Firm to Place Warning on Arthritis Drug
Johnson & Johnson, acting ahead of a regulatory review, Wednesday warned that patients who take its Remicade rheumatoid arthritis drug face an increased risk of tuberculosis.
The drug maker said it is adding a “black box” warning to the Remicade label, the strongest possible for prescription drugs. A Food and Drug Administration committee is scheduled to review Remicade’s safety record Friday.
Johnson & Johnson, which markets the drug through its Centocor unit, said patients who use Remicade face more than twice the normal risk of developing tuberculosis.
The action raises the stakes in the $6.9-billion market for rheumatoid arthritis drugs. An FDA panel today will review an experimental rheumatoid arthritis drug from Thousand Oaks-based Amgen Inc. that, if approved, could benefit from Remicade safety concerns.
The Amgen treatment, Kineret, faces its own regulatory hurdles. In clinical trials, patients using Kineret developed infections at twice the rate of patients who took a placebo. FDA reviewers are expected to look closely at the safety data.
However, Dr. Michael Schiff, who conducted clinical trials on Kineret and other rheumatoid arthritis medications at the Denver Arthritis Clinic, said: “The safety profile is good. . . . We didn’t see cases of TB in Kineret that we’ve seen in Remicade.”
Kineret, Remicade and a third drug, Enbrel, represent a new generation of bioengineered rheumatoid arthritis drugs that work by suppressing the immune system. For reasons that are not well understood, the immune system of rheumatoid arthritis patients attacks healthy joint tissue, causing painful inflammation and joint damage. About 2.1 million Americans have the disease, most of them women and many of them in middle-age.
Methotrexate, a cancer drug, has long been the standard treatment for severe rheumatoid arthritis. Doctors are beginning to use the new biotech drugs to supplement or, in the case of Enbrel, replace methotrexate as a first-line treatment. Combined sales of Enbrel and Remicade this year are expected to exceed $1 billion.
The drugs work differently, but patients who use any of them face an increased risk of infection, experts said. The degree of risk varies, and only Remicade has been linked to an elevated risk of tuberculosis.
Johnson & Johnson said 84 cases of TB have been reported among the 170,000 patients treated with Remicade since its introduction in 1998. Julie McHugh, vice president for immunology marketing for Centocor, said the rate of TB infection among Remicade users is 15 per 100,000 patients. She said the rate in the general population is six per 100,000.
She said Johnson & Johnson believes the rate is higher with Remicade than with competing drugs because it has broader distribution in Europe, where rates of latent tuberculosis are higher. She said 52 of the 84 cases were in Europe. The company strengthened the warning in Europe this year.
FDA documents showed that of 226 patients taking Remicade who had serious infections, 7.5% developed tuberculosis. Just 1% of Enbrel patients who had serious infections developed tuberculosis.
