Felzartamab AMR

Felzartamab in Chronic Active Antibody-Mediated Rejection

Patient / Population Intervention / Exposure Comparison Outcome

In 22 kidney-transplant recipients with chronic active antibody-mediated rejection, felzartamab resolved rejection morphology more often than placebo.

Design

Phase 2 RCT

Endpoint

Resolution of morphologic antibody-mediated rejection at week 24 (key secondary/efficacy endpoint; the trial's primary outcome was the safety and side-effect profile of felzartamab)

Relevance

ResultResolution of AMR at wk 24: 9/11 (82%) vs 2/10 (20%); difference 62 pp (95% CI 19 to 100); risk ratio 0.23 (95% CI 0.06 to 0.83). Recurrent AMR observed during follow-up.

Mayer KA, et al. N Engl J Med. 2024;391(2):122-132. 10.1056/NEJMoa2400763

Discussion & critique

First evidence-based option in chronic active AMR, but a very small sample; phase 3 is awaited.