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Kidney Week

Abstract: FR-OR084

Patient-Reported Outcomes in the Phase 2 BESTOW Trial Comparing Tegoprubart to Tacrolimus in Kidney Transplant Recipients

Session Information

Category: Transplantation

  • 2002 Transplantation: Clinical

Authors

  • Adams, Andrew B., Department of Surgery, University of Minnesota Medical School, Minneapolis, Minnesota, United States
  • Tedesco-Silva, Helio, Division of Nephrology, Hospital do Rim, Federal University of São Paulo, São Paulo, Brazil
  • Potter, Steven, MedStar Georgetown Transplant Institute and Georgetown University School of Medicine, Washington, District of Columbia, United States
  • Laurito, Marcela, Eledon Pharmaceuticals, Irvine, California, United States
  • Li, Yulan, Eledon Pharmaceuticals, Irvine, California, United States
  • Thomas, Elizabeth, Eledon Pharmaceuticals, Irvine, California, United States
  • Crespo, Marta, Department of Nephrology, Hospital del Mar and Nephropathy Research Group, Hospital del Mar Research Institute, Barcelona, Spain
  • Woodle, E. Steve, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States
  • Bestard, Oriol, Nephrology and Kidney Transplantation Laboratory, Vall d'Hebron Research Institute and Department of Nephrology and Kidney Transplantation, Vall d'Hebron University Hospital, Barcelona, Spain
  • Hovland, David N., Eledon Pharmaceuticals, Irvine, California, United States
  • Habibi, Sepideh, Eledon Pharmaceuticals, Irvine, California, United States
  • Kamar, Nassim, Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire de Toulouse and INFINITY, Toulouse Institute for Infectious and Inflammatory Diseases, Toulouse, France
  • Perrin, Steven, Eledon Pharmaceuticals, Irvine, California, United States
  • Demetris, Anthony J., Department of Pathology, Division of Transplantation Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania, United States
  • Katz, Eliezer, Eledon Pharmaceuticals, Irvine, California, United States
  • Vincenti, Flavio, Departments of Medicine and Surgery, University of California, San Francisco, California, United States
Background

The Phase 2 BESTOW trial showed that tegoprubart adequately controlled rejection and preserved kidney function with a favorable safety profile versus tacrolimus as the core of the immunosuppressive regimen in adults receiving their first kidney transplant. Kidney transplantation can impact patients' health-related quality of life (HRQoL) owing to treatment burden, impaired physical health, and ongoing psychological distress; patient-reported outcomes (PROs) are invaluable for understanding these factors. This is the first report of HRQoL PROs from BESTOW.

Methods

BESTOW was a multicenter, randomized, open-label, active-controlled trial (NCT05983770). Patients received tegoprubart 20 mg/kg intravenously on days 1, 3, 7, 14, 21, 28, and every 21 days thereafter, or oral tacrolimus twice daily; both arms received rabbit antithymocyte globulin induction and maintenance with mycophenolate mofetil/mycophenolic acid and corticosteroids. Alongside key safety and efficacy measures, PROs were assessed at baseline, 25 and 52 weeks (W) post-transplant. Changes in kidney disease-related HRQoL were assessed using the Kidney Disease Quality of Life 36-Item Short-Form instrument (KDQOL-SF 36); higher scores indicate better HRQoL. Kidney transplantation medication side effects were assessed using the Modified Transplant Symptom Occurrence and Symptom Distress scale (MTSOSD-59R); lower scores indicate fewer symptoms.

Results

Of 127 treated patients, 107 (N=51 tegoprubart; N=56 tacrolimus) completed study treatment to W52. HRQoL improvements from baseline were observed at W52 across all 5 KDQOL-SF 36 subscales with tegoprubart, and 4 of 5 subscales with tacrolimus (Table); improvements were greater with tegoprubart than tacrolimus on the SF-12 mental component summary and the symptoms and problems scale (Table). The improvement in symptoms was also reflected in the MTSOSD-59R, with a numerically greater reduction in total symptom score from baseline observed with tegoprubart versus tacrolimus at W25, which was more pronounced by W52 (Table).

Conclusion

PROs of the BESTOW study suggest improved HRQoL in patients receiving tegoprubart versus tacrolimus after kidney transplantation.

Funding

  • Commercial Support –  Eledon Pharmaceuticals, Inc.