Abstract: SA-PO0806
Obinutuzumab Facilitates Tubular Repair in Lupus Nephritis Independently of Histologic or Clinical Response: Post Hoc Analyses of Urine Epidermal Growth Factor in the Phase 3 REGENCY Trial
Session Information
- Glomerular Diseases: Lupus Nephritis, Monoclonal Gammopathy-Related Disease, and Transplantation
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Clarke, Holly, Genentech, Inc., South San Francisco, California, United States
- Mejia-Vilet, Juan M., Department of Nephrology and Mineral Metabolism Salvador Zubirán National Institute of Medical Sciences and Nutrition, Mexico City, Mexico
- Lanza, Ben, Roche UK Ltd, Welwyn Garden City, England, United Kingdom
- Yu, Peiqing, Hoffmann-La Roche Ltd, Mississauga, Ontario, Canada
- Omachi, Theodore A., Genentech, Inc., South San Francisco, California, United States
- Pendergraft, William Franklin, Genentech, Inc., South San Francisco, California, United States
- Raghu, Harini, Genentech, Inc., South San Francisco, California, United States
- Rovin, Brad, Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, Ohio, United States
Background
Epidermal growth factor (EGF) production decreases in kidney tubular injury associated with acute injury and chronic kidney disease. To investigate its potential as a non-invasive biomarker of tubular damage in lupus nephritis (LN), urine EGF (uEGF) was measured longitudinally in the REGENCY trial (NCT04221477) of obinutuzumab (OBI) in LN.
Methods
uEGF (pg/mg urine creatinine) was measured by ELLA. A subset of patients (pts) receiving placebo (PBO) or OBI (n=31 each) had a kidney biopsy around Week (Wk)76. The NIH activity index (AI) and chronicity index (CI) were scored centrally and correlations were performed using the Spearman method. Histologic response was defined as AI≤1 at Wk76.
Results
At baseline (BL) and Wk76, uEGF was inversely correlated with CI and components of CI (Table 1). Compared with PBO, OBI increased uEGF levels at Wk24, with improvements through Wk76. While there was no clear difference in BL uEGF levels between treatment groups, uEGF was generally higher in eventual histologic responders (Fig 1A). OBI resulted in increased uEGF through Wk76 in both histologic responders and non-responders, while PBO showed no change or decrease (Fig 1A). uEGF increased in all pts who achieved complete renal response (CRR) at Wk76 across treatment groups. uEGF increased in OBI-treated, but not PBO-treated pts who did not achieve CRR at Wk76 (Fig 1B).
Conclusion
uEGF levels were associated with kidney histology changes during treatment and increased uEGF levels were observed alongside the resolution of clinical and histologic activity. uEGF also improved with OBI even in non-responders, suggesting OBI may improve tubular health independent of complete clinical or histologic resolution.
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.