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A recent survey showed that patients with Parkinson disease quickly adapted to using continuous subcutaneous apomorphine infusion therapy, with high amount of recommending the device to others.
Pinky Agarwal, MD, FAAN
(Credit: Evergreen Health)
In an interview-based survey of patient experiences on continuous subcutaneous apomorphine infusion (CSAI) therapy from the InfusON study (NCT02339064), respondents reported that they adapted quickly to using the CSAI device and easily incorporated it into their daily routine, with most patients saying they would recommend CSAI to others living with Parkinson disease (PD). These responses are critical to understanding the usage of CSAI for PD since patient experience is considered a key driver by clinicians for how long they typically will stay on the treatment.1
Presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders, held September 27 to October 1, in Philadelphia, Pennsylvania, by lead author Pinky Agarwal, MD, FAAN, a neurologist of Booth Gardner Parkinson’s Care Center at EvergreenHealth, 63% of respondents reported the ability to independently set up and start CSAI therapy while the rest had assistance from their care partner. Notably, patient responses showed that they developed confidence with the setup of the infusion and wore the device quickly, with 79% of respondents being comfortable with the setup and 68% adapting to wearing the device in about 2 weeks.
In the InfusON study, performed in the United States, investigators enrolled levodopa-treated patients with PD who had unsatisfactory control of motor fluctuations despite optimization of oral medication. During the study, patients initiated CSAI in an outpatient clinic with a 1-2 mg bolus which was followed by 1 mg/h infusion titrated to optimal efficacy and tolerability to not exceed 8 mg/h or 150 mg/day. Researchers then had participants enter a 52-week maintenance period. In the current survey, 19 patients from 9 sites who completed the maintenance period and entered the study's extension, which provided an avenue for continued therapy until commercial availability, consented to provide their responses on experience with the treatment.
Additional responses from the survey showed that only 16% of patients reported the device to be uncomfortable once they were used to it; however this did not lead to discontinuation, as noted by the researchers. Although a majority of patients stated that it initially required longer than 10 minutes to set up the infusion (74%), once adjusted to the process, most completed the setup between 5 to 10 minutes (89%). Investigators also noted that though patients reported alternating infusion sites on the body, with the abdomen and upper arms/shoulders as the most frequently used locations. Overall, 95% of respondents recommended CSAI for other patients that need treatment for motor fluctuations in PD.
READ MORE: Nocturnal and Morning Akinesia Still Prevalent After Nighttime Add-On Parkinson Medications
Earlier this year, at the 3rd Annual Advanced Therapeutics in Movement and Related Disorders (ATMRD) Congress, held by the PMD Alliance from June 22-25, 2024, responder rate data from the open-label, phase 3 InfusON trial demonstrated that CSAI therapy significantly reduced OFF time in patients with PD, with benefits sustained through 52 weeks of the maintenance period.2 Conducted by lead author Stuart Isaacson, MD, FAAN, director for the Parkinson’s Disease and Movement Disorders Center of Boca Raton in Florida, the study included outpatients with recurrent motor fluctuations despite optimized PD medications.
Participants initiated CSAI with a 1-2 mg bolus, followed by a 1mg (0.2mL)/h infusion. CSAI was then titrated in 0.5-1 mg/h increments at clinic visits (1-10 days apart) to an optimal rate based on response and tolerability (maximum 8 mg/h). Other PD medications could be adjusted to manage dopaminergic adverse effects. Researchers defined responders as those with at least 2 hours of improvement in OFF time from baseline.
At the CSAl initiation dose, authors reported that reduction in OFF time was noted, with 27% meeting response criteria prior to the first titration visit. Notably, responder rates continued to improve with CSAI optimization, reaching 61% by the start of the maintenance period and sustained through 52 weeks of the maintenance period. Additionally, diary measures showed immediate improvement upon CSAI initiation, with reductions in OFF time and improvement in good ON time that increased with CSAI optimization in the titration period and was sustained throughout the maintenance period.
Among 99 patients who were initiated on CSAI, 94 had post-baseline efficacy data and 85 completed the titration period. The patients enrolled typically required 3 to 5 titration visits (median = 4 visits) for CSAI optimization. The median duration of the titration period was 30 days. About 48 participants reduced concomitant PD medications during the titration period to manage dopaminergic AEs, with median time to first medication reduction of 9 days (range 2 to 44 days).
The adverse events (AEs) reported during CSAI titration were mainly mild to moderate in severity, with infusion site nodules and/or erythema, dyskinesia, and nausea as the most observed. The noted infusion site reactions were not severe, largely self-limiting, seldom led to discontinuation, and did not impact efficacy. Authors noted that dyskinesia was managed by lowering concomitant PD medications, as all patients had dyskinesia or history of dyskinesia at baseline. Nausea could be managed by slower titration; although patients received pretreatment with trimethobenzamide (Tigan), it is no longer available in the United States and its efficacy is not well-established.
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