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Abstract: SA-OR066

A Phase III Study of Abatacept on Standard of Care in Patients with Active Class III or IV Lupus Nephritis

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Appel, Gerald B., Columbia University Medical Center, New York, New York, United States
  • Dooley, Mary A., University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
  • Wofsy, David, University of California San Francisco, San Francisco, California, United States
  • Takeuchi, Tsutomu, Keio University, Minato, Tokyo, Japan
  • Malvar, Ana, Hospital Fernández, Buenos Aires, Argentina
  • Doria, Andrea, University of Padova, Padova, Italy
  • Romero-Díaz, Juanita, Instituto Nacional de Ciencias Médicas y Nutrición, Mexico City, Mexico
  • Chan, Daniel Tak Mao, University of Hong Kong, Hong Kong, Hong Kong
  • Elegbe, Ayanbola Olajumoke, Bristol-Myers Squibb, Princeton, New Jersey, United States
  • Furie, Richard, Northwell Health, Great Neck, New York, United States
  • Jayne, David R.W., University of Cambridge, Cambridge, United Kingdom
  • Maldonado, Michael, Bristol-Myers Squibb, Princeton, New Jersey, United States
Background

Novel treatments (tx) for active class III or IV lupus nephritis (LN) are needed. This study compared IV abatacept (ABA) vs placebo (pbo) on background therapy for tx of active proliferative LN.

Methods

This was a 24-month (M), randomized, Phase III, double-blind study with long-term extension. Patients (pts) were randomized to pbo or IV ABA every 4 wks on background of MMF + corticosteroids (CS). Primary endpoint: complete response (CR; UPCR ≤0.5, preserved eGFR, no cellular casts, CS ≤10 mg/day) at Year (Yr) 1. We report all blinded data up to Yr 3 of tx.

Results

405 pts were randomized (ABA n=202; pbo n=203). At baseline: mean age=33 yrs, UPCR=3.78, eGFR=95 mL/min. ABA 77%, pbo 79% completed Yr 1; fewer discontinued during Yr 2 (ABA 14%, pbo 22%). There were no differences between tx arms in CR rates at Yr 1 (ABA 35.1%, pbo 33.5%, p=0.73; primary endpoint). Sustained CR (two successive visits) were more frequent and occurred earlier in ABA pts. CR rates were higher and non-response rates lower in ABA arm in Yr 2 and 3. Benefits were driven by improvement in proteinuria, seen as early as 3 M and sustained up to 3 yrs (Figure). There was no between-group difference in eGFR over 3 yrs. Safety in Yr 1 was consistent with the known profile of ABA (serious AE [SAE] rate ABA 24%, pbo 19%). SAE rates after Yr 1 were lower (ABA 6%, pbo 13%). More sustained improvements in SLE-related biomarkers (C3, C4, anti-dsDNA) were seen in ABA-treated pts over 3 yrs.

Conclusion

The study failed to meet its primary endpoint. Up to 3 yrs of tx, abatacept-treated pts had more rapid improvement in proteinuria, which led to earlier, sustained CR with a favorable safety profile.
Writing assistance provided by Caudex.

Funding

  • Commercial Support