Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: A multicenter, randomized, phase III study - 10/04/25

Doi : 10.1016/j.jaad.2025.03.018

Lixin Xia, MD, PhD ^a, Guoying Miao, MM ^b, Xiumin Yang, MD, PhD ^c, Yumei Li, MD, PhD ^d, Yunsheng Liang, MD, PhD ^e, Yanling Li, MM ^f, Linfeng Li, MD, PhD ^g, Liping Ma, MD, PhD ^h, Furen Zhang, MD, PhD ^i,^j, Rixin Chen, MM ^k, Xinsuo Duan, MM ^l, Lihua Wang, MM ^m, Yanyan Feng, MD, PhD ⁿ, Ziyan Li, MM ^h, Fengyan Lu, MB ^o, Jinyan Wang, MB ^p, Shuping Guo, MM ^q, Jiawen Zhao, MM ^h, Liming Wu, MD, PhD ^r, Yong Cui, MD, PhD ^s, Shanshan Li, MD, PhD ^t, Chao Ji, MD, PhD ^u, Xiaodong Li, MD, PhD ^v, Tiechi Lei, MD, PhD ^w, Juanli Fan, MM ^x, Xinghua Gao, MD, PhD ^a,^⁎
^a Department of Dermatology, The First Hospital of China Medical University, Shenyang, China
^b Department of Dermatology, Affiliated Hospital of Hebei Engineering University, Handan, China
^c Department of Dermatology, Beijing Tongren Hospital, CMU, Beijing, China
^d Department of Dermatology, Affiliated Hospital of Jiangsu University, Zhenjiang, China
^e Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou, China
^f Department of Dermatology, The Second Hospital of Hebei Medical University, Shijiazhuang, China
^g Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
^h Clinical Development Division, CSPC Megalith Biopharmaceutical Co., Ltd, Shijiazhuang, China
ⁱ Department of Dermatology, Hospital for Skin Diseases, Shandong First Medical University, Jinan, China
^j Shandong Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Sciences, Jinan, China
^k Department of Dermatology, Nanyang First People's Hospital, Nanyang, China
^l Department of Dermatology, Affiliated Hospital of Chengde Medical University, Chengde, China
^m Department of Dermatology, Central Hospital Affiliated to Shandong First Medical University, Jinan, China
ⁿ Department of Dermatology, Chengdu Second People's Hospital, Chengdu, China
^o Department of Dermatology, Qujing No.1 Hospital, Qujing, China
^p Department of Dermatology, Ningbo No.2 Hospital, Ningbo, China
^q Department of Dermatology, First Hospital of Shanxi Medical University, Taiyuan, China
^r Department of Dermatology, Affiliated Hangzhou First People’s Hospital, School of Medicine, Westlake University, Hangzhou, China
^s Department of Dermatology, China-Japan Friendship Hospital, Beijing, China
^t Department of Dermatology, The First Bethune Hospital of Jilin University, Changchun, China
^u Department of Dermatology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
^v Department of Dermatology, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China
^w Department of Dermatology, Renmin Hospital of Wuhan University, Wuhan, China
^x Department of Dermatology, Yuncheng Central Hospital, Shanxi Medical University, Yuncheng, China

^∗Correspondence to: Xinghua Gao, MD, PhD, Department of Dermatology, The First Hospital of China Medical University, 155 Nanjing North Street, Heping District, Shenyang, Liaoning 110001, P.R. China.Department of DermatologyThe First Hospital of China Medical University155 Nanjing North StreetHeping DistrictShenyangLiaoning110001P.R. China

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Abstract

Background

SYSA1902 is a biosimilar of ustekinumab.

Objective

Evaluate the efficacy and safety of SYSA1902 compared with reference ustekinumab in patients with moderate-to-severe plaque psoriasis.

Methods

Eligible patients were randomized to receive SYSA1902 or ustekinumab (Stelara, Janssen) 45 mg subcutaneously at week 0, 4, 16, 28, and 40. The primary end point was the percentage improvement from baseline in psoriasis area and severity index (PASI) at week 12. Equivalence was verified if the 95% CI of difference was within ± 15%.

Results

A Total of 446 patients were assigned to SYSA1902 (n = 224) and ustekinumab groups (n = 222). At week 12, the mean percentage change from baseline in PASI was 86.4% in the SYSA1902 group and 84.7% in the ustekinumab group, with a difference of 1.68% (95% CI, −1.45 to 4.81), which fell within the equivalence margins. PASI 75 at week 12 was achieved by 185 (83.3%) of patients receiving SYSA1902 versus 172 (79.3%) receiving ustekinumab. Overall treatment-emergent adverse events rate was 89.3% and 85.6% in the SYSA1902 and ustekinumab groups. Most treatment-emergent adverse events were mild to moderate, with upper respiratory tract infection being the most common.

Limitations

Data limited to Chinese patients.

Conclusion

SYSA1902 is equivalent to ustekinumab for the treatment of moderate-to-severe plaque psoriasis.

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Key words : interleukin 12/23 monoclonal antibody, plaque psoriasis Ustekinumab, SYSA1902

Abbreviations used : BSA, FAS, LS, MMRM, PASI, PPS, sPGA, TEAEs

Plan

Introduction

Material and methods

Study design and participants

Randomization and masking

Patients and disease characteristics

Efficacy

Safety

Pharmacokinetics and immunogenicity

Discussion

Conclusion

	Funding sources: CSPC Megalith Biopharmaceutial Co, Ltd.
	IRB approval status: Reviewed and approved by independent review committee of the first hospital of China Medical University; approval #2023YL009-2
	Chictr.org.cn registration: CHiCTR2300069534 registered on March 20, 2023
	Statement on any prior presentation: Part of our resulted will be presented as ePoster in the 2025 AAD annual meeting.