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)
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
Diagnosis of PsA2 according to CASPAR
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
Obesity impeded ultrasound examination
Adult patients with moderate to severe plaque psoriasis
Cohort
Prospective
IL-17i
DrugIL-17 inhibitors
Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24
Glasgow Ultrasound Enthesitis Scoring System (GUESS) is an ultrasonographic score of lower limb enthesitis including superior pole of the patella-quadriceps tendon enthesis, inferior pole of the patella-proximal patellar ligament enthesis, tibial tuberosity-distal patellar ligament enthesis, superior pole of the calcaneus-achilles tendon enthesis and inferior pole of the calcaneus-plantar aponeurosis enthesis, composed of assessments of degenerative changes such as tendon thickness, existence of enthesitis, bursitis, or erosions. It is calculated as follows: one point was scored for each abnormality at each site examined, giving a possible maximum total score for both lower extremities 36. A higher score of GUESS represents more serve inflammation and involvement of enthesis while a lower score represents better outcomes.
Change of Glasgow Ultrasound Enthesitis Scoring System(GUESS) from baseline to week 4, 12, 36, 52
Glasgow Ultrasound Enthesitis Scoring System (GUESS) is an ultrasonographic score of lower limb enthesitis including superior pole of the patella-quadriceps tendon enthesis, inferior pole of the patella-proximal patellar ligament enthesis, tibial tuberosity-distal patellar ligament enthesis, superior pole of the calcaneus-achilles tendon enthesis and inferior pole of the calcaneus-plantar aponeurosis enthesis, composed of assessments of degenerative changes such as tendon thickness, existence of enthesitis, bursitis, or erosions. It is calculated as follows: one point was scored for each abnormality at each site examined, giving a possible maximum total score for both lower extremities 36. A higher score of GUESS represents more serve inflammation and involvement of enthesis while a lower score represents better outcomes.
Complete resolution of enthesitis from baseline to week 24
Complete resolution of enthesitis from baseline to week 24 based on enthesis assessed by GUESS. It means the percentage reaching a score of 0 for each enthesis. Higher percentage represents higher improvement.
Complete resolution of enthesitis from baseline to week 52
Complete resolution of enthesitis from baseline to week 52 based on enthesis assessed by GUESS. It means the percentage reaching a score of 0 for each enthesis. Higher percentage represents higher improvement.
New bone erosion, bursitis, osteophytes at week 24
New bone erosion, bursitis, osteophytes at week 24 based on enthesis assessed by GUESS. It means the percentage that the score changes from 0 to 1 in the item of 'erosion, bursitis, osteophytes' for each enthesis. Higher percentage represents more worsening of inflammation.
Risk factors at baseline contributing to PsA development
Risk factors at baseline contributing to PsA development (psoriasis phenotype, severity, comorbidities, genetic predisposition, obesity)
Association of risk factors with the development of PsA
Association of risk factors with the development of PsA at 52 weeks
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