Objective: This study aims to evaluate the incidence of subcutaneous (SC) nodules in Parkinson’s patients treated with continuous 24-hour SC infusion of foslevodopa/foscarbidopa (LDp/CDp) and identify possible risk factors that may drive nodule development.

Background: Continuous SC LDp/CDp infusion is a new and emerging therapy for Parkinson’s Disease but there are limited data on SC nodule occurrence in relation to patient characteristics and infusion volume.

Method: 16 patients (10 male, 6 female) were treated as part of the Abbvie M15-741, M15-736 and M20-098 studies with assessments at 1, 3, 6, and 12 months. At each visit, two movement disorder nurses performed abdominal palpation to assess SC nodules, count and location.

Baseline characteristics (LEDD, disease duration, BMI, age, gender) were also collected. Patients were instructed to perform daily abdominal massage to SC nodules for at least 10 minutes using the hand, spiky rubber massage ball or handheld massage device.

A linear mixed-effects model was used to evaluate the effect of therapy duration (months), 24-hour infusion volumes and baseline characteristics on nodule counts across the timepoints while accounting for inter-subject variability.

Results: All patients remained on treatment at 12 months and SC nodules were identified in all patients (n=16, 100%) with 56% of patients (n=9) developing nodules by week 1.

A significant increase in nodule count was observed (mean nodules at 12 months 3.2, SD 2.3, min 1, max 9), with significant between-subject variability that was driven by 24-hour infusion volume only (β=0.227, p<0.001) and not related to therapy duration (β=0.041, p=0.338).

Post-hoc analysis revealed a significant positive correlation between 24-hour infusion volume and nodule formation Spearman’s (ρ = 0.678, p < 0.001). There was a weak positive correlation between LEDD at baseline and nodule count during the study period Spearman’s (ρ = 0.200, p = 0.019). Other baseline characteristics collected were not predictive of nodule formation.

Conclusion: SC nodules are likely to occur in most if not all Parkinson’s patients treated with LDp/CDp 24 hour infusion therapy. Our data suggests 24 hour infusion volume (ie dose) is the primary driver of nodule development. However with education, assessment and support from movement disorder specialist nurses, all patients were able to remain on treatment beyond 12 months.

References: Aldred, Jason et al. “Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson’s Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study.” Neurology and therapy vol. 12,6 (2023): 1937-1958.

Fung VSC, Aldred J, Arroyo MP, et al. Continuous subcutaneous foslevodopa/foscarbidopa infusion for the treatment of motor fluctuations in Parkinson’s disease: Considerations for initiation and maintenance. Clin Park Relat Disord 2024; Feb 10;10: 100239.

Soileau MJ, Aldred J, Budur K, et al. Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson’s disease: a randomised, double-blind, active-controlled, phase 3 trial. Lancet Neurol. 2022 Dec;21(12):1099-1109.

Todd, Amy, and Cherry-Ann James. “Apomorphine nodules in Parkinson’s disease: best practice considerations.” British journal of community nursing vol. 13,10 (2008): 457-63.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/incidence-and-determinants-of-nodule-formation-in-continuous-subcutaneous-foslevodopa-foscarbidopa-infusion-therapy/