Publications by authors named "S Buatois"
Aims: Crovalimab is a novel C5 inhibitor administered first intravenously and then subcutaneously in patients with paroxysmal nocturnal haemoglobinuria (PNH) naive to complement inhibition or switching from eculizumab or ravulizumab. Crovalimab showed efficacy and safety comparable to eculizumab in the pivotal COMMODORE 2 and supporting studies.
Methods: We characterized crovalimab pharmacokinetics and the relationship between exposure pharmacokinetic parameters and pharmacodynamic biomarkers, efficacy and safety endpoints using pooled data (healthy volunteers [n = 9], naive [n = 210] and switched [n = 211] patients).
Objectives: To evaluate the tolerability of crovalimab versus eculizumab in C5 inhibitor (C5i)-naive and -experienced patients with PNH from COMMODORE 2, 3 and 1 (NCT04434092, NCT04654468 and NCT04432584).
Methods: Pooled safety data were assessed in the total crovalimab and eculizumab populations and by C5i-naive versus C5i-switched status in patients receiving crovalimab. Analyses include 6.
A fully automatic tool for development of population pharmacokinetic models.
CPT Pharmacometrics Syst Pharmacol
October 2024
Population pharmacokinetic (PK) models are widely used to inform drug development by pharmaceutical companies and facilitate drug evaluation by regulatory agencies. Developing a population PK model is a multi-step, challenging, and time-consuming process involving iterative manual model fitting and evaluation. A tool for fully automatic model development (AMD) of common population PK models is presented here.
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- Crovalimab is a new C5 inhibitor that can be self-administered every four weeks and is being tested in a phase 3 trial against another treatment, eculizumab, for patients with paroxysmal nocturnal hemoglobinuria (PNH).
- The trial's focus shifted from efficacy to safety due to not meeting recruitment goals, and exploratory endpoints included various measures of patient health and satisfaction.
- Results showed that while both treatments had adverse events, crovalimab showed sustained effectiveness and 85% of patients preferred it over eculizumab, suggesting it might be a more manageable treatment option for long-term PNH care.
Article Synopsis
- - Crovalimab is a new treatment for paroxysmal nocturnal hemoglobinuria that allows for easy self-administration every four weeks and is shown to be as effective as the existing treatment eculizumab in maintaining hemolysis control and avoiding transfusions.
- - The COMMODORE 2 trial involved 204 patients and compared the effects of crovalimab with eculizumab over 24 weeks, finding similar outcomes for key health measures, including hemoglobin stabilization and fatigue reduction.
- - Both treatments were safe, with no cases of meningococcal infections reported, and many patients preferred crovalimab after switching from eculizumab, showcasing its favorable benefit-risk profile.