Efficacy and safety of Benvitimod in the treatment of psoriasis: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

HAO Tianlong , LIU Yuan , ZHANG Yun , YUAN Hailong ,  YANG Zhihui

Department of Pharmacy, Air Force Medical Center, Beijing 100142, P. R. China;

Corresponding?author：

YANG Zhihui, Email: yangzhihui084045@126.com

Keywords：

Benvitimod; Psoriasis; Efficacy; Safety; Meta-analysis; Systematic review

DOI：

10.7507/1672-2531.202510186

Video：

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Objective To systematically evaluate the efficacy and safety of Benvitimod in the treatment of psoriasis. Methods The CNKI, VIP, WanFang Data, SinoMed, PubMed and Cochrane Library databases were electronically searched to collect randomized controlled trials (RCTs) related to the objectives from inception to September 2025. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.4 software. Results A total of 8 RCTs involving 1 890 patients were included. The results of meta-analysis showed that the Benvitimod group had higher PASI 50, PASI 75, PASI 90, PGA response rates, and the differences were statistically significant. Total adverse reactions in the Benvitimod group were more frequent, but the difference in the incidence rate of serious adverse events between the two groups was not statistically significant. Conclusion Current evidence shows that Benvitimod has significant efficacy in the treatment of psoriasis. Although the incidence of adverse events is relatively high, it does not increase the incidence of severe adverse reactions. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.

Citation： HAO Tianlong, LIU Yuan, ZHANG Yun, YUAN Hailong, YANG Zhihui. Efficacy and safety of Benvitimod in the treatment of psoriasis: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2026, 26(7): 834-837. doi: 10.7507/1672-2531.202510186 Copy

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2.	Eder L, Widdifield J, Rosen CF, et al. Trends in the prevalence and incidence of psoriasis and psoriatic arthritis in Ontario, Canada: a population-based study. Arthritis Care Res (Hoboken), 2019, 71(8): 1084-1091.
3.	Griffiths CEM, Armstrong AW, Gudjonsson JE, et al. Psoriasis. Lancet, 2021, 397(10281): 1301-1315.
4.	Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol, 2008, 58(5): 826-850.
5.	Schmitt J, Rosumeck S, Thomaschewski G, et al. Efficacy and safety of systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials. Br J Dermatol, 2014, 170(2): 274-303.
6.	Zhang J, Xia Z, Guo W, et al. Cost-effectiveness of secukinumab versus other biologics in the treatment of moderate-to-severe plaque psoriasis: the Chinese healthcare system perspective. Dermatol Ther (Heidelb), 2023, 13(11): 2681-2696.
7.	Rothhammer V, Quintana FJ. The aryl hydrocarbon receptor: an environmental sensor integrating immune responses in health and disease. Nat Rev Immunol, 2019, 19(3): 184-197.
8.	Balogh B, Pet? á, Fehér P, et al. Tapinarof nanogels as a promising therapeutic approach. Pharmaceutics, 2025, 17(6): 731.
9.	Carmona-Rocha E, Rusi?ol L, Puig L. New and emerging oral/topical small-molecule treatments for psoriasis. Pharmaceutics, 2024, 16(2): 239.
10.	Chan JJ. Psoriasis: an update on topical and systemic therapies. Aust Prescr, 2025, 48(3): 87-92.
11.	Higgins JP, Altman DG, G?tzsche PC, et al. The Cochrane collaboration's tool for assessing risk of bias in randomised trials. BMJ, 2011, 343: d5928.
12.	Igarashi A, Tsuji G, Fukasawa S, et al. Tapinarof cream for the treatment of plaque psoriasis: efficacy and safety results from 2 Japanese phase 3 trials. J Dermatol, 2024, 51(10): 1269-1278.
13.	Stein Gold L, Bhatia N, Tallman AM, et al. A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: secondary efficacy and patient-reported outcomes. J Am Acad Dermatol, 2021, 84(3): 624-631.
14.	Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of Tapinarof cream for plaque psoriasis. N Engl J Med, 2021, 385(24): 2219-2229.
15.	Cai L, Chen GH, Lu QJ, et al. A double-blind, randomized, placebo- and positive-controlled phase Ⅲ trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis. Chin Med J (Engl), 2020, 133(24): 2905-2909.
16.	Robbins K, Bissonnette R, Maeda-Chubachi T, et al. Phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of plaque psoriasis. J Am Acad Dermatol, 2019, 80(3): 714-721.
17.	Zang YN, Jiang DL, Cai L, et al. Use of a dose-response model to guide future clinical trial of benvitimod cream to treat mild and moderate psoriasis. Int J Clin Pharmacol Ther, 2016, 54(2): 87-95.
18.	Bissonnette R, Bolduc C, Maari C, et al. Efficacy and safety of topical WBI-1001 in patients with mild to moderate psoriasis: results from a randomized double-blind placebo-controlled, phase Ⅱ trial. J Eur Acad Dermatol Venereol, 2012, 26(12): 1516-1521.
19.	Bissonnette R, Stein Gold L, Rubenstein DS, et al. Tapinarof in the treatment of psoriasis: a review of the unique mechanism of action of a novel therapeutic aryl hydrocarbon receptor-modulating agent. J Am Acad Dermatol, 2021, 84(4): 1059-1067.
20.	Polonio CM, McHale KA, Sherr DH, et al. The aryl hydrocarbon receptor: a rehabilitated target for therapeutic immune modulation. Nat Rev Drug Discov, 2025, 24(8): 610-630.
21.	Dawe HR, Di Meglio P. The aryl hydrocarbon receptor (AHR): peacekeeper of the skin. Int J Mol Sci, 2025, 26(4): 1618.
22.	Bitterman D, Kabakova M, Wang JY, et al. The role of aryl hydrocarbon receptor agonists in the treatment of vitiligo. Arch Dermatol Res, 2024, 316(9): 659.
23.	Lin X, Meng X, Lin J. The role of aryl hydrocarbon receptor in the pathogenesis and treatment of psoriasis. J Cutan Med Surg, 2024, 28(3): 276-286.
24.	Silverberg JI, Boguniewicz M, Quintana FJ, et al. Tapinarof validates the aryl hydrocarbon receptor as a therapeutic target: a clinical review. J Allergy Clin Immunol, 2024, 154(1): 1-10.
25.	中華醫學會皮膚性病學分會銀屑病專業委員會. 中國銀屑病診療指南(2023版). 中華皮膚科雜志, 2023, 56(7): 573-625.

1. Takeshita J, Grewal S, Langan SM, et al. Psoriasis and comorbid diseases: implications for management. J Am Acad Dermatol, 2017, 76(3): 393-403.
2. Eder L, Widdifield J, Rosen CF, et al. Trends in the prevalence and incidence of psoriasis and psoriatic arthritis in Ontario, Canada: a population-based study. Arthritis Care Res (Hoboken), 2019, 71(8): 1084-1091.
3. Griffiths CEM, Armstrong AW, Gudjonsson JE, et al. Psoriasis. Lancet, 2021, 397(10281): 1301-1315.
4. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol, 2008, 58(5): 826-850.
5. Schmitt J, Rosumeck S, Thomaschewski G, et al. Efficacy and safety of systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials. Br J Dermatol, 2014, 170(2): 274-303.
6. Zhang J, Xia Z, Guo W, et al. Cost-effectiveness of secukinumab versus other biologics in the treatment of moderate-to-severe plaque psoriasis: the Chinese healthcare system perspective. Dermatol Ther (Heidelb), 2023, 13(11): 2681-2696.
7. Rothhammer V, Quintana FJ. The aryl hydrocarbon receptor: an environmental sensor integrating immune responses in health and disease. Nat Rev Immunol, 2019, 19(3): 184-197.
8. Balogh B, Pet? á, Fehér P, et al. Tapinarof nanogels as a promising therapeutic approach. Pharmaceutics, 2025, 17(6): 731.
9. Carmona-Rocha E, Rusi?ol L, Puig L. New and emerging oral/topical small-molecule treatments for psoriasis. Pharmaceutics, 2024, 16(2): 239.
10. Chan JJ. Psoriasis: an update on topical and systemic therapies. Aust Prescr, 2025, 48(3): 87-92.
11. Higgins JP, Altman DG, G?tzsche PC, et al. The Cochrane collaboration's tool for assessing risk of bias in randomised trials. BMJ, 2011, 343: d5928.
12. Igarashi A, Tsuji G, Fukasawa S, et al. Tapinarof cream for the treatment of plaque psoriasis: efficacy and safety results from 2 Japanese phase 3 trials. J Dermatol, 2024, 51(10): 1269-1278.
13. Stein Gold L, Bhatia N, Tallman AM, et al. A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: secondary efficacy and patient-reported outcomes. J Am Acad Dermatol, 2021, 84(3): 624-631.
14. Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of Tapinarof cream for plaque psoriasis. N Engl J Med, 2021, 385(24): 2219-2229.
15. Cai L, Chen GH, Lu QJ, et al. A double-blind, randomized, placebo- and positive-controlled phase Ⅲ trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis. Chin Med J (Engl), 2020, 133(24): 2905-2909.
16. Robbins K, Bissonnette R, Maeda-Chubachi T, et al. Phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of plaque psoriasis. J Am Acad Dermatol, 2019, 80(3): 714-721.
17. Zang YN, Jiang DL, Cai L, et al. Use of a dose-response model to guide future clinical trial of benvitimod cream to treat mild and moderate psoriasis. Int J Clin Pharmacol Ther, 2016, 54(2): 87-95.
18. Bissonnette R, Bolduc C, Maari C, et al. Efficacy and safety of topical WBI-1001 in patients with mild to moderate psoriasis: results from a randomized double-blind placebo-controlled, phase Ⅱ trial. J Eur Acad Dermatol Venereol, 2012, 26(12): 1516-1521.
19. Bissonnette R, Stein Gold L, Rubenstein DS, et al. Tapinarof in the treatment of psoriasis: a review of the unique mechanism of action of a novel therapeutic aryl hydrocarbon receptor-modulating agent. J Am Acad Dermatol, 2021, 84(4): 1059-1067.
20. Polonio CM, McHale KA, Sherr DH, et al. The aryl hydrocarbon receptor: a rehabilitated target for therapeutic immune modulation. Nat Rev Drug Discov, 2025, 24(8): 610-630.
21. Dawe HR, Di Meglio P. The aryl hydrocarbon receptor (AHR): peacekeeper of the skin. Int J Mol Sci, 2025, 26(4): 1618.
22. Bitterman D, Kabakova M, Wang JY, et al. The role of aryl hydrocarbon receptor agonists in the treatment of vitiligo. Arch Dermatol Res, 2024, 316(9): 659.
23. Lin X, Meng X, Lin J. The role of aryl hydrocarbon receptor in the pathogenesis and treatment of psoriasis. J Cutan Med Surg, 2024, 28(3): 276-286.
24. Silverberg JI, Boguniewicz M, Quintana FJ, et al. Tapinarof validates the aryl hydrocarbon receptor as a therapeutic target: a clinical review. J Allergy Clin Immunol, 2024, 154(1): 1-10.
25. 中華醫學會皮膚性病學分會銀屑病專業委員會. 中國銀屑病診療指南(2023版). 中華皮膚科雜志, 2023, 56(7): 573-625.

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