Objective: Evaluate outcomes (up to 3 years) from the ongoing Extension Period of the InfusON study (NCT02339064) of continuous subcutaneous apomorphine infusion (CSAI).

Background: Primary data from the InfusON study showed that CSAI as adjunctive treatment for Parkinson disease (PD) motor fluctuations was generally safe and well-tolerated. CSAI provided ongoing reduction in OFF time and corresponding improvement in Good ON time (ON time without troublesome dyskinesia) over a 52-Week Maintenance Period.

Method: This open-label study, conducted in the U.S., enrolled individuals experiencing ≥3 hours (h) daily OFF time despite optimized levodopa plus current or prior use of ≥1 additional therapy. CSAI was initiated with a 1-2 mg bolus followed by 1 mg/h infusion, titrated to optimal efficacy and tolerability (not exceeding 8 mg/h or 150 mg/day), after which participants entered a 52-week Maintenance Period. Individuals completing the Maintenance Period could continue in an Extension Period. Results, including changes in OFF time and Good ON time, are presented descriptively (observed cases) from a 15JUN2023 data cut.

Results: Of 99 participants treated, 69 completed Maintenance Week 12 (primary efficacy timepoint), and 48 completed Maintenance Week 52. Of 45 participants who continued into the Extension Period, 27 completed ≥2 years and 21 completed ≥3 years of CSAI treatment. By Maintenance Week 12, the mean (SD) daily OFF time had decreased by -3.0 (3.2) h from a baseline of 6.6 (2.4) h (primary efficacy endpoint), and this was sustained at the 1‑year: -3.2 (3.2) h, 2-year: -2.9 (3.2) h and 3-year: -3.8 (4.3) h visits. The corresponding Week 12 increase in Good ON time was 3.1 (3.4) h from a baseline of 9.3 (2.6) h, and this was also sustained at the 1-year: 3.7 (3.3) h, 2-year: 3.2 (3.4) h and 3-year: 3.7 (3.6) h visits. The fraction of participants who rated themselves as improved compared to baseline (Patient Global Impression of Change) was 90% at 1 year, 90% at 2 years, and 86% at 3 years. The most common adverse events were infusion site nodules, most of which were mild in severity.

Conclusion: These data support the long-term safety, tolerability, and efficacy of adjunctive CSAI.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/continuous-subcutaneous-apomorphine-infusion-for-parkinson-disease-motor-fluctuations-long-term-data-from-the-ongoing-infuson-extension-study/