The efficacy of Qfitlia AT-DR treatment was assessed by comparing the Qfitlia AT-DR treatment data from the long-term extension study, ATLAS-OLE, to the control data from studies ATLAS-INH and ATLAS-A/B.^1,5

Excluded from the trial were patients with known coexisting coagulation disorders other than hemophilia A or B, an increased risk of thrombosis as assessed by a history of arterial or venous thromboembolism, significant valvular disease or atrial fibrillation, coexisting thrombophilic disorders (eg, Factor V Leiden mutation), antithrombin activity <60% at screening, platelet count ≤100,000/μL, eGFR ≤45 mL/min (using the MDRD), or clinically significant liver disease.³

^*ATLAS-INH was a randomized, multicenter, open-label clinical study in 57 adult and pediatric males (aged ≥12 years) with hemophilia A or B with inhibitory antibodies to FVIII or FIX who had previously received on-demand (episodic) treatment with BPAs for bleeding. ATLAS-A/B was a randomized, multicenter, open-label clinical study in 120 adult and pediatric males (aged ≥12 years) with hemophilia A or B without inhibitory antibodies to FVIII or FIX who had previously received on-demand (episodic) treatment with factor replacement for bleeding. Eligible patients in both trials were randomized in a 2:1 ratio to receive Qfitlia prophylaxis (80 mg SC once monthly) or the comparator arm (BPA on-demand or factor replacement on-demand, respectively) to treat breakthrough bleeding episodes for 9 months.³
^† ATLAS-PPX was an exploratory, Phase 3, open-label study evaluating the efficacy and safety of Qfitlia prophylaxis in 80 males aged ≥12 years with hemophilia A or B, with or without inhibitors, who had received prior BPA or factor replacement prophylaxis. Participants continued their prior BPA or factor replacement prophylaxis for 6 months before switching to once-monthly 80 mg Qfitlia prophylaxis for 7 months (onset and efficacy periods).⁴
^‡ To mitigate the risk of thrombotic events, an AT-DR with the target antithrombin activity range of 15% to 35% was implemented in ATLAS-OLE when studies ATLAS-INH and ATLAS-A/B were nearly completed.³
§ ATLAS-OLE, a multicenter, multinational, open-label extension study, assessed the safety and efficacy of Qfitlia using dose modifications based on antithrombin activity levels.^1,3