Objective: Determine if baseline factors are associated with the apomorphine sublingual film (APL) dose required to achieve FULL “ON.”

Background: APL is approved for the on-demand treatment of “OFF” episodes associated with Parkinson’s disease (PD).

Method: Patients with PD and “OFF” episodes on stable PD medications were enrolled in 2 studies (pivotal: NCT02469090; long-term safety and efficacy: NCT02542696). APL dose titration occurred in patients who were “OFF” to determine the effective and tolerable dose (10–35 mg; 5-mg increments) that converted them to FULL “ON” within 45 min. Baseline factors evaluated included age, body mass index, gender, region, predose MDS-UPDRS Part III score, modified Hoehn and Yahr score when “ON,” time since PD diagnosis, baseline daily levodopa dose, length and number of “OFF” episodes, and use of dopamine agonists at baseline or monoamine oxidase-B inhibitors at any time. Association between baseline factors and APL dose that achieved FULL “ON” during titration was assessed by Spearman rank correlation and/or other descriptive statistics.

Results: This analysis evaluated 414 patients who completed dose titration across both studies. Moderate positive correlations were observed with APL dose resulting in FULL “ON” and predose MDS-UPDRS Part III score (n=414; r=0.233; 95% CI: 0.140, 0.322) and baseline daily levodopa dose (n=400; r=0.240; 95% CI: 0.145, 0.330). Higher (30–35 mg) vs lower (10–15 mg) APL doses, respectively, were required for patients with predose MDS-UPDRS Part III score ≥44 and <88 (58–61% vs 26–37%), PD diagnosis ≥5 years (87–91% vs 78–81%), baseline levodopa ≥900 mg/d (61–74% vs 44–45%), and baseline dopamine agonist use (74–76% vs 47–54%) to convert from “OFF” to FULL “ON.”

Conclusion: Baseline factors, including predose MDS-UPDRS Part III score, baseline daily levodopa dose, PD duration, and baseline dopamine agonist use may predict the doses of apomorphine sublingual film required to achieve an effective and tolerable FULL “ON.” Patients with more advanced disease may require higher doses of apomorphine sublingual film.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-for-off-episodes-in-parkinsons-disease-analysis-of-baseline-factors/