Objective: Examine dyskinesia and quality of life (QoL) outcomes in patients experiencing meaningful clinical improvements in “off” time during treatment with foslevodopa/foscarbidopa (LDp/CDp).

Background: Clinical trials of continuous subcutaneous LDp/CDp infusion demonstrated safety and efficacy in patients with advanced Parkinson’s disease (aPD). Interim data from the ongoing, real-world ROSSINI study (NCT06107426) show significant reductions in “off” time after 6 months (M) of treatment with LDp/CDp.

Method: Patients from the ROSSINI study with baseline and 6M follow-up data were included. “Off” time and dyskinesia hours were measured by MDS-UPDRS items 4.3 and 4.1, respectively, and PD-related QoL by PDQ-39 summary index (SI). Outcomes were evaluated among patients with ≥1-hour reduction (minimal clinically important difference) or ≥3-hour reduction in “off” time. Among these groups, least-squares mean changes from baseline to 6M were estimated using a mixed model for repeated measures (MMRM) adjusted for country. Data were summarized as mean (SD) among patients who achieved complete elimination of “off” time.

Results: Among the 40 patients with baseline and 6M “off” time data, 33 (82.5%) had a ≥1-hour reduction, 24 (60%) had ≥3-hour reduction, and 6 (15%) achieved complete elimination of “off” time (mean [SD] change, -5.2 [0.7] hours). Patients with ≥1-hour “off” time reduction showed a 1.2-hour (SE 0.4, P=.004) decrease in dyskinesia and a 5.4-point (SE 2.4, n=28, P=.026) PDQ-39 SI improvement. Those with ≥3-hour “off” time reduction showed a non-significant 0.7-hour (SE 0.5, P=.127) reduction in dyskinesia time, but a 6.4-point (SE 2.8, n=19, P=.024) PDQ-39 SI improvement. Among the 6 patients with complete “off” time elimination, mean (SD) dyskinesia time decreased from 2.4 (3.5) hours at baseline to 0.3 (0.5) hours at 6M, and PDQ-39 SI improved from 37.4 (18.7) to 29.1 (19.2) points (n=5).

Conclusion: A high proportion of patients treated with LDp/CDp through 6M showed meaningful improvements in “off” time, accompanied by reduced dyskinesia, suggesting increased time spent in the therapeutic window with LDp/CDp infusion. Numerically greater improvements in QoL were observed among patients with larger reductions in “off” time.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/real-world-impact-of-off-time-reduction-with-foslevodopa-foscarbidopa-in-advanced-parkinsons-disease-post-hoc-analysis-of-the-rossini-study/