Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany.
UCB Pharma, Brussels, Belgium and.
Rheumatology (Oxford). 2022 Jul 6;61(7):2875-2885. doi: 10.1093/rheumatology/keab841.
Fat lesions (FLs) on MRI T1 sequences are considered to be early indicators of structural spinal progression in axial spondyloarthritis (axSpA) patients. In this post-hoc analysis from RAPID-axSpA, we assess whether tumour necrosis factor inhibitor (TNFi) treatment over 4 years impacts FLs in spinal vertebral edges (VEs) of patients with axSpA.
In RAPID-axSpA (NCT01087762), a 4-year, phase 3 randomized trial, participants were randomized to certolizumab pegol (CZP; 400 mg loading dose at Weeks 0/2/4 then 200/400 mg every 2/4 weeks) or placebo (PBO) at baseline; PBO-randomized participants switched to CZP at Week 16/24 (denoted PBO-randomized/CZP). Spinal MRI scans were taken at Weeks 0, 12, 48, 96 and 204. Changes in proportions of VEs with FLs are reported as odds ratios (ORs) between time points.
Overall, 136 participants (CZP: 89, PBO-randomized/CZP: 47) had a baseline and ≥1 post-baseline MRI. The OR (95% confidence interval) vs baseline of FLs was higher in PBO-randomized/CZP vs CZP-randomized participants at Weeks 48 [3.35 (2.16-5.19) vs 1.45 (1.07-1.97)], 96 [2.62 (1.77-3.88) vs 1.84 (1.36-2.48)] and 204 [2.55 (1.59-4.06) vs 1.71 (1.23-2.37)]. Across 204 weeks, FLs increased more in VEs with baseline inflammation [Week 204 OR: 4.84 (2.56-9.18)] than those without [OR: 1.15 (0.78-1.71)]. VEs in which inflammation was resolved by Week 12 had lower FL prevalence at Weeks 48, 96 and 204 compared with VEs with unresolved inflammation.
Early and sustained suppression of inflammation mitigates the risk of long-term FL development in the spine in study participants with axSpA evaluated over 4 years.
ClinicalTrials.gov, https://clinicaltrials.gov, NCT01087762.
MRI T1 序列上的脂肪病变（FLs）被认为是轴性脊柱关节炎（axSpA）患者结构脊柱进展的早期指标。在 RAPID-axSpA 的这项事后分析中，我们评估了肿瘤坏死因子抑制剂（TNFi）治疗 4 年后是否会影响 axSpA 患者脊柱椎体边缘（VE）的 FLs。
在 RAPID-axSpA（NCT01087762）中，一项为期 4 年的 3 期随机试验中，参与者被随机分配接受培塞利珠单抗（CZP；第 0、2、4 周给予负荷剂量 400mg，然后每 2、4 周给予 200/400mg）或安慰剂（PBO）治疗；PBO 随机分组的参与者在第 16/24 周转换为 CZP（记为 PBO 随机分组/CZP）。在第 0、12、48、96 和 204 周时进行脊柱 MRI 扫描。FLs 在 VE 中的比例变化以时间点之间的比值比（OR）报告。
总体而言，136 名参与者（CZP：89 名，PBO 随机分组/CZP：47 名）基线时有且至少有 1 次基线后 MRI。与 CZP 随机分组参与者相比，PBO 随机分组/CZP 参与者在第 48 周（3.35[2.16-5.19] vs 1.45[1.07-1.97]）、第 96 周（2.62[1.77-3.88] vs 1.84[1.36-2.48]）和第 204 周（2.55[1.59-4.06] vs 1.71[1.23-2.37]）时 FLs 的 OR 更高。在 204 周时，基线时有炎症的 VE 中 FLs 的增加更多[第 204 周 OR：4.84（2.56-9.18）]，而无炎症的 VE 中则更少[OR：1.15（0.78-1.71）]。在第 12 周炎症得到缓解的 VE 与炎症未得到缓解的 VE 相比，在第 48、96 和 204 周时 FLs 的发生率更低。
在评估时间超过 4 年的 axSpA 研究参与者中，早期和持续抑制炎症可降低脊柱长期 FL 发展的风险。
ClinicalTrials.gov，https://clinicaltrials.gov，NCT01087762。
