OBJECTIVE To assess the effect of bimekizumab on pain, morning stiffness, and fatigue in patients with nonradiographic and radiographic axial spondyloarthritis (axSpA) in the phase III BE MOBILE studies (ClinicalTrials.gov: NCT03928704 and NCT03928743). METHODS Patients were randomized to bimekizumab 160 mg or placebo every 4 weeks; and all patients received bimekizumab from week 16. Patients reported spinal pain, peripheral pain, morning stiffness, and fatigue to week 52. Total and nocturnal spinal pain were each assessed on a 0-10 numerical rating scale (NRS). Individual Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) items (0-10-point NRS) assessed peripheral arthritis pain (question [Q] 3), enthesitis pain/discomfort (Q4), morning stiffness (mean of Q5 and Q6), and fatigue (Q1). Functional Assessment of Chronic Illness Therapy Fatigue subscale score (FACIT-Fatigue) is also reported. RESULTS At week 16, bimekizumab-treated patients reported lower mean nocturnal spinal pain, total spinal pain, and BASDAI scores (nominal except for nocturnal spinal pain; all P ≤ 0.001), as well as higher FACIT-Fatigue scores (nominal P < 0.05) vs placebo, indicating improved symptom levels. Improvements continued to week 52 in continuous bimekizumab-treated patients and in placebo-bimekizumab switchers. A higher proportion of bimekizumab- vs placebo-randomized patients achieved increasingly stringent thresholds for low spinal and peripheral pain at week 16; this was sustained or improved at week 52. Results were similar for morning stiffness and fatigue. At week 52, over half of patients were considered FACIT-Fatigue responders (≥ 8-point increase in score). CONCLUSION Bimekizumab treatment led to rapid improvements in levels of pain and morning stiffness. Substantial improvements were seen in all domains across the full disease spectrum of axSpA and continued to week 52.

中文翻译：

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使用 Bimekizumab 改善中轴型脊柱关节炎的疼痛、晨僵和疲劳：III 期 BE MOBILE 研究的结果。


目的 在 III 期 BE MOBILE 研究中评估 bimekizumab 对非影像学和影像学中轴型脊柱关节炎 （axSpA） 患者疼痛、晨僵和疲劳的影响 （ClinicalTrials.gov： NCT03928704 和 NCT03928743）。方法 患者随机接受 bimekizumab 160 mg 或安慰剂组，每 4 周一次;所有患者从第 16 周开始接受 bimekizumab。患者报告到第 52 周时出现脊髓疼痛、外周疼痛、晨僵和疲劳。全身和夜间脊髓疼痛均采用 0-10 数字评定量表 （NRS） 进行评估。个体 Bath 强直性脊柱炎疾病活动指数 （BASDAI） 项目（0-10 分 NRS）评估了外周关节炎疼痛（问题 [Q] 3）、附着点炎疼痛/不适 （Q4）、晨僵（Q5 和 Q6 的平均值）和疲劳 （Q1）。还报告了慢性病治疗疲劳分量表评分 （FACIT-Fatigue） 的功能评估。结果 在第 16 周，与安慰剂相比，bimekizumab 治疗的患者报告的平均夜间脊髓疼痛、总脊髓疼痛和 BASDAI 评分较低 （除夜间脊髓疼痛外的名义评分;均 P ≤ 0.001），FACIT-疲劳评分较高 （名义 P < 0.05），表明症状水平有所改善。连续 bimekizumab 治疗患者和安慰剂-bimekizumab 转换者的改善持续到第 52 周。与安慰剂随机分配的患者相比，更高比例的 bimekizumab 患者在第 16 周时达到了越来越严格的低脊柱和外周疼痛阈值;这在第 52 周时持续或改善。晨僵和疲劳的结果相似。在第 52 周时，超过一半的患者被认为是 FACIT-疲劳反应者 （≥评分增加了 8 分）。结论 Bimekizumab 治疗导致疼痛和晨僵程度的快速改善。 在 axSpA 的整个疾病谱的所有领域都观察到了实质性改善，并持续到第 52 周。