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QfitliaTM (fitusiran): ATLAS clinical trial design


The Qfitlia clinical program was studied for over 7 years in people with hemophilia A or B, with or without inhibitors1,2

The ATLAS clinical trial program included two parent studies (ATLAS-INH and ATLAS-A/B), a supportive study (ATLAS-PPX), and an open-label extension study (ATLAS-OLE)3

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

The ATLAS-OLE trial included a diverse patient population who were treated with the AT-DR3

Hemophilia A 174 patients1

59 with inhibitors 115 without inhibitors

Hemophilia B 53 patients1

19 with inhibitors 34 without inhibitors

This study included patients between the ages of 12 and 72 years.1,3

Discover how Qfitlia performed

Learn how Qfitlia delivered proven bleed protection in the ATLAS clinical trials.3

Safety from the ATLAS trials

Find out more about safety

MOA=mechanism of action.

References

  1. Qfitlia Prescribing Information. Genzyme Corporation. Cambridge, MA.

  2. Machin N, et al. J Blood Med. 2018;9:135-140.

  3. Advate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA.

  4. Adynovate Prescribing Information. Takeda Pharmaceutical U.S.A., Inc. Lexington, MA.

  5. Afstyla Prescribing Information. CSL Behring LLC. Kankakee, IL.

  6. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA.

  7. Esperoct Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ.

  8. Helixate Prescribing Information. CSL Behring LLC. Kankakee, IL.

  9. Hemlibra Prescribing Information. Genentech, Inc. San Francisco, CA.

  10. Jivi Prescribing Information. Bayer HealthCare LLC. Whippany, NJ.

  11. Kogenate Prescribing Information. Bayer HealthCare LLC. Whippany, NJ.

  12. Kovaltry Prescribing Information. Bayer HealthCare LLC. Whippany, NJ.

  13. Novoeight Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ.

  14. Nuwiq Prescribing Information. Octapharma USA, Inc. Paramus, NJ.

  15. Xyntha Prescribing Information. Wyeth Pharmaceuticals LLC. Philadelphia, PA.

MAT-AE-2500302-V1-April-25