Levodopa-Carbidopa Intestinal Gel Effective for Dyskinesia in Advanced Parkinson Disease

September 14, 2020

Improvement in dyskinesia occurred after 2 weeks of treatment with levodopa-carbidopa intestinal gel and was sustained throughout the study.

Data from the phase 3b DYSCOVER study (NCT02799381) in patients with advanced Parkinson disease (aPD) demonstrated that treatment with levodopa-carbidopa intestinal gel (LCIG) significantly improved dyskinesia compared to optimized medical treatment (OMT), supporting the idea that LCIG can be an effective treatment for dyskinesia in patients with aPD.1

Presented at the 2020 MDS Virtual Congress, September 12–16, 2020, the primary end point of mean change from baseline in dyskinesia, as measured by the Unified Dyskinesia Rating Scale (UDysRS), was significantly improved in the LCIG group (n = 24; –17.4 [±2.8]) compared to the OMT group (n = 26; –2.3 [±2.6]) at week 12 (mean difference, –15.1; 95% CI, –21.5 to –8.6; P <.001).

Notably, the improvement in dyskinesia occurred after 2 weeks of treatment and was sustained throughout the course of the study.

Investigators of the study noted that the observed safety events in the study were in line with the established LCIG safety profile. Treatment-emergent adverse events (TEAEs) were reported in 27 patients (44.3%), 18 (64.3%) of which were treated with LCIG and 9 (27.3%) who were treated with OMT. There were serious AEs that occurred in 2 (7.1%) patients treated with LCIG.

Patients randomized to OMT continued their current anti-PD medication regimen for the duration of the study. All ant-PD medications and medications to treat dyskinesia remained stable during the duration of the study unless adjustments were medically indicated.

The total daily dose of infusion LCIG was composed of a morning dose, continuous maintenance infusion dose and extra doses. According to clinicaltrials.gov, a temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a patient’s response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy.

Overall, women made up 48.5% of patients on OMT and 57.1% of patients treated with LCIG. The baseline age was 68.7 (±7.2) and 69.3 (±7.0) years for both the OMT and LCIG groups, respectively. Both groups had similar PD duration (OMT: 12.8 years [±6.4]; LCIG: 12.7 years [±1.7]).

LCIG, otherwise known as Duopa (AbbVie), was approved for the treatment of motor fluctuations for people with aPD in January 2015.2 It is currently indicated in the EU for the treatment of levodopa-responsive PD with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. Duopa is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally placed tube.

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REFERENCES
1. Alvarez EF, Spanaki C, Pekkonen E, et al. Effect of levodopa-carbidopa intestinal gel versus optimized medical treatment on dyskinesia in advanced Parkinson’s disease patients: final results of the randomized 12-week DYSCOVER study. Presented at MDS Virtual Congress; September 12–16, 2020. Abstract 867
2. AbbVie announces U.S. FDA approval of Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. News release. North Chicago, Ill: AbbVie. January 12, 2015. Accessed September 14, 2020. https://news.abbvie.com/news/abbvie-announces-us-fda-approval-duopa-carbidopa-and-levodopa-enteral-suspension-for-treatment-motor-fluctuations-in-patients-with-advanced-parkinsons-disease.htm#:~:text=DUOPA%20was%20reviewed%20and%20approved,%C2%AE%20outside%20the%20United%20States.