Psoriasis, Moderate to Severe Psoriasis
Conditions
Keywords
Psoriasis, Comorbidities, Tildrakizumab, Burden disease
Brief summary
Psoriasis is a chronic inflammatory disease that affects 125 million people around the world with major repercussions on physical and emotional quality of life of patients. Many studies confirmed the association between psoriasis and comorbidities as cardio vascular diseases, gastroinstestinal, kidney diseases, cancers, infections or mood disorders. Psoriasis, specially, when it is severe, is associated with highest mortality and a disease burden linked to comorbidities. Understanding this disease burden associated to psoriasis is crucial for an optimal medical care. Tildrakizumab is indicated in treatment of moderate-to-severe plaque psoriasis in adults who need a systemic treatment, also, in case of failure, intolerance or contraindication to a systemic treatment, including Methotrexate. The aim of TILFLEX study is to evaluate the efficacy, safety and flexibility of Tildrakizumab in patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight \> 90Kg. The main objective is to evaluate the efficacy of Tildrakizumab 200mg at week (W)28.
Detailed description
Psoriasis is a common chronic inflammatory disease affecting between 2% and 4% of the French population and around 125 million people worldwide 1-3. Psoriasis has a significant impact on physical and emotional quality of life, comparable to that caused by other serious diseases. Epidemiological data, together with basic scientific research into the natural history and biology of psoriasis, have led to the recognition of this disease as a pathology with significant repercussions on health, going beyond skin involvement alone. Severe psoriasis is associated with an increased risk of mortality, with cardiovascular causes being the most common. Indeed, these patients have an elevated risk of cardiovascular death (HR 1.57; CI95% 1.26-1.96) compared to a population of patients without psoriasis. Further studies are needed to determine whether the increased mortality rate or excess mortality is due to psoriasis itself, treatments, behaviours or other factors. Many studies confirmed the association between psoriasis and comorbidities as cardio vascular diseases, gastroinstestinal, kidney diseases, cancers, infections or mood disorders. Psoriasis, specially, when it is severe, is associated with highest mortality and a disease burden linked to comorbidities. Understanding this disease burden associated to psoriasis is crucial for an optimal medical care. Tildrakizumab 200mg has already shown its long-term efficacy in treatment of psoriasis and safety in clinical trials such as ReSurface 1 and ReSurface 2 and retrospective studies in patients with a high disease burden or body weight ≥ 90 kg. Further prospectives investigations in real-life are required to confirm the efficacy of Tildrakizumab 200mg in patients with psoriasis and high disearse burden (comorbidities, difficult-to-treat locations, severe form of psoriasis, treatment failure…).
Interventions
OTHERPsoriasis clinical assessment
Global evaluation of psoriasis and specific evaluation by areas if applicable
OTHERAssessment of comorbidities
Medical history of patient and assessment of comorbidities at each visit
DLQI questionnaire at each visit
OTHERWell-being evaluation
Evaluation by questionnaire WHO-5 (french version) at each visit
OTHERTreatment compliance
Assessment by a self-adminitreted questionnaire at W28, W52, W76
Self-administreted questionnaire at W0 and W76
Sponsors
Clin4all
Almirall, SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with a diagnosis of moderate to severe chronic plaque psoriasis documented in the medical record, defined by: PASI ≥ 10 And/or body surface area (BS) affected ≥ 10% And/or DLQI ≥ 10 2. Disease diagnosis \> 6 months (regardless of severity at diagnosis) 3. Body weight ≥ 90kg and/or a high burden of disease (assessed by physician) 4. Indication for treatment with an IL-23 inhibitor. Tildrakizumab 200mg must be the selected anti-IL-23 therapy prior to enrolling the patient in the study. 5. Patient 18 years of age or older at the inclusion visit 6. French social security affiliation/entitlement
Exclusion criteria
1. Patient unable to comply with study requirements (complete study questionnaires) 2. Patient who, in the opinion of the investigator, should not participate in the study. This opinion should be documented in the patient's record. 3. Patient included in an interventional clinical trial at inclusion. Except in exceptional cases, concurrent participation in an interventional clinical trial will not be possible during the course of the study and must be discussed in advance with the Sponsor. 4. Vulnerable patient or patient under court protection 5. Patients with known hypersensitivity to IL-23 inhibitors 6. Patients with active HIV, HBV or HCV infection at the time of inclusion 7. Patient with a history of untreated latent tuberculosis or active tuberculosis at inclusion 8. Patient with any other serious active infection\* present at inclusion that contraindicates anti-IL23 use. 9. Pregnant or lactating patients at baseline. Patients of childbearing potential will be informed of the need to use effective contraception during treatment\*\*.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specific response to Tildrakizumab at Week28 (W28) | Week 28 | The response will be assessed by PASI absolute (Psoriasis Area and Severity Index), score from 0 to 72 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the maintenance of efficacy of Tildrakizumab | Week 52 and week 76 | Maintenance of treatment response will be assessed by PASI (Psoriasis Area and Severity Index) absolute at Week 52 and Week 76 according to Tildrakizumab dose (200mg or 100mg). |
| Impact of treatment on perceived quality of life | Week 0, Week 28, Week 52 and Week 76 | Changes in the DLQI (Dermatology Life Quality Index) score. Description of each dimension of the DLQI (Dermatology Life Quality Index) score. The total score ranges from 0 to 30, and each of the 10 questions is scored on a 4 point Likert scale |
| Impact of treatment on well-being | Week 0, Week 28, Week 52 and Week 76 | Changes in the well-being score assessed by the WHO-5 Well-Being Index, a short, self-reported questionnaire that measures current mental well-being over the past two weeks. Total sum of the 5 items, ranging from 0 (worst quality of life) to 25 (best quality of life). |
| To study the safety of Tildrakizumab | Week 28, Week 52 and Week 76 | Describe the nature and frequency of adverse events throughout follow-up. |
Countries
France
Outcome results
None listed