TITUSVILLE, N.J., Oct. 23, 2016 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) and its development partner, Bayer, today announced results of two new real-world studies confirming the positive benefit-risk profile of XARELTO® (rivaroxaban) in treating venous thromboembolism (VTE), or blood clots, and reducing the risk of recurrence.
One study showed that people with VTE taking XARELTO® for longer than three months had a lower risk of VTE recurrence, without an increase in major bleeding, compared to those taking the medicine for only three months. The second was the first readout from Janssen's Post-Marketing Safety Surveillance (PMSS) study in VTE, which showed the rates and patterns of major bleeding in people taking XARELTO® for VTE in routine clinical practice were consistent with those reported in clinical trials. Results of both studies were presented at the American College of Chest Physicians (CHEST) Annual Meeting 2016.
VTE is a collective term encompassing deep vein thrombosis (DVT), a blood clot in a deep vein (usually the leg), and pulmonary embolism (PE), when a clot travels to the lung. VTE affects more than 900,000 Americans each year, and one-third of these occurrences will be fatal. Once a person experiences VTE, they are at increased risk of it occurring again.
Real-World Study Confirms Benefit of Extended Use of XARELTO® in VTE
In nearly 5,000 people who were diagnosed with their first VTE, researchers examined the long-term safety and effectiveness of XARELTO® and found those who continued taking XARELTO® for up to one 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 three months. Specifically:
At three months, recurrent VTE occurred in 0.57 percent of people in the continued cohort* and 1.19 percent in the discontinued cohort** (p<0.05). Major bleeding occurred in 0.51 percent and 0.72 percent, respectively (p>0.05).
At six months, recurrent VTE occurred in 1.07 percent of people in the continued cohort and 2.10 percent in the discontinued cohort (p<0.05). Major bleeding occurred in 0.79 percent and 0.72 percent, respectively (p>0.05).
At 12 months, recurrent VTE occurred in 1.45 percent of people in the continued cohort and 2.60 percent in the discontinued cohort (p<0.05). Major bleeding occurred in 1.06 percent and 1.13 percent, respectively (p>0.05).
Clinical guidelines recommend people diagnosed with VTE be treated with an anticoagulant, such as rivaroxaban, for a minimum of three months when they are at the highest risk of experiencing a recurrence. However, the risk still remains after treatment ends and up to 10 percent of people will have a recurrent event within the first year.1
"This study in a broad real-world setting affirms the ACCP guidelines for the extended treatment of an unprovoked VTE," said Dr. Scott Kaatz, lead study investigator and hospitalist, Henry Ford Hospital. "Extended treatment with rivaroxaban showed a decrease in recurrent VTE without an increase in major bleeding and is consistent with a previous clinical trial."
This study builds on findings from the Phase 3 EINSTEIN clinical program, which was used by regulatory authorities worldwide to approve XARELTO® for the treatment of DVT and PE and reduction in the risk of recurrence of DVT and PE. The EINSTEIN-Extension study found continuing treatment with XARELTO® for an additional six to 12 months beyond the initial treatment period resulted in significantly fewer VTE recurrences (1.3 percent) versus placebo (7.1 percent), p<0.001. There was no difference in major bleeding between the two groups.
Study Confirms Safety Profile of XARELTO® in VTE
Also presented were the first results from Janssen's ongoing PMSS VTE study, which follows people with DVT and PE in the U.S. taking XARELTO®. Like Janssen's PMSS study in non-valvular atrial fibrillation (NVAF), this retrospective, observational study evaluates major bleeding in these patients in a real-world, post-approval setting, using electronic health records from the U.S. Department of Defense (DoD) database.
The first data cut of 9,638 people with VTE (5,426 with DVT; 4,212 with PE) showed:
Of the 9,638 people taking XARELTO®, 130 (1.3 percent) experienced a major bleeding event, translating into an incidence rate of 2.47 per 100 person-years2, primarily in gastrointestinal sites.
With DVT, major bleeding events in PMSS were observed in 74 people with DVT (1.4 percent), translating into an incidence rate of 2.74 per 100 person-years.
With PE, major bleeding events in PMSS were observed in 56 people with PE (1.3 percent), translating into an incidence rate of 2.18 per 100 person-years.
People who experienced major bleeding were typically older, female and had more comorbidities; fatal outcomes were rare.
"Post-marketing research is invaluable to physicians who are continually looking to understand how a medicine is performing in real-world settings in order to make informed treatment decisions for their patients," said PMSS study investigator W. Frank Peacock, MD, FACEP, Associate Chair and Research Director, Emergency Medicine, Baylor College of Medicine. "We have been closely examining the use of rivaroxaban in daily clinical practice for more than three years in people with non-valvular atrial fibrillation, and are pleased to expand our work to those with VTE."
The PMSS study in VTE was designed by Janssen in conjunction with the DoD and Health ResearchTx LLC (HRTX), and in agreement with the U.S. Food and Drug Administration (FDA), 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.
Commitment to Real-World Research and Patient Access
To date, more than 91,000 people have been enrolled in real-world studies for XARELTO® across all six approved indications in the U.S., including DVT, PE and NVAF, and the number is growing. Real-world studies are part of the EXPLORER clinical research program for XARELTO®, which also seeks to evaluate the potential role of the medicine in addressing additional critical medical needs. A collaborative research effort between Janssen and Bayer, EXPLORER is a blend of completed and ongoing studies and registries, including six additional indication-seeking programs underway in the United States. More than 275,000 people will have participated by the time of its completion.
"These results add to a rapidly growing body of real-world research for XARELTO®, and specifically in the case of VTE, reaffirm the results observed in our landmark EINSTEIN clinical trial program," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. "Beyond our clinical work, we are also committed to making XARELTO® affordable and accessible for the patients who need it."
XARELTO® leads the non-vitamin K antagonist oral anticoagulant (NOAC) class by having the strongest affordability and access position in the U.S. For qualifying people with commercial insurance using the Janssen CarePath savings card, XARELTO® has no cost.3 For people with Medicare and commercial insurance, XARELTO® is broadly reimbursed, with more than 95 percent of commercial patients and people on Medicare Part D covered at the lowest branded co-pay. XARELTO® is also now preferred by CVS Caremark and has the lowest average out-of-pocket cost of any NOAC available in the U.S. today with more than 20 million prescriptions written for XARELTO® in the U.S. since its launch.
There are limitations associated with real-world research, which may include data entry error or incompleteness, differing behaviors in clinical vs. real-world settings, and limited generalizability to all hospitals.
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Last updated on: 25/10/2016
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