Robinson Philip C, Machado Pedro M, Haroon Nigil, Gensler Lianne S, Reveille John D, Taieb Vanessa, Vaux Thomas, Fleurinck Carmen, Oortgiesen Marga, de Peyrecave Natasha, Deodhar Atul
University of Queensland School of Clinical Medicine, Brisbane, Queensland, Australia.
University College London, London, UK.
ACR Open Rheumatol. 2022 Sep;4(9):819-824. doi: 10.1002/acr2.11486. Epub 2022 Jul 14.
The impact of the COVID-19 pandemic on patients with inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), has been variable. Here, we assess disease activity and health-related quality of life (HRQoL) through the pandemic in patients with AS.
In the open-label extension (OLE) of the phase 2b BE AGILE study, patients with AS received 160 mg of subcutaneous bimekizumab every 4 weeks. We assessed Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Quality of Life (ASQoL) scores in the OLE immediately before and during the COVID-19 pandemic (September 2019 to April 2021).
A total of 232 patients remained in the BE AGILE OLE and were included in this post hoc study at the start of the analysis period (September 1, 2019); 12 patients had a COVID-19 treatment-emergent adverse event, and no cases resulted in death. The number of missed bimekizumab doses due to COVID-19 (11 doses) was minimal, and missed assessments remained low (≤5%) compared with the prepandemic period. Mean ASDAS-CRP (1.8), BASDAI (2.4), and ASQoL scores (2.8) in the OLE were low at pre-pandemic baseline and remained stable at 1.7 to 1.8, 2.2 to 2.4, and 2.0 to 2.8, respectively, across successive 3-month periods immediately before and during the pandemic. ASDAS-CRP, BASDAI, and ASQoL stability was consistent across major study countries.
Disease activity and HRQoL remained stable during the COVID-19 pandemic in patients with AS receiving bimekizumab in the BE AGILE OLE, with no indication of negative effects on these outcomes.
2019冠状病毒病（COVID-19）大流行对强直性脊柱炎（AS）等炎性风湿性疾病患者的影响各不相同。在此，我们评估了AS患者在大流行期间的疾病活动度和健康相关生活质量（HRQoL）。
在2b期BE AGILE研究的开放标签扩展（OLE）中，AS患者每4周接受160mg皮下注射比美吉珠单抗。我们在COVID-19大流行之前（2019年9月）和期间（2019年9月至2021年4月）的OLE中评估了C反应蛋白强直性脊柱炎疾病活动评分（ASDAS-CRP）、巴斯强直性脊柱炎疾病活动指数（BASDAI）和强直性脊柱炎生活质量（ASQoL）评分。
共有232名患者留在BE AGILE OLE中，并在分析期开始时（2019年9月1日）纳入了这项事后研究；12名患者出现了COVID-19治疗中出现的不良事件，无病例导致死亡。因COVID-19导致的比美吉珠单抗漏用剂量（11剂）极少，与大流行前相比，漏评率仍较低（≤5%）。OLE中的平均ASDAS-CRP（1.8）、BASDAI（2.4）和ASQoL评分（2.8）在大流行前基线时较低，在大流行之前和期间紧接着的连续3个月期间分别稳定在1.7至1.8、2.2至2.4和2.0至2.8。在主要研究国家中，ASDAS-CRP、BASDAI和ASQoL的稳定性是一致的。
在BE AGILE OLE中接受比美吉珠单抗治疗的AS患者在COVID-19大流行期间疾病活动度和HRQoL保持稳定，没有迹象表明对这些结果有负面影响。
