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.”