Published results showed certain preoperative and postoperative doses of osocimab used in patients undergoing unilateral knee arthroplasty met noninferiority and superiority criteria for the incidence of venous thromboembolism compared with enoxaparin.
Researchers randomly assigned 813 patients undergoing unilateral knee arthroplasty to receive single IV osocimab postoperative doses of 0.3 mg/kg (n=107), 0.6 mg/kg (n=65), 1.2 mg/kg (n=108) or 1.8 mg/kg (n=106); preoperative doses of 0.3 mg/kg (n=109) or 1.8 mg/kg (n=108); or 40 mg of subcutaneous enoxaparin once daily (n=105) or 2.5 mg of oral apixaban twice daily (n=105) for at least 10 days or until venography. Researchers considered venous thromboembolism incidence between 10 and 13 days postoperatively as the primary outcome and major or clinically relevant non-major bleeding assessed until 10 to 13 days postoperatively as the primary safety outcome.
In the primary analysis, researchers included 600 of the 813 randomly assigned patients s in the per-protocol population. Results showed 23.7%, 15.7%, 16.5% and 17.9% of patients who received 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg and 1.8 mg/kg of osocimab postoperatively, respectively, had incidence of venous thromboembolism between 10 and 13 days postoperatively. Researchers also found venous thromboembolism occurred in 29.9% and 11.3% of patients receiving 0.3 mg/kg and 1.8 mg/kg of osocimab preoperatively, respectively, as well as among 26.3% of patients receiving enoxaparin and 14.5% of patients receiving apixaban.
Compared with enoxaparin, researchers noted osocimab given postoperatively met criteria for noninferiority with risk differences of 10.6% at the 0.6 mg/kg dose, 9.9% at the 1.2 kg/mg dose and 8.4% at the 1.8 mg/kg dose. Results showed the preoperative osocimab dose of 1.8 mg/kg met criteria for superiority with a risk difference of 15.1% compared with enoxaparin. However, prespecified criteria for noninferiority was not achieved with postoperative and preoperative osocimab doses of 0.3 mg/kg, with risk differences of 2.6% postoperatively and –3.6% preoperatively, according to results. Researchers found 4.7% of patients receiving osocimab, 5.9% of patients receiving enoxaparin and 2% of patients receiving apixaban experienced major or clinically relevant non-major bleeding.
“Further studies are needed to establish efficacy and safety of osocimab relative to standard thromboprophylaxis,” the authors wrote. – by Casey Tingle
Disclosures: Weitz reports he received compensation for his role in the study and serving as a consultant for which he has received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Ionis, Janssen, Merck, Novartis, Pfizer, Anthos, Tetherex and Portola. Please see the study for all other authors’ relevant financial disclosures.