This promotional material is intended for UK Healthcare Professionals (HCPs) experienced in the diagnosis and management of Parkinson’s disease only. Adverse event reporting can be found below
For levodopa-responsive patients with Complex/Advanced Parkinson's disease
Consider DUODOPA when available combinations of Parkinson medicinal products have not given satisfactory results
A different method of administration1
DUODOPA's continuous intestinal administration avoids issues related to delayed gastric emptying, enabling consistent delivery with rapid absorption1-4
Smooth and consistent levodopa delivery3,5-7
Treatment strategies that provide a continuous flow of dopamine, and can thus mimic normal physiological dopamine stimulation, have potential to improve control of people with Complex/Advanced PD3,7
Individualised delivery1
Dosing is individually optimised to suit the patient over a 16-hour period, but can be provided up to 24 hours a day if medically justified1,3,7
Why is continuous dopaminergic stimulation, which can be an alternative to pulsatile, non-continuous stimulation, important?3,5-7
Over time, progressive neurodegeneration and the chronic use of oral dopaminergic therapy, such as levodopa, cause intermittent stimulation of dopamine receptors in the brain, which may lead to treatment-resistant motor complications5,6
Continuous infusion of DUODOPA can provide a smooth and consistent delivery of levodopa8
In a multicentre, multiple-dose, open-label study of 19 subjects with Complex/Advanced PD receiving DUODOPA over 30 days:8
- DUODOPA rapidly achieved therapeutic plasma levels of levodopa8
- DUODOPA maintained stable plasma levodopa levels over 16 hours8
- DUODOPA's continuous intestinal delivery allows rapid absorption, avoiding fluctuations in drug delivery that result from erratic gastric emptying1,8
Adapted from Nyholm D et al. 2013.
PD=Parkinson's disease; SD=standard deviation.
In a study, DUODOPA provided predictability of 'ON' time and 'OFF' time9
A 54-week, international, prospective, open-label study assessed the safety and efficacy of DUODOPA in Complex/Advanced PD patients with severe motor fluctuations (N=354). Safety was the primary endpoint; for the majority of patients AEs were mild or moderate and transient. Secondary endpoints included 'OFF' time, 'ON' time with/without troublesome dyskinesia, UPDRS and HRQoL outcomes.9
Complex/Advanced patients with severe motor fluctuations on DUODOPA had a significant increase in 'ON' time without troublesome dyskinesia and a significant decrease in 'OFF' time compared with baseline (both p<0.001), which was sustained throughout the study.9
Adapted from Fernandez HH et al. 2015.
AE=adverse event; HRQoL=health-related quality of life; PD=Parkinson's disease; UPDRS=Unified Parkinson's Disease Rating Scale.
In a study, benefits in non-motor symptoms were sustained over a period of two years with DUODOPA10
The GLORIA registry: A 24-month, non-interventional, observational registry study, evaluating the long-term efficacy of DUODOPA on motor and non-motor symptoms, QoL and safety in Complex/Advanced PD patients (N=375).10
Significant and sustained improvements in motor fluctuations and some associated non-motor symptoms were observed, particularly in:10*
- Sleep/fatigue (p<0.001)10
- Mood/cognition (p=0.004)10
- Gastrointestinal symptoms (p<0.001)10
Adapted from Antonini A et al. 2017.
*Improvement measured by reduction from baseline in the mean non-motor symptoms scale (NMSS) scores.
GI=gastrointestinal; NMSS=non-motor symptoms scale; PD=Parkinson's disease; QoL=quality of life.
COSMOS Study - exploring the effect of DUODOPA in reducing the rate of polypharmacy12
In a study, patients initiating DUODOPA experienced a reduced rate of polypharmacy12
The COSMOS study: A multi-country, retrospective, cross-sectional, post-marketing observational study of advanced Parkinson’s disease patients treated with DUODOPA for at least 12-months (N=409)* which investigated the effect of DUODOPA in reducing polypharmacy for the treatment of advanced Parkinson’s disease. The primary endpoint was the percentage of patients receiving DUODOPA monotherapy immediately after DUODOPA initiation (following PEG-J procedure) and at 3, 6, 9, and 12 months after DUODOPA initiation.12
Real-world evidence is collected outside of controlled clinical trials. It is observational in nature which gives clinical associations. It must be interpreted alongside randomised control trials and product labels.
After initiating DUODOPA, 56.6% (n=214) of patients were able to achieve LCIG monotherapy or daytime monotherapy, an increase from 28.4% (n=101) compared to baseline.12
n=patients with non-missing data. Patients were grouped by their treatment regimen at 12 months, including 31 patients with inconclusive/missing treatment regimen data.
Adapted from Fasano A et al. 2021
PD=Parkinson’s disease; LCIG=Levodopa/carbidopa intestinal gel; LCIG Monotherapy=use of LCIG only with no add-on PD medications; LCIG Daytime Monotherapy=use of LCIG with add-on PD medications used in the evening after the daily LCIG infusion hours are completed; LCIG Polytherapy=use of LCIG with add-on medications at any time, including during LCIG infusion hours; PEG-J=percutaneous endoscopic gastro-jejunostomy.
DUOGLOBE Study - post-hoc analysis of interim dataset13
The DUOGLOBE interim analysis: DUOGLOBE was a 3-year, prospective, multinational, post-marketing, observational analysis of the long-term effectiveness of DUODOPA in patients with Complex/Advanced PD. A post-hoc analysis of an interim DUOGLOBE dataset was conducted to evaluate if patients identified by experienced clinicians as having Complex/Advanced PD met the ‘5 or 2 or 1’ criteria and the relationship of the ‘5 or 2 or 1’ criteria to effectiveness and safety outcomes of DUODOPA treatment during routine care. Self-reported off time from baseline to 6 months after beginning DUODOPA therapy was used as an efficacy measure.13
Real-world evidence is collected outside of controlled clinical trials. It is observational in nature which gives clinical associations. It must be interpreted alongside randomised control trials and product labels.
In Complex/Advanced Parkinson’s patients, the ‘5 or 2 or 1’ criteria aligned with clinician assessment13
98% of patients selected for LCIG on clinical grounds fulfilled at least one of the ‘5 or 2 or 1’ criteria13
Overall cohort N=139
Over 90% (n=74) of patients reported having two or more hours of ‘OFF’ time daily at baseline13
57% (n=47) of patients were taking oral levodopa at least five times a day13
38% (n=31) reported experiencing at least 1 hour of troublesome dyskinesia daily13
68% of patients fulfilled two or more of the ‘5 or 2 or 1’ criteria and 20% fulfilled all three13
Percentage of patients meeting criteria for a diagnosis of Complex/Advanced PD13
Overall cohort N=139. Analysis population meeting one or more Delphi-consensus threshold criteria for a diagnosis of Complex/Advanced PD n=82.
Meet at least ONE
threshold criteria
Meet at least TWO
threshold criteria
Meet all THREE
threshold criteria
After 6 months on DUODOPA, patients in all groups ('5 or 2 or 1’) experienced significant reductions from baseline in ‘OFF’ time.13
Adapted from Aldred et al. 2021
*Patients who reported <2 hours per day of ‘OFF’ time (n=8) had insufficient sample sizes for analysis of the effectiveness outcomes. There are limitations regarding sample size as a few groups in this study were too small to analyse; however, information can still be gleaned from those patients in the larger counterpart subgroup.
**Statistically significant at p<0.001.
***Statistically significant at p<0.01.
PD=Parkinson’s disease.
Safety and tolerability9,10
A generally well-understood safety profile with years of experience9,10
- Levodopa therapy has been used in clinical practice for over 40 years and has an established and well-understood safety profile1,14
- DUODOPA can provide continuous infusion of levodopa, the gold standard treatment, for levodopa-responsive Parkinson's disease in Complex/Advanced patients1,4,15
- A safety analysis was performed for patients who received DUODOPA in all studies, to allow for a summary of the drug-related adverse reactions1,9,16
Drug-related undesirable effects that occur frequently with the DUODOPA system:1
*Adverse drug reactions observed in clinical trials. Frequencies assigned reflect adverse event frequencies and are regardless of causality assigned by the investigator.1
†Impulse control disorders: pathological gambling, increased libido and hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including DUODOPA.1
- Another analysis was performed for patients who received DUODOPA or placebo gel via PEG-J to allow for a summary of procedure- and device-related adverse reactions in all studies1,9,16
Device- and procedure-related undesirable effects that occur frequently with the DUODOPA system include:1
*Adverse drug reactions observed in clinical trials. Frequencies assigned reflect adverse event frequencies and are regardless of causality assigned by the investigator.1
†Complication of device insertion was a commonly reported adverse reaction for both the nasojejunal tube and the PEG-J. This adverse reaction was co-reported with 1 or more of the following adverse reactions for the nasojejunal tube: oropharyngeal pain, abdominal distention, abdominal pain, abdominal discomfort, pain, throat irritation, gastrointestinal injury, esophageal haemorrhage, anxiety, dysphagia, and vomiting. For the PEG-J, this adverse reaction was co-reported with 1 or more of the following adverse reactions: abdominal pain, abdominal discomfort, abdominal distension, flatulence, or pneumoperitoneum. Other non-serious adverse reactions that were co-reported with complication of device insertion included abdominal discomfort, abdominal pain upper, duodenal ulcer, duodenal ulcer haemorrhage, erosive duodenitis, gastritis erosive, gastrointestinal haemorrhage, peritonitis, pneumoperitoneum, small intestine ulcer.1
PEG-J=percutaneous endoscopic gastro-jejunostomy
- Most device and procedure related adverse reactions to DUODOPA occurred during the first 28 days after the PEG-J procedure1,9,16
- Serious side effects include: Anaphylactic reaction, leukopenia, thrombocytopenia, agranulocytosis, neuroleptic malignant syndrome, eye disorders, gastrointestinal bleeding and duodenal ulceration, malignant melanoma, completed suicide, suicide attempt, depression, phlebitis, rash, sepsis, convulsion, optic ischaemic neuropathy, erythema; haemolytic anaemia - observed with oral levodopa/carbidopa.1
DUODOPA has a generally well-understood safety profile9
A 54-week, international, prospective, open-label study assessed the safety and efficacy of DUODOPA in Complex/Advanced PD patients with severe motor fluctuations (N=354).9
324 (91.5%) of the 354 enrolled patients completed the NJ phase and proceeded to PEG-J.9
Adapted from Fernandez HH et al. 2015.
*A single event could be coded to >1 preferred term.
AE=adverse event; NJ=nasojejunal; PEG-J=percutaneous endoscopic gastro-jejunostomy.
- For the majority of patients adverse events were mild (18.5%) or moderate (43.8%) and transient9
- Low withdrawal rate (7.6%) due to adverse events, most commonly due to complication of insertion of device9
Please refer to the DUODOPA Summary of Product Characteristics (SmPC) for further information on adverse events, contraindications, special warnings, and precautions for use.
References
- DUODOPA (levodopa/carbidopa intestinal gel) Summary of Product Characteristics.
- Burack M, et al. Mov Disord Clin Pract 2018;5:383-93.
- Antonini A. J Mov Disord 2009;2:4-9.
- Slevin JT, et al. J Parkinsons Dis 2015;5:165-74.
- Olanow CW, et al. Nat Clin Pract Neurol 2006;2(7):382-92.
- Thanvi BR and Lo TCN. Postgrad Med J 2004;80:452-8.
- Nyholm D. Parkinsonism Relat Disord 2007;13:S13-7.
- Nyholm D, et al. AAPS J 2013;15:316–23.
- Fernandez HH, et al. Mov Disord 2015;30(4):500–9.
- Antonini A, et al. Parkinsonism Relat Disord 2017;45:13–20 and Supplementary Data.
- Antonini A, et al. Neurodegener Dis Manag 2018;8:161-70.
- Fasano A, et al. Mov Disord. 2021;36(8):1853–62.
- Aldred J, et al. Neurodegener Dis Manag. 2020;10(5):309–23.
- Poewe W, et al. Clin Interv Aging 2010;5:229-38.
- Boyd JT, et al. Clin Park Relat Disord 2020;2:25-34.
- Olanow CW, et al. Lancet Neurol 2014;13:141-9.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores.
Adverse events should also be reported to AbbVie on [email protected]
UK-DUOD-230105. Date of preparation: December 2023.
