Janssen Pharmaceuticals, Inc. (Janssen) and its development partner, Bayer HealthCare, today announced the results from their real-world study XALIA showing that, in people with deep vein thrombosis (DVT), the rates of major bleeding and recurrent blood clots for XARELTO® (rivaroxaban) in routine clinical practice were generally consistent with those observed in Phase 3 research. Patients taking XARELTO® also had shorter length of hospital stays than those given standard anticoagulation. The prospective study was presented at the 2015 American Society of Hematology (ASH) Annual Meeting and simultaneously published in Lancet Hematology.
"On average, every 37 seconds someone in the Western world dies from a venous blood clot, so it is important we understand the effectiveness and safety of available treatment options for these potentially life-threatening blood clots," said XALIA principal investigator Professor Alexander G. G. Turpie, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. "The real-world insights from XALIA confirm the positive benefit-risk profile of rivaroxaban for the treatment of deep vein thrombosis that was observed in the Phase 3 EINSTEIN-DVT study, signalling that the medicine is performing as expected in patients that physicians typically see in everyday clinical practice."
XALIA – which included approximately 5,000 patients from 21 countries – evaluated the safety and effectiveness of XARELTO®, taken once daily, for the treatment of DVT in routine clinical practice as compared to standard anticoagulation. The primary outcome was the incidence of adverse events (major bleeding, recurrent blood clots and all-cause mortality). Healthcare resource utilization, including length of stay, also was evaluated. A propensity score analysis was completed to address differences in baseline characteristics and help correct any selection bias. Methodological and other differences between the studies limit the ability to directly compare results of XALIA to the pivotal Phase 3 EINSTEIN-DVT study, which was used by regulatory authorities worldwide to approve XARELTO®.
Key XALIA findings (from the propensity score analysis) included:
- Major bleeding occurred in 0.8 percent of patients receiving XARELTO® and 2.1 percent of those receiving standard anticoagulation (HR 0.77; CI 0.40-1.50; p=0.44). There were no fatal bleeding events in the XARELTO® group; two fatal bleeding events occurred in the standard anticoagulation group. In EINSTEIN-DVT, major bleeding occurred in 0.8 percent of patients taking XARELTO® and there was one fatal bleeding event.
- Recurrent blood clots occurred in 1.4 percent of patients receiving XARELTO® and 2.3 percent of those receiving standard anticoagulation (HR 0.91; CI 0.54-1.54; p=0.72). In EINSTEIN-DVT, recurrent blood clots occurred in 2.1 percent of patients taking XARELTO®.
- All-cause mortality occurred in 0.4 percent of patients taking XARELTO® and 3.4 percent of those taking standard anticoagulation (HR 0.51; CI 0.24-1.07; p=0.07). In EINSTEIN-DVT, all-cause mortality occurred in 2.2 percent of patients taking XARELTO®.
As hospitalization for blood clots remains a major healthcare cost, the study also examined hospital admissions and found them to be shorter in duration for patients treated with XARELTO® compared to those receiving standard anticoagulation. Specifically, the mean length of hospital stay was 5.0 days for patients treated with XARELTO® and 7.7 days for those treated with standard anticoagulation (geometric means ratio 0.66; CI 0.61-0.72).
Janssen Pharmaceuticals, Inc.