Management of moderate to severe plaque psoriasis with Kyntheum® in daily practice
- Conditions
- L40.0Psoriasis vulgaris
- Registration Number
- DRKS00013604
- Lead Sponsor
- EO Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 668
Inclusion Criteria
1) Adult patients (= 18 years).
2) Patients must be a candidate for systemic therapy with Kyntheum® according to SmPC and local guidelines.
3) Decision to start treatment with Kyntheum® in a patient was taken before enrolment in the study.
4) Patients must have understood and voluntarily signed the ICF.
Exclusion Criteria
1) Patients who are enrolled in any interventional clinical trial in parallel.
2) Patients who are already treated or have been previously treated with Kyntheum® before enrolment.
3) Patients, who did not sign the informed consent or incapacitated patients, who are not able to provide informed consent and/ or are under institutionalized care.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Proportion of patients achieving an absolute PASI value of <= 3 at week 12.<br><br>2) Proportion of patients who continued with Kyntheum® after 12 weeks of treatment achieving sPGA success (defined as clear = 0 and almost clear = 1) at week 52.<br>
- Secondary Outcome Measures
Name Time Method 1) Short term effectiveness during induction phase (until week 12).<br><br>2) Long term effectiveness of continued Kyntheum® treatment as measured by the proportion of patients over time on a quarterly basis and at week 52.<br><br>3) Description of the frequency of adverse events.<br><br>4) Description of patient profiles with regard to demographics, disease severity, previous treatment regimens, satisfaction with previous treatment and reasons for choosing Kyntheum®.<br><br>5) Patient Reported Outcomes (PROs) at week 12 and week 52.<br>