Improvement in Uninterrupted Good ON Time and Reduction in OFF Periods with CSAI Treatment
Daniel Kremens1, Robert Hauser2, Andrea Formella3, Milan Joshi3, Mindy Grall3
1Sidney Kimmel Medical College of Jefferson University Comprehensive Parkinson's Disease and Movement Disorders Center, 2University of South Florida Parkinson's Disease and Movement Disorders Center, 3Supernus Pharmaceuticals
Objective:

Evaluate the effect of continuous subcutaneous apomorphine infusion (CSAI) on daily OFF time and Good ON time (ON without troublesome dyskinesia) via diaries in people with Parkinson disease (PD) and motor fluctuations.

Background:

The Phase 3 open-label InfusON study (NCT02339064) showed that, after 12 weeks of maintenance treatment with CSAI, patients’ daily OFF time decreased by a mean of ‑3.0 hours with a corresponding increase in Good ON time (+3.1 hours).

Design/Methods:
InfusON enrolled individuals experiencing ≥3 hours of daily OFF time despite optimized therapy. Patients were titrated to optimal CSAI rates before entering a 52-week Maintenance Period. OFF time was measured at Week 12 using Hauser PD diaries. In this post hoc analysis, patient data were analyzed via heat maps showing periods of sleep, OFF time, Good ON time, and ON time with troublesome dyskinesia at 30-minute intervals. The longest period of uninterrupted Good ON time was also determined.
Results:

Of 99 enrolled patients, 65 had evaluable diaries at Baseline and Week 12. The infusion rate at Week 12 was median (range) 4 (1,7) mg/h. Waking‑hour diary entries showed reduced OFF time for most patients (mean ± SD: ‑3.1 ± 3.16 h from Baseline: 6.6 ± 2.43), with some patients reporting no waking hour OFF time. The percent change from Baseline in the number of OFF periods was -40 ± 35.4%. The mean daily longest duration of uninterrupted Good ON time increased from 4.4 ± 2.73 h at Baseline to 9.6 ± 5.80 h at Week 12. Despite dyskinesia being commonly reported during titration, heat maps showed fewer patients reporting troublesome dyskinesia at Week 12 (n=6) than at Baseline (n=12).

Conclusions:

CSAI therapy reduced patients’ daily number of OFF periods, reduced overall OFF time, and on average more than doubled longest duration uninterrupted Good ON time.

10.1212/WNL.0000000000211272
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.