Two novel drug treatments show promise against gout and colitis, painful conditions that plague millions of people worldwide.
Febuxostat, which is awaiting approval from U.S. regulators, would be the first new medicine in four decades for gout, which is becoming more common in this country. Gout has long been associated with rich diets, and afflicted such figures in history as Benjamin Franklin, Henry VIII and Alfred Lord Tennyson.
Infliximab, sold under the brand name Remicade for arthritis and Crohn’s disease, was shown to sharply reduce bloody diarrhea, abdominal cramps and other symptoms of ulcerative colitis, another immune system disorder that erodes the large intestine.
The studies were reported in Thursday’s New England Journal of Medicine.
The gout study involved about 760 patients and compared febuxostat with allopurinol, both of which remove excess urate from the blood. Urate deposits crystals in the feet and other joints, causing bouts of painful inflammation.
“You need to be able to follow these patients, I believe, much longer” to see if febuxostat reduces gout attacks better, said lead researcher Dr. Michael Becker, a rheumatologist and professor at University of Chicago.
Still, he said febuxostat will be helpful to the many patients who cannot take allopurinol or have weak kidneys.
“For them, it’s going to be a big advance,” said Dr. Petros Efthimiou, a rheumatologist at University of Medicine and Dentistry of New Jersey in Newark.
Gout, a type of arthritis, is so painful patients cannot tolerate bedding touching tender spots. Yet there have been no new drugs since 1964. Up to 3 million Americans have gout, the majority of them men, Efthimiou said.
“We’re seeing it more and more,” Efthimiou said, with the population’s increasing obesity and diets rich in purines, found in foods such as asparagus, meat gravies and broth, mushrooms and organ meats.
All eight researchers who wrote the gout study are employees of or, like Becker, consultants to the drug’s maker, TAP Pharmaceutical Products, which is running longer-term studies.
Remicade, a genetically engineered drug, was tested on hundreds of patients with poorly controlled colitis in two international studies led by Belgian researchers.
After about a year, about 20 percent of patients on Remicade and just 9 percent on a dummy medication had so few symptoms they were taken off steroids, immune-suppressing drugs that have serious side effects and cannot be taken very long.
“This is as good as we’ve done” with treatments for this “horrible” disease, said Dr. Scott Plevy, co-director of the Inflammatory Bowel Disease Center at University of Pittsburgh. He was not involved in the study.
Plevy said current drugs do not control colitis well for three-fourths of patients, and cutting out the diseased segment of intestine is risky and not always a cure.
But he said because of infections and other side effects with Remicade, the expensive drug should be limited to patients in whom the safer first-line drugs have failed, he said.
About 700,000 Americans have ulcerative colitis.
The study was partly funded by the drug’s maker, Centocor, part of Johnson & Johnson.
