Rheumazentrum Ruhrgebiet, Herne, and Department of Biochemistry, Ruhr Universität, Bochum, Germany
Rheumazentrum Ruhrgebiet, Herne, and Department of Biochemistry, Ruhr Universität, Bochum, Germany.
RMD Open. 2022 Jul;8(2). doi: 10.1136/rmdopen-2021-002165.
To study the efficacy and safety of ixekizumab (IXE) in patients with radiographic (r-) and non-radiographic (nr-)axial spondyloarthritis (axSpA) for up to 116 weeks.
COAST-Y (NCT03129100) is the 2-year extension study following COAST-V, COAST-W and COAST-X. Patients were treated with either 80 mg IXE every 4 weeks or 2 weeks, as assigned in the originating studies. Efficacy was assessed in all participants continuously treated with IXE through week 116 and in subgroups based on disease subtype and dosing. Missing data were handled by non-responder imputation for categorical variables and modified baseline observation carried forward for continuous variables. Safety data were analysed in all patients having received ≥1 IXE dose.
Of 932 patients who received ≥1 IXE dose, 773 enrolled in COAST-Y (82.9%); 665 of which (86.0%) completed week 116. Of 352 continuously treated patients, the proportion achieving Assessment of Spondyloarthritis International Society (ASAS40) at week 52 was 51.4%, which increased to 56.0% at week 116. The proportion of patients achieving ASAS40 at week 116 was 64.9% and 57.7% for biological disease-modifying antirheumatic drug (bDMARD)-naïve patients with r-axSpA and nr-axSpA, respectively, and 47.0% for TNFi-experienced patients. The proportion of patients achieving Ankylosing Spondylitis Disease Activity Score <2.1 through week 116 was 57.0% and 52.9% for bDMARD-naïve patients with r-axSpA and nr-axSpA, respectively, and 33.6% for TNFi-experienced patients. Incidences of treatment-emergent adverse events and serious adverse events were consistent with previous reports.
IXE treatment led to sustained long-term improvements in patients with axSpA, with similar efficacy for r-axSpA and nr-axSpA, and for patients receiving the approved every 4 weeks dose. The safety profile of IXE was consistent with previous reports. No new safety signals were identified.
研究依喜珠单抗（IXE）在影像学（r-）和非影像学（nr-）轴性脊柱关节炎（axSpA）患者中的疗效和安全性，最长可达 116 周。
COAST-Y（NCT03129100）是 COAST-V、COAST-W 和 COAST-X 之后的 2 年扩展研究。患者接受 80mg IXE 每 4 周或每 2 周一次治疗，具体方案取决于原始研究中的分组。通过在第 116 周持续接受 IXE 治疗的所有参与者和基于疾病亚型和剂量的亚组评估疗效。缺失数据通过类别变量的未应答者插补和连续变量的末次观测值结转进行处理。所有接受过至少 1 剂 IXE 的患者均进行安全性数据分析。
在接受过至少 1 剂 IXE 的 932 例患者中，有 773 例（82.9%）入组 COAST-Y；其中 665 例（86.0%）完成了第 116 周。在 352 例持续治疗患者中，第 52 周时达到评估强直性脊柱炎国际学会（ASAS）40 应答的比例为 51.4%，第 116 周时增加至 56.0%。第 116 周时，达到 ASAS40 的患者比例分别为生物制剂改善病情抗风湿药（bDMARD）初治的 r-axSpA 和 nr-axSpA 患者 64.9%和 57.7%，以及 TNFi 治疗经验患者 47.0%。第 116 周时，达到强直性脊柱炎疾病活动度评分（ASDAS）＜2.1 的患者比例分别为 bDMARD 初治的 r-axSpA 和 nr-axSpA 患者 57.0%和 52.9%，以及 TNFi 治疗经验患者 33.6%。治疗期间发生的不良事件和严重不良事件的发生率与既往报告一致。
IXE 治疗可使 axSpA 患者长期持续改善，r-axSpA 和 nr-axSpA 患者以及接受批准的每 4 周剂量的患者疗效相似。IXE 的安全性特征与既往报告一致。未发现新的安全性信号。
