Impact of 6-month earlier versus postponed initiation of rotigotine on long-term outcome: post hoc analysis of patients with early Parkinson’s disease with mild symptom severity

Abstract

Objective: Investigate impact of 6-month earlier versus postponed initiation of rotigotine in patients with early Parkinson’s disease (PD) with mild symptom severity.

Background: Long-term benefit of rotigotine in early-PD has been demonstrated: SP702 (NCT00594165) and SP716 (NCT00599196) were long-term, open-label extensions of double-blind, placebo-controlled studies of 6-month maintenance; rotigotine was well tolerated for up to 6 years, and demonstrated efficacy (Unified Parkinson’s Disease Rating Scale [UPDRS] II + III below baseline) for ∼ 2 years (SP702) and ∼ 4 years (SP716).

Methods: Post hoc analysis of patients at Hoehn and Yahr 1–2; groups defined by treatment received in 6-month double-blind studies: ‘Rotigotine–Rotigotine’ received rotigotine (n = 221), ‘Placebo–Rotigotine’ received placebo (n = 125).

Results: At the start of open-label rotigotine maintenance, UPDRS II + III mean ± SD change from double-blind baseline was: −8.5 ± 10.6 ‘Rotigotine–Rotigotine’, −7.7 ± 9.0 ‘Placebo–Rotigotine.’ After this initial improvement scores gradually increased: It took ∼ 45 months for mean scores to cross baseline in ‘Rotigotine–Rotigotine’, and ∼ 21 months in ‘Placebo–Rotigotine.’ At the time mean UPDRS II + III had crossed baseline in ‘Placebo–Rotigotine’ (open-label week 84; ∼ 21 months), treatment difference (LS-mean) to ‘Rotigotine–Rotigotine’ change from baseline was −3.89 (95% CI −6.94, −0.84); p = 0.013.

Conclusions: In this post hoc analysis, 6-month earlier initiation of rotigotine resulted in slower return to baseline mean UPDRS II + III; initiation of rotigotine in patients with minimal/no functional disability or impairment may lead to an extended benefit.

Keywords:

• activities of daily living
• early Parkinson’s disease
• long-term efficacy
• motor control
• rotigotine transdermal patch
• Unified Parkinson’s Disease Rating Scale

Declaration of interest

This study was supported by UCB Pharma, Monheim am Rhein, Germany. The sponsors were involved in the design of the study, the analysis and interpretation of data and in the decision to submit the paper for publication. The authors acknowledge Emily Thompson, PhD (Evidence Scientific Solutions, London, UK) for writing assistance which was funded by UCB Pharma, Brussels, Belgium, and Cédric Laloyaux, PhD (Global Publications Manager, UCB Pharma, Brussels, Belgium) for publication coordination. L Timmermann has received payments as a consultant for Medtronic Inc., Boston Scientific, SAPIENS, St Jude Medical, Bayer Healthcare, UCB Pharma, Archimedes Pharma; has received honoraria as a speaker on symposia sponsored by TEVA Pharmaceuticals, Lundbeck Pharma, Bracco, Gianni PR, Medas Pharma, UCB Pharma, Desitin Pharma, Boehringer Ingelheim, GlaxoSmithKline, Eumecom, Orion Pharma, Medtronic, Boston Scientific, Cephalon, Abbott, GE Medical, Archimedes, Bayer. The institution of L Timmermann, not L Timmermann personally, received funding by the German Research Foundation, the German Ministry of Education and Research, Manfred und Ursula Müller Stiftung, Klüh Stiftung, Hoffnungsbaum e. V., NBIA DISORDERS SOCIETY USA, Köln Fortune, Medtronic, Deutsche Parkinson Vereinigung. Archimedes Pharma, Abbott, Bayer, UCB Pharma, Zur Rose Pharma, TEVA Pharmaceuticals. LW Elmer has received speaker’s bureau honoraria or consulting fees from Lundbeck, Novartis, TEVA Pharmaceuticals, and UCB Pharma; and has received research or unrestricted educational grant support from TEVA Pharmaceuticals. M Asgharnejad, B Boroojerdi, E Dohin, and F Woltering are salaried employees of UCB Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Notes