Use of Real-World Data to Evaluate the Importance of Antiemetic Pretreatment for Apomorphine hydrochloride [APO, Apokyn®] subcutaneous Injection Initiation and Maintenance in People with Parkinson Disease (P13-11.016)

Abstract

<h3>Objective:</h3> Real-world data from a clinical educator (CE) database was used to evaluate whether changes in antiemetic availability affected Apokyn treatment maintenance. <h3>Background:</h3> APO is an “on demand” treatment to rapidly alleviate OFF episodes in people with Parkinson Disease (PwP). To decrease potential for nausea and vomiting with APO initiation (a common dopamine agonist side effect), antiemetic pretreatment with trimethobenzamide (Tigan) has been recommended. However in 2021, a widespread Tigan shortage (due to cessation of manufacturing), left clinicians without a suitable antiemetic for use with APO in PwP and questions arose as to whether pretreatment was needed. <h3>Design/Methods:</h3> The Circle of Care (CoC) program (sponsored by Supernus Pharmaceuticals) provides Clinical Educators (CEs) to teach consenting patients how to correctly self-administer Apokyn and aid in initiation and maintenance needs. The CoC database was analyzed from 2019–2021 to determine 1) the percentage of patients first initiating APO who received a Tigan reminder call (a proxy for Tigan use), 2) APO initiation dose and 3) all cause treatment discontinuation within 90 days of initiation (a proxy for tolerability). <h3>Results:</h3> Data were available for 1910 unique patient starts. Due to Tigan shortage APO initiations without antiemetic pretreatment rose from 30% in 2019 and 2020 to &gt;80% by end of 2021. Despite a Tigan shortage, initiation doses did not change substantially across the 2019, 2020, and 2021 evaluation with 35.5%. 34%. 39.5%, respectively, starting at 1.0 mg and 59%, 61%, and 57%, respectively, initiating at 2.0 mg. All cause discontinuation within 90 days of initiation also remained largely constant across the 3-year evaluation period (26%, 23% and 23%, respectively) and did not differ by Tigan use [23% in both Tigan users and nonusers in 2021]. <h3>Conclusions:</h3> Overall, our analysis demonstrates that PwP can successfully initiate apomorphine SC injection without antiemetic prophylaxis. <b>Disclosure:</b> Cindy Happel has stock in Supernus Pharmaceutical. Ms. Grall has received personal compensation for serving as an employee of Supernus Pharmaceuticals. Ms. Grall has stock in Supernus. Dr. Formella has received personal compensation for serving as an employee of Adamas Pharmaceuticals, Inc. Dr. Formella has received personal compensation for serving as an employee of Supernus Pharmaceuticals, Inc. Dr. Formella has stock in Adamas Pharmaceuticals. Dr. Formella has stock in Supernus Pharmaceuticals, Inc..