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Abstract Number: 0784

Kidney-Related Outcomes and Steroid-Sparing Effects in Patients with Active Lupus Nephritis Treated with Obinutuzumab: A Post Hoc Analysis of a Phase 2 Trial

Brad Rovin1, Jorge Ross Terres2, Sophia Giang3, Thomas Schindler4, Armando Turchetta5, Jay Garg2, Richard Furie6, William F. Pendergraft III2 and Ana Malvar7, 1Ohio State University, Columbus, OH, 2Genentech, Inc., South San Francisco, CA, 3Genentech, Inc., San Francisco, CA, 4F. Hoffmann-La Roche Ltd, Basle, Switzerland, 5F. Hoffmann-La Roche Ltd, Basel, Switzerland, 6Northwell Health, Manhasset, NY, 7Hospital Fernandez, Buenos Aires, Argentina

Meeting: ACR Convergence 2023

Keywords: B-Cell Targets, Biologicals, glucocorticoids, Lupus nephritis, Renal

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Session Information

Date: Sunday, November 12, 2023

Title: Abstracts: SLE – Treatment I: Renal

Session Type: Abstract Session

Session Time: 2:00PM-3:30PM

Background/Purpose: Preservation of long-term kidney function and sustained reduction of glucocorticoid use are major therapeutic goals in lupus nephritis (LN). In the randomized, double-blind, placebo-controlled, Phase 2 NOBILITY trial (NCT02550652), patients with proliferative LN receiving obinutuzumab with standard-of-care therapy showed clinically meaningful improvement in complete and overall renal responses (CRR and ORR) at Weeks 52, 76 and 104 compared with those receiving placebo and standard-of-care therapy.1 We conducted a post hoc analysis of NOBILITY to assess kidney-related outcomes and steroid-sparing effects.

Methods: Cox regression analysis was conducted for the time to first kidney-related event (death, doubling of serum creatinine and treatment failure), LN flare and first 30% and 40% eGFR decline from baseline. The eGFR slope was assessed in a linear mixed-effects model. Assessment of a steroid-sparing effect of ≤7.5 mg/day of prednisone while achieving CRR at Weeks 76 and 104 without use of >7.5 mg/day of prednisone between Weeks 64 and 76 and Weeks 92 and 104, respectively, was calculated by the Cochran–Mantel–Haenszel test stratified for race (Afro-Caribbean/African American vs others) and country (US vs non-US). Glucocorticoid dose was imputed by the LOCF method for patients who discontinued the study and/or for missing data. All patients met ACR classification criteria for systemic lupus erythematosus and had biopsy-proven proliferative LN.

Results: Obinutuzumab significantly reduced the risk of kidney-related events or death (HR, 0.40; 95% CI, 0.20 to 0.80), LN flare (HR, 0.43; 95% CI, 0.20 to 0.95) and time to first eGFR decline of 30% (HR, 0.20; 95% CI, 0.06 to 0.61) and 40% (HR, 0.09; 95% CI, 0.01 to 0.73) (Figure). Risk of sustained eGFR decline of 30% and 40% was numerically lower, and a significant difference in attenuation of eGFR slope decline was observed between patients receiving obinutuzumab and standard-of-care therapy and those receiving placebo and standard-of-care therapy (annual slope difference, 4.10 mL/min/year; 95% CI, 0.14 to 8.08). Patients receiving obinutuzumab and standard-of-care therapy were significantly more likely to achieve CRR at Week 76 without receiving >7.5 mg/day of prednisone from Week 64 through 76 than those receiving placebo and standard-of-care therapy (24 of 63 patients [38.1%] vs 10 of 62 [16.1%], respectively; P< 0.01). A similar trend was observed at Week 104 without receiving >7.5 mg/day of prednisone from Week 92 through 104, but this did not reach statistical significance.

Conclusion: Obinutuzumab, in addition to increasing the possibility of achieving CRR, significantly reduced the risk of kidney-related events, eGFR decline, time to LN flare and eGFR slope decline in a post hoc analysis, suggesting that obinutuzumab in combination with standard-of-care therapy may positively impact kidney-related outcomes. In addition, a significant steroid-sparing effect was observed at Week 76. Obinutuzumab is being evaluated in patients with active proliferative LN in the global registrational Phase 3 REGENCY trial (NCT04221477).

Reference
1. Furie RA, et al. Ann Rheum Dis. 2022;81:100-107.

Supporting image 1


Disclosures: B. Rovin: AstraZeneca, 2, 5, Aurinia, 2, 5, Biogen, 2, F. Hoffmann-La Roche Ltd, 2, Genentech, 2, GlaxoSmithKlein(GSK), 2, Novartis, 2; J. Ross Terres: F. Hoffmann-La Roche Ltd, 11, Genentech, Inc., 3; S. Giang: F. Hoffmann-La Roche Ltd, 11, Genentech, Inc., 3; T. Schindler: F. Hoffmann-La Roche Ltd, 3, 11; A. Turchetta: F. Hoffmann-La Roche Ltd, 3, 11; J. Garg: F. Hoffmann-La Roche Ltd, 11, Genentech, Inc., 3; R. Furie: Biogen, 2, 5; W. Pendergraft III: F. Hoffmann-La Roche Ltd, 11, Genentech, Inc., 3; A. Malvar: F. Hoffmann-La Roche Ltd, 2, Genentech, Inc., 2.

To cite this abstract in AMA style:

Rovin B, Ross Terres J, Giang S, Schindler T, Turchetta A, Garg J, Furie R, Pendergraft III W, Malvar A. Kidney-Related Outcomes and Steroid-Sparing Effects in Patients with Active Lupus Nephritis Treated with Obinutuzumab: A Post Hoc Analysis of a Phase 2 Trial [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/kidney-related-outcomes-and-steroid-sparing-effects-in-patients-with-active-lupus-nephritis-treated-with-obinutuzumab-a-post-hoc-analysis-of-a-phase-2-trial/. Accessed .
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