Pippa Wysong

May 03, 2005

May 3, 2005 (Fort Lauderdale) -- The monoclonal antibody infliximab (Remicade) is showing efficacy in patients with uveitis, regardless of the origins of the disease.

Ten-week results of a safety and efficacy trial using the drug in 49 patients with uveitis were presented here at the annual meeting of the Association for Research in Vision and Ophthalmology by Marc de Smet, MD, an ophthalmologist at the Academic Center University of Amsterdam in the Netherlands.

"The results suggest that Remicade, for all forms of posterior uveitis, seems to be beneficial," Dr. de Smet said. Findings come from the Remicade European Study for Chronic Uveitis (RESCU), a multicenter trial that included patients from 10 European centers.

Of the conditions patients had when they entered the study, nine had Behcet's disease, five had sarcoidosis, 11 had intermediate uveitis, 10 had birdshot retinochoroiditis, seven had idiopathic vasculitis, and seven had sympathetic ophthalmia.

"Part of the excitement with infliximab is that this is a very specific antibody that is directed against TNF-α [tumor necrosis factor α]. TNF-α is a cytokine that plays an important role very early in the immune cascade. If you're able to block it you should be able to inhibit the inflammation," Dr. de Smet told Medscape in an interview.

If infliximab turns out to be useful as a single agent, it means patients would not have to use prednisone or other immunosuppressants, and hence avoid the adverse effects associated with long-term use of those drugs, Dr. de Smet said.

At baseline, patients had a median visual acuity score of 70 in the right eye and 68 in the left eye. At week 10, the scores improved to 79 and 78, respectively. The patients all had advanced disease and were refractory to other treatments.

At this point in the study, the patients had not discontinued all other medications. "The majority are still on some medications but it's an ongoing study," Dr. de Smet said. However, there has been a significant reduction in the use of steroids.

Patients were given 5 mg/kg of infliximab at weeks 0, 2, and 6, then every eight weeks up to 48 weeks. While many patients have participated in the study for much longer than 10 weeks, only the first 10 weeks of data have been analyzed. Future data will be presented, Dr. de Smet said.

"What we found was there was a significant improvement in vision in patients...there [was] a reduction in the amount of haze and...a reduction in the use of steroids, as well as other medications," Dr. de Smet said.

It is also hoped that because of the cytotoxic activity the drug has against inflammatory cells it may trigger a long-term remission. This is another aspect researchers are tracking in this ongoing study. Patients will be followed for more than the 48 weeks of treatment.

In the 10-week period, four patients discontinued the drug: two because of increases in liver enzymes (it is uncertain if this was related to infliximab), one patient stopped because of the development of a severe rash, and the fourth had tuberculosis.

This study was funded by Centocor.

ARVO 2005 Annual Meeting: Abstract 1139. Presented May 2, 2005.

Reviewed by Gary D. Vogin, MD

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