Psoriasis, Etanercept, Infliximab, Cost-effectiveness (kosteneffectiviteit)
Conditions
Interventions
Etanercept will be self administered by subcutaneous injection, 50 mg twice weekly.
Infliximab is an intravenous treatment with 5 mg/kg at week 0,2,6 and then every 8 weeks.
At week 12, according
Sponsors
Academic Medical Center (AMC), Department of dermatology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults patients (18-75 years of age) 2. Psoriasis Area and Severity Index (PASI > 10) and/or Body Surface Area (BSA) > 10. 3. Failed, contraindicated and/or intolerant to UV therapy, and methotrexate or cyclosporin. 4. Informed consent. 5. Able to complete Dutch questionnaires.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation. 2. Active (or chronic) infections including Hepatitis B and C viral infections, HIV and tuberculosis. 3. Malignancy in last 10 years, except BCC and cervical in situ cancer. 4. Demyelinating disease. 5. Congestive heart failure. 6. Allergic and hypersensitivity reactions to study drugs or ingredients. 7. Any live virus or bacterial vaccination within 3 months. 8. Severe liver- or kidney function disorders (3 times upper limits of the parameters).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: - PASI75 and PGA as clinical psoriasis severity measures at week 12 and 24. -Improvement of HRQOL: Skindex-17, the generic SF-36 and PAGA. -Treatment satisfaction: Treatment Medication Satisfaction Questionnaire (TMSQ) score. - The incremental cost effectiveness ratio (ICER) of infliximab relative to etanercept will be calculated and estimated in terms of costs per QALY, by using the EQ-5D. - Nonmedical costs and medical cost outside the hospital, using the Labor and Health Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of remission will be analysed. - Patients perspectives will be analysed. - Presence of neutralising antibodies will be measured. - Side effects will be evaluated. - The improvement of nailpsoriasis will be evaluated. | — |
Contacts
Public ContactA.C.Q. Vries
Academic Medical Center (AMC) Department of Dermatology
Outcome results
None listed