RINVOQ® (upadacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1
RINVOQ achieved the primary endpoints of clinical remission per adapted Mayo score at Induction Week 8 and Maintenance Week 521,2
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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UC: ulcerative colitis; UEGW: United European Gastroenterology Week.
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REFERENCES
- RINVOQ Summary of Product Characteristics.
- Danese S, Vermeire S, Zhou W, et al. Lancet. 2022;399(10341):2113–2128.
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ALL-RNQG-220224 Date of preparation: February 2024
Adverse events should also be reported to AbbVie on GBPV@abbvie.com
Efficacy
Continuous infusion of Duodopa® can provide a smooth and consistent delivery of levodopa1
- Duodopa® rapidly achieves therapeutic plasma levels of levodopa1
- Duodopa® maintains stable plasma levodopa levels over 16 hours1
- Continuous intestinal delivery with Duodopa® allows rapid absorption, avoiding fluctuations in drug delivery that result from erratic gastric emptying1,4
Adapted from Nyholm D et al. 2013.
In a multicentre, multiple-dose, open-label study of 19 subjects with advanced PD receiving Duodopa® over 30 days:1 Treatment is usually administered during the patient's awake period. If medically justified, Duodopa® may be administered for up to 24 hours4
PD=Parkinson's disease; SD=Standard deviation.
1. Nyholm D, et al. AAPS J 2013;14:316–23.
2. Fernandez HH, et al. Mov Disord 2015;30(4):500–9.
3. Freire-Alvarez E, et al. Mov Disord. 2021;36(11):2615-23.
4. Duodopa® Summary of Product Characteristics, available on www.medicines.ie.
Duodopa® provides predictability of 'ON' time and 'OFF' time1
- Duodopa® has proven to provide 4.8 hours more ON time without troublesome dyskinesia compared with baseline1
- Duodopa® has proven to provide 4.4 hours less OFF time compared with baseline1
- Duodopa® showed a significant improvement in the motor symptoms of PD, sustained up to 54 weeks.1
Adapted from Fernandez HH et al. 2015.
A 54-week, international, prospective, open-label study assessed the safety and efficacy of Duodopa® in 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.1
AE=adverse event; HRQoL=health-related quality of life; PD=Parkinson's disease; UPDRS=Unified Parkinson's Disease Rating Scale.
1. Fernandez HH, et al. Mov Disord 2015;30(4):500-9.
- In the DYSCOVER study Duodopa® significantly improved dyskinesia compared with OMT1
- Duodopa® treatment had sustained and significant improvements in UDysRS total scores through Week 12 compared to OMT (P<0.001)1
DYSCOVER: A phase 3b, open-label, randomised, multicentre, 12-week study (N=61 ). Advanced PD patients were randomised to receive either OMT (n=33) or Duodopa® (n=28).1*
The UDysRS (Unified Dyskinesia Rating Scale) has established metric properties that can measure all aspects of dyskinesia with a comprehensive score.1
*Patients in the OMT group continued their optimised and stable anti-PD medication. Patients in the Duodopa® group discontinued all other anti-PD medications other than amantadine prior to treatment initiation on Day 1.1
OMT =optimised medical treatment; PD=Parkinson's disease; SE=standard error; UDysRS=Unified Dyskinesia Rating Scale.
1. Freire-Alvarez E, et al. Mov Disord. 2021 ;36(11):2615-23.
Reduced pill burden
In the COSMOS study, Duodopa® demonstrated a reduced rate of polypharmacy1
A multi-country, retrospective, cross-sectional, post-marketing observational study of 409 advanced PD patients treated with Duodopa® for at least 12-months, investigating the effect of Duodopa® in reducing polypharmacy. 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.1
Duodopa® monotherapy=Duodopa® only with no add-on PD medications; Duodopa® daytime monotherapy=Duodopa® with add-on PD medications used in the evening after the daily infusion hours are completed; Duodopa® polytherapy=Duodopa® with add-on medications at any time.
n= patients with non-missing data.
PEG-J=percutaneous gastrojejunostomy; PD=Parkinson's disease.
1. Fasano A, et al. Mov Disord. 2021; doi: 10.1002/mds.28596.
A multi-country, retrospective, cross-sectional, post-marketing observational study of 409 advanced PD patients treated with Duodopa® for at least 12-months, investigating the effect of Duodopa® in reducing polypharmacy. 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.1
COMT =catechol-O-methyl transferase; DA=dopamine agonist; MAO-B=monoamine oxidase-B; NMDA=N-methyl-D-aspartate; PD=Parkinson's disease; PEG-J=percutaneous gastrojejunostomy.
1. Fasano A, et al. Mov Disord. 2021; doi: 10.1002/mds.28596.