Home > Nephrology > ERA 2024 > Clazakizumab improves albumin and inflammation in participants undergoing haemodialysis

Clazakizumab improves albumin and inflammation in participants undergoing haemodialysis

Presented by
Prof. Glenn Chertow, Stanford University School of Medicine, Stanford, CA, USA
Conference
ERA 2024
Trial
Phase 3, OSIBIL6ESKD
Clazakizumab, a monoclonal antibody targeting IL-6, reduced inflammatory marker levels and increased serum albumin with manageable safety in participants with atherosclerotic cardiovascular disease receiving haemodialysis, according to phase 2 data.

The POSIBIL6ESKD trial (NCT05485961) is a phase 2b/3 trial enrolling participants with a history of atherosclerotic cardiovascular disease, with/without diabetes and a hs-CRP >2 mg/L who are receiving maintenance dialysis. In the phase 2b dose-ranging trial part, participants were randomised 1:1:1:1 to 2.5, 5, or 10 mg IV clazakizumab every 4 weeks, or placebo. The primary endpoint was the change from baseline at week 12 in hs-CRP. In total, 127 participants were included [1].

All 3 clazakizumab doses decreased mean hs-CRP levels which was sustained over time. After 12 weeks, the geometric mean change in hs-CRP was -86%, -90% and -92% with clazakinumab 2.5, 5, and 10 mg, respectively, while the placebo group led to a 19% increase in hs-CRP. Twelve weeks of clazakizumab increased serum albumin by 0.28, 0.25, and 0.21 g/dL (2.5, 5, and 10 mg, respectively), compared with a 0.04 g/dL increase with placebo. “In clinical practice, considering the time course of 6 months, let alone 3 months, I very rarely see an increase of serum albumin much greater than 0.2 or 0.3 g/dL”, highlighted Prof. Glenn Chertow (Stanford University School of Medicine, Stanford, CA, USA), placing the findings into context. In terms of safety, clazakinumab led to 2 episodes of grade 3 neutropenia and 2 episodes of thrombocytopenia which were managed by withholding the investigational treatment. Furthermore, serious infections were observed in all clazakizumab groups and incidences increased with increasing doses.

“Low-dose clazakizumab reduced inflammatory markers associated with cardiovascular disease and increased serum albumin in a small cohort of participants receiving haemodialysis with background inflammation”, summarised Prof. Chertow. “A phase 3 trial using 5 mg clazakizumab is underway.”

  1. Chertow G, et al. A Phase 2b/3 trial assessing IL-6 inhibition with clazakizumab in patients with cardiovascular disease or diabetes on dialysis: Results from Phase 2b. Abstract #7, ERA 2024, 23–26 May, Stockholm, Sweden.

Medical writing support was provided by Mihai Surducan, PhD.

Copyright ©2024 Medicom Medical Publishers



Posted on