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Kidney Week

Abstract: SA-PO884

Atacicept in IgA Nephropathy (IgAN): Continued Protective Titers to Diphtheria and Tetanus and Balanced Infections vs. Placebo with a Focus on COVID-19

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Barratt, Jonathan, University of Leicester, Leicester, United Kingdom
  • Maes, Bart D., AZ Delta vzw, Roeselare, West-Vlaanderen, Belgium
  • Israni, Rubeen K., Vera Therapeutics, Inc., Brisbane, California, United States
  • Wei, Xuelian, Vera Therapeutics, Inc., Brisbane, California, United States
  • Tesar, Vladimir, Univerzita Karlova, Praha, Czechia
  • Appel, Gerald B., Columbia University, New York, New York, United States
  • Suzuki, Yusuke, Juntendo Daigaku, Bunkyo-ku, Tokyo, Japan
  • Lin, Celia J.F., Vera Therapeutics, Inc., Brisbane, California, United States
  • Lafayette, Richard A., Stanford University, Stanford, California, United States
Background

Atacicept is a dual anti-BLyS/APRIL fusion protein currently in clinical development for IgA nephropathy (IgAN) treatment. Better understanding vaccine response and immunity with atacicept, especially to COVID-19, may help assess atacicept’s benefit risk profile. Atacicept has been studied in IgAN in the Ph2a JANUS study which measured tetanus and diphtheria vaccine titers up to 72w, and the Ph2b ORIGIN study where impact of atacicept on COVID-19 infection rates and severity could be assessed.

Methods

JANUS and ORIGIN were double-blind placebo (PBO) controlled studies that enrolled adults with biopsy-proven IgAN and UPCR >0.75g/g who were on stable doses of renin-angiotensin system inhibitors. Patients (pts) were randomized 1:1:1 to PBO, atacicept 25, or 75mg SC qw for 72w in JANUS (n=16) and 2:1:2:2 to PBO, atacicept 25, 75, or 150mg SC qw for 36w in ORIGIN (n=116). In JANUS, tetanus and diphtheria titers were measured at 1, 48 and 72w in addition to safety assessments. In ORIGIN, safety data on infections were analyzed by treatment arm up to 36w.

Results

The JANUS population was 50% male with baseline (BL) median age 44; the ORIGIN population was 59% male, median age 37. No JANUS pts changed from protective to nonprotective status for diphtheria or tetanus toxin; overall infections were balanced between atacicept and PBO. ORIGIN pts across atacicept and PBO arms had similar rates of overall and COVID-19 infections (Table). All pts with COVID-19 had ≥1 COVID-19 vaccine dose prior to infection. No COVID-19 infection was serious; most were mild. Median duration of COVID-19 infection was 7.5 (IQR 7, 9) days. There were no permanent discontinuations although some COVID-19 infections led to temporary study drug interruption. No COVID-19 infection was reported as study drug related.

Conclusion

Atacicept treatment was associated with continued protective immunity to tetanus and diphtheria in the Ph2a JANUS study. In JANUS and ORIGIN, infections were balanced between atacicept and PBO with no increase in incidence or severity of COVID-19 infections in the Ph2b ORIGIN study.

Funding

  • Commercial Support – Vera Therapeutics