A recent clinical trial has demonstrated that imlifidase, an investigational drug, is more effective than plasmapheresis (PLEX) in reducing donor-specific antibodies (DSAs) in kidney transplant recipients experiencing antibody-mediated rejection. The findings, presented at ASN Kidney Week 2024, highlight imlifidase's potential as a superior treatment option for this patient population.
The Phase 2 randomized, open-label, multi-center, multi-national trial involved 30 patients with antibody-mediated rejection. Researchers evaluated the maximum reduction of all DSA levels after initiating treatment with either PLEX or imlifidase.
Superior Antibody Reduction with Imlifidase
The study revealed a median reduction of DSA of 97% for imlifidase compared to 42% for PLEX on day 5. Furthermore, the time to median maximum DSA depletion was significantly shorter with imlifidase, at 15 hours after a single dose, compared to 9 days for a median of 6 PLEX sessions.
Expert Commentary
Stanley Jordan, MD, corresponding author from Cedars-Sinai Medical Center, stated, "These data further underscore imlifidase's consistent and efficient ability to reduce antibodies, which is important for patients who require safe and efficient reduction of DSA levels. We believe these data are important because it is the first head-to-head comparison of imlifidase versus frequently used standard of care treatment. The performance of imlifidase in this patient model was consistent with that observed in other indications and could be of relevance in other indications in which plasma exchange is used as the primary standard of care to address pathogenic antibodies."
Future Directions
Future research will focus on controlling the antibody rebound process, which is critical for long-term success in reducing DSAs and preventing antibody rejection.
