The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the cumulative incidence of persistent flares (PASI> 5 for >=
3 months).
Secondary outcome
Secondary outcomes are the percentage of successful dose reductions, the course
of disease activity (PASI), incidence of short disease flares (PASI> 5 once),
course of disease-related quality of life (DLQI), predictors for successful
dose reduction, side effects, antibody formation and trough levels of biologics
(PK), health-status (SF-36), quality-adjusted life-years (EQ-5D-5L), volumes of
care (iMTA Medical Consumption Questionnaire), loss of productivity and
presenteeism (Productivity Cost Questionnaire).
Background summary
Biologics are very effective treatments for psoriasis. Research indicated that
the dose of TNFα-blocking biologics can be reduced in a proportion of patients.
Safety profiles can improve and costs can be reduced if the reduction of the
dose is successful. Recently, the newest generation of biologics entered the
market: interleukin (IL) 17 and IL23 inhibitors. These biologics are
increasingly prescribed. It is not yet known whether dose reduction of these
agents is possible, and to what extent they can be reduced. The new agents have
different mechanisms of action and safety profiles compared to TNFα-blockers.
The timely investigation of the possibilities for dose reduction of new
biologics is therefore important.
Study objective
The primary goal is to investigate whether controlled dose reduction of IL17 or
IL23 inhibiting biologics is not inferior compared to usual care. This is
measured by comparing the proportion of long-term disease flares between the
two groups (dose reduction group versus usual care group). Secondary goals are:
determining the proportion of patients with successful dose reduction, clinical
effectiveness measured with the Psoriasis Area and Severity score (PASI) score,
Dermatology Life Quality Index (DLQI) scores, predictors for successful dose
reduction, safety, and cost-effectiveness of dose reduction. Pharmacokinetic
(PK) analysis will be performed for modeling.
Study design
a multicenter, practice-oriented, pragmatic, randomized, controlled,
non-inferiority study.
Study burden and risks
There is a risk for disease exacerbation due to dose tapering. This risk will
be kept as low as possible by strictly monitoring the patients and change
therapy in case of increasing PASI scores and/or DLQI index to an unacceptable
level. The burden of this study regarding study measurements is expected to be
minimal: (non-invasive) disease severity measurements will be performed, like
PASI scores that are already standard of care in some of the centres (5 minutes
extra time). Patients will be asked to fill in 4 questionnaires on quality of
life and costs every 3 months during the study (approx. 10 minutes duration).
Every 3 months, one extra vial of blood will be asked from the patients, most
of the time this will be done at moments when blood is already drawn for usual
care. There is direct individual benefit only in those patients that can be
reduced in dose. On group level, the safety profile of these new drugs is
expected to improve, and costs are expected to decrease by at least 30% with
the proposed strategy in patients with stable disease.
Rene Descartesdreef 1
Nijmegen 6525GL
NL
Rene Descartesdreef 1
Nijmegen 6525GL
NL
Listed location countries
Age
Inclusion criteria
• Plaque psoriasis (primarily)
• Treatment for 6 months at least with IL23 or IL17 inhibitor in a normal dose
(dose advised by the label)
• PASI (Psoriasis Area and Severity Index) <= 5 at inclusion and in previous 6
months (in previous 6 months, it should be clear from the patient record that
psoriasis was clear/almost clear if no PASI scores are available).
• DLQI <= 5 at inclusion
Exclusion criteria
• Another indication than plaque psoriasis as the main indication for biologic
use (e.g. receives biologic for rheumatoid arthritis as the main indication).
• Concomitant use of systemic immunosuppressants other than methotrexate or
acitretin (e.g. prednisone, cyclosporine etc).
• Severe comorbidities with short life-expectancy (e.g. metastasized tumour).
• Presumed inability to follow the study protocol.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004230-42-NL |
| ClinicalTrials.gov | NCT04340076 |
| CCMO | NL71920.091.19 |