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Abstract: ASN Annual Meeting 2020 -- Digital Meeting |
Rovin BH, Martinez GA, Alvarez A, et al.
Two-Year Results from a Randomized, Controlled Study of Obinutuzumab for Proliferative Lupus Nephritis
ASN Annual Meeting 2020 -- Digital Meeting
J Am Soc Nephrol (Oct) 31:53A 2020
BACKGROUND
NOBILITY demonstrated improved renal responses and complete B-cell depletion with the humanized type II anti-CD20 monoclonal antibody obinutuzumab (OBI) compared with placebo (PBO) through 18 months in patients with proliferative lupus nephritis (LN) when added to standard of care therapies. Two-year results from NOBILITY are reported here.
METHODS
Patients with class III/IV LN received mycophenolate and steroids and were randomized to OBI or PBO. The primary endpoint was complete renal response (CRR) at week 52. Patients were followed through week 104. Secondary endpoints included overall renal response (ORR) and modified CRR (mCRR).
RESULTS
CRR was greater with OBI than PBO at week 52 (35% vs. 23%, P = 0.115), week 76 (40% vs. 18%, P = 0.007), and week 104 (41% vs 23%, P = 0.026; Table). At week 104, OBI patients had greater improvement in eGFR (+6.5 vs. -3.2 mL/min/1.73 m2, P = 0.018), UPCR, anti-dsDNA, C3, and C4. Serious adverse events (OBI 25% vs. PBO 30%), serious infections (8% vs. 18%) and deaths (1 vs. 4) were not increased with OBI.
CONCLUSION
NOBILITY demonstrated a sustained benefit of OBI through week 104, approximately 18 months after the final OBI infusion. There were no unexpected safety findings. OBI use in LN will be further evaluated in the Phase 3 REGENCY trial.
TABLE. WEEK 104 RESULTS
Week 104 Endpoint OBI
(n=63)PBO
(n=62)Difference (80% CI) P Value CRR 41% 23% 19% (8, 29) 0.026 ORR 54% 29% 25% (14, 36) 0.005 mCRR 56% 33% 22% (11, 33) 0.015 C3 >90 mg/dL 76% 47% 29% (19, 40) 0.008 C4 >10 mg/dL 95% 74% 21% (13, 29) 0.001 Mean change in eGFR from baseline (mL/min/1.73 m2) +6.5 -3.2 9.7 (1.7, 18) 0.018 Mean change in UPCR from baseline -2.3 -1.4 -0.96 (-1.4, -0.57) 0.002 CRR=UPCR <0.5, serum creatinine (SCr) ≤upper limit of normal (ULN) and ≤115% of baseline, <10 red blood cells per high power field (RBCs/HPF), and no RBC casts. ORR = CRR or partial renal response=UPCR <1 (<3 if baseline UPCR ≥3) and ≤50% of baseline, SCr ≤115% of baseline, and ≤50% increase in urinary RBCs (or <10 RBCs/HPF). mCRR = UPCR <0.5, SCr ≤ ULN.
c Copyright 2020 -2021 American Society of Nephrology. Reproduced with permission.
All ASN abstracts from the 2020 Annual Meeting are available at this link and also are archived in .pdf form at ASN-Online.org
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