Efficacy and Safety of Xeligekimab Compared to Other IL-17A Inhibitors for Chinese Patients with Moderate-to-severe Plaque Psoriasis: A Matching-adjusted Indirect Comparisons
DOI:
https://doi.org/10.2340/actadv.v106.adv-2025-0183Keywords:
Xeligekimab, IL-17A inhibitors, matching-adjusted indirect comparison, Chinese population, plaque psoriasis, long-term efficacyAbstract
Direct comparative evidence between IL-17A inhibitors for plaque psoriasis in Chinese populations remains limited. This study evaluated the comparative effectiveness of Xeligekimab vs Secukinumab and Ixekizumab through matchingadjusted indirect comparisons (MAICs). Individual patient data from the Xeligekimab trial (N=281) were weighted to match baseline characteristics from Chinese trials of Secukinumab (N=221) and Ixekizumab (N=176/92). Matching variables were determined following NICE and EUnetHTA MAIC guidelines, incorporating prognostic factors identified through multivariate regression. Primary endpoints included PASI 75/90/100 achievement at weeks 12, 52 and 60. At week 12, Secukinumab showed numerically higher PASI 75 (97.7% vs 93.0%, p=0.052) without statistical significance, while other endpoints were comparable (all p>0.05). At week 52, Xeligekimab showed significantly higher PASI 100 achievement (57.8% vs 42.1%, p=0.005) and DLQI 0/1 (68.8% vs 47.5%, p<0.001) vs Secukinumab. At week 60, Xeligekimab maintained significantly higher PASI 75 vs Ixekizumab (92.6% vs 76.1%, p<0.001) with lower infection rates during induction period (7.9% vs 34.7%, p<0.001) and maintenance period (22.4% vs 56.5%, p<0.001). This MAIC provides hypothesis-enerating evidence that Xeligekimab may offer advantages in specific long-term efficacy endpoints and safety outcomes, requiring confirmation in direct randomized controlled trials.
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References
Ding X, Wang T, Shen Y, Wang X, Zhou C, Tian S, et al. Prevalence of psoriasis in China: a population-based study in six cities. Eur J Dermatol 2012; 22: 663–667 DOI: https://doi.org/10.1684/ejd.2012.1802
Chen K, Wang G, Jin H, Xu J, Zhu X, Zheng M, et al. Clinic characteristics of psoriasis in China: a nationwide survey in over 12000 patients. Oncotarget 2017; 8: 46381–46389 DOI: https://doi.org/10.18632/oncotarget.18453
3. Gao X, Pan W, Zheng M, Li F, Dong X, Lv D, et al. Efficacy and safety analysis in Chinese patients with moderate-to-severe psoriasis from a phase 3 trial: impact of treatment withdrawal and retreatment of ixekizumab. Adv Ther 2025; 42: 334–347 DOI: https://doi.org/10.1007/s12325-024-03030-5
Huang YW, Tsai TF. Remission duration and long-term outcomes in patients with moderate-to-severe psoriasis treated by biologics or tofacitinib in controlled clinical trials: a 15-year single-center experience. Dermatol Ther 2019; 9: 553–569 DOI: https://doi.org/10.1007/s13555-019-0310-5
Cui L, Chen R, Subedi S, Yu Q, Gong Y, Chen Z, et al. Efficacy and safety of biologics targeting IL-17 and IL-23 in the treatment of moderate-to-severe plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials. Int Immunopharmacol 2018; 62: 46–58. DOI: https://doi.org/10.1016/j.intimp.2018.06.020
NMPA. Drug approval documents for secukinumab and ixekizumab. 2019.
Blair HA. Xeligekimab: first approval. Drugs 2025; 85: 97–101 DOI: https://doi.org/10.1007/s40265-024-02125-1
Keam SJ. Vunakizumab: first approval. Drugs 2024; 84: 1481–1485 DOI: https://doi.org/10.1007/s40265-024-02110-8
Kuang Y, Li Y, Lv C, Li M, Zhang Z, Chen Y, et al. Unmet needs and treatment preference of systemic treatments for moderate-to-severe psoriasis from the perspectives of patients and dermatologists in China. Dermatol Ther 2024; 14: 1245–1257 DOI: https://doi.org/10.1007/s13555-024-01159-3
Signorovitch JE, Sikirica V, Erder MH, Xie J, Lu M, Hodgkins PS, et al. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health 2012; 15: 940–947 DOI: https://doi.org/10.1016/j.jval.2012.05.004
Cai L, Jiang C, Zhang G, Fang H, Wang J, Li Y, et al. A multicentre randomized double-blind placebo-controlled phase III study of the efficacy and safety of xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis. Br J Dermatol 2024; 191: 336–343 DOI: https://doi.org/10.1093/bjd/ljae062
Cai L, Zhang JZ, Yao X, Gu J, Liu QZ, Zheng M, et al. Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis. Chin Med J 2020; 133: 2665–2673 DOI: https://doi.org/10.1097/CM9.0000000000001163
Li X, Zheng J, Pan WL, Zheng M, Lu Y, Li FQ, et al. Efficacy and safety of ixekizumab in Chinese patients with moderateto- severe plaque psoriasis: 60-week results from a phase 3 study. Int J Dermatol Venereol 2022; 5: 181–190. DOI: https://doi.org/10.1097/JD9.0000000000000244
AG N P S. Secukinumab (Cosentyx ®) [Package insert]. 2019.
COMPANY E L A. Ixekizumab (TALTZ®) [Package insert]. 2019.
Unit D S. NICE DSU technical support document 18: methods for population-adjusted indirect comparisons in submissions to NICE. 2016.
CG H. Practical guideline for quantitative evidence synthesis: direct and indirect comparisons. 2015.
Zhang D, Qiu J, Liao X, Xiao Y, Shen M, Deng Y, et al. Comparison of efficacy of anti-interleukin-17 in the treatment of psoriasis between Caucasians and Asians: a systematic review and meta-analysis. Front Med 2021; 8: 814938 DOI: https://doi.org/10.3389/fmed.2021.814938
Luna PC, Chu CY, Fatani M, Borlenghi C, Adora A, Llamado LQ, et al. Psychosocial burden of psoriasis: a systematic literature review of depression among patients with psoriasis. Dermatol Ther 2023; 13: 3043–3055 DOI: https://doi.org/10.1007/s13555-023-01060-5
Anguita-Montenegro B, Águila V, Palacios-Moya E, García-Arpa M, Sánchez-Caminero MP, Luque-Jiménez M. Perceived quality of life in patients with psoriasis treated with interleukin 17 or 23 inhibitors. Farm Hosp 2024; 48: T204–T211 DOI: https://doi.org/10.1016/j.farma.2024.04.012
Thomas SE, Barenbrug L, Hannink G, Seyger MMB, de Jong EMGJ, van den Reek JMPA. Drug survival of IL-17 and IL-23 inhibitors for psoriasis: a systematic review and metaanalysis. Drugs 2024; 84: 565–578 DOI: https://doi.org/10.1007/s40265-024-02028-1
Chongqing Genrix Biopharmaceutical Co. L. Xeligekimab injection (GR1501) [Package insert]. 2024.
Shen ZW, Wu KQ, Jin TH, Zhao J, Jiang Q, Guo T, et al. Pharmacokinetics, safety, and immunogenicity of intravenous and subcutaneous single-dose QX002N injection in healthy subjects: a randomized, open, parallel, single-center, phase I study. Rheumatol Ther 2024; 11: 977–988 DOI: https://doi.org/10.1007/s40744-024-00683-0
Zheng M, Chen X, Wang F, Chen J, Jackson K, Yang F, et al. Pharmacokinetics, safety, and efficacy of ixekizumab in Chinese patients with moderate-to-severe plaque psoriasis: a phase 1, single- and multiple-dose study. Adv Ther 2023; 40: 3804–3816 DOI: https://doi.org/10.1007/s12325-023-02575-1
Brembilla NC, Boehncke WH. Revisiting the interleukin 17 family of cytokines in psoriasis: pathogenesis and potential targets for innovative therapies. Front Immunol 2023; 14: 1186455 DOI: https://doi.org/10.3389/fimmu.2023.1186455
Torres T, Chiricozzi A, Puig L, Lé AM, Marzano AV, Dapavo P, et al. Treatment of psoriasis patients with latent tuberculosis using IL-17 and IL-23 inhibitors: a retrospective, multinational, multicentre study. Am J Clin Dermatol 2024; 25: 333–342 DOI: https://doi.org/10.1007/s40257-024-00845-4
Sun R, Wang L, Xia H. Disease burden of tuberculosis in China from 1990 to 2021 and its prediction to 2036. Front Public Health 2024; 12: 1506266 DOI: https://doi.org/10.3389/fpubh.2024.1506266
He CX, Wu C, Zhang L, Jin HZ. Interleukin-17A inhibitors in patients with psoriasis and tuberculosis infection: a 2-year prospective study on safety without preventive treatment. Dermatol Ther 2024; 14: 893–906 DOI: https://doi.org/10.1007/s13555-024-01130-2
Nogueira M, Warren RB, Torres T. Risk of tuberculosis reactivation with interleukin (IL)-17 and IL-23 inhibitors in psoriasis - time for a paradigm change. J Eur Acad Dermatol Venereol 2021; 35: 824–834 DOI: https://doi.org/10.1111/jdv.16866
Wu C, He C, Wang H, Wang W, Jin H. Impact of IL-17A inhibitors on serum uric acid levels in psoriatic patients with hyperuricemia: a prospective observational study. Psoriasis 2024; 14: 153–166 DOI: https://doi.org/10.2147/PTT.S486152
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