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      • This website is for UK Healthcare Professionals only

      Your patients with complex/advanced PD may be ready for non-oral therapies

      But a treatment gap remains

      patients with complex/
      advanced PD receive non-oral therapies (n=4,200/49,300)6-8*

       

      *Calculated using 2020 Hospital Pharmacy Audit data (purchased from IQVIA) and total 2020 PD prevalence data using Parkinson’s UK report (as referenced).
      Prevalence of complex Parkinson’s disease applied from the 2019 Parkinson’s UK report (as referenced).

      The 5-2-1 criteria could help you identify patients with PD who may be progressing into the complex/advanced stage and may be eligible for non-oral therapies. Look out for the following signs:2

      ≥ 5 times per day when oral levodopa is taken

      ≥ 2 hours per day of ‘OFF’ time

      ≥ 1 hour per day with troublesome dyskinesia

      5-2-1 open dialogue resource

      Get support for practical and early non-oral therapy discussions with tips on how to have an open conversation with patients and their loved ones

      Download the 5-2-1 resource

      Learn about the progression of PD

      Learn more

      Why there may be a need for non-oral therapies as PD progresses?

      Worsening gastric emptying over time in patients with PD can result in erratic absorption of oral regimens11

      Gastrointestinal dysfunction, with erratic gastric emptying worsening over the years, can be a common cause of poor absorption of oral regimens in patients with PD.11

      Oral regimens can become increasingly complex as PD progresses12 and complex treatment may be associated with non-adherence.13

      Worsening gastric emptying over time in patients with PD can result in erratic absorption of oral regimens11

      Gastrointestinal dysfunction, with erratic gastric emptying worsening over the years, can be a common cause of poor absorption of oral regimens in patients with PD.11

      Oral regimens can become increasingly complex as PD progresses12 and complex treatment may be associated with non-adherence.13

      of patients may experience a narrowing of the therapeutic window due to continuous neurodegeneration within 5 years of starting oral treatment, making it difficult to deliver an optimal dose to control symptoms without triggering treatment-related dyskinesia11

      5-2-1 open dialogue resource

      Get support for practical and early non-oral therapy discussions with tips on how to have an open conversation with patients and their loved ones

      Download the 5-2-1 resource

      Discover more about the impact of sub-optimally controlled PD in your patients

      Learn more

      Sub-optimally controlled symptoms of PD can have a negative impact on a patient’s life14-18

      Patients with PD who experience ‘OFF’ time may have diffculty performing everyday activities and communicating effectively16,19-21

      In an online US survey of 2,110 patients with PD, that assessed their lived experience of ‘OFF’ periods:

      Nearly a quarter of their waking hours were spent in ‘OFF’ state (mean disease duration 6.1 years), which comprised both motor and non-motor symptoms.19

      Patients with PD reported a wide range of motor symptoms during their ‘OFF’ times, with some describing these symptoms as ‘constant tremors’, being ‘frozen in place’ and ‘moving in slow motion’.19

      View Study Information

      Findings from 3 studies whose aims all included exploring the impact of ‘OFF’ periods on PD patients (An online survey of 305 patients exploring the impact of ‘OFF’ time on health related quality of life and daily functioning in people with PD, a scoping review that included 23 studies that evaluated the impact or experience of ‘OFF’ periods in PD patients, and an epidemiological survey of a multicentre, observational crosssectional study of 617 patients assessing the frequency of wearing ‘OFF’ in patients with PD and its impact on quality of life.

      ‘OFF’ times made it impossible for them to leave the house on their own and affected their ability to communicate effectively.16,20,21

      View Study Information

      People with PD who experience troublesome dyskinesia may have difficulty with a range of daily activities14

      An analysis that assessed the impact of dyskinesia on activities of daily living using pooled United Dyskinesia Rating Scale (UDysRS) data from two Phase 3 clinical trials showed that mild-to-severe impacts of dyskinesia can include impact on:

      Walking and balance

      Public and social settings

      Exciting or emotional settings

      Hobbies and activities

      Handwriting

      Dressing

      View Study Information

      5-2-1 open dialogue resource

      Get support for practical and early non-oral therapy discussions with tips on how to have an open conversation with patients and their loved ones

      Download the 5-2-1 resource

      Discover why earlier patient assessment for non-oral therapies is important

      Learn more

      Consider assessing earlier?

      Peer-reviewed opinions support earlier introduction of non-oral therapies in patients with complex/advanced Parkinson’s disease3

      When left too late, non-oral therapies may no longer be an appropriate treatment option for patients with PD3

      When initiation of non-oral therapies is left too late, progressive neurodegeneration in PD can mean patients’ capacity to respond to these treatments may be significantly reduced.3,22

      In patients with PD, consider non-oral therapies before severe motor symptoms and loss of functioning worsen.4

      Based on a peer-reviewed opinion article that aimed to support the social and economic benefits of optimised treatment for patients with PD

      Early introduction of non-oral therapies may allow patients with PD to have better control of motor symptoms and an impact on quality of life, which may allow patients to live at home or stay at work for longer23

      View Study Information

      Hospital Episode Statistics (HES) data (2013–2018)24*

      Patients with complex/advanced PD treated with non-oral therapies

      compared to

      Patients with complex/advanced PD without dementia and not receiving non-oral therapies

      3.6

      fewer mean emergency admissions over 5 years†

      45.9

      %

      fewer patients with emergency admissions

      53.2

      fewer mean 5-year bed days†

      6.7

      %

      fewer patients with record of hip fracture‡

      Patients with complex/advanced PD treated with non-oral therapies

      compared to

      Patients with complex/advanced PD without dementia and not receiving non-oral therapies

      3.6

      fewer mean emergency admissions over 5 years†

      45.9%

      fewer patients with emergency admissions

      53.2

      fewer mean 5-year bed days†

      6.7%

      fewer patients with record of hip fracture‡

      Patients with complex or advanced PD treated with non-oral therapies had fewer emergency hospital admissions and hip fractures compared to those on other treatment24*†‡

      *Hospital Episode Statistics (HES) is a database of administrative healthcare data maintained by NHS digital. This applies to England only. †Means are total admissions over 5 years divided by no. of patients. ‡Any diagnosis of fracture of femur (ICD-10 Code S72).24

      HES data for complex/advanced PD patients24

      Parkinson’s UK estimated the prevalence of PD in England at 114,560 in 2015*†24

      Measure
      All units are N unless specified      		 All advanced
      PD patients‡      		 Advanced PD patients‡ without dementia and no advanced treatment Advanced treatment patients§
      Patients 13,310 7,106 2,499
      Males (%) 62.3 59.2 67.7
      Mean age (years) 74.2 77.2 61.9
      Mean 5-year admissions** 7.4 7.2 6.7
      Mean 5-year emergency admissions** 4.9 5.3 1.7
      Patients with emergency admission (%) 90.2 98.4 52.5
      Mean 5-year bed days** 72.3 75.7 22.5
      Patients with overnight stay (%) 97.3 98.7 89.3
      Patients with any record of dementia (%)†† 29.8 0.0 10.3
      Patients with any record of hip fracture (%)‡‡ 8.7 9.3 2.6

      *PD patients: patients with any diagnosis of PD, primary or secondary (ICD-10 code G20, PD). †Estimated value using age and gender-specific prevalence rates from the Clinical Practice Research Datalink (CPRD) and extrapolated to the population of England in mid-2015 to estimate the number of people living with Parkinson’s. The study population consisted of patients aged 20 or over with a record for Parkinson’s in their clinical or referral file during the period 1 January 1988 to 31 December 2015. Patients with <6 months of up-to-standard follow-up in the CPRD were also excluded. ‡Advanced PD patients: patients with a primary diagnosis of PD AND any diagnosis of abnormalities of gait and mobility (ICD-10 code R26, abnormalities of gait and mobility) OR any diagnosis of dyskinesia (ICD-10 codes G248/249, G248 (other dystonia) and G249 (dystonia unspecified) record dyskinesia where it is not specified in G240–247). §Advanced treatment patients: patients with a record of deep brain stimulation, apomorphine or Duodopa (levodopa/carbidopa intestinal gel). Age at first admission with any Parkinson’s disease diagnosis. **Means are total admissions over 5 years divided by number of patients. ††Any diagnosis of either Dementia in Parkinson’s disease (ICD-10 Code F023) or Hallucinations (R44) or Persistent delusional disorders (F22). ‡‡Any diagnosis of Fracture of Femur (ICD-10 Code S72).

      Measure
      All units are N unless specified      		 All advanced
      PD patients‡
      Patients 13,310
      Males (%) 62.3
      Mean age (years) 74.2
      Mean 5-year admissions** 7.4
      Mean 5-year emergency admissions** 4.9
      Patients with emergency admission (%) 90.2
      Mean 5-year bed days** 72.3
      Patients with overnight stay (%) 97.3
      Patients with any record of dementia (%)†† 29.8
      Patients with any record of hip fracture (%)‡‡ 8.7
      Measure
      All units are N unless specified      		 Advanced PD patients‡ without dementia and no advanced treatment
      Patients 7,106
      Males (%) 59.2
      Mean age (years) 77.2
      Mean 5-year admissions** 7.2
      Mean 5-year emergency admissions** 5.3
      Patients with emergency admission (%) 98.4
      Mean 5-year bed days** 75.7
      Patients with overnight stay (%) 98.7
      Patients with any record of dementia (%)†† 0.0
      Patients with any record of hip fracture (%)‡‡ 9.3
      Measure
      All units are N unless specified      		 Advanced treatment patients§
      Patients 2,499
      Males (%) 67.7
      Mean age (years) 61.9
      Mean 5-year admissions** 6.7
      Mean 5-year emergency admissions** 1.7
      Patients with emergency admission (%) 52.5
      Mean 5-year bed days** 22.5
      Patients with overnight stay (%) 89.3
      Patients with any record of dementia (%)†† 10.3
      Patients with any record of hip fracture (%)‡‡ 2.6

      *PD patients: patients with any diagnosis of PD, primary or secondary (ICD-10 code G20, PD). †Estimated value using age and gender-specific prevalence rates from the Clinical Practice Research Datalink (CPRD) and extrapolated to the population of England in mid-2015 to estimate the number of people living with Parkinson’s. The study population consisted of patients aged 20 or over with a record for Parkinson’s in their clinical or referral file during the period 1 January 1988 to 31 December 2015. Patients with <6 months of up-to-standard follow-up in the CPRD were also excluded. ‡Advanced PD patients: patients with a primary diagnosis of PD AND any diagnosis of abnormalities of gait and mobility (ICD-10 code R26, abnormalities of gait and mobility) OR any diagnosis of dyskinesia (ICD-10 codes G248/249, G248 (other dystonia) and G249 (dystonia unspecified) record dyskinesia where it is not specified in G240–247). §Advanced treatment patients: patients with a record of deep brain stimulation, apomorphine or Duodopa (levodopa/carbidopa intestinal gel). Age at first admission with any Parkinson’s disease diagnosis. **Means are total admissions over 5 years divided by number of patients. ††Any diagnosis of either Dementia in Parkinson’s disease (ICD-10 Code F023) or Hallucinations (R44) or Persistent delusional disorders (F22). ‡‡Any diagnosis of Fracture of Femur (ICD-10 Code S72).

      5-2-1 open dialogue resource

      Get support for practical and early non-oral therapy discussions with tips on how to have an open conversation with patients and their loved ones

      Download the 5-2-1 resource

      Discover how the 5-2-1 criteria could help you assess whether patients are ready for non-oral therapies

      Learn more

      1. Duodopa (levodopa/carbidopa intestinal gel) Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed: December 2022.

      2. Antonini A, et al. Curr Med Res Opin. 2018;34:2063–73.

      3. Mills J, Martin A. Br J Neurosci Nurs. 2015;11(2):92–7.

      4. Worth PF. Pract Neurol. 2013;13(3):140–52.

      5. NICE. Parkinson’s disease in adults. Available at: www.nice.org.uk/guidance/ng71. Accessed December 2022.

      6. Parkinson’s UK. 2019 Parkinson’s audit: Summary report. Available from: https://www.parkinsons.org.uk/professionals/

      uk-parkinsons-audit-transforming-care. Accessed December 2022.

      7. AbbVie. Data on ]le, HPA data for DAT patients, UK-DUOD-220019.

      8. Parkinson’s UK. Reporting on Parkinson’s: Information for journalists. Available at: https://www.parkinsons.org.uk/

      about-us/reporting-parkinsons-information-journalists. Accessed December 2022.

      9. Nyholm D. Parkinsonism Relat Disord. 2007;13 Suppl:S13–7.

      10. Olanow CW, et al. Nat Clin Pract Neurol. 2006;2(7):382–92.

      11. Varanese S, et al. Parkinsons Dis. 2010;2010:480260.

      12. Fleisher JE, Stern MB. Curr Neurol Neurosci Rep. 2013;13(10):382.

      13. Grosset KA, et al. Mov Disord. 2005;20(11):1502–7.

      14. Pahwa R, et al. Parkinsonism Relat Disord. 2019;60:118–25.

      15. Odin P, et al. Parkinsonism Relat Disord. 2015;21:1133–44.

      16. Kerr C, et al. Qual Life Res. 2016;25(6):1505–15.

      17. Haahr A, et al. J Adv Nurs. 2011;67(2):408–17.

      18. Antonini A, et al. Neurol Ther. 2022;11(1):303–18.

      19. Mantri S, et al. J Patient Cent Res Rev. 2021;8(3):232–8.

      20. Rastgardani T, et al. Mov Disord Clin Pract. 2018;5(5):461–70.

      21. Stocchi F, et al. Parkinsonism Relat Disord. 2014;20(2):204–11.

      22. Thanvi BR, Lo TCN. Postgrad Med J. 2004;80(946):452–8.

      23. Lökk J, et al. Eur Neurol Rev. 2012;7(2):113–7.

      24. AbbVie Ltd. Data on File. REF-37728.

      25. Smolensky L, et al. Sci Data. 2020;7(1):67.

      Duodopa (levodopa/carbidopa intestinal gel) prescribing information

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.

      Adverse events should also be reported to AbbVie on [email protected] 

       

       UK-DUOD-220207. Date of preparation: December 2022

      Thank you, your feedback will be used to help AbbVie to deliver the most relevant materials which can help support you in treating your patients with PD.

      Mantri S, et al. 202119

      Study type: Online survey.

      Aim: To assess the lived experience of ‘OFF’ periods for people with Parkinson’s disease.

      Patient population: 2,110 people living in the US, who had self-reported Parkinson’s disease (PD), reporting taking 1 or more PD medications, and reported experiencing periods of ‘OFF’ time at the start of the survey (a subset of the Fox Insight* cohort).

      Methods: The survey assessed: (1) what patients called periods where their PD symptoms return when talking to friends and family, (2) description of the ‘OFF’ experience, (3) triggers for ‘OFF’ symptoms, (4) coping strategies for ‘OFF’ time, outside of medication.

      *Fox Insight is an online, longitudinal health study of people with and without PD to provide insight into the lived experience, genetics and variability of PD.25

      Kerr C, et al. 201616

      Study type: Online survey.

      Aim: To explore the impact of ‘OFF’ time on health-related quality of life (HRQoL) and daily functioning in people with Parkinson’s (PwP) relative to ‘ON’ time.

      Patient population: 305 people across the UK, France, Spain and Italy with advanced Parkinson’s experiencing motor fluctuations/wearing-off with levodopa.

      Methods: The survey explored: (1) the impact of ‘OFF’ time on HRQoL, (2) the impact of ‘OFF’ time on functioning and ability to undertake usual activities, and (3) the value of ‘OFF’ time relative to other factors associated with Parkinson’s through a stated preference discrete choice experiment (SPDCE).

      Rastgardani T, et al. 201820

      Study type: A scoping review.

      Aim: To research on understanding, impact, and communication regarding ‘OFF’ periods to identify issues warranting further research.

      Methods: The relevant literature was found by searching MEDLINE, EMBASE, Cochrane Library, CINAHL, and PsycINFO from 2006 to January 2018 for “wearing off”, “fluctuations”, “Parkinson”, “impact” and “communication” and refined by the investigators. Overall, 26 studies were included – 23 evaluated the impact or experience of ‘OFF’ periods in patients, three evaluated the impact upon carepartners, two papers addressed understanding of ‘OFF’ periods, one study evaluated communication about ‘OFF’ periods, and three studies evaluated a facilitator of communication about ‘OFF’ periods.

      Patient populations of interest: (1) patients with Parkinson’s disease (PD) experiencing ‘OFF’ periods, (2) carepartners of patients with ‘OFF’ periods, and (3) practising physicians managing patients with ‘OFF’ periods.

      Publication types of interest: (1) survey studies, (2) qualitative or mixed-methods studies, and (3) randomised or pragmatic controlled trials or observational studies that described the impact of interventions to promote and support communication about ‘OFF’ periods.

      Objectives: (1) what is known about the personal experience and impact of ‘OFF’ periods on patients and carepartners beyond global reduction in health-related quality of life, (2) the understanding of ‘OFF’ periods among patients, carepartners, and their physicians, and (3) communication regarding ‘OFF’ symptoms between patients, carepartners, and physicians.

      Stocchi F, et al. 2014 – The DEEP study21

      Study type: An epidemiological survey of a multicentre, observational cross-sectional study.

      Aim: To assess the frequency of Wearing-OZ (WO) in patients with Parkinson’s disease (PD), and its impact on Quality of Life (QoL).

      Patient population: 617 consecutive ambulatory patients with PD, who were on dopaminergic treatment for ≥1 year.

      Methods: In a single visit, WO was diagnosed based on neurologist assessment, as well as using the validated Italian version of a patient self-rated 19-question Wearing-OZ Questionnaire (WOQ-19); WO was defined for scores ≥2. QoL was evaluated by the 8-item Parkinson’s Disease Questionnaire (PDQ-8).

      Pahwa R, et al. 201914

      Study type: Pooled analysis of Unified Dyskinesia Rating Scale (UDysRS) data from EASE LID and EASE LID 3 (pivotal Phase 3 clinical trials of ADS-5102 in dyskinetic patients).

      Aim: To assess the impact of dyskinesia on activities of daily living (ADLs), and the effects of ADS-5102 vs. placebo using UDysRS data.

      Patient population: 196 patients who had troublesome dyskinesia (≥1 hour/day) and at least mild functional impact of dyskinesia, as documented at screening and baseline by a score ≥2 on item 4.2 of the Movement Disorder Society-United Parkinson’s Disease Rating Scale (MDS-UPDRS).

      Methods: Pooled results compare data at baseline (pre-treatment) and during treatment at Week 12, assessment time points common to both trials.

      Efficacy measures:

      • UDysRS Part 1B – Patient (and/or a caregiver) assesses, with reference to the preceding week, whether “jerking or twisting movements called on-dyskinesias usually cause problems” with ten ADLs (speech; chewing and swallowing; eating tasks; dressing; hygiene; handwriting; doing hobbies and other activities; walking and balance; public and social settings; and exciting or emotional settings)

      • UDysRS Part 3 – Clinician assesses the intensity of dyskinesia in seven regions of the patient’s body (face, neck, trunk, left arm/shoulder, right arm/shoulder, left leg/hip, and right leg/hip) during each of four observed ADL tasks (communication, drinking, dressing, and ambulation)

      • UDysRS Part 4 – Clinician assesses the global disability caused by dyskinesia during each of these ADL tasks

      Lökk J, et al. 201223

      Study type: Peer-reviewed opinion article.

      Aim: To support the social and economic benefits of optimised treatment for patients with Parkinson’s disease.

      Methods: Commentary on the economic burden of Parkinson’s disease (PD) citing 10 publications concerning health economic data and modelling, including an economic simulation study that compared the costs of standard of care vs. duodopa® (levodopa/carbidopa intestinal gel).