Kenneth V., Hackensack University Medical Center, Hackensack, New Jersey, United States
  • Nozu, Kandai, Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan
  • Mizerska-wasiak, Malgorzata, Department of Pediatrics and Nephrology, Medical University of Warsaw, Warsaw, Poland
  • Garcia, Clotilde Druck, Child and Adolescent Care, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA) and Department of Pediatrics (UFCSPA), Santo Antonio Children Hospital, Porto Alegre, Santa Case de Porto Alegre, Brazil
  • Angeletti, Andrea, Division of Nephrology, IRCCS Institute Giannina Gaslini, Genova, Italy
  • Ding, Jie, Department of Pediatrics, Peking University First Hospital, Beijing, China
  • Han, Xiaoyan, Roche (China) Holding Ltd, Shanghai, China
  • Li, Sijing, Roche (China) Holding Ltd, Shanghai, China
  • Schaefer, Franz, Division of Pediatric Nephrology, University Hospital Heidelberg, Heidelberg, Germany
  • Lehane, Patricia B., Roche UK Ltd, Welwyn Garden City, England, United Kingdom
Background

INShore (NCT05627557) comparing obinutuzumab (OBI) vs mycophenolate mofetil (MMF) in participants (pts) with idiopathic nephrotic syndrome aged ≥2 to 25 years met its primary endpoint at Week 52: 95.5% receiving OBI achieved sustained complete remission (SCR) vs 73.2% receiving MMF (adjusted difference 23.4%; P=0.0031) (Figure 1A). This post hoc analysis assessed the impact of prior rituximab (RTX) use on the primary efficacy outcome.

Methods

All pts were in CR (urine protein-to-creatinine ratio ≤0.2 g/g) at entry. Glucocorticoids and MMF did not require washout. B-cell–depleting therapies (including RTX) were discontinued ≥9 months prior to randomization.

Results

A total of 85 pts (OBI n=44; MMF n=41) were enrolled (Table 1). Prior RTX was received by 18 (41%) and 9 pts (22%) in the OBI and MMF arms, respectively, with time of last dose prior to randomization ranging from 9.4 to 80.1 (OBI) and 9.7 to 51.6 months (MMF). At baseline, no pts had B-cell depletion.
With OBI, 17/18 pts (94.4%) who had prior RTX achieved SCR at Week 52 vs 25/26 pts (96.2%) with no prior RTX. With MMF, 5/9 pts (55.6%) who had prior RTX achieved SCR at Week 52, vs 25/32 pts (78.1%) with no prior RTX (Figure 1B).

Conclusion

Despite the imbalance of prior RTX use with a higher proportion in the OBI arm, there was no impact on the primary efficacy outcome in either arm at Week 52. The likelihood of achieving SCR with OBI was high and comparable in pts with and without prior RTX use.

Acknowledgment

Funded by F. Hoffmann-La Roche Ltd. Editorial assistance was provided by Nucleus Global, an Inizio company, and funded by F. Hoffmann-La Roche Ltd.

Funding

  • Commercial Support – F. Hoffmann-La Roche Ltd.