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news.UCB, a biopharmaceutical company, has presented data at the 62nd American Academy of Neurology annual meeting in Toronto, Canada, which showed that patients with moderate to severe Restless Legs Syndrome (RLS) using Rotigotine Transdermal System has achieved sustained improvements in symptoms over 5 years of treatment.
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UCB claimed that the study of Rotigotine in patients with moderate to severe RLS was the longest ever open label prospective follow-up of a placebo-controlled phase II trial in RLS. The final 5-year results confirm the safety and efficacy of Rotigotine seen at previous interim analyses, with over a third of patients followed up remaining symptom free after 5 years of treatment.
Of the 295 patients with moderate to severe RLS who entered the study, 43% have completed the 5-year follow up. The mean dose of Rotigotine was 2.43mg/24 hours after initial titration and 3.09mg/24 hours at the end of the study. 59% of patients were classified as remitters and 39% as symptom-free.
A comparison of 1, 2 and 5-year efficacy data (with 220, 191 and 126 patients respectively) showed that improvements in RLS symptoms remained stable throughout the follow-up period. Improvements in IRLS scores were 17.4 points at 1 year, 17.2 points at 2 years, and 18.7 points at 5 years.
Diego Garcia-Borreguero, director of sleep research institute in Madrid, Spain, said: “Many people with RLS will have spent months or years trying to get a diagnosis and find a treatment that can help them. So these 5-year results provide additional evidence that, once they start using Rotigotine, people with RLS may experience long term relief from their symptoms, and a significant proportion may become symptom free.”