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)

Korábbi kezelés

• Any known rheumatic disease, positive rheumatoid factor/anti-citrullinated protein antibodies, prior treatment with anti-rheumatic drugs
• Treatment with systemic corticosteroids within 12 weeks or 5 half-lives of screening
• Pregnant or lactating women or women with plan for conception 5 months before or after treatment
• History of alcohol or drug abuse or evidence of abuse within 6 months prior to baseline
• 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)

Más betegség

• 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.
• Current or relevant history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
• History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years
• History of hypersensitivity to any component of the study drug

Laborértékek

• 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.
• Any liver function abnormality: aspartate aminotransferase (AST) > 2xULN, alanine aminotransferase (ALT) > 2xULN, total bilirubin (TBIL) > 2xULN
• Abnormal renal function: serum creatinine > 2.0 mg/dl

Egyéb

• Diagnosis of PsA2 according to CASPAR
• Obesity impeded ultrasound examination
• Participated in other clinical trials
• Unable or unwilling to undergo repeated venipuncture

• Adult patients ( ≥ 18 years of age) with chronic plaque-type psoriasis
• Meet one of the following conditions: Psoriasis Area and Severity Index [PASI] score > 6, or scalp involvement, or nail involvement.
• 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
• Psoriasis is inadequately controlled by current topical therapy or phototherapy
• Able to sign the informed consent