Journal of the American Academy of Dermatology · 2025
Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: A multicenter, randomized, phase III study.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Xia Lixin, Miao Guoying, Yang Xiumin, Li Yumei, Liang Yunsheng, Li Yanling, Li Linfeng, Ma Liping, Zhang Furen, Chen Rixin, Duan Xinsuo, Wang Lihua, Feng Yanyan, Li Ziyan, Lu Fengyan, Wang Jinyan, Guo Shuping, Zhao Jiawen, Wu Liming, Cui Yong, Li Shanshan, Ji Chao, Li Xiaodong, Lei Tiechi, Fan Juanli, Gao Xinghua
Аннотация
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.
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.