Co-stimulation blockade with dazodalibep, belacept may prevent kidney allograft rejection
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Key takeaways:
- Incidence of composite efficacy failure was 25% by weeks 12, 24 and 48.
- Further research is needed, but interim results offer hope for improving outcomes in kidney transplantation.
Dual co-stimulation blockade with dazodalibep and belacept may prevent kidney allograft rejection, according to research presented at the American Transplant Congress.
“The purpose of this study was to test dual coast simulation blockade, combining dazodalibep, a non-antibody biologic antagonist of CD40L, with belacept, a CTLA-4-Fc protein, as the sole maintenance anti-rejection therapy for adults undergoing kidney transplantation,” Allan D. Kirk, MD, PhD, of the department of surgery at the Duke University Medical Center, said during a presentation at the meeting.
The phase 2a, single-arm, open-label pilot study involved 20 adults with low immunologic risk undergoing a first kidney transplant. Participants received lymphocyte depleting induction and corticosteroids, followed by intravenous DAZ+Bela the day after surgery and repeated every 2 to 4 weeks post-transplantation. It was the sole maintenance antirejection therapy in adults undergoing kidney transplantation, Kirk said.
The primary endpoint was incidence of composite efficacy failure, including treated biopsy-proven acute rejection of grade 1A or higher, graft loss or death, 24 weeks after transplantation. Secondary endpoints were the incidence of composite efficacy failure, antibody-mediated rejection and treated acute rejections in week 48. All final data represents an interim analysis, Kirk said.
Researchers found both drugs were well-tolerated, with one patient stopping due to neutropenia. Allograft and patient survival was 100%. Incidence of composite efficacy failure was 25% by weeks 12, 24 and 48, Kirk said. The mean eGFR of patients at week 48 was 71.3 mL/min/1.73 m2. Researchers found three cases of antibody-mediated rejection and six cases of treated acute rejections.
While further research is needed, Kirk said the results offer hope for improving outcomes for kidney transplant patients and reducing the need for immunosuppressive drugs.
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Kirk AD, et al. A pilot study evaluating dual co-stimulation blockade with dazodalibep and belacept for prophylaxis of kidney allograft rejection. Presented at: American Transplant Congress; June 3-7, 2023; San Diego (hybrid).
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