An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

An Efficacy Study of Secukinumab in Enthesitis of Psoriatic Arthritis Patients as Measured by Imaging Test

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of enthesitis in psoriatic arthritis patients. This study will be the first randomized trial of a biologic therapy in participants with psoriatic arthritis, using imaging test.

Inclusion Criteria:

• aged 18 years or older,;
• had received a diagnosis of psoriatic arthritis at least 6 months previously, fulfilled the Classification Criteria for Psoriatic Arthritis (CASPAR);
• had at least 1 active enthesitis (confirmed by ultrasound) ;
• had active arthritis (at least 3 tender/painful and 3 swollen joints) ;
• had active plaque psoriasis (there was no criteria for minimum psoriasis severity) at screening and baseline.

Exclusion Criteria:

• History of surgery or trauma at the site examined by ultrasound (hand, elbow, knee, ankle, etc.);
• Local injection of glucocorticoids or other drugs at the site examined by ultrasound in recent 6 weeks;
• Peripheral neuropathy;
• Use of IL-17 or IL-12/23 inhibitors in the last 12 months;Use of infliximab, adamumab, golimumab, and cetuzumab in the last 10 weeks;PUVA treatment for the last 4 weeks;Use of topical treatment or UVB phototherapy that may have an effect on psoriasis in the last 2 weeks;
• recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease; evidence of active or latent or inadequately treated Mycobacterium tuberculosis; aspartate transaminase (AST) or alanine transaminase (ALT) >3x upper limit of normal (ULN) at screening; estimated creatinine clearance <40 mL/min.