Study Highlights Added Benefit of Alirocumab in HeFH Patients Requiring Apheresis
Regeneron and Sanofi announced positive data from ODYSSEY ESCAPE, a Phase 3 study which evaluated Praluent (alirocumab) in patients with heterozygous familial hypercholesterolemia (HeFH) requiring regular apheresis therapy.
ODYSSEY ESCAPE was a double-blind, randomized, multicenter, placebo-controlled Phase 3 trial evaluating the efficacy and safety of Praluent (alirocumab) in 62 patients with HeFH undergoing regular weekly or bi-weekly baseline apheresis treatment. Patients either received Praluent 150mg SC every 2 weeks or placebo, in addition to their existing cholesterol therapy. The primary endpoint was the reduction in the need for apheresis treatment.
Study findings showed that the addition of Praluent to existing regimen significantly reduced the need for apheresis treatment by 75% compared to placebo (P<0.0001), meeting the primary endpoint. Additionally, 93% of Praluent-treated patients experienced at least 50% reduction in their apheresis procedures and nearly 63% no longer required apheresis after 6 weeks of treatment. Adjunctive therapy with Praluent significantly reduced LDL cholesterol starting at Week 6, with a 55% greater reduction vs. placebo, and lasting until trial completion at Week 18, with 46% greater reduction vs. placebo (P<0.0001). Praluent-treated patients experienced approximately 50% LDL reduction from baseline vs. 2% increase in placebo-treated patients, with an average LDL cholesterol level of 2.3mmol/L (90mg/dL) vs. 4.8mmol/L (185mg/dL) 6 weeks after treatment, respectively.
Rates of adverse events (AEs) between the treatment groups were comparable, with the most common AEs including fatigue, nasopharyngitis, diarrhea, myalgia, upper respiratory infection, headache, arthralgia, and back pain. Detailed results will be presented at the ESC Congress 2016.
Praluent, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is currently indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol.