Ikonomidis 2019.

Methods	Effects of treatment with biological agents on vascular and cardiac function in psoriasis Phase 4, RCT, parallel arms, investigator‐blind Monocentric: Attikon Hospital, Athens Starting date: May 2014
Participants	Randomised: 200 Incusion criteria patients with psoriasis Age‐ and sex‐matched patients with CAD, with untreated hypertension and healthy Exclusion criteria: For psoriasis patients were presence of wall motion abnormalities and ejection fraction ≤ 50%, psoriatic arthritis, history of acute coronary syndrome, familial hyperlipidaemia, insulin dependent‐diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumours. CAD was excluded in psoriasis patients by absence of clinical history, angina and reversible myocardial ischaemia, as assessed by dobutamine stress echocardiography or thallium scintigraphy For the group of CAD patients, we only included those without a history of ST elevation myocardial infarction in order to exclude the presence of transmural scar compromising myocardial function indices. Thus, CAD patients with wall motion abnormalities and ejection fraction of ≤ 50% were excluded. In addition, history of acute coronary syndrome without ST‐segment elevation within the last year, familial hyperlipidaemia, insulin dependent‐diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumour in normal controls, CAD was excluded by the presence of normal ECG, absence of clinical history and absence of reversible ischaemia by means of treadmill test or dobutamine stress echocardiography
Interventions	Intervention 1: Etanercept 50 mg Intervention 2: Ustekinumab 45 mg Intervention 3: Cyclosporine 2.5 ‐ 3 mg/kg Intervention 4: Secukinumab 300 mg Intervention 5: Apremilast 30 mg
Outcomes	Primary outcome: Comparison of effect (improvement or deterioration) of treatment with biological vs. non‐biological agents on endothelial function in psoriasis Comparison of effect (improvement or deterioration) of treatment with biological vs. non‐biological agents on vascular function in psoriasis at 12 weeks Comparison of effect (improvement or deterioration) of treatment with biological vs. non‐biological agents on cardiac function in psoriasis at 12 weeks Secondary outcome: Differences and similarities in endothelial function between psoriasis and control groups at 12 weeks Differences and similarities in vascular function between psoriasis and control groups at 12 weeks Differences and similarities in cardiac function between psoriasis and control groups at 12 weeks
Notes	NCT02144857 Contact: Ignatios Ikonomidis, Dr2105831264ignoik@gmail.com Contact: Maria Varoudi, Dr6909001116mvaroudi@gmail.com