Off-periods and Work, Inbrija’s Ability to Keep Dyskinesia at Bay Among Studies at Congress

Catarina Silva, MSc avatar

by Catarina Silva, MSc |

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Phase 3 trial analysis

Use of Inbrija (levodopa inhalation powder) helps to effectively manage off episodes in Parkinson’s disease without an increase in troublesome dyskinesia, or involuntary muscle movement, according to data being presented by Acorda Therapeutics at the International Congress of Parkinson’s Disease and Movement Disorders.

Results from a separate study presented at the meeting, running in France through Sept. 26, show off episodes can negatively affect work productivity in Parkinson’s patients.

Dopaminergic medications, like levodopa, help to control Parkinson’s motor symptoms. But as disease progresses, people typically need to gradually increase their dose to maintain the same level of benefit. Even with such increases, they sometimes experience a reappearance or worsening of symptoms (off periods) due to the diminishing effects of dopaminergic therapy.

In the second study, “Impact of OFF periods on aspects of employment for people with Parkinson’s disease,” presented as a scientific poster, researchers characterized the burden of off periods on work absence and productivity.

They used data from the “Financial and Social Impact of Parkinson’s Disease Survey” conducted by the Michael J. Fox Foundation (MJFF) and the Parkinson’s Foundation between Sept. 17 and Oct. 8, 2018.

The online survey was completed by the patients, their care partners, family members or close friends. It compared the burden — in terms of work productivity — of off periods in people reporting to experience them in the past 12 months to those reporting no experience of off periods while on dopaminergic therapy.

A total 1,602 surveys were returned, with 70% completed by Parkinson’s patients and 20% by caregivers, family members, or close friends. Off periods were reported by 881 (55%) of survey respondents, and an absence of off-period symptoms by 434 (27%). Around 18% (287 people) did not know if they had experienced an off period over the previous year or failed to respond to the question.

Of the 881 patients reporting off periods, 176 (20%) worked full or part-time. Among those without such reports, 90 (21%) worked full or part-time. Those with off periods were more likely to report poorer work productivity in comparison to the other group (72% vs. 43%).

Almost half (48%) of patients with off periods reported at least 10 days each month of low productivity, compared to the 29% of those without an off period. And 34% of them missed, on average, at least three working days each month because of their disease, compared to the 21% of patients without off periods.

“PD [Parkinson’s disease] can have a financial burden on patients and their families,” the researchers wrote. “More effective management of OFF periods and other PD symptoms may alleviate this burden.”

In scientific poster “Dyskinesia Rates in Patients with Parkinson’s Disease on CVT-301 (levodopa inhalation powder),” researchers summarized the results of an analysis of Inbrija’s effects on Parkinson’s dyskinesia (involuntary muscle movement).

Inbrija, developed and marketed by Acorda, is an inhaled formulation of levodopa approved by the U.S. Food and Drug Administration (FDA) to treat symptoms of Parkinson’s disease during off episodes. When inhaled, this dry powder formulation bypasses the digestive system to deliver a higher and more consistent dose of levodopa to the brain.

In a 12-week, randomized and placebo-controlled Phase 3 study (known as SPAN-PD, NCT02240030), 339 Parkinson’s patients on a carbidopa/levodopa regimen and experiencing off episodes were treated with Inbrija or placebo. Results found that treatment at an 84 mg dose significantly eased motor symptoms as soon as 30 minutes after taking a dose.

More than half of patients (58%) given Inbrija also had control of their motor symptoms, meaning they went from an off period to an on state. They also maintained that on state when evaluated up to an hour after treatment administration, compared to 36% in the placebo group.

Researchers for this study analyzed the effects of Inbrija on patient dyskinesia. They obtained reports in the form of diaries made by patients, recording time with dyskinesia that occurred over three consecutive days prior to each study visit.

Adverse events during the SPAN-PD study were also examined, as were trial investigator ratings of dyskinesia’s occurrence and severity at 60 minutes post-dose, measured by the Unified Parkinson’s Disease Rating Scale (UPDRS) part IV (motor complications).

On average, patients took two doses of Inbrija (84 mg) per day during the trial.

Four (3.5%) patients on Inbrija reported dyskinesia-like event lasting three days, in contrast to none in the placebo group. No one withdrew from the study due to dyskinesia.

At week 12, examiner-rated dyskinesia at one hour post-dose was of 16.7% among Inbrija-treated patients and 8% among people in the placebo group. All were rated mild to moderate, with the exception of one placebo patient whose dyskinesia was judged severe.

“In this phase 3 study of [Inbrija], adverse events and examiner ratings of mild to moderate dyskinesia were reported more frequently for [Inbrija] compared to placebo, but there was no increase in troublesome dyskinesia according to the patient reported diary and the overall impact on UPDRS part IV dyskinesia score was minimal,” the researchers concluded.

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