Efficacy outcomes:
-PASI. Assessment of severity of lesions. Determination by physical examination and scaling that combines the assessment of the severity of the lesions (erythema, induration and scaling) and a single score affected area encompassing a range of 0 (no disease) to 72 (maximum severity). Measuring time: weeks 0, 12, 24, 36, 40, 44, 48, 52, 56 and 60.
- Percent improvement in PASI from baseline. (PASI 50, 75, 90, 100). Determining the percent reduction of PASI by the formula:% reduction in PASI (PASI initial - current PASI) / initial PASI * 100. Measuring Time: Weeks 12, 24, 36, 40, 44, 48, 52, 56 and 60.
- Proportion of patients with PASI 50, 75, 90, 100, PASI ≥ 50 but <75 and PASI <50. Patients who achieve a percentage reduction in PASI equal to or greater than 50 percent are classified as PASI 50, and respectively and for the rest of the categories. Measuring Time: Weeks 12, 24, 36, 48 and 60.
- Time to relapse. Time to loss of PASI 50 and PASI 75 response for patients who achieved PASI 50 or greater. Measuring time: Week 36
- Proportion of patients with relapsed. Measuring Time: Weeks 40, 44, 48, 52, 56 and 60.
- Investigator Global Assessment (IGA mod 2011). Static scale modified (2011) of 5 points from the overall assessment of the specialist. Measuring time: weeks 0, 12, 24, 36, 40, 44, 48, 52, 56 and 60.
- Proportion of patients with IGA ≤1. Measuring Time: Weeks 12, 24, 36, 48 and 60.
- Scale quality of life (DLQI, Dermatology Life Quality Index). Questionnaire with 10 subjects reporting the patient to measure the effect of psoriasis on 6 different aspects of quality of life. Each question has 4 possible answers: no, a little, a lot, and much that is qualified from 0 to 3, respectively. The sum of the response covers range from 0 (none) to 30 (a lot) points. Values 0 and 1 indicate no negative impact on quality of life and more than 10 represents a big impact. Measuring time: weeks 0, 12, 24, 36, 48 and 60.
Safety outcomes:
Incidence of Adverse Events (AE) (type (name of AE), Intensity (Mild, Moderate, Severe), Gravity (Serious, Not serious), causality relationship (Very Likely, Likely, Possible, Not related, Unknown). Measuring time: Weeks 0, 2, 4, 6, 8, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60.
Immunological outcomes:
Percent subpopulations in peripheral blood lymphoid cells, total count of peripheral blood lymphoid cells, frequency T cell precursors, frequency of IFN-gamma secreting T cells, serum cytokines concentration, expression pattern Percent cytosine, Percent of lymphocyte activation. Measuring time: weeks 0, 12, 24, 36, 60.