Two Real-World Studies Evaluate Xarelto in Treating VTE
October 23, 2016—Janssen Pharmaceuticals, Inc. and its development partner, Bayer HealthCare, announced results of two real-world studies confirming the benefit-risk profile of Xarelto (rivaroxaban) in treating venous thromboembolism (VTE) and reducing the risk of recurrence. Results of both studies were presented at CHEST, the 2016 annual meeting of the American College of Chest Physicians held October 22–26 in Los Angeles, California.
According to the companies, the first study showed that patients with VTE taking Xarelto for longer than 3 months had a lower risk of VTE recurrence, without an increase in major bleeding, compared to those taking the medicine for only 3 months.
The second study was the first readout from Janssen's Post-Marketing Safety Surveillance (PMSS) study in VTE, which showed that the rates and patterns of major bleeding in patients taking Xarelto for VTE in routine clinical practice were consistent with those reported in clinical trials.
The companies stated that in approximately 5,000 patients who were diagnosed with their first VTE, investigators examined the long-term safety and effectiveness of Xarelto and found that those patients who continued taking Xarelto for up to 1 year had significantly lower rates of VTE recurrence at all measured time points, without an increased risk of major bleeding, compared to those who discontinued Xarelto after 3 months.
The investigators reported that at 3 months, recurrent VTE occurred in 0.57% of patients in the continued cohort and 1.19% in the discontinued cohort (P < .05). Major bleeding occurred in 0.51% and 0.72%, respectively (P > .05). At 6 months, recurrent VTE occurred in 1.07% of patients in the continued cohort and 2.1% in the discontinued cohort (P < .05). Major bleeding occurred in 0.79% and 0.72%, respectively (P > .05). At 12 months, recurrent VTE occurred in 1.45% of patients in the continued cohort and 2.6% in the discontinued cohort (P < .05). Major bleeding occurred in 1.06% and 1.13%, respectively (P > .05).
The companies noted that clinical guidelines recommend that patients diagnosed with VTE be treated with an anticoagulant, such as rivaroxaban, for a minimum of 3 months when they are at the highest risk of experiencing a recurrence. However, the risk still remains after treatment ends, and up to 10% of patients will have a recurrent event within the first year.
In the PMSS VTE study, which follows patients with DVT and PE in the United States taking Xarelto, this retrospective, observational study evaluates major bleeding in these patients in a real-world, postapproval setting, using electronic health records from the US Department of Defense (DoD) database.
According to the companies, the first data cut of 9,638 patients with VTE (5,426 with DVT; 4,212 with PE) taking Xarelto showed 130 patients (1.3%) experienced a major bleeding event, translating into an incidence rate of 2.47 per 100 patient-years, primarily in gastrointestinal areas.
With DVT, major bleeding events in PMSS were observed in 74 patients with DVT (1.4%), translating into an incidence rate of 2.74 per 100 patient-years. With PE, major bleeding events in PMSS were observed in 56 patients with PE (1.3%), translating into an incidence rate of 2.18 per 100 patient-years. Patients who experienced major bleeding were typically older, female, and had more comorbidities; fatal outcomes were rare, stated the companies.
Finally, the companies noted that the PMSS study in VTE was designed by Janssen in conjunction with the DoD and Health ResearchTx LLC, and in agreement with the US Food and Drug Administration, to proactively ascertain, analyze, and report potential side effects with Xarelto use, including major bleeding events, associated risk factors, and bleeding-related clinical outcomes in people with VTE taking Xarelto PMSS is a retrospective study with no comparator arm.