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| |  Oral Calcineurin Inhibitor Reduces Inflammation, Dependence on Steroids in Treatment of Uveitis: Presented at ARVO By Cameron Johnston FT. LAUDERDALE, Fla -- May 8, 2009 -- Voclosporin has been shown in 3 clinical trials to successfully reduce the inflammation associated with chronic, active noninfectious uveitis, while at the same time permitting the patient to substantially curtail the use of other medications, according to data from 3 studies presented here at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting on May 4. James Rosenbaum MD, Medicine and Cell Biology, Casey Eye Institute, Oregon Health Sciences University, Portland, Oregon, discussed data from the 3 trials which were conducted at 57 centres in 7 countries. One study enrolled 218 patients with active noninfectious uveitis in the posterior of the eye. A second study looked at 232 patients with quiescent disease, and a third studied anterior disease in 108 patients. The trials were conducted under the acronym of LUMINATE (Luveniq Uveitis Multicenter Investigation of a New Approach to Treatment). All 3 studies evaluated voclosporin in doses of 0.2, 0.4, and 0.6 mg/kg, administered twice daily. Mean ages of patients in these studies were in the range of 36 to 42 years, and the patients had had the condition for at least 4 years. In the study involving the posterior eye, vitreous haze improved significantly compared with placebo at week 16 and at week 24. The mean magnitude of effect was a 1-point change from baseline, which Dr. Rosenbaum said was clinically significant. For patients who had quiescent disease, those treated with voclosporin had half the rate of recurrences in a 6-month period compared with patients who were treated with a placebo (21% vs 45%). Among patients who had anterior uveitis, the average cellular response at the front of the eye was reduced from approximately 25 white blood cells per high-powered field, to an average of 6% to 10% per field. The same effect was seen in patients who received the placebo, so it cannot be said that the drug was effective in treating anterior uveitis. "This was the most unexpected, and unanticipated result from any of these trials," said Dr. Rosenbaum. Another important clinical outcome from these studies, he continued, was that patients were able to reduce the use of other drugs to treat their uveitis. In particular, he said, at baseline 73% of patients were receiving a mean of 15.6 mg/day of corticosteroid. At week 26, the mean corticosteroid dose used was <4 mg/day. Previous studies have indicated that the mean dose of steroid given to patients with ocular inflammation is around 44 mg/day, and that even for maintenance dosing, patients are receiving around 36 mg/day. Therefore, it can be seen that treatment with voclosporin would represent a significant clinical benefit in helping patients reduce their use of steroids. Voclosporin was not without its side effects, however. More patients (8.2%) receiving the 0.4 mg/kg dose experienced a drop in glomerular filtration rate of more than 30% compared with patients who received the placebo (4.1%). This reduction in renal function was also believed to be responsible for an increase in mean systolic blood pressure by 6 mm Hg, Dr. Rosenbaum said. He noted that there were no meaningful changes in cholesterol or triglyceride levels. "The US Food and Drug Administration has recognized that the treatment of uveitis is an unmet medical need, and therefore, has granted voclosporin fast-track status for this indication," Dr. Rosenbaum said in his oral presentation. Funding for this study was provided by Lux Biosciences Inc.
[Presentation title: LUVENIQ (LX211/Voclosporin) as Corticosteroid-Sparing Therapy in Sight-Threatening Non-Infectious Uveitis: Results From Three Prospective, Randomized, Multicenter, Double-Masked, Placebo-Controlled Phase 2/3 Clinical Trials. Abstract 2021]
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