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Abstract Number: 2593

Similar Efficacy and Safety of Biosimilar Candidate IBI303 and Reference Products of Adalimumab in Patients with Ankylosing Spondylitis : Results from a Randomized, Double-Blind, Phase III Study

Xu Huji1, Li Zhijun2, Wu Jian3, Xing Qian4, Guixiu Shi5, Li Juan6, Liu Xu7, Lijun Wu8, Li Xiaomei9, Tan Wenfeng10, Dongyi He11, Bi Liqi12, Li Hongbin13, Xiao Zhengyu14, Shuai Zongwen15, Li Xiaoxia16, Wang Yongfu17, Luo Li18, Zheng Yi19, Xiao Weiguo20, Zhou Hui21, Lu Yushan21, Zheng Shirui21 and Wang Xiong21, 1Shanghai Changzheng Hospital, Shanghai, China, 2The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, 3The First Affiliated Hospital of Soochow University, Suzhou, China, 4Qingdao municipal hospital, Qingdao, China, 5The First Affiliated Hospital of Xiamen University, Xiamen, China, 6Nanfang Hospital, Southern Medical University, Guangzhou, China, 7Peking University People’s Hospitalv, Beijing, China, 8People's Hospital of Xinjiang Uygur Autonomous Region, Wulumuqi, China, 9Anhui Provincial Hospital, Hefei, China, 10Jiangsu Province Hospital, Nanjing, China, 11Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China, 12China-Japan Friendship Hospital, Changchun, China, 13The Affiliated Hospital of Inner Mongolia Medical University, Huhehaote, China, 14The First Affiliated Hospital of Shantou University Medical College, Shantou, China, 15The First Affiliated Hospital of Anhui Medical University, Hefei, China, 16Xuanwu Hospital Capital Medical University, Beijing, China, 17The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science & Technology, Baotou, China, 18The First Affiliated Hospital of XinJiang Medical University, Wulumuqi, China, 19Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China, 20The First Hospital of China Medical University, Shenyang, China, 21Innovent Biologics (Suzhou) Co. Ltd, Shanghai, China

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adalimumab, ankylosing spondylitis (AS) and biosimilars

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Session Information

Date: Tuesday, October 23, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: IBI303, an injection of recombinant human anti-tumor necrosis factor-α monoclonal antibody, is adalimumab biosimilar candidate. Physicochemical properties assessment and non-clinical studies showed the structure, pharmacodynamics and pharmacokinetics of IBI303 were similar to adalimumab. This study compared the efficacy and safety of IBI303 with adalimumab in patients with ankylosing spondylitis (AS).

Methods: This was a randomized, double-blind, and adalimumab-controlled phase III clinical study. Patients met the classification criteria of the 1984 modified New York criteria for AS and in active disease were enrolled, and assigned to IBI303 or adalimumab groups in 1:1 ratio. The primary endpoint was the percentage of patients achieving the Assessment of SpondyloArthritis International Society (ASAS) 20 response criteria at week 24. Patients without data at week 24 were treated as non-responders. The safety and immunogenicity of the two groups were also compared.

Results: A total of 438 patients were randomized (IBI303, n=220; adalimumab, n=218) . Baseline demographics were generally similar between the two groups. At week 24, there were 75.0%(165/220) and 72.5%(158/218)patients achieved ASAS20 response in IBI303 and adalimumab group, respectively, and 95% confidence interval (CI) of differences between the two groups was -5.7% to 10.8%, indicating the IBI303 was equivalence to that of adalimumab in efficacy. Results of other efficacy endpoints were comparable between the two groups (Table 1). The overall incidence of adverse events (AEs) was 79.1% for IBI303 group and 81.7% for adalimumab group, respectively (Table 2). The most common AEs in IBI303 group were upper respiratory tract infection (24.5%), alanine aminotransferase increased (12.7%) and hyperuricaemia (10.5%), while in adalimumab group were upper respiratory tract infection (20.6%), alanine aminotransferase increased (19.3%) and Aspartate aminotransferase increased (10.6%). The positive rate of antidrug antibodies was 58.6% and 61.9%, and the positive rate of neutralizing antibodies was 46.5% and 51.1% in IBI303 and adalimumab group, but had no observable impact on ASAS20 response.

Conclusion: This study demonstrated IBI303 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe AS.

Table 1. ASAS response rates at week 24 (Full analysis set)

IBI303

N=220

n (%)

Adalimumab

N=218

n (%)

difference (95%CI)

P value

ASAS20

165(75.0)

158(72.5)

2.5% (-5.7%, 10.8%)

0.5732

ASAS40

137(62.3)

134(61.5)

0.8%(-8.3%, 9.9%)

0.8636

ASAS partial remission

65(29.5)

74(33.9)

-4.4%(-13.1%, 4.3%)

0.3724

Table 2. Summary of AEs

IBI303

N=220

n (%)

Adalimumab

N=218

n (%)

Treatment-emergent adverse events

174 (79.1)

178 (81.7)

Significant AEs

119 (54.1)

113 (51.8)

Serious adverse events

7 (3.2)

8 (3.7)

AEs leading to study discontinuation

6 (2.7)

5 (2.3)


Disclosure: X. Huji, None; L. Zhijun, None; W. Jian, None; X. Qian, None; G. Shi, None; L. Juan, None; L. Xu, None; L. Wu, None; L. Xiaomei, None; T. Wenfeng, None; D. He, None; B. Liqi, None; L. Hongbin, None; X. Zhengyu, None; S. Zongwen, None; L. Xiaoxia, None; W. Yongfu, None; L. Li, None; Z. Yi, None; X. Weiguo, None; Z. Hui, Innovent Biologics (Suzhou) Co. Ltd, 3; L. Yushan, Innovent Biologics (Suzhou) Co. Ltd, 3; Z. Shirui, Innovent Biologics (Suzhou) Co. Ltd, 3; W. Xiong, Innovent Biologics (Suzhou) Co. Ltd, 3.

To cite this abstract in AMA style:

Huji X, Zhijun L, Jian W, Qian X, Shi G, Juan L, Xu L, Wu L, Xiaomei L, Wenfeng T, He D, Liqi B, Hongbin L, Zhengyu X, Zongwen S, Xiaoxia L, Yongfu W, Li L, Yi Z, Weiguo X, Hui Z, Yushan L, Shirui Z, Xiong W. Similar Efficacy and Safety of Biosimilar Candidate IBI303 and Reference Products of Adalimumab in Patients with Ankylosing Spondylitis : Results from a Randomized, Double-Blind, Phase III Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/similar-efficacy-and-safety-of-biosimilar-candidate-ibi303-and-reference-products-of-adalimumab-in-patients-with-ankylosing-spondylitis-results-from-a-randomized-double-blind-phase-iii-study/. Accessed .
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