In a nutshell
This study evaluated the long-term effectiveness and safety of device-aided therapies (DATs) for the treatment of real-world patients with advanced Parkinson’s disease (PD). The data showed that in the long-term, DATs are well maintained among these patients.
Some background
Parkinson's disease (PD) is a disorder in which part of the brain is progressively damaged over many years. The main cause is the loss of nerve cells in a part of the brain called "substantia nigra", which leads to a reduction in a molecule involved in the body's movement (called dopamine). Therefore, common PD symptoms include involuntarily shaking of particular parts of the body (tremor), slow movements, and stiff and inflexible muscles. The standard treatment for this disorder is levodopa. However, long-term levodopa use is associated with several negative effects. These include periods of decreased effectiveness (off-times).
Device-aided therapies (DATs) may be required to achieve adequate symptom control in patients with advanced PD. DATs that are available at present are continuous subcutaneous apomorphine (Apokyn) infusion (CSAI), deep brain stimulation (DBS), and levodopa–carbidopa intestinal gel (Duodopa; LCIG).
Continuous subcutaneous apomorphine infusion (CSAI) is an effective treatment option for patients with PD. CSAI uses an electronic delivery device (pump), in order to maintain constant blood levels of apomorphine. Apomorphine reduces the periods of decreased effectiveness associated with levodopa treatment. LCIG is a gel of continuous delivery into the intestine through a tube. This method of delivery helps levodopa in the bloodstream to last longer, reducing off-times. Deep brain stimulation (DBS) is a treatment that is used when PD medications are not controlling symptoms. DBS involves a surgeon placing thin wires in the brain to stimulate certain parts of it. DBS is known to improve PD symptoms.
All these DATs have shown good results in clinical trials. However, in clinical trials, patients are carefully selected to be fit and without additional medical conditions. The long-term effectiveness and safety of DAT in real-world patients with advanced PD are still missing.
Methods & findings
This study involved 161 patients with advanced PD. 23 patients were treated with CSAI, 62 patients were treated with LCIG, and 76 patients were treated with DBS. The average follow-up period was 9.5 years.
The average time to stop the treatment was 86.4 months for LCIG and 42.4 months for CSAI. After 1 year, 89.3% of patients on LCIG and 82.4% of those on CSAI were still receiving treatment.
12 months after initiating treatment, 5.9% of the patients treated with CSAI, 14.3% of the patients treated with LCIG, and 10.7% of the patients treated with DBS, were not receiving any additional anti-parkinsonian therapy.
The most commonly reported side effect was redness or infection around the implant site (22.6% with LCIG, 5.3% with DBS, and 0% with CSAI).
At the last recorded visit, 5.9% of the patients treated with CSAI, 28.6% of the patients treated with LCIG, and 13.3% of the patients treated with DBS received DAT as monotherapy.
During the first 12 months after initiation, 65.2% of the patients treated with CSAI, 45.2% of the patients treated with LCIG, and 1.3% of the patients treated with DBS had no reported hospitalization days.
Annual healthcare visit costs decreased after treatment with LCIG (US$9491 vs. $8146) and increased after treatment with DBS ($4113 vs. $7677) and CSAI ($6378 vs. $8277).
The bottom line
This study concluded that in the long-term, DATs are well maintained among patients with advanced PD. Treatment with LCIG was associated with longer treatment persistence than treatment with CSAI, and LCIG was associated with higher rates of use as a monotherapy compared with CSAI or DBS.
The fine print
This study was funded by AbbVie Inc., the manufacturer of LCIG. The sample size was small. This study only included Israeli patients.
Published By :
Advances in therapy
Date :
Mar 10, 2022
