Analysis: Remicade fights joint disease

AMSTERDAM, Netherlands, June 22 (UPI) -- The blockbuster anti-inflammatory drug Remicade (infliximab) is safe and effective in controlling the symptoms of a debilitating, arthritic condition known as ankylosing spondylitis (AS) for up to five years, said a new study released this week.

Researchers reported findings from the study -- which received support from the drug's sponsors Centocor and Shering-Plough -- at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, held this week in Amsterdam, the Netherlands.

AS, also known as Bechterew's disease, is a potentially disabling rheumatic disease causing arthritis of the spine and sacroiliac joints and, sometimes, inflammation of the peripheral joints, eyes, lungs, and heart valves.

"This is the first drug in its class to show this kind of staying power for AS out to five years," lead investigator and presenter Jurgen Braun, professor of rheumatology at Ruhr University in Bochum, Germany, told United Press International.

"We need to focus more and more on treating people with this disease earlier, to help slow the progression of disease. Now we know that the efficacy of this drug will endures. This is good news for the clinician and the patient," he said.

According to the U.K.-based Arthritis Research Campaign, AS affects up to 0.5 percent of the populations in developed Western nations. The Spondylitis Association, located in the United States, estimates that between 350,000 and one million Americans suffer from AS.

Remicade -- a top seller in a drug class known as anti-tumor necrosis factor alpha (TNF-alpha) therapies -- is approved in the United States and other markets for reducing signs and symptoms in patients with AS, and to treat other inflammatory conditions.

At the molecular level, Remicade targets TNF-alpha, which plays a role in the cascade of events leading to Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.

"The most critical question these days is whether and how long this type of treatment can be performed. Here we report our experience of a total of five years of infliximab therapy," the authors wrote in the study report.

The investigators initially enrolled 69 subjects into a three-year active-treatment study, and each patient received 5mg/kg of intravenous infusion of infliximab every six weeks.

At the end of 3 years, treatment was discontinued, with the subjects retreated if signs of disease reappeared.

Forty-one patients, or 97.6 percent who completed three years were still on active treatment at the completion of year five.

The researchers reported that at the end of year five, 34.1 percent of the subjects were in complete remission, and 68.3 percent had achieved a 50 percent regression of their disease activity.

"The clinical efficacy of infliximab persisted," the study authors said.

"No major side effects occurred during the fifth year of infliximab therapy. Even after withdrawal and readministration infliximab showed persistent clinical benefit over five years of treatment."

The team also noted there were no major side effects in the five-year study, and at the end of the trial, almost 60 percent of the initially included patients were still being treated with infliximab.

Commenting on the new data, EULAR president Tore Kvien, rheumatologist and professor of rheumatology at the University of Oslo, Norway told UPI, "The new data point again to the importance of anti-TNF-alpha therapy for AS. It looks like anti-TNF treatment could be at least as good for this disease as it is in treating rheumatoid arthritis. As a clinician treating patients, it is encouraging to know that the efficacy is maintained out to five years."

He added, "Now we need more studies to help us discern if this is finding a class effect for anti-TNF drugs."

Symptoms of AS including back pain usually appear in people when they are under 35 years-old, typically in the late teens or twenties. Severe disease can eventually lead to fusing of the spinal vertebrae and structural erosion in hips and other joints. AS can also eventually damage internal organs, peripheral joints and vision.