Apokyn Initiation Without Antiemetic Prophylaxis Does Not Affect Tolerability in Parkinson Disease

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In recent analysis indicated that initiating apomorphine hydrochloride injection without antiemetic premedication was well-tolerated among patients with Parkinson disease.

Cindy Happel, RN, BSN  (Credit: LinkedIn)

Cindy Happel, RN, BSN

(Credit: LinkedIn)

A real-world analysis showed initiation of apomorphine hydrochloride injection (Apokyn; Supernus Pharmaceuticals) treatment without antiemetic prophylaxis, which is routinely performed in the United States, did not negatively impact tolerability in patients with Parkinson disease (PD). These findings suggest that flexible dose initiation and titration strategy, endorsed by a comprehensive support network such as the Clinical Educator Program (CEP), supports a successful treatment initiation.1

Among 149 patients with PD who initiated Apokyn without antiemetic premedication, 62% of initiated treatment at a 1.0 mg (0.1 mL) starting dose and 36% initiated treatment at a 2.0 mg (0.2 mL) dose. This contrasts to data from a prior patient cohort where -36% of the patients initiated at 1.0 mg and -61% initiated at 2.0 mg. Investigators further noted that the lack of antiemetic did not appear to affect treatment continuation. Approximately 19% of patients in the current analysis discontinued the treatment, for any reason, prior to completing 3 months of the therapy, compared with 24% in a prior cohort.

These results were presented by lead author Cindy Happel, RN, BSN, associate director of the Clinical Education Program at Supernus Pharmaceuticals, at the 3rd Annual Advanced Therapeutics in Movement and Related Disorders (ATMRD) Congress, held by the PMD Alliance from June 22-25, 2024. This analysis assessed Apokyn initiation doses and 3-month patient outcomes between September 1, 2022, and April 30, 2023, following the US label change in 2022 which included the initiation of the therapy without antiemetic pretreatment. Furthermore, researchers compared the data with a similar analysis of data assessing initiation with and without trimethobenzamide conducted between 2019 and 2021, prior to the label change.

READ MORE: Levodopa-Enhancing Activity Observed With Bezisterim in Phase 2A Study of Parkinson Disease

Top Clinical Takeaways

  • The findings showed that initiating Apokyn without antiemetic premedication did not negatively impact tolerability or continuation rates in patients with Parkinson disease.
  • Flexible dosing strategies, particularly starting at 1.0 mg and titrating based on patient response, displayed as effective for Apokyn initiation.
  • The Clinical Educator Program provides essential support through in-home visits, contributing to the success of Apokyn treatment initiation.

The CEP, part of the comprehensive Supernus-sponsored Circle network, offers support, including in-home visits, for patients with PD treated with Apokyn. In the CEP protocol, clinical educators are required to schedule a visit with each patient prior to initiation of Apokyn and during the post-initiation period. Clinical educator time logs were collected from the CEP database, which is the data used in the current analysis.

In the United States, trimethobenzamide was the antiemetic of option for patients with PD who initiated treatment with Apokyn to quickly manage their OFF episodes. Ever since the cessation of the United States trimethobenzamide manufacture in 2021, Apokyn initiations were largely done in patients with PD without antiemetic pretreatment. A prior analysis showed that lack of trimethobenzamide availability did not influence tolerably, as assessed by 90-day Apokyn continuation rates. Authors noted that clinicians who prescribe to patients are advised to consider initiating Apokyn at 1.0 mg (0.1 mL) instead of 2 mg (0.2 mL) in the absence of trimethobenzamide and titrating based on individual patient tolerability as well as effect.

The effectiveness of Apokyn for treatment of the OFF episodes in patients with advanced PD was established in randomized, placebo-controlled trials. The change from baseline in Part III of the Unified Parkinson’s Disease Rating Scale (UPDRS) served as the primary assessment measure in each study.2

A randomized, double-blind, placebo-controlled, parallel-group trial was conducted in 29 patients with advanced PD who had at least 2 hours of OFF time per day despite an optimized oral regimen for PD including levodopa and an oral dopaminergic agonist. After PD medications were withheld overnight, patients were titrated on Apokyn or placebo until they achieved a therapeutic response, defined as a response similar to the response to their usual dose of levodopa. Approximately 90% of patients receiving Apokyn versus none on placebo achieved a therapeutic response in 20 minutes of dosing.2 Apokyn-treated patients had a 23.9-point change compared with minimal change with placebo (P <.001); in addition, Apokyn aborted 95% of OFF episodes compared with 23% for placebo (P <.001).

In a similar study with 62 patients, Apokyn reversed OFF episodes in as early as 10 minutes. When used during an OFF episode Apokyn improved mobility quickly, with a robust 24.2-point reduction in mean UPDRS Part III motor scores at 20 minutes (primary end point) and a 19.9-point reduction at 10 minutes (secondary end point).3

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REFERENCES
1. Happel C, Grall M, Formella A. Initiation of apomorphine hydrochloride injection (Apokyn®) in the absence of an antiemetic in people with Parkinson's disease. Presented at: ATMRD; June 22-25, 2024; Washington, DC.
2. Dewey RB, Hutton JT, LeWitt PA, Factor SA. A randomized, double-blind, placebo-controlled trial of subcutaneously injected apomorphine for parkinsonian off-state events. Arch Neurol. 2001;58(9):1385-1392. doi:10.1001/archneur.58.9.1385
3. Pfeiffer RF, Gutmann L, Hull KL Jr, Bottini PB, Sherry JH; The APO302 Study Investigators. Continued efficacy and safety of subcutaneous apomorphine in patients with advanced Parkinson's disease. Parkinsonism Relat Disord. 2007;13(2):93-100. doi:10.1016/j.parkreldis.2006.06.012
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