Continuous, subcutaneous apomorphine infusion for Parkinson disease motor fluctuations: Results from the phase 3, long-term, open-label United States InfusON study.

BackgroundContinuous subcutaneous apomorphine infusion (CSAI) has been used globally since the 1980s for Parkinson disease (PD) motor fluctuations but has not been available in the United States (US).ObjectiveEvaluate CSAI for motor fluctuations in the US setting.MethodsThis open-label study (NCT02339064) enrolled patients with PD experiencing ≥3 hours (h) daily OFF time despite optimized levodopa and current/prior use of at least one other adjunctive therapy. CSAI was initiated with a 1-2 mg bolus followed by 1 mg/h infusion titrated to optimal efficacy and tolerability. Following titration, patients entered a 52-week maintenance period.ResultsOf 99 patients treated, 85 completed the titration period, 69 completed maintenance week 12 and 48 completed maintenance week 52. Common treatment-related adverse events included infusion site nodules and erythema, dyskinesia, nausea, and somnolence, each of which occurred more frequently during the titration period. Reduction in OFF time began at CSAI initiation and reached a mean of 3.0 ± 3.18 h/day by maintenance week 12 (primary efficacy endpoint), with a corresponding increase in Good ON time of 3.1 ± 3.35 h/day. By maintenance week 12, 68% of patients rated themselves as much or very much improved, 62% had at least a 2-h reduction in daily OFF time, and mean concomitant oral levodopa and levodopa equivalent doses (excluding CSAI) had been reduced by 198 mg/day and 283 mg/day, respectively. Improvements were maintained through week 52.ConclusionsThis study supports the clinical utility of CSAI to reduce OFF time and increase Good ON time in patients with motor fluctuations inadequately controlled with oral therapy.