Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients With Psoriasis

NCT07169682 | Completed FDA Drug

• 1 other identifier: 3610/20-05-2021
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Psoriasis; Cardiovascular Disease; Atherosclerosis

Keywords

psoriasis; atherosclerosis; cardiovascular disease; psoriatic arthritis

Outcome Measures

Primary Outcomes (2)

• change of pulse wave velocity (PWV) from baseline to week 24 and 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

  from enrollment to the end of treatment at week 52

• change of augmentation index normalized to 75 beats/min (AIx75) from baseline to week 24 and 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

  from enrollment to the end of treatment at week 52

Secondary Outcomes (7)

• 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

• change in ankle-brachial index (ABI)

  From enrollment to the end of treatment at 52 weeks

• 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

Study Arms (3)

Group 1

IL17 inhibitor

Drug: interleukin 17 inhibitor

Group 2

IL23 inhibitor

Drug: interleukin-23 inhibitor

Group 3

conventional systemic agent or apremilast

Drug: conventional systemic agent or apremilast

Interventions

interleukin 17 inhibitor DRUG

52 weeks

Group 1

interleukin-23 inhibitor DRUG

52 weeks

Group 2

conventional systemic agent or apremilast DRUG

52 weeks

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with plaque psoriasis with or without psoriatic arthritis, who were monitored in the outpatient department for psoriasis of "Andreas Syngros" hospital for skin diseases and were planed to start treatment with an IL17 inhibitor or an IL23 inhibitor on a conventional systemic agent/apremilast

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Andreas Syggros Hospital of Venereal and Dermatological Diseases: collaborator

Study Sites (1)

Andreas Sygros Hospital

Athens, 17124, Greece

Location

Related Publications (1)

• Tsiogka A, Soulaidopoulos S, Gregoriou S, Rompoti N, Panagakis P, Papoutsaki M, Kostakis P, Kontochristopoulos G, Tsioufis K, Vlachopoulos C, Stratigos A, Rigopoulos D. Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients with Psoriasis: An Observational Study. Dermatol Ther (Heidelb). 2025 Dec;15(12):3777-3792. doi: 10.1007/s13555-025-01549-1. Epub 2025 Oct 8.

  PMID: 41060491 DERIVED

MeSH Terms

Conditions

Psoriasis; Cardiovascular Diseases; Atherosclerosis; Arthritis, Psoriatic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dermatologist, clinical research associate

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 12, 2025
• Study Start: September 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)