戈利木单抗治疗非放射性轴性脊柱关节炎患者的疗效和安全性：一项停药和再治疗研究（GO-BACK）。

Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK).

机构信息

Merck & Co., Inc., Rahway, NJ, USA.

Reumatika Centrum Reumatologii, Warsaw, Poland.

出版信息

Rheumatology (Oxford). 2023 Nov 2;62(11):3601-3609. doi: 10.1093/rheumatology/kead112.

OBJECTIVES

The GO-BACK study was designed to evaluate the efficacy and safety of golimumab (GLM) treatment withdrawal in adults with non-radiographic axial spondyloarthritis (nr-axSpA) who demonstrate inactive disease during a 10-month open-label (OL) GLM run-in.

METHODS

Eligible participants received OL GLM in period 1. In period 2, participants who achieved inactive disease were randomized 1:1:1 to receive double-blind (DB) treatment with monthly placebo (PBO, treatment withdrawal) or continued GLM treatment given monthly (GLM QMT) or every 2 months (GLM Q2MT). Participants who did not have a disease flare continued DB treatment for ∼12 months. Participants with a disease flare discontinued DB treatment and resumed monthly OL GLM. Primary endpoint compared the proportion of participants without a disease flare in the continued GLM treatment groups (QMT or Q2MT) vs PBO in a multiplicity-controlled, step-down fashion. Safety follow-up continued for ∼3 months after last treatment.

RESULTS

A total of 188 patients, out of the 323 enrolled, were eligible for participation in period 2. Both GLM QMT and GLM Q2MT were superior to treatment withdrawal (PBO) in preventing disease flare (P < 0.001), with a treatment-difference vs PBO of 50.4% and 34.4% for the GLM QMT and GLM Q2MT groups, respectively. The time-to-first flare was significantly longer (log-rank P < 0.0001) with GLM treatment compared with PBO. Of 53 participants (in Q2MT or PBO) who had a confirmed disease flare, 51 (96.2%) attained a clinical response within 3 months of restarting OL GLM. Adverse events were consistent with the known GLM safety profile.

CONCLUSION

Among participants with active nr-axSpA who attained inactive disease after 10 months of GLM treatment, continued GLM treatment is well tolerated and provides superior protection against disease flares compared with GLM withdrawal. (EudraCT: 2015-004020-65, registered on 30 March 2022; NCT: 03253796, registered on 18 August 2017.).

目的

GO-BACK 研究旨在评估戈利木单抗（GLM）治疗停药在接受 10 个月开放性标签（OL）GLM 导入期治疗后疾病处于缓解状态的非放射学中轴型脊柱关节炎（nr-axSpA）成年患者中的疗效和安全性。

方法

符合条件的参与者在第 1 期接受 OL GLM 治疗。在第 2 期，达到疾病缓解的参与者以 1:1:1 的比例随机接受每月安慰剂（PBO，治疗停药）或继续每月（GLM QMT）或每 2 个月（GLM Q2MT）接受 GLM 治疗。未出现疾病发作的参与者继续接受 DB 治疗约 12 个月。出现疾病发作的参与者停止 DB 治疗并恢复每月 OL GLM 治疗。主要终点是比较继续 GLM 治疗组（QMT 或 Q2MT）与 PBO 组在多重控制、逐步下降方式下无疾病发作的患者比例。在最后一次治疗后继续进行大约 3 个月的安全性随访。

结果

在 323 名入组患者中，共有 188 名患者有资格参加第 2 期研究。与 PBO 相比，GLM QMT 和 GLM Q2MT 均能更好地预防疾病发作（P<0.001），GLM QMT 和 GLM Q2MT 组与 PBO 相比的治疗差异分别为 50.4%和 34.4%。与 PBO 相比，接受 GLM 治疗的患者首次发作时间明显延长（对数秩 P<0.0001）。在 53 名（Q2MT 或 PBO）确诊疾病发作的参与者中，51 名（96.2%）在重新开始 OL GLM 治疗后 3 个月内获得临床缓解。不良事件与已知的 GLM 安全性特征一致。

结论

在接受 10 个月 GLM 治疗后疾病缓解的活动性 nr-axSpA 患者中，继续 GLM 治疗耐受性良好，与 GLM 停药相比，能更好地预防疾病发作。（EudraCT：2015-004020-65，于 2022 年 3 月 30 日注册；NCT 03253796，于 2017 年 8 月 18 日注册）。