Braun Jürgen, Baraliakos Xenofon, Kiltz Uta, Krüger Klaus, Burmester Gerd R, Wassenberg Siegfried, Thomas Matthias H
From the Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum, Herne; Rheumatologisches Praxiszentrum München; Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin; Rheumazentrum Ratingen, Ratingen; Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany.
M. Thomas is a full-time employee of MSD Sharp & Dohme GmbH, Haar. U. Kiltz received an unrestricted grant from AbbVie. G.R. Burmester received lecture and/or consulting fees from MSD. K. Krüger received speaker fees and research grants from AbbVie, MSD, and Pfizer.
J Rheumatol. 2020 Jan;47(1):35-41. doi: 10.3899/jrheum.181040. Epub 2019 Mar 15.
International recommendations for the management of axial spondyloarthritis including ankylosing spondylitis (AS) recommend a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) level of disease activity of ≥ 4 to initiate treatment with biologics. We aimed to evaluate the level of disease activity used to initiate tumor necrosis factor inhibitor (TNFi) treatment and the level of responses to treatment based on different BASDAI cutoffs.
This is a posthoc analysis of the noninterventional, prospective, GO-NICE study in the subgroup of biologic-naive AS treated with golimumab (GOL) 50 mg subcutaneously once monthly.
Of the 244 biologic-naive AS patients at baseline, 70.5% had a BASDAI ≥ 4 (Group 1), 14.3% had 2.8 to < 4 (Group 2), and 15.2% had even < 2.8 (Group 3). A total of 134 patients (54.9%) completed the 24-month observational period. The mean BASDAI in Groups 1, 2, and 3 was initially 5.9 ± 1.3, 3.4 ± 0.4, and 2.0 ± 0.8, decreased to 2.2 ± 2.0, 1.9 ± 1.2, and 1.0 ± 1.2 within 3 months (all p < 0.0001 vs baseline), and decreased significantly to 2.2 ± 1.7, 1.9 ± 1.7, and 1.4 ± 1.0 at Month 24 (all p < 0.005), respectively. BASDAI 50% improvement was noted in 68.8%, 44.8%, and 45.2% of patients at Month 3, and in 84.9%, 61.9%, and 55.0% at Month 24.
TNFi treatment was initiated in almost a third of AS patients with lower disease activity states as assessed by BASDAI cutoff of ≥ 4. Patients with a BASDAI between 2.8 and < 4 appeared to benefit significantly from GOL treatment, while patients with BASDAI < 2.8 did not. This finding should lead to a reevaluation of the established BASDAI cutoff of ≥ 4.
包括强直性脊柱炎（AS）在内的轴性脊柱关节炎管理的国际建议推荐，采用巴斯强直性脊柱炎疾病活动指数（BASDAI）评估疾病活动水平，当疾病活动度≥4时开始使用生物制剂治疗。我们旨在评估用于启动肿瘤坏死因子抑制剂（TNFi）治疗的疾病活动水平，以及基于不同BASDAI临界值的治疗反应水平。
这是一项对非干预性、前瞻性GO-NICE研究的事后分析，该研究针对的是初治AS亚组，患者每月皮下注射一次50mg戈利木单抗（GOL）。
在基线时的244例初治AS患者中，70.5%的患者BASDAI≥4（第1组），14.3%的患者BASDAI为2.8至<4（第2组），15.2%的患者BASDAI甚至<2.8（第3组）。共有134例患者（54.9%）完成了24个月的观察期。第1、2和3组的平均BASDAI最初分别为5.9±1.3、3.4±．4和2.0±0.8，在3个月内降至2.2±2.0、1.9±1.2和1.0±1.2（与基线相比，所有p<0.0001），并在第24个月时分别显著降至2.2±1.7、1.9±1.7和1.4±1.0（所有p<0.005）。在第3个月时，分别有68.8%、44.8%和45.2%的患者BASDAI改善50%，在第24个月时，这一比例分别为84.9%、61.9%和55.0%。
根据BASDAI临界值≥4评估，近三分之一疾病活动度较低的AS患者开始接受TNFi治疗。BASDAI在2.8至<4之间的患者似乎从GOL治疗中显著获益，而BASDAI<2.8的患者则未获益。这一发现应促使对既定的BASDAI临界值≥4进行重新评估。
