Abstract Details

Title Increased “Off” Time is Associated with Poorer Clinical and Humanistic Outcomes in Patients with Advancing Parkinson’s Disease: Results From the PROSPECT Observational Study

Topic Movement Disorders

Presentation(s) P5 - Poster Session 5 (11:45 AM-12:45 PM)

Poster/Presentation
Number 16-013

Objective Evaluate association of increased “Off” time with clinical and humanistic outcomes in people with advanced Parkinson’s disease (PwP) inadequately managed by oral PD therapies.

Background As PD progresses, managing symptoms with oral regimens becomes more challenging. Real-world evidence linking increased “Off” time with worsened motor and non-motor symptoms (NMS) and diminished quality of life (QoL) is limited.

Design/Methods The 24-month international, prospective observational PROSPECT study enrolled levodopa-responsive adults (≥30 years) with ≥2.5 “Off” hours/day despite optimized oral PD therapies. Normalized “Off” hours/day were calculated from PD Hauser diaries. Clinical outcomes included morning akinesia, fall incidence, episodes of motor fluctuations/day, NMS, and sleep disturbance. Humanistic outcomes included QoL, activities of daily living, activity impairment, and treatment satisfaction. “Off” time and outcomes were assessed at baseline and every 6 months with data pooled across visits. Associations were analyzed by adjusted logistic and robust linear regressions.

Results

There were 842 observation visits across 229 PwP, with baseline mean (SD) age of 67.8 (9.4) years, Hoehn & Yahr stage score of 2.3 (0.9), PD duration of 8.7 (5.4) years, and motor fluctuation duration of 6.0 (5.2) years. Mean (SD) “Off” time was 4.4 (2.6) hours, with 74% of observations ≥3 hours/day, suggesting poorly managed PD. Each 1-hour increase in “Off” time raised morning akinesia odds by 37.7% (P<.001). Hourly increases in “Off” time were significantly associated with higher NMSS (worsening NMS), PDSS-2 (poorer sleep quality), PDQ-39 (poorer PD-related QoL), and WPAI (greater activity impairment) scores; more motor fluctuation episodes/day; and lower scores for EQ-5D-5L/EQ-VAS (poorer QoL) and TSQM-9 in 2 domains (reduced treatment global satisfaction and perceived treatment effectiveness) (all P<.05).

Conclusions

Increased “Off” hours/day was associated with worse clinical and humanistic outcomes in a real-world setting of PwP on oral regimens. This highlights the critical need for earlier optimization of PD treatment strategies, including regimens beyond oral therapies.

Authors/Disclosures
Pilar Sanchez Alonso PRESENTER	Pilar Sanchez Alonso has received personal compensation in the range of $500-$4,999 for serving as a Consultant for zambon. Pilar Sanchez Alonso has received personal compensation in the range of $0-$499 for serving as a Consultant for Bial. The institution of Pilar Sanchez Alonso has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for abbvie. Pilar Sanchez Alonso has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for zambon. Pilar Sanchez Alonso has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for bial. Pilar Sanchez Alonso has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for abbvie.
David J. Houghton, MD (Ochsner Health)	Dr. Houghton has nothing to disclose.
Fabienne Ory	Fabienne Ory has received personal compensation in the range of $500-$4,999 for serving as a Consultant for abbvie. Fabienne Ory has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for abbvie. Fabienne Ory has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for aguettant. Fabienne Ory has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for abbvie. The institution of Fabienne Ory has received research support from fondation santé recherche.
Tomoko Oeda, MD, PhD	Dr. Oeda has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. The institution of Dr. Oeda has received research support from Japan Blood Products Organization.
Delaram Safarpour, MD, MSCE, FAAN (Parkinson Center Oregon Health & Science University)	Dr. Safarpour has received personal compensation in the range of $500-$4,999 for serving as a Consultant for 2nd MD. Dr. Safarpour has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Safarpour has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Safarpour has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Insightec. Dr. Safarpour has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BlueRock. Dr. Safarpour has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia. Dr. Safarpour has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific. The institution of Dr. Safarpour has received research support from Medtronic. The institution of Dr. Safarpour has received research support from Amneal. The institution of Dr. Safarpour has received research support from CND life science.
Lars Bergmann, MD (Abbvie GmbH & Co)	Lars Bergmann has received personal compensation for serving as an employee of Abbvie. Lars Bergmann has stock in Abbvie.
Pavnit Kukreja, PharmD (AbbVie)	Dr. Kukreja has received personal compensation for serving as an employee of AbbVie. Dr. Kukreja has stock in AbbVie.
Koray Onuk	Koray Onuk has nothing to disclose.
siting wang	Mr. wang has received personal compensation for serving as an employee of Abbvie Inc,. Mr. wang has stock in Abbvie Inc.
Connie H. Yan, PhD, PharmD (AbbVie Inc)	Dr. Yan has received personal compensation for serving as an employee of AbbVie Inc. Dr. Yan has stock in AbbVie Inc.
David G. Standaert, MD, PhD, FAAN (Univ of Alabama - Dept of Neurology)	Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie, Inc. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curium. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CVS/Pharmacy. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll Biopharma. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for F. Hoffman LaRoche. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Aventis. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theravance, Inc. Dr. Standaert has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for International Parkinson and Movement Disorder Society. The institution of Dr. Standaert has received research support from Abbvie, Inc. The institution of Dr. Standaert has received research support from American Parkinson Disease Association. The institution of Dr. Standaert has received research support from National Institutes of Health. The institution of Dr. Standaert has received research support from F. Hoffman LaRoche. Dr. Standaert has received publishing royalties from a publication relating to health care. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with National Institutes of Health. Dr. Standaert has a non-compensated relationship as a Chair, Scientific Advisory Board with American Parkinson Disease Association that is relevant to AAN interests or activities.

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