Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial - PubMed (original) (raw)
Randomized Controlled Trial
. 2012 Jun;125(11):1845-51.
Ke Wang, Hong-Zhong Jin, Tian-Wen Gao, Sheng-Xiang Xiao, Jin-Hua Xu, Bao-Xi Wang, Fu-Ren Zhang, Chun-Yang Li, Xiao-Ming Liu, Cai-Xia Tu, Su-Zhen Ji, Yang Shen, Xue-Jun Zhu
Affiliations
- PMID: 22884040
Randomized Controlled Trial
Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial
Hai-Zhen Yang et al. Chin Med J (Engl). 2012 Jun.
Abstract
Background: Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-α. The purpose of this study was to validate the efficacy and safety of 5 mg/kg infliximab therapy in Chinese patients with moderate to severe plaque psoriasis.
Methods: In this multicenter, double-blind, placebo-controlled trial, 129 patients with moderate-to-severe psoriasis were randomized to the induction therapy (weeks 0, 2 and 6) with infliximab 5 mg/kg (n = 84) or placebo (n = 45), followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group, and infliximab 5 mg/kg scheduled at weeks 10, 12 and 16 in the placebo group. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI 75 response rate) from baseline at week 10.
Results: At week 10, 81.0% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo (P < 0.001). A significant improvement in PASI, Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), was seen from week 6 through week 14 in the infliximab group compared with the placebo group. Through week 22, PASI, PGA, DLQI were well maintained. The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance. However, there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal.
Conclusions: Infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis. Most drug-induced adverse events were mild to moderate, and well tolerated. Screening for tuberculosis is essential and prophylactic treatment should be given if necessary.
Similar articles
- Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial.
Torii H, Nakagawa H; Japanese Infliximab Study investigators. Torii H, et al. J Dermatol Sci. 2010 Jul;59(1):40-9. doi: 10.1016/j.jdermsci.2010.04.014. Epub 2010 May 4. J Dermatol Sci. 2010. PMID: 20547039 Clinical Trial. - Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial.
Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C, Li S, Dooley LT, Griffiths CE; EXPRESS study investigators. Reich K, et al. Lancet. 2005 Oct 15-21;366(9494):1367-74. doi: 10.1016/S0140-6736(05)67566-6. Lancet. 2005. PMID: 16226614 Clinical Trial. - Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial.
Gottlieb AB, Evans R, Li S, Dooley LT, Guzzo CA, Baker D, Bala M, Marano CW, Menter A. Gottlieb AB, et al. J Am Acad Dermatol. 2004 Oct;51(4):534-42. doi: 10.1016/j.jaad.2004.02.021. J Am Acad Dermatol. 2004. PMID: 15389187 Clinical Trial. - Etanercept and efalizumab for the treatment of psoriasis: a systematic review.
Woolacott N, Hawkins N, Mason A, Kainth A, Khadjesari Z, Vergel YB, Misso K, Light K, Chalmers R, Sculpher M, Riemsma R. Woolacott N, et al. Health Technol Assess. 2006 Nov;10(46):1-233, i-iv. doi: 10.3310/hta10460. Health Technol Assess. 2006. PMID: 17083854 Review. - Anti-TNF agents for paediatric psoriasis.
Sanclemente G, Murphy R, Contreras J, García H, Bonfill Cosp X. Sanclemente G, et al. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD010017. doi: 10.1002/14651858.CD010017.pub2. Cochrane Database Syst Rev. 2015. PMID: 26598969 Free PMC article. Review.
Cited by
- Short term efficacy of biological treatment for moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis.
Ismail O, Jaber K, Jaber Y, Froukh U, Younis A, Albdour K, Momani Y, Almaani N. Ismail O, et al. Arch Dermatol Res. 2024 Oct 18;316(10):699. doi: 10.1007/s00403-024-03398-y. Arch Dermatol Res. 2024. PMID: 39424649 - Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis.
Armstrong AW, Warren RB, Zhong Y, Zhuo J, Cichewicz A, Kadambi A, Junqueira D, Westley T, Kisa R, Daamen C, Augustin M. Armstrong AW, et al. Dermatol Ther (Heidelb). 2023 Nov;13(11):2839-2857. doi: 10.1007/s13555-023-01034-7. Epub 2023 Oct 6. Dermatol Ther (Heidelb). 2023. PMID: 37801281 Free PMC article. - Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
Sbidian E, Chaimani A, Guelimi R, Garcia-Doval I, Hua C, Hughes C, Naldi L, Kinberger M, Afach S, Le Cleach L. Sbidian E, et al. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD011535. doi: 10.1002/14651858.CD011535.pub6. Cochrane Database Syst Rev. 2023. PMID: 37436070 Free PMC article. Review. - Risk of Candida Infection and Serious Infections in Patients with Moderate-to-Severe Psoriasis Receiving Biologics: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Feng Y, Zhou B, Wang Z, Xu G, Wang L, Zhang T, Zhang Y. Feng Y, et al. Int J Clin Pract. 2022 Sep 21;2022:2442603. doi: 10.1155/2022/2442603. eCollection 2022. Int J Clin Pract. 2022. PMID: 36212052 Free PMC article. Review. - Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
Sbidian E, Chaimani A, Garcia-Doval I, Doney L, Dressler C, Hua C, Hughes C, Naldi L, Afach S, Le Cleach L. Sbidian E, et al. Cochrane Database Syst Rev. 2022 May 23;5(5):CD011535. doi: 10.1002/14651858.CD011535.pub5. Cochrane Database Syst Rev. 2022. PMID: 35603936 Free PMC article. Updated. Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical