接受戈利木单抗治疗的炎症性关节炎患者的 4 年随访：来自观察性多中心 NOR-DMARD 研究的数据。
Four-year follow-up of inflammatory arthropathy patients treated with golimumab: Data from the observational multicentre NOR-DMARD study.
机构信息
Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Division of Rheumatology, Department of Medicine, Hospital of Southern Norway Trust, Kristiansand, Norway.
Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
出版信息
Semin Arthritis Rheum. 2020 Feb;50(1):12-16. doi: 10.1016/j.semarthrit.2019.07.003. Epub 2019 Jul 12.
OBJECTIVE
To compare (1) golimumab drug survival and efficacy in bDMARD naïve compared with non-naïve rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (ax-SpA) patients, (2) golimumab drug survival in RA and PsA patients treated with/without concomitant csDMARDs, (3) predictors of golimumab drug discontinuation.
METHODS
Patients starting golimumab were included from the prospective observational multicenter Norwegian DMARD study. Drug survival was explored by Kaplan-Meier analyses with log rank test. Treatment responses were compared using ANCOVA. Univariate and multivariate Cox regression analyses were performed to identify predictors of golimumab discontinuation.
RESULTS
We included 808 patients (163 RA, 266 PsA, 379 ax-SpA). Golimumab drug survival after 1/2/4 years were not significantly different between bDMARD naïve and non-naïve patients (all, p ≥ 0.12; RA, p ≥ 0.07; PsA, p ≥ 0.28; ax-SpA, p ≥ 0.61), nor between RA (p ≥ 0.10) and PsA (p ≥ 0.07) patients treated with vs. without csDMARD comedication. bDMARD naïve compared with non-naïve ax-SpA patients had better 3-month ASDAS/BASDAI/MHAQ responses (p ≤ 0.02). bDMARD naïve compared with non-naïve RA and PsA patients had a trend towards better treatment responses. Identified predictors of 4-year golimumab discontinuation were patient's global and female gender in patients overall and in subgroups of PsA and ax-SpA patients, and patient's global and CRP in RA.
CONCLUSION
Golimumab drug survival was not significantly different between bDMARD naïve and non-naïve RA, PsA and ax-SpA patients, nor between RA and PsA patients treated with vs. without concomitant csDMARDs. Treatment responses were significantly better for bDMARD naïve than non-naïve ax-SpA patients. Identified predictors of golimumab discontinuation were patient's global and female gender in patients overall and in subgroups of PsA and ax-SpA patients, and patient's global and CRP in RA.
目的
比较（1）初治与未初治类风湿关节炎（RA）、银屑病关节炎（PsA）和中轴型脊柱关节炎（ax-SpA）患者使用戈利木单抗的药物生存情况和疗效，（2）初治与未初治 RA 和 PsA 患者接受戈利木单抗联合/不联合 csDMARD 治疗的药物生存情况，（3）戈利木单抗停药的预测因素。
方法
本研究纳入了前瞻性观察性多中心挪威 DMARD 研究中开始使用戈利木单抗的患者。通过对数秩检验的 Kaplan-Meier 分析来探索药物生存情况。使用 ANCOVA 比较治疗反应。采用单变量和多变量 Cox 回归分析识别戈利木单抗停药的预测因素。
结果
共纳入 808 例患者（163 例 RA、266 例 PsA、379 例 ax-SpA）。初治与未初治患者的戈利木单抗药物生存情况在 1/2/4 年时均无显著差异（均，p≥0.12；RA，p≥0.07；PsA，p≥0.28；ax-SpA，p≥0.61），也未在 RA（p≥0.10）和 PsA（p≥0.07）患者中观察到接受 vs. 不接受 csDMARD 联合治疗的差异。与未初治 ax-SpA 患者相比，初治 ax-SpA 患者在 3 个月时的 ASDAS/BASDAI/MHAQ 缓解更好（p≤0.02）。初治与未初治 RA 和 PsA 患者的治疗反应有改善趋势。戈利木单抗停药 4 年的预测因素是患者整体及 PsA 和 ax-SpA 患者亚组的患者整体和女性性别，以及 RA 患者的患者整体和 CRP。
结论
初治与未初治 RA、PsA 和 ax-SpA 患者的戈利木单抗药物生存情况无显著差异，也未在 RA 和 PsA 患者中观察到接受 vs. 不接受 csDMARD 联合治疗的差异。与未初治 ax-SpA 患者相比，初治 ax-SpA 患者的药物生存情况更好。戈利木单抗停药的预测因素是患者整体及 PsA 和 ax-SpA 患者亚组的患者整体和女性性别，以及 RA 患者的患者整体和 CRP。
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