AMSTERDAM, the Netherlands—Infliximab (Remicade), the most widely used anti–tumor necrosis factor alpha (TNF-alpha) biologic therapy for a variety of inflammatory conditions, is safe and effective for up to 5 years for the treatment of ankylosing spondylitis (AS).
Investigators reported these findings at the annual meeting of the European League Against Rheumatism (EULAR)/ European Congress of Rheumatology.
“This is very good news for clinicians and patients, since no other drug in this class has yet shown 5-year endurance and safety for ankylosing spondylitis,” lead investigator Jurgen Braun, MD, professor of rheumatology at Ruhr University in Bochum, Germany, told .
AS causes arthritis of the spine and sacroiliac joints, sometimes also leading to inflammation of the peripheral joints, eyes, lungs, and heart valves.
A total of 69 patients were initially enrolled in a 3-year active-treatment study; each received 5 mg/kg of intravenous infliximab every 6 weeks. Patients were re-treated if signs of disease reappeared, which was usually the case. Ongoing disease activity was assessed with standard AS research tools.
Of the original 69 patients, 54 completed 1 year, 49 completed 2 years, and 43 completed 3 years. Forty-one patients (97.6%) who completed 3 years of the study were still receiving active treatment at the end of 5 years.
At the end of the fifth year, 34.1% of the patients were in complete remission, and 68.3% had achieved a 50% regression of their disease activity.
The durable clinical efficacy of infliximab persisted, and there were no major side effects. Even after the drug was withdrawn and then readministered, patients showed “persistent clinical benefit” during the 5-year period, according to the investigators.
“From these new data and from the fact that the research goes out to 5 years, it appears that anti-TNF treatment might be as effective for ankylosing spondylitis as it has proven to be for rheumatoid arthritis,” Tore K. Kvien, MD, PhD, president of EULAR and rheumatologist and professor of rheumatology at the University of Oslo in Norway, told IMWR. “We need more ongoing information about this drug and others in its class to see if these results are unique to infliximab or if we see an emerging anti-TNF class effect.”
The Spondylitis Association of America estimates that between 350,000 and 1 million people in the United States suffer from AS. The FDA approved infliximab in 2004 for the treatment of AS.