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)

Conditions: Psoriasis (PsO); Enthesitis; Psoriasis Arthritis; Secukinumab

Summary: 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)


Eligibility criteria:
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)