Continuous levodopa/carbidopa infusion shows favourable safety and efficacy

Continuous levodopa/carbidopa infusion (ND0612) showed a favourable safety profile and was well-tolerated over the longer term in patients with Parkinson’s disease (PD) who have motor fluctuations. Patients achieved clinically relevant increases in ON-time without troublesome dyskinesia, as well as decreases in OFF-time.

These were the main conclusions drawn from the 3-year data of the BeyoND study (NCT02726386) [1]. This open-label study evaluates the long-term safety of ND0612 in PD patients who experience ≥2 hours of daily OFF-time. The results confirmed the previously published positive outcomes after 1 year [2]. In this study, 214 participants entered, 120 of whom completed 1 year and 114 participants entered the extension study (OLE). The 3-year results were presented by Dr Aaron Ellenbogen (Michigan Institute for Neurological Disorders, MI, USA). He said that 94 (82.5%) participants completed ≥2 years and 76 (80.1%) completed ≥3 years of ND0612 treatment; some participants were already in their 7^th year. Of the 20 participants who discontinued, 10 withdrew consent, and 4 experienced intolerable side effects (AEs).

At baseline, participants who entered the extension phase had a mean (± SD) OFF-time of 5.6 (± 2.9) hours, and the mean Unified Parkinson’s Disease Rating Scale (UPDRS) motor score was 26.1 (±12.8). 57 (50%) had a modified Hoehn and Yahr Scale score of 2; 27 (23.7%) a score of 2,5; and 30 (26.3%) a score of 3. The systemic safety profile was comparable to expected profiles for an LD/CD product, according to Dr Ellenbogen. In year 1 of the OLE (n=114), 73.7% of had drug-related AEs; in year 2 (n=111) this percentage dropped to 36.9%; in year 3 (n=94) it was 39.4%. Infusion site reactions were common, mostly mild, and rarely led to discontinuation, Dr Ellenbogen observed. These reactions also tended to decrease over time: from 60.5% of patients in year 1, to 26.1% in year 2 and 27.7% in year 3. The incidence of infusion-site infection decreased from 19.3% in year 1 to 9.9% in year 2 and was 11.7% in year 3. Dyskinesia was seen in 3.5% of participants in year 1, none in year 2, and 1.1% in year 3.

Exploratory efficacy results in 45 participants at month 36 showed those participants had a mean reduction in OFF-time of -2.81 hours. The increase in Good ON-time was 2.79 hours.

1. 1. Ellenbogen AL, et al. Safety and efficacy of continuous subcutaneous levodopa/carbidopa infusion for Parkinson’s disease. Three-year data from the open-label BeyoND study. Session PL4.003, AAN 2023 Annual Meeting, 22–27 April, Boston, USA.
   2. Poewe W, et al. Mov Disord 2021;36(11):2687–92.

 

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Posted on 2 May, 2023