Abstract: SA-OR073
Efficacy and Safety of Obinutuzumab in Adolescents with Active Lupus Nephritis: Primary Results from POSTERITY, a Phase II Global Trial
Session Information
- Late-Breaking Research Orals: Pediatrics, Genetics, and Glomerular Diseases
October 24, 2026 | Location: Four Seasons Ballroom 2, Convention Center
Abstract Time: 04:30 PM - 04:42 PM
Category: Pediatric Nephrology
- 1800 Pediatric Nephrology
Authors
- Vivarelli, Marina, Laboratory of Nephrology and Clinical Trial Center, Bambino Gesù Children's Hospital IRCCS, Rome, Italy
- Levy, Deborah, Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada
- Vega Cornejo, Gabriel, CREA de Guadalajara, Guadalajara, Mexico
- Terreri, Maria Teresa, Universidade Federal de São Paulo, São Paulo, Brazil
- Zurowska, Aleksandra, Department of Pediatrics, Nephrology and Hypertension, Medical University of Gdansk, Gdansk, Poland
- Zuta, Adolfina Elizabeth, Instituto de Ginecología y Reproducción, Lima, Peru
- Calzada-Hernández, Joan, Pediatric Rheumatology Department, Hospital Sant Joan de Déu, Barcelona, Spain
- Hogan, Julien, Pediatric Nephrology Department, Robert Debré Hospital, APHP, Paris, France
- Enciso-Peláez, Sandra, Clinstile, S.A. de C.V., Mexico City, Mexico
- Remesal, Agustin, Paediatric Rheumatology Unit, Hospital Infantil La Paz, Madrid, Spain
- Oni, Louise, UCL Centre for Bladder and Kidney Health, London, United Kingdom
- Yu, Peiqing, F. Hoffmann-La Roche, Mississauga, Ontario, Canada
- Erblang, Felix, F. Hoffmann-La Roche, Basel, Switzerland
- Mitrofanova, Olga, F. Hoffmann-La Roche, Basel, Switzerland
- Pendergraft, William Franklin, Genentech, South San Francisco, California, United States
- Lehane, Patricia B., Roche Products Limited, Welwyn Garden City, United Kingdom
Background
The type II anti-CD20 monoclonal antibody obinutuzumab (OBI) demonstrated superiority over placebo (PBO) for achieving complete renal response (CRR) in the Phase III REGENCY study (NCT04221477) in adults with active lupus nephritis (LN). To address the critical need for targeted therapies in early-onset disease, POSTERITY (NCT05039619) was designed as the first global, randomized, double-blind, PBO-controlled trial dedicated exclusively to pediatric patients with active LN (Figure 1); here, we present primary results from the adolescent cohort (12–<18 years).
Methods
Patients were randomized 2:1 to receive OBI or PBO, added to standard background therapy. The primary endpoint was the proportion of patients who achieved CRR at Week 76. Selected secondary endpoints included CRR at Week 24 and Week 52, CRR at Week 76 with successful prednisone taper (≤7.5 mg/day from Weeks 64–76), overall renal response at Week 76, and time to onset of CRR over 76 weeks. The evaluation of treatment effect relied entirely on descriptive statistics without formal hypothesis testing. Safety was evaluated based on incidence of adverse events.
Results
Of 30 patients, 20 were randomized to OBI and 10 to PBO. A higher proportion of patients achieved CRR at Week 76 (primary endpoint) with OBI vs PBO, showing a clinically meaningful treatment benefit with the 95% CI excluding no effect of OBI (Table 1). The secondary endpoints evaluated also showed a consistent clinically meaningful treatment effect across multiple measures of disease control favoring OBI vs PBO. OBI was well tolerated; safety findings were consistent with the known profile in adults, with no new safety signals identified.
Conclusion
These results in a dedicated adolescent cohort with active class III or IV ± V LN support OBI as a potential targeted intervention in a population with limited treatment options.
Acknowledgment
Third-party writing assistance was furnished by the Publications Division of Omnicom Health Medical Communications.
Funding
- Commercial Support – F. Hoffmann-La Roche Ltd.