A large U.S. study of a decades-old arthritis drug made by Merck & Co. disclosed over the weekend that the arthritis that most patients had complained about was a random side effect of using the medicine.
Researchers at Purdue University in Indiana found that patients taking hydroxychloroquine — known as the JAK inhibitor — for multiple years in the mid-1990s had the highest rate of developing rheumatoid arthritis.
The revelation would set back a decade of efforts by JAK inhibitor advocates to show that the medicine, which Merck manufactures under the name Remicade, can reduce life-threatening complications in people with inflammatory bowel disease.
Researchers who collected the data in the “Remicade Study Study” plan to present it next month at a Society of Rheumatology meeting in San Francisco. In a statement, Timothy Sims, vice president for global inflammatory diseases at Johnson & Johnson’s research-based unit New Brunswick, N.J.-based Janssen Biotech Inc., said the release of the data didn’t damage the drug’s sales.
Remicade, the most-prescribed arthritis medicine in the U.S., generated $3.8 billion in sales in the latest quarter, or more than 12 percent of the company’s total pharmaceutical revenue. Those numbers will drop soon after the drug loses its key patent in 2018, which will open the door for new competitors to marketing expensive alternatives.
There have been strong years for Remicade over the past decade, but sales have started to slow due to competition from the rival Enbrel from Amgen Inc. and Pfizer Inc. But part of J&J’s strategy to keep those numbers at or near recent peaks has been to promote Remicade as a treatment for inflammatory bowel disease, or ulcerative colitis, which can lead to heart problems.
Sims said on a conference call with investors Wednesday that while the study found that hydroxychloroquine may have caused some ulcerative colitis, it didn’t say it was the cause. The study also found that patients got a higher-than-expected benefit from Remicade’s use as a treatment for ulcerative colitis, he said.
“We believe that approximately half of all patients who started the study with ulcerative colitis were not actually cured,” Sims said, though he didn’t have data on the benefits that were being measured.
Remicade was used for 19 years in the study — from the mid-1990s to 2004 — before being refilled for the 2,819 patients who finished it.
Sims said a pair of reasons for the study’s findings: It was not designed to account for the age of the patients, some of whom had gotten Pfizer’s Aricept from 1990 to 1994. JAK inhibitors aren’t approved to treat ulcerative colitis and were already known to cause several types of immune system disorders.
And JAK inhibitors were exposed in the early 1990s when there wasn’t much data on ulcerative colitis, so some patients might have picked up drug-related symptoms after that, Sims said.
“Nobody knows for sure,” he said.
Catherine Lee contributed to this report.