Navarro-Compán Victoria, Rudwaleit Martin, Dubreuil Maureen, Magrey Marina, Marzo-Ortega Helena, Mease Philip J, Walsh Jessica A, Dougados Maxime, de la Loge Christine, Fleurinck Carmen, Massow Ute, Vaux Thomas, Taieb Vanessa, Deodhar Atul
V. Navarro-Compán, MD, PhD, MSc, Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain;
M. Rudwaleit, MD, University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany.
J Rheumatol. 2025 Jan 1;52(1):23-32. doi: 10.3899/jrheum.2024-0223.
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).
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.
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 ≤ 0.001), as well as higher FACIT-Fatigue scores (nominal < 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).
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.
在III期BE MOBILE研究（ClinicalTrials.gov：NCT03928704和NCT03928743）中评估比美吉珠单抗对非放射学和放射学轴向脊柱关节炎（axSpA）患者疼痛、晨僵和疲劳的影响。
患者每4周随机接受160mg比美吉珠单抗或安慰剂治疗；所有患者从第16周开始接受比美吉珠单抗治疗。患者报告至第52周的脊柱疼痛、外周疼痛、晨僵和疲劳情况。脊柱总疼痛和夜间疼痛均采用0至10分数字评分量表（NRS）进行评估。分别通过巴斯强直性脊柱炎疾病活动指数（BASDAI）单项（0至10分NRS）评估外周关节炎疼痛（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功能评估疲劳子量表评分（FACIT-疲劳）。
在第16周时，与安慰剂相比，接受比美吉珠单抗治疗的患者报告夜间脊柱平均疼痛、脊柱总疼痛和BASDAI评分更低（夜间脊柱疼痛为名义值；均≤0.001），以及FACIT-疲劳评分更高（名义值<0.05），表明症状水平有所改善。持续接受比美吉珠单抗治疗的患者和从安慰剂转换为比美吉珠单抗治疗的患者至第52周时改善仍在持续。在第16周时，与安慰剂组相比，随机接受比美吉珠单抗治疗的患者中达到更低脊柱和外周疼痛更严格阈值的比例更高；在第52周时这种情况持续存在或有所改善。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≥8分）。
比美吉珠单抗治疗使疼痛和晨僵水平迅速改善。在axSpA整个疾病谱的所有领域均观察到显著改善，且持续至第52周。
