A Prospective Study to Assess the Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS)

Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS): a Single-center, Prospective, Exploratory, Open-label Study

It is an observational, single-center, prospective, exploratory, open-label study to assess the efficacy and safety of IL-17 inhibitors on subclinical enthesitis in patients with moderate to severe psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS)

Inclusion Criteria:

1. Adult patients ( ≥ 18 years of age) with chronic plaque-type psoriasis
2. Meet one of the following conditions: Psoriasis Area and Severity Index [PASI] score > 6, or scalp involvement, or nail involvement.
3. Inflammatory changes on ultrasound consistent with OMERACT definition at least at one peripheral attachment point at screening, defined as thickening and/or abnormal echogenicity of tendons or ligaments at the site of their insertion into the bone (within 2 mm of the talar cortex), and active Doppler signals that may indicate structural damage such as bone erosion, syndesmophytes/calcifications
4. Psoriasis is inadequately controlled by current topical therapy or phototherapy
5. Able to sign the informed consent

Exclusion Criteria:

1. Diagnosis of PsA2 according to CASPAR
2. Any known rheumatic disease, positive rheumatoid factor/anti-citrullinated protein antibodies, prior treatment with anti-rheumatic drugs
3. Treatment with systemic corticosteroids within 12 weeks or 5 half-lives of screening
4. Obesity impeded ultrasound examination
5. Pregnant or lactating women or women with plan for conception 5 months before or after treatment
6. Participated in other clinical trials
7. Concurrent significant medical problems, including but not limited to the following: uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 95 mmHg), congestive heart failure (NYHA class III or IV), total white blood cell count < 2500/μl, or platelets < 100,000/μl or neutrophils < 1500/μl or hemoglobin < 8.5 g/dL at screening.
8. Any liver function abnormality: aspartate aminotransferase (AST) > 2xULN, alanine aminotransferase (ALT) > 2xULN, total bilirubin (TBIL) > 2xULN
9. Abnormal renal function: serum creatinine > 2.0 mg/dl
10. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection, defined as a positive PPD skin test or Mycobacterium tuberculosis interferon-gamma release assay (IGRA) test.
11. Current or relevant history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
12. History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years
13. Unable or unwilling to undergo repeated venipuncture
14. History of alcohol or drug abuse or evidence of abuse within 6 months prior to baseline
15. History of hypersensitivity to any component of the study drug
16. Did not accept live vaccines within 4 weeks prior to enrollment, do not have plan of vaccination program during the study, and no live vaccines are planned > 6 months after the last dose of the study (herpes zoster vaccine > 12 months)