Kirkham Bruce, Nash Peter, Reina Delia, Navarra Sandra, Quebe-Fehling Erhard, Gaillez Corine, Sastre Carlos, Mease Philip J
Guys Hospital and St Thomas NHS Trust, London, UK.
Griffith University, Brisbane, Australia.
Clin Exp Rheumatol. 2023 Mar;41(3):589-596. doi: 10.55563/clinexprheumatol/vezf95. Epub 2022 Jul 28.
Dactylitis is an important clinical domain of psoriatic arthritis (PsA) associated with significant burden of disease and impaired function. Post-hoc analysis of the FUTURE 5 study was performed to evaluate the efficacy of secukinumab in patients with dactylitis at baseline over 2 years.
Randomised patients received secukinumab 300mg with loading dose (LD)/150mg LD/150mg without loading dose/placebo. Assessment of dactylitis was based on Leeds Dactylitis Index. Exploratory analyses included resolution of dactylitis based on severity, time to first resolution of dactylitis (Kaplan-Meier estimate) and resolution of dactylitis (heatmap analysis). Clinical efficacy outcomes, composite domains of disease activity, health-related quality of life (HRQoL) and radiographic progression using van der Heijde-modified total Sharp score were assessed in patients with/without dactylitis at baseline.
Overall, 389/996 (39%) patients presented with dactylitis at baseline, had more active clinical disease and greater disease activity than those without dactylitis at baseline. Resolution of dactylitis was observed across all treatment groups at Week 104. Improvement in joints, enthesitis, skin psoriasis, nail outcomes, physical function and HRQoL were sustained over 2 years in patients with dactylitis at baseline. With secukinumab treatment, >80% of patients did not show structural radiographic progression. The proportion of non-structural radiographic progressors were comparable across patients with/without dactylitis at baseline with secukinumab treatment over 2 years.
Patients with dactylitis at baseline were associated with higher burden of disease. Secukinumab provided sustained improvements across all clinical outcomes, QoL and inhibition of radiographic progression in PsA patients with dactylitis at baseline over 2 years.
指（趾）炎是银屑病关节炎（PsA）的一个重要临床领域，与显著的疾病负担和功能受损相关。对FUTURE 5研究进行事后分析，以评估司库奇尤单抗在基线时有指（趾）炎的患者中2年的疗效。
随机分组的患者接受司库奇尤单抗300mg负荷剂量（LD）/150mg LD/150mg无负荷剂量/安慰剂。指（趾）炎的评估基于利兹指（趾）炎指数。探索性分析包括根据严重程度判断指（趾）炎的缓解情况、指（趾）炎首次缓解的时间（Kaplan-Meier估计）以及指（趾）炎的缓解情况（热图分析）。对基线时有/无指（趾）炎的患者评估临床疗效结局、疾病活动综合领域、健康相关生活质量（HRQoL）以及使用范德海伊德改良总Sharp评分的放射学进展情况。
总体而言，389/996（39%）的患者在基线时出现指（趾）炎，与基线时无指（趾）炎的患者相比，其临床疾病更活跃，疾病活动度更高。在第104周时，所有治疗组均观察到指（趾）炎的缓解。基线时有指（趾）炎的患者在2年内关节、肌腱端炎、皮肤银屑病、指甲情况、身体功能和HRQoL持续改善。接受司库奇尤单抗治疗后，超过80%的患者未出现放射学结构进展。在接受司库奇尤单抗治疗2年的患者中，基线时有/无指（趾）炎的患者非结构放射学进展者的比例相当。
基线时有指（趾）炎的患者疾病负担更高。司库奇尤单抗在2年内使基线时有指（趾）炎的PsA患者的所有临床结局、生活质量得到持续改善，并抑制了放射学进展。
