Safety and Effectiveness of Switching to Ravulizumab from Eculizumab in Kidney Transplant Recipients with Atypical Hemolytic Uremic Syndrome: A Global Registry Analysis
Bibliographic record
Abstract
Background: Atypical hemolytic uremic syndrome (aHUS) is a disease of complement dysregulation that causes kidney failure and has a propensity to recur after kidney transplant (KTx) with graft loss. Ravulizumab (RAV) and eculizumab (ECU) are C5 inhibitors approved for the treatment of aHUS. We assessed the real-world safety and effectiveness of switching from ECU to RAV in KTx recipients with aHUS for immediate, complete, and sustained terminal complement inhibition. Methods: The Global aHUS Registry is a multicenter study (NCT01522183) enrolling patients (pts) with aHUS since 2012. Safety and effectiveness outcomes were assessed in KTx recipients with aHUS who switched from ECU to RAV up to April 22, 2024. Safety analyses included pts with a KTx before RAV initiation; pt characteristic and effectiveness analyses included KTx recipients who received RAV for ≥3 months and had ≤1 month between ECU discontinuation and RAV initiation. Results: Overall, 29 pts (25 adults) were included in safety analyses; 21 adverse events (AEs) were reported in 15 pts at or after RAV initiation, and none were unexpected. During RAV treatment, no new AEs of thrombotic microangiopathy or kidney impairment, and no meningococcal infections or deaths were reported. Among 21 pts (20 adults) included in the pt characteristic and effectiveness analyses, median (range) age at RAV initiation was 35 (11–72) years, and 67% had a reported pathogenic complement variant or anti-complement factor H antibodies. Median (range) time on treatment was 66 (4–158) months for ECU and 24 (5–43) months for RAV; median (range) time from last KTx to RAV initiation was 56 (4–184) months. Mean (standard deviation) estimated glomerular filtration rate was 50 (25) mL/min/1.73m2 at last record before or at RAV initiation and 50 (28) mL/min/1.73m2 at last follow-up after RAV initiation. Among 29 KTx events in these 21 pts, no rejections or graft failures were reported after RAV initiation. Conclusion: This analysis from the Global aHUS Registry provides real-world evidence of the successful transition from ECU to RAV in KTx recipients with aHUS, with stable kidney function and no unexpected safety concerns. Funding: Commercial Support - Alexion, AstraZeneca Rare Disease
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".