Reumatologia clinica · 2025
Usefulness of ultrasound in the assessment of the efficacy of apremilast in psoriatic arthritis: Articular, enthesitic and nail index.
Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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de Agustin Juan José, Añez Gustavo Adolfo, Reina Delia, Heredia Sergi, Ramirez Julio, Cuervo Andrea Mireya, Rodriguez Jesus, Moragues Carmen, Moya Patricia, Laiz Alonso Ana Maria, Moreno Mireia, Arevalo Marta, Pujol Manel, Salvador Georgina, Busquets Noemi, Ponce Andres, Pascual Pastor Maria
Аннотация
BACKGROUND: Psoriatic arthritis (PsA) affects joints and entheses. The objective is to use ultrasound (US) to see inflammatory changes in joints and entheses in patients with active PsA starting Apremilast.
PRIMARY OBJECTIVE: 20% reduction in the US index (UIC) at 12 months.
METHODOLOGY: Multicenter, prospective, open-label study. Patients with PsA (≥2 swollen joints) and ≥2 US synovitis in joints and ≥1 US enthesitis at screening were recruited. Follow-up was 52 weeks (baseline and 1, 6, 9, 12 months). US (joint, tendon, and entheses), clinical (SJC, TJC, LEI, PGA, PtGA), and biological (ESR and CRP) parameters were recorded.
RESULTS: 48 patients were evaluated, 46 were included in the follow-up and 26 completed the 52-week study. The primary endpoint was achieved, with reductions of up to 40%. All clinical and ultrasound variables decreased significantly after 12 months. 75 adverse events (AEs) were recorded in 33 patients, and only one serious event (SAE). Reasons for withdrawal included AEs (6 patients), lack of efficacy (8 patients), and other reasons (loss to follow-up, withdrawal of consent) for 6 patients.
CONCLUSIONS: Changes in different domains of PsA in patients treated with Apremilast can be best identified by ultrasound. Ultrasound is an excellent tool to study joints, tendons, and entheses in PsA. Apremilast is a safe, well-tolerated, and effective treatment for several patterns of PsA (joints, entheses) as demonstrated by ultrasound. Ultrasound can also identify nail diseases in patients with PsA.
PRIMARY OBJECTIVE: 20% reduction in the US index (UIC) at 12 months.
METHODOLOGY: Multicenter, prospective, open-label study. Patients with PsA (≥2 swollen joints) and ≥2 US synovitis in joints and ≥1 US enthesitis at screening were recruited. Follow-up was 52 weeks (baseline and 1, 6, 9, 12 months). US (joint, tendon, and entheses), clinical (SJC, TJC, LEI, PGA, PtGA), and biological (ESR and CRP) parameters were recorded.
RESULTS: 48 patients were evaluated, 46 were included in the follow-up and 26 completed the 52-week study. The primary endpoint was achieved, with reductions of up to 40%. All clinical and ultrasound variables decreased significantly after 12 months. 75 adverse events (AEs) were recorded in 33 patients, and only one serious event (SAE). Reasons for withdrawal included AEs (6 patients), lack of efficacy (8 patients), and other reasons (loss to follow-up, withdrawal of consent) for 6 patients.
CONCLUSIONS: Changes in different domains of PsA in patients treated with Apremilast can be best identified by ultrasound. Ultrasound is an excellent tool to study joints, tendons, and entheses in PsA. Apremilast is a safe, well-tolerated, and effective treatment for several patterns of PsA (joints, entheses) as demonstrated by ultrasound. Ultrasound can also identify nail diseases in patients with PsA.