Remicade Therapy Shows Rapid Improvement of Disease Activity in AS Patients
9/12/2003
Remicade (infliximab) has been found to significantly improve disease activity indicators in patients with ankylosing spondylitis (AS) following a one-year study conducted by German researchers.
The study, funded by Schering-Plough USA, set out to gauge the long-term efficacy and safety of Remicade in the treatment of AS. By monitoring 69 participants’ Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, researchers concluded that a three-month treatment regimen of Remicade improved patients’ scores by up to 50 percent. BASDAI scores help doctors and patients alike judge the severity of disease activity over an extended duration of time.
Documentation states that the study was an open, observational, extension study of a three-month, randomized, placebo-controlled trial. All patients who had tolerated Remicade or placebo therapy for three months entered the open extension trial. Remicade was administered at a dosage of five mg/kg every six weeks after the induction phase, which lasted up to six weeks. The primary end point was a startling 50 percent improvement in BASDAI scores.
Positive reaction to therapy yielded durable response indicators for up to a year. The safety profile of Remicade in AS was comparable to that observed in the post-marketing experience of the approved indications, which gives patients no added reason for concern.
Of the original 69 participants, four reported serious adverse reactions that were possibly related to the use of Remicade and resulted in the discontinuation of the study, but not before the positive results of the remaining 65 patients were tracked.
Remicade is an anti-tumor necrosis factor monoclonal antibody, which is becoming increasingly popular in the treatment of various forms of spondyloarthropathy.