Abstract Details

CSAI delivered using a wearable pump has been used worldwide to treat motor fluctuations in PD patients, but there are few prospective evidence-based trials performed. We report here the final 52-week results of the AP2-3000 study.

Evaluate long-term safety and efficacy of continuous subcutaneous apomorphine infusion (CSAI) for motor fluctuations in Parkinson’s disease (PD) patients treated in United States (US) settings.

This open-label study (clinicaltrials.gov NCT02339064) enrolled PD patients with ≥3 hours daily OFF time despite optimized antiparkinsonian therapy (levodopa plus ≥1 additional PD medication). Patients were titrated to optimal CSAI rates for best efficacy and minimal adverse events (AEs) before entering a 52-week maintenance period.

Of the 99 patients enrolled, 85 entered maintenance, 69 completed 12 weeks, and 48 completed 52-week maintenance treatment. The mean ± SD daily dose through Week 52 was 45.2 ± 23.1mg. Treatment-related AEs included infusion site nodules (77.8%), dyskinesia (38.4%), nausea (29.3 %), infusion site erythema (27.3%), and somnolence (25.3%), all of which occurred more frequently during the dose titration and optimization period. At Maintenance Week 12, daily OFF time decreased by a mean ± SD -3.0 ± 3.2 hours from baseline (primary efficacy endpoint), and ON time without troublesome dyskinesia increased by 3.1 ± 3.4 hours. Overall, 68.0% of patients rated themselves “much/very much” improved and mean daily levodopa and levodopa equivalent doses decreased by -198mg and -283mg, respectively. Responder analysis at Maintenance Week 12 showed that 62.1% of patients achieved ≥2 hours improvement in daily OFF from Baseline. Endpoints at Week 52 were consistent with Week 12 improvements.

CSAI reduced OFF time, increased ON time without troublesome dyskinesia, and allowed for oral PD medication reduction in patients inadequately controlled by optimized levodopa therapy. AEs were consistent with prior studies of CSAI in the PD population.