Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain

Amgen153 enrolled

Overview

Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology. The present study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.

Study Type

OBSERVATIONAL

Enrollment

153

Conditions

Psoriasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult male and female (≥ 18 years). * Patients diagnosed with moderate to severe plaque psoriasis and for which treatment with apremilast is indicated according to the doctor's criteria (established before the patient enters the study) and according to the specifications of the medication's data sheet * Patients with available data regarding the PASI and DLQI assessments at the moment of initiating treatment with apremilast. * Patients for whom, according to the physician's criteria (established prior to patient's entry into the study) and according to the specifications of the drug's prescribing information, apremilast treatment is indicated. * All patients who, according to the routine clinical practice, initiated apremilast treatment for the first time 3 months (+/- 4 weeks) before their inclusion in the study (patients may or may not have completed 3 months of apremilast treatment). * Patients who have previously received at least one systemic treatment for moderate to severe plaque psoriasis. * Patients who have not previously been treated with a biological agent for moderate to severe plaque psoriasis. * Patients who agree to participate in the study by signing the informed consent. * Patients who are able to understand and complete the questionnaires specified in the study protocol. Exclusion Criteria: • Patients participating in another study at the time of entering the study.

Outcomes

Primary Outcomes

Percentage of subjects achieving PBI ≥ 1

Patient Benefit Index (PBI) is a measure of the benefit associated with a patient-reported treatment consisting of the administration of two questionnaires: the Patient needs questionnaire (PNQ), administered at baseline, and the patient benefit questionnaire (PBQ), administered during treatment

Time frame: Approximately 7 months

Secondary Outcomes

Describe the persistence of apremilast treatment

Is defined as the duration of time from initiation to discontinuation of therapy.

Time frame: Approximately 7 months

Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis

Pruritus intensity measures: Usually used scales are based on patient perception: Visual analogue scale (VAS). Horizontal line of 100 mm, with descriptive signs at the ends indicating "no itching" and "the worst imaginable itch". The score is obtained by measuring the distance in millimeters from the beginning of the line to a vertical mark placed by the patient to indicate the intensity of the pain