Abstract Details

Title The real-world use of istradefylline for Parkinson’s disease: Post-marketing surveillance of safety and effectiveness in Japan

Topic Movement Disorders

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 254

Objective To assess safety and effectiveness of long-term istradefylline in the real-world setting.

Background Istradefylline, an adenosine A_2A receptor antagonist (non-dopaminergic anti-Parkinson’s disease [PD] medication), is indicated in the USA and Japan as adjunct to levodopa-containing products for PD patients experiencing “off” episodes. We previously reported an interim analysis of real-world use in Japan; the final results are now available.

Design/Methods We conducted an observational, prospective, regulatory post-marketing surveillance (PMS) study in Japan. Patients were enrolled from May 2013 to May 2017 and followed for 1 year. Patients initiating 20 mg, once-daily istradefylline (increased to 40 mg as required) to improve wearing-off symptoms were included. Adverse events and adverse drug reactions (ADRs) were recorded. The occurrence of psychiatric symptoms was the priority survey item. Effectiveness was determined using the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III, physician-assessed motor function, and global assessment.

Results The safety and effectiveness analysis sets included 1,318 and 1,284 patients, respectively. The mean patient age was 71.5 years. The mean levodopa dose was 414.2 mg/day, most patients were receiving concomitant anti-PD medications, and the mean duration of istradefylline therapy was 293.9 days. Regarding safety, 20.8% of patients experienced ADRs and 3.0% had serious ADRs. The most common ADR was dyskinesia (4.9%). Psychiatric ADRs occurred in 4.9% of patients; most frequently hallucination (2.4%) and visual hallucination (1.4%). The mean (standard deviation) UPDRS Part III total score was significantly reduced from 32.8 (17.4) at baseline to 29.6 (17.0) and 28.9 (16.4) at 6 months and 1 year, respectively (both p<0.001). Physicians rated istradefylline as effective in 59.8% of patients, ineffective in 21.0%, and unevaluable in 19.2%.

Conclusions The final results from this PMS showed that long-term use of istradefylline is well-tolerated and effective for PD patients experiencing wearing-off with levodopa therapy in the real-world setting.

Authors/Disclosures
Makio Takahashi PRESENTER	Makio Takahashi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin Co., Ltd.
Satoru Ito (Kyowa Kirin Co., Ltd.)	No disclosure on file
	No disclosure on file
	No disclosure on file

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