Generic less effective in treating Crohn's, J&J study finds
Johnson & Johnson's Remicade fought the bowel disorder Crohn's disease better than the generic medicine prescribed by doctors, a result that may help J&J win thousands more patients for its second-best-selling drug.
Remicade eased symptoms in 44 percent of patients when used on its own, and in 57 percent when combined with azathioprine, the generic that doctors typically turn to when initial treatments fail, J&J said in a statement yesterday, citing a company-sponsored study. Both of those regimens beat the 31 percent remission rate for azathioprine alone, the New Brunswick, N.J., drug maker said.
About half of the 500,000 Crohn's patients in the United States take azathioprine, said study author William Sandborn, a gastroenterologist at the Mayo Clinic in Rochester, Minn. J&J sponsored the study to see how many of those might do just as well starting off on Remicade, a switch that may earn the company as much as $22,000 per patient. Remicade, an anti-inflammatory also used against rheumatoid arthritis, generated $3.3 billion for the company last year. A boost among Crohn's patients could help J&J offset losses it is suffering as other top sellers, such as the schizophrenia pill Risperdal, cede ground to cheaper generic copies.
Crohn's is a chronic disease that can cause abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is no known cause, nor a cure. Eighty percent of patients need surgery to repair bowel damage after 15 years, a sign of the inadequacy of treatment, Sandborn said.
The disease is typically treated first with steroids or aminosalicylates. If those don't work, doctors usually move to azathioprine and, if that fails, to Remicade.
While the generic drug costs about $2,000 annually, as much as 11 times less than a year of Remicade, "what this data says is it's less expensive but it's also less effective," Sandborn said.
The J&J-sponsored study is scheduled to be released today, in Orlando, Fla., at the annual meeting of the American College of Gastroenterology.
The researchers followed 508 Crohn's sufferers in the United States, Europe, and Israel, for 26 weeks. The scientists found healing of the digestive lining in 44 percent of patients who took the Remicade-azathioprine combination and 30 percent of those on Remicade alone, compared with 17 percent of those being treated solely with the generic.
The study also found Remicade to be about as safe as the generic, Sandborn said. After 30 weeks, 24 percent of patients taking azathioprine alone developed complications such as infections, tuberculosis, or colon cancer, compared with 16 percent of those getting Remicade and 14 percent with the combination.
Remicade is one in a class of drugs, known as anti-TNF inhibitors, linked to increased risks of infections and cancer in some patients. The US Food and Drug Administration last month ordered J&J to add new warnings to the drug's prescribing information. 