COMMUTE-a: Additional positive results with crovalimab in adolescents and adults with aHUS

Crovalimab led to high response rates in adolescents and adults with atypical haemolytic uraemic syndrome (aHUS), while being associated with some serious infections, according to data reported by Dr Bradley Dixon (University of Colorado Anschutz, CO, USA) [1].

The COMMUTE-a (NCT04861259) phase 3 trial was the sister study of COMMUTE-p (NCT04958265) and had a similar study design. Briefly, patients were eligible if they were aged ≥12 years and had a body weight ≥40 kg. As in the paediatric study, 2 cohorts were enrolled: a treatment-naïve cohort (no prior complement inhibitor therapy) and a switch cohort. The primary endpoint was the proportion of patients achieving a complete thrombotic microangiopathy response (cTMAr) at any time through week 25, defined as a platelet count ≥ the lower limit of normal, normalisation of lactate dehydrogenase (LDH), and a ≥25% improvement in serum creatinine from baseline. A prespecified efficacy threshold of 40% was set for the primary endpoint. Each cohort included 41 patients.

The trial met its primary endpoint. In the treatment-naïve cohort, 59.5% of patients (95% CI 43.5%–73.7%) achieved cTMAr by week 25, with a median time to response of 12.1 weeks. Among the 17 patients who required dialysis at baseline, all had discontinued dialysis by week 25. In the switch cohort, all 41 patients maintained cTMAr through week 25, and all remained off dialysis. Overall, crovalimab was well tolerated. Serious infections were reported in 14.6% of patients in the treatment-naïve cohort and 17.1% of patients in the switch cohort. Transient immune complex reactions occurred in 9.8% of patients in the switch cohort, and all resolved within 2 weeks.

“The study met its primary endpoint, with 59.5% of treatment-naïve patients achieving cTMAr by the end of the primary analysis period,” concluded Dr Dixon. “All patients in the switch cohort met their efficacy endpoint of maintenance of cTMAr control. Together, these findings support a favourable benefit-risk profile for crovalimab, further reinforced by the results from COMMUTE-p.”

Dixon B, et al. Efficacy, safety and pharmacokinetics/pharmacodynamics of crovalimab for atypical haemolytic uraemic syndrome (aHUS): Phase III COMMUTE-a trial. ERA 2026, 3–6 June. Glasgow, Scotland.