Atherosclerosis, Cardiovascular Disease, Psoriasis
Conditions
Keywords
psoriasis, atherosclerosis, cardiovascular disease, psoriatic arthritis
Brief summary
Data on the antiatherogenic effect of IL23 inhibitors are sparse. This study aimed to assess the impact of one-year treatment with an IL17 or IL23 inhibitor on arterial stiffness in patients with moderate-to-severe psoriasis. This observational cohort study included patients with moderate-to-severe psoriasis treated with either an IL17 inhibitor or an IL23 inhibitor or a conventional systemic agent/apremilast (control group) for 52 weeks. The primary outcome was the evaluation of changes in carotid-femoral pulse wave velocity (PWV) and augmentation index normalized to 75 beats/min (AIx75) after 24 and 52 weeks. Secondary outcomes were the comparison of change in PWV and AIx75 between the study groups and the assessment of psoriasis disease severity scores and in ankle-brachial index (ABI).
Interventions
DRUGinterleukin 17 inhibitor
52 weeks
DRUGinterleukin-23 inhibitor
52 weeks
DRUGconventional systemic agent or apremilast
52 weeks
Sponsors
Andreas Syggros Hospital of Venereal and Dermatological Diseases
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate-to-severe psoriasis (Psoriasis Area Severity Index (PASI) score \> 10 or Body Surface Area (BSA) \>10 or Dermatology Life Quality Index (DLQI) \>10) * Indication for treatment with an IL17 or an IL23 inhibitor based on disease characteristics and comorbidities
Exclusion criteria
* Prior treatment with an IL17 or an IL23 inhibitor * Prior therapy with an TNFa-inhibitor for up to 3 months before entering the study * Chronic or severe acute infections, malignancy * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of pulse wave velocity (PWV) from baseline to week 24 and 52 | from enrollment to the end of treatment at week 52 | PWV can range from approximately 6.6 m/s in patients under 30 to 11.7 m/s in patients over 70 years of age; higher scores mean a worse outcome |
| change of augmentation index normalized to 75 beats/min (AIx75) from baseline to week 24 and 52 | from enrollment to the end of treatment at week 52 | no single universally accepted normal range for an AIx@75; lower values indicate better arterial health, with values below 20-25% often considered optimal, and values above 30% associated with increased arterial stiffness and cardiovascular risk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparison of change in PWV between the study groups | From enrollment to the end of treatment at 52 weeks | — |
| change in psoriasis area severity index (PASI) | From enrollment to the end of treatment at 52 weeks | range 0-72; higher scores mean a worse outcome |
| change in ankle-brachial index (ABI) | From enrollment to the end of treatment at 52 weeks | range 0.9-1.4; higher scores mean worse outcome |
| comparison of change in AIx75 between the study groups | from enrollment to the end of treatment at 52 weeks | — |
| change in body surface area (BSA) | From enrollment to the end of treatment at 52 weeks | values 0-100%, higher scores mean a worse outcome |
| change in physician's global assessment (PGA) | From enrollment to the end of treatment at 52 weeks | range 0-5; higher scores mean a worse outcome |
| change in dermatology life quality index (DLQI) | From enrollment to the end of treatment at 52 weeks | range 0-30; higher scores mean a worse outcome |
Countries
Greece
Outcome results
None listed