Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Occurrence of skin cancer |
Occurrence of skin cancer (spinocellular carcinomas [including carcinoma in situ (Bowen) and keratoacanthomas], basocellular carcinomas and melanomas). |
Up to 5 years of follow up for each patient |
|
Secondary |
Physicians global assessment of disease (PGA) score |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Psoriasis Area and Severity Index (PASI) Score |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Body surface area |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Dermatology Life Quality Index (DLQI) Score |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Global Self Assessed (GSA) Score |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) index score |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Patient Report of Extent of Psoriasis Involvement (PREPI) score |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Number of patients reporting acceptable symptom state : acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Number of patients reporting clinically important improvement in psoriasis activity during the last 48 hours compared to baseline |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Occurrence of Adverse Events and Serious Adverse Events |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Occurrence of Events of special interest such as infectious diseases, autoimmune diseases, lymphoma and blood disorders, multiple solid tumors, cardiovascular diseases, etc. |
|
[Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Drug survival rate (proportion of patients still exposed to treatment |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Socio-demographic and clinical data: age, sex, socio-professional category, body mass index (BMI) and phototype (Fitzpatrick) |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Lifestyle data: family life, tobacco consumption, alcohol consumption and history of natural and artificial UV exposure |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Number of patients with history and comorbidities |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Number of patients with previous systemic treatments including phototherapy and acitretin |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Number of patients with systemic treatments |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Number of patients with concomitant treatments |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Daily dose of systemic treatments |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|
Secondary |
Therapeutic strategy: duration of systemic treatments, dosages, change in systemic treatments, reasons for modifications of systemic treatments |
|
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year. |
|