Dosages can be lowered succesfully in patients with a stable low disease activity and quality of life. This improves safety and cost-effectiveness.
ID
Bron
Aandoening
psoriasis, biologics, tnf-alfa remmers, etanercept, adalimumab, ustekinumab, dosis reductie, dose reduction, dose decrease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Psoriasis Area and Severity Index (PASI) at 12 months
Achtergrond van het onderzoek
Moderate to severe psoriasis can be treated succesfully with biologics. However, we do not know what the lowest possible dose is in individual patients that have a stable low disease activity. We propose to lower the dose with tight control of disease activity (PASI score) and dermatology-related quality of life (DLQI) in order to improve safety and cost-effectivenes.
Doel van het onderzoek
Dosages can be lowered succesfully in patients with a stable low disease activity and quality of life. This improves safety and cost-effectiveness.
Onderzoeksopzet
0-3-6-9-12 months
Onderzoeksproduct en/of interventie
Lowering frequency of biologic given
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(1) Treatment of at least 6 months with one biologic
(2) During the last 6 months, subsequent low disease activity scores (PASI (psoriasis area and severity index) <5) until the moment of inclusion. At least 2 PASI scores should be available.
(3) Good disease-related quality of life (DLQI (dermatology life quality index) ≤5) at the moment of inclusion in the study
• Established diagnosis of plaque psoriasis.
• Receiving treatment with adalimumab, etanercept, or ustekinumab.
• Age ≥18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Psoriasis itself is not the main reason for biologic prescription (e.g. when a patient has RA and psoriasis, and RA is the main reason for the biologic).
• Concomitant use of immunosupressants other than methotrexate or acitretin for psoriasis.
• Severe comorbidities with short life-expectancy (e.g. metastasized tumour).
• Presumed inability to follow the study protocol.
• Infliximab use
Opzet
Deelname
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| Register | ID |
|---|---|
| NTR-new | NL5161 |
| NTR-old | NTR5301 |
| Ander register | ZonMw project : 80-83600-98-40024 |