Alirocumab reduces need for apheresis therapy

Sanofi and Regeneron announced positive topline results from the ODYSSEY ESCAPE trial demonstrating that the addition of alirocumab to weekly or bi-weekly apheresis therapy reduced the frequency of apheresis therapy compared with placebo among patients with heterozygous familial hypercholesterolemia.

ODYSSEY ESCAPE is a randomized, double blind, phase 3, placebo-controlled trial of 62 patients at 14 centers in the United States and Germany. Patients received regular baseline apheresis therapy at fixed intervals of every week or every 2 weeks prior to randomization. Patients were randomly assigned to receive subcutaneous alirocumab (Praluent, Sanofi/Regeneron; n = 41) every 2 weeks or placebo (n = 21) in addition to their existing treatment regimen. The double blind treatment period comprised two intervals: for the first 6 weeks, patients remained on their established apheresis schedule at baseline; for the following 12 weeks apheresis frequency was adjusted based on the patient’s LDL response to treatment, according to a press release.

The trial met its primary endpoint, demonstrating that patients who received alirocumab on top of their existing treatment regimen reduced the frequency of their apheresis therapy by 75% compared with placebo (P < .0001). Sixty-three percent of patients assigned alirocumab no longer required apheresis, compared with 0% of patients assigned placebo, according to the release.

The most common adverse events in the trial were fatigue (15% alirocumab group vs. 10% placebo group), nasopharyngitis (10% vs. 5%), diarrhea (10% vs. 0%), myalgia (10% vs. 5%), upper respiratory infection (7% vs. 19%), headache (7% vs. 5%), arthralgia (7% vs. 10%) and back pain (5% vs. 10%), according to the release.

ODYSSEY ESCAPE is part of the phase 3 ODYSSEY program, which includes more than 25,000 patients.

Detailed results will be presented at future medical meetings, according to the release.