Huashan Hospital affiliated to Fudan University 上海(ShangHai), Shanghai, China
Yu Xue1, Jiankang Hu2, Dongzhou Liu3, Jingyang Li4, Huaxiang Wu5, Chunyu Tan6, Lie Dai7, Mengru Liu8, Hongying Li8 and Hejian Zou1, 1Huashan Hospital affiliated to Fudan University, Shanghai, China, 2Jiangxi Pingxiang People’s Hospital, Shanghai, China, 3Shenzhen People’s Hospital （The Second Clinical Medical College of Jinan University）, Shanghai, China, 4Zhuzhou Central Hospital, Shanghai, China, 5The Second Affiliated Hospital Zhejiang University School of Medicine, Shanghai, China, 6West China Hospital of Sichuan University, Shanghai, China, 7Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Shanghai, China, 8Eli Lilly and Company, Shanghai, China
Background/Purpose: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, has demonstrated efficacy in global clinical trials in patients with radiographic axial spondyloarthritis (r-axSpA)/ankylosing spondylitis (AS). To evaluate the efficacy and safety of ixekizumab in Chinese patients with r-axSpA.
Methods: This study was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, outpatient study. Patients were randomized to ixekizumab 80 mg Q4W (IXE80Q4W) with a 160 mg starting dose or placebo (1:1) in the 16-Week Blinded Treatment Dosing Period.
The primary endpoint was ASAS40 (ASAS: SpondyloArthritis international Society) response rate at week 16 in biological disease-modifying anti-rheumatic drugs (bDMARD)-naive patients with r-axSpA. Non-responder imputation was used for handling missing data.
Results: A total of 147 patients were randomized to receive IXE80Q4W (n=74) or placebo (n=73).
The primary endpoint was met; ASAS40 response rate was significantly higher in the IXE80Q4W group than placebo (40.9% vs. 7.8%, p< 0.001) at week 16 among the bDMARD- naive patients with r-axSpA.
All key secondary endpoints were also achieved in the intent-to-treat population (including bDMARD-naive and TNFi experienced patients), ASAS40 response rate was significantly higher in the IXE80Q4W group than placebo (37.8% vs. 8.2%, p< 0.001) at week 16; ASAS20 response rate in the IXE80Q4W and placebo group were 59.5% and 35.6% (p=0.006) at week 16, respectively; change from baseline in BASDAI (MMRM) had significantly improved in the IXE80Q4W group than placebo (LSM: -2.39 vs. -0.90, p＜0.001) at week 16.
In the IXE80Q4W group and placebo group, 45 (60.8%) and 36 (49.3%) patients reported ≥1 TEAEs, respectively. Most TEAEs were mild in severity, the proportions of patients with serious adverse events were low (2.7% and 1.4%), and no deaths were reported.
Conclusion: Ixekizumab demonstrated superior efficacy than placebo and a favorable safety profile in Chinese patients with r-axSpA.
Disclosures: Y. Xue, None; J. Hu, None; D. Liu, None; J. Li, None; H. Wu, None; C. Tan, None; L. Dai, None; M. Liu, Eli Lilly; H. Li, Eli Lilly; H. Zou, None.
