After a large-scale analysis, Bristol-Myers Squibb Co. and Pfizer Inc. said that patients on their blood thinner Eliquis had lower rates of stroke and major bleeding in a real-world environment than patients on Johnson & Johnson's Xarelto and Pradaxa from C.H. Boehringer Sohn AG & Co. KG, better known as Boehringer Ingelheim.
The drugmakers based their conclusion, which they presented at the annual American College of Cardiology meeting on March 11, on analysis of five health plan databases, including Medicare data and claims information from commercial insurers Humana Inc. and UnitedHealth Group Inc.'s Optum, as well as market researchers Truven MarketScan and IMS.
Real-world data such as this covers many of the lives and different patient types in the U.S., Christoph Koenen, head of Cardiovascular Development at Bristol-Myers Squibb, said in an interview.
The combined databases gave Bristol-Myers and Pfizer access to 180 million people's claims, of which roughly 150,000 from a nearly two-year period were assessed, Koenen said.
The analysis, dubbed Aristophanes, comes after randomized, controlled clinical studies such as Aristotle, the late-stage trial that led to Eliquis' approval.
The blood thinner "is a very important and growing franchise" for Bristol-Myers, Chairman and CEO Giovanni Caforio said in the company's fourth-quarter earnings call in February. The company reported $4.9 billion in global sales for Eliquis in 2017, a 46% bump year over year that includes Pfizer's $2.5 billion cut.
Real-world data has its limitations because of various circumstances in patients' lives and treatment, such as adherence to daily regimens and other health factors. However, it can also give payers and physicians information about a diverse and high-risk population not generally included in clinical trials, Koenen said.
"To some extent, the population you observe in a randomized, controlled clinical trial might not be 100% as representative as you would see in the U.S.," he said, noting that many real-world patients can often be older, or have other risk factors.
There are no clinical, head-to-head trials of the three blood thinners assessed.
J&J's Xarelto made $2.5 billion in 2017, more than a 9% increase on a year-over-year basis. Boehringer Ingelheim is a private company, but its Pradaxa was one of the first on the market in this particular class of blood thinners.
The Aristophanes study is part of a larger Bristol-Myers Squibb and Pfizer partnership on real-world data that includes analysis of 16 databases around the world.