Pharmaceutical Business review

Sustained benefits found with Schering-Plough and Centocor’s Remicade

Recently, a team of researchers in the UK set out to test the effectiveness of anti-TNF-alpha therapy on a small sample of patients with very early, poor-prognosis, previously untreated RA.

Based at Leeds General Infirmary, the research team recruited 20 patients with a diagnosis of RA meeting the American College of Rheumatology’s criteria. At the study’s onset, the patients were randomly divided into two treatment groups. One group received a standard dosage of a TNF-alpha inhibitor, infliximab (also known by the commercial name Remicade), while the other group received a placebo.

All 20 RA patients adhered to their assigned treatment for a full year. To closely monitor the impact of anti-TFN-alpha therapy on synovitis, the inflammation of the membrane lining the joints, as well as bone erosions, every patient underwent magnetic resonance imaging (MRI) scans of the hand at baseline, at four weeks, and then at eight-week intervals until 54 weeks. The MRI scans were repeated a final time at 104 weeks – one year after the patients stopped taking infliximab.

At its one-year culmination, the study achieved its primary goal for RA patients given the advantage of early anti-TNF-alpha therapy: disease remission to avert joint damage. At 14 weeks, according to the MRI findings, patients taking infliximab combined with methotrexate showed a significant reduction in levels of synovitis compared to their baseline scores and to their counterparts.

At 24 weeks, the infliximab group had significantly fewer new telltale signs of joint erosions than the placebo group. Throughout the course of the study, up to week 104, remission rates were greater among those patients prescribed infliximab plus methotrexate. Seven out of ten of the patients had met the ACR response criteria for remission, compared with two out of ten patients in the placebo plus methotrexate group.

One year after withdrawing from anti-TNF-alpha therapy, the patients in this group continued to experience therapeutic benefits. These patients scored significantly higher on measures of function and quality of life than the patients who had been treated with conventional DMARDs alone.

“This appears to emphasize the importance of not only adequate disease suppression over time, but also of rapid disease suppression for optimal improvement in these outcomes,” notes the study’s author, Mark Quinn. “Rapid control of disease activity may prevent patients from entering the ‘sick role’ and may avoid the socioeconomic disadvantages associated with chronic illness, which extend beyond the anti-inflammatory nature of the therapy.”