Effect of osocimab in preventing VTE among patients undergoing knee arthroplasty

In the FOXTROT trial, researchers investigated the noninferiority of osocimab to enoxaparin for thromboprophylaxis after knee arthroplasty. The Phase II study involved 813 patients undergoing unilateral knee arthroplasty at 54 sites in 13 countries. Participants were randomized to receive single I.V.

In the FOXTROT trial, researchers investigated the noninferiority of osocimab to enoxaparin for thromboprophylaxis after knee arthroplasty. The Phase II study involved 813 patients undergoing unilateral knee arthroplasty at 54 sites in 13 countries. Participants were randomized to receive single I.V. osocimab postoperative doses of 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, or 1.8 mg/kg; preoperative doses of 0.3 mg/kg or 1.8 mg/kg; or 40 mg of subcutaneous enoxaparin once daily or 2.5 mg of oral apixaban twice daily for at least 10 days or until venography. The primary outcome—venous thromboembolism incidence between 10-13 days postoperatively—occurred in 23.7% of patients receiving 0.3 mg/kg, 15.7% of those receiving 0.6 mg/kg, 16.5% of those receiving 1.2 mg/kg, and 17.9% of those receiving 1.8 mg/kg of osocimab postoperatively; 29.9% of those receiving 0.3 mg/kg and 11.3% of those receiving 1.8 mg/kg of osocimab preoperatively; 26.3% of those receiving enoxaparin; and 14.5% of those receiving apixaban. "Given postoperatively, 0.6 mg/kg, 1.2 mg/kg, and 1.8 mg/kg doses of osocimab met criteria for noninferiority compared with enoxaparin at the prespecified noninferiority margin of 5%," the researchers report. Additionally, they noted that preoperative osocimab 1.8 mg/kg met the superiority criteria compared with enoxaparin.