Publications by authors named "M Toukam"
Article Synopsis
- * Results from the NOVA clinical trial show that while patients on Q6W dosing had lower levels of natalizumab compared to Q4W dosing, they still maintained significant clinical efficacy with most patients experiencing stable disease markers over 72 weeks.
- * Key findings included a 23.6% increase in soluble vascular cell adhesion molecule-1 (sVCAM-1) levels in the Q6W
Introduction: Following NOVA (part 1) and the approval of the subcutaneous (SC) route of administration of natalizumab by the European Medicines Agency, an extension phase of the NOVA phase IIIb study (part 2) was initiated to collect patient preference data for SC versus intravenous (IV) dosing in patients receiving every-6-week (Q6W) dosing of natalizumab. This study was performed to evaluate patient preference for SC versus IV natalizumab administration and explore the efficacy, safety, and pharmacology characteristics of both routes of administration.
Methods: In part 2, participants received natalizumab (Tysabri) 300 mg via IV infusion Q6W for 36 weeks and then were randomized to 48 weeks of crossover treatment (24 weeks SC Q6W and 24 weeks IV Q6W, or vice versa).
Background: Antimicrobial resistance (AMR) is a major health concern with high rates in low-income countries. Bacteriology laboratories sustain the fight against AMR by providing antibiotic susceptibility testing (AST) results to ensure appropriate therapies. These laboratories generate a lot of data, which are usually used for prospective interventions.
View Article and Find Full Text PDFPurpose: The objective of this analysis was to develop a population pharmacokinetic (PPK) model to characterize camidanlumab tesirine (Cami) pharmacokinetics based on the phase 1 study in relapsed/refractory lymphoma (NCT02432235).
Methods: An initial PPK model was developed based on a two-compartment model with parallel linear and nonlinear elimination pathways. Pharmacokinetic parameters were evaluated for correlation with potential demographic covariates; significant covariates were retained in the final model.
Purpose: To investigate camidanlumab tesirine (Cami) exposure-response (E-R) relationships, using an integrated population pharmacokinetic model, for patients with classical Hodgkin lymphoma (cHL) and non-Hodgkin lymphoma enrolled in an open-label, phase 1 study (NCT02432235).
Methods: Exploratory analyses investigated relationships between exposure measures (C, C, and C) and the occurrence of binary variables (overall response rate [ORR] and selected adverse events [AEs]) and nonbinary variables (overall survival [OS]).
Results: Exploratory analyses showed a significant, positive relationship between exposure and ORR/OS.