Objectives To assess the effects of filgotinib on inflammatory and structural changes at various spinal locations, based on MRI measures in patients with active AS in the TORTUGA trial. Methods In the TORTUGA trial, patients with AS received filgotinib 200 mg (n = 58) or placebo (n = 58) once daily for 12 weeks. In this post hoc analysis, spine MRIs were evaluated using the Canada–Denmark (CANDEN) MRI scoring system to assess changes from baseline to week 12 in total spine and subscores for inflammation, fat, erosion and new bone formation (NBF) at various anatomical locations. Correlations were assessed between CANDEN inflammation and clinical outcomes and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI scores and between baseline CANDEN NBF and baseline BASFI and BASMI scores. Results MRIs from 47 filgotinib- and 41 placebo-treated patients were evaluated. There were significantly larger reductions with filgotinib vs placebo in total spine inflammation score and most inflammation subscores, including posterolateral elements (costovertebral joints, transverse/spinous processes, soft tissues), facet joints and vertebral bodies. No significant differences were observed for corner or non-corner vertebral body inflammation subscores, spine fat lesion, bone erosion or NBF scores. In the filgotinib group, the change from baseline in the total inflammation score correlated positively with the SPARCC spine score. Baseline NBF scores correlated with baseline BASMI but not BASFI scores. Conclusions Compared with placebo, filgotinib treatment was associated with significant reductions in MRI measures of spinal inflammation, including in vertebral bodies, facet joints and posterolateral elements. Trial registration ClinicalTrials.gov (https://clinicaltrials.gov), NCT03117270.

中文翻译：

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Filgotinib 可减少强直性脊柱炎的椎体和后外侧脊柱炎症：TORTUGA 试验的结果

目的基于 TORTUGA 试验中活动性 AS 患者的 MRI 测量，评估丝氨酸对不同脊柱部位炎症和结构变化的影响。方法 在 TORTUGA 试验中，AS 患者每天一次接受 filgotinib 200 mg (n = 58) 或安慰剂 (n = 58) 治疗，持续 12 周。在这项事后分析中，脊柱 MRI 使用加拿大 - 丹麦 (CANDEN) MRI 评分系统进行评估，以评估从基线到第 12 周的总脊柱变化以及各种解剖部位炎症、脂肪、侵蚀和新骨形成 (NBF) 的子评分。地点。评估了 CANDEN 炎症和临床结果与加拿大脊柱关节炎研究联盟 (SPARCC) MRI 评分之间以及基线 CANDEN NBF 与基线 BASFI 和 BASMI 评分之间的相关性。结果评估了 47 名 filgotinib 和 41 名安慰剂治疗患者的 MRI。filgotinib 与安慰剂相比，在脊柱总炎症评分和大多数炎症亚评分（包括后外侧元素（肋椎关节、横突/棘突、软组织）、小关节和椎体）方面的降幅明显更大。对于角或非角椎体炎症子评分、脊柱脂肪病变、骨侵蚀或 NBF 评分，未观察到显着差异。在 filgotinib 组中，总炎症评分相对于基线的变化与 SPARCC 脊柱评分呈正相关。基线 NBF 评分与基线 BASMI 相关，但与 BASFI 评分无关。结论 与安慰剂相比，filgotinib 治疗与脊柱炎症的 MRI 测量值显着降低相关，包括椎体、小关节和后外侧元素。试验注册 ClinicalTrials.gov (https://clinicaltrials.gov)，NCT03117270。