Objective: Outline European Union (EU) long-term experience with higher doses (≥6 mg/h or ≥100 mg/d) of continuous subcutaneous apomorphine infusion (CSAI).

Background: The EU TOLEDO and US InfusON trials provide phase 3 data supporting CSAI efficacy and safety for Parkinson disease (PD) motor fluctuation treatment. Infusion rates up to 9 mg/h were reported in TOLEDO, and total daily doses as high as 144 mg/d were reported in InfusON. However, only 11 patients from these two clinical trials had exposure rates ≥ 6mg/h and/or ≥100mg/d for ≥365 days, and this small sample limits the generalizability of the safety information. Therefore, we gathered additional real-world data (RWD) on higher dose use from EU sites, where CSAI is extensively used.

Method: Anonymized patient data, including basic demographics, apomorphine dosing, duration of use, and adverse events (AE), were provided by movement disorders specialists in France and Spain, and through patient databases in the UK and the Netherlands for patients using average CSAI doses ≥100mg/d or ≥6 mg/h for at least 1 year.

Results: RWD were available for 63 patients from the EU sites, with mean age 71.2±8.03 years, 66.7% male sex, and median (range) PD duration 19.0 (8.0, 47.0) years. Modal doses ≥100 mg/d were used by 74.6% (41.3% with ≥128 mg/d) of PD patients. Modal infusion rates ≥6 mg/h were used by 95.2% (15.9% with ≥8 mg/h) of PD patients. In the RWD sample, 43% of patients reported any AE, most commonly skin nodules (38.1%). No other AE was reported by more than one patient.

Conclusion: CSAI is an important option for patients with advancing PD. The data suggest patients may benefit from, and can be safely maintained on, CSAI doses ≥6mg/h or ≥100 mg/d. These EU data extend the safety information about higher daily doses and higher infusion rates of apomorphine. RWD surrounding the need for higher doses as well as the safety and efficacy of long-term exposure to higher CSAI doses in U.S. patients may provide additional information about the administration of CSAI.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/european-experience-with-long-term-continuous-subcutaneous-apomorphine-infusions-at-higher-doses/