Asai Shuji, Fujibayashi Takayoshi, Oguchi Takeshi, Hanabayashi Masahiro, Hayashi Masatoshi, Matsubara Hiroyuki, Ito Takayasu, Yabe Yuichiro, Watanabe Tsuyoshi, Hirano Yuji, Kanayama Yasuhide, Kaneko Atsushi, Kato Takefumi, Takagi Hideki, Takahashi Nobunori, Funahashi Koji, Takemoto Toki, Asai Nobuyuki, Watanabe Tatsuo, Ishiguro Naoki, Kojima Toshihisa
a Department of Orthopedic Surgery , Nagoya University Graduate School of Medicine , Nagoya , Aichi , Japan.
b Department of Orthopedic Surgery , Konan Kosei Hospital , Konan , Aichi , Japan.
Mod Rheumatol. 2018 Mar;28(2):221-226. doi: 10.1080/14397595.2017.1332558. Epub 2017 Jul 13.
This study aimed to investigate predictors of biologic discontinuation due to insufficient response as a surrogate for relapse in patients with rheumatoid arthritis (RA) who achieved clinical remission with biologic treatment.
This study was performed based on data from a multicenter registry, and included 404 patients who achieved clinical remission within the first year of treatment with their first biologic. Cumulative retention rate of the first biologic was estimated using Kaplan-Meier curves, and the impact of patient characteristics on biologic discontinuation was assessed with Cox proportional hazards models.
During follow-up, 50 patients discontinued their first biologic due to insufficient response. Overall discontinuation rates due to insufficient response after achieving remission were 6%, 11%, and 19% at 1, 2, and 5 years, respectively. Multivariate analysis revealed that concomitant glucocorticoids at achieving remission [hazard ratio (HR): 3.80, 95% confidence interval (CI): 1.89-7.64)] and a higher level of C-reactive protein (CRP) at achieving remission (HR: 1.47 per 1 mg/dL, 95% CI: 1.09-1.99) independently predict discontinuation due to insufficient response after achieving remission.
Patients with RA who achieved remission with concomitant glucocorticoid treatment and a higher level of CRP are at high risk of subsequent biologic discontinuation due to insufficient response.
本研究旨在调查类风湿关节炎（RA）患者在接受生物制剂治疗后达到临床缓解时，因疗效不佳导致生物制剂停用（作为复发替代指标）的预测因素。
本研究基于多中心登记数据进行，纳入了404例在首次使用生物制剂治疗的第一年内达到临床缓解的患者。使用Kaplan-Meier曲线估计首次生物制剂的累积保留率，并通过Cox比例风险模型评估患者特征对生物制剂停用的影响。
在随访期间，50例患者因疗效不佳停用了首次使用的生物制剂。缓解后因疗效不佳导致的总体停用率在1年、2年和5年时分别为6%、11%和19%。多变量分析显示，缓解时同时使用糖皮质激素[风险比（HR）：3.80，95%置信区间（CI）：1.89 - 7.64]以及缓解时较高水平的C反应蛋白（CRP）（每1mg/dL的HR：1.47，95%CI：1.09 - 1.99）独立预测缓解后因疗效不佳导致的停用。
在使用糖皮质激素治疗且CRP水平较高的情况下达到缓解的RA患者，因疗效不佳导致后续生物制剂停用的风险较高。
