Department of Dermatology and Venereology, Chong Qing Three Gorges Central Hospital, Chongqing 404100, China.
J Immunol Res. 2020 Jul 17;2020:4975628. doi: 10.1155/2020/4975628. eCollection 2020.
To investigate the efficacy and safety of guselkumab in the treatment of moderate-to-severe plaque psoriasis.
A systematic review was undertaken to identify double-blind randomized controlled trials (RCTs). PubMed, Web of Science, Cochrane Library, EMBASE, and Google Scholar databases were searched before 1 March 2020. The odds ratios (ORs) with 95% confidence interval (CI) were calculated. All analyses were conducted with intention-to-treat basis. A range of sensitivity analyses was undertaken.
A total of 7 articles contained 1206 plaque psoriasis patients with guselkumab, 585 patients with placebo, and 1250 patients with adalimumab were included. The results indicated that guselkumab had better efficacy than placebo or adalimumab for Psoriasis Area and Severity Index score reductions from baseline of 75% (PASI 75) (OR = 61.37, 95% CI = 31.15 to 120.91; OR = 3.08, 95% CI = 2.35 to 4.06), Investigator's Global Assessment scores of 0 or 1 (IGA 0/1) (OR = 65.75, 95% CI = 45.54 to 94.95; OR = 2.79, 95% CI = 2.17 to 3.59), and Dermatology Life Quality Index scores of 0 or 1 (DLQI 0/1) (OR = 29.64, 95% CI = 18.80 to 46.73; OR = 1.86, 95% CI = 1.50 to 2.31). The guselkumab had similar safety with placebo or adalimumab about the incidence of adverse events (AEs) (OR = 1.05, 95% CI = 0.86 to 1.29; OR = 0.97, 95% CI = 0.79 to 1.19) and serious adverse events (SAEs) (OR = 1.03, 95% I = 0.47 to 2.27; OR = 0.91, 95% CI = 0.44 to 1.87). Meanwhile, there was no statistically significant association of infections and serious infections compared with the placebo or adalimumab group. The guselkumab was more effective and had the similar tolerance.
The guselkumab had excellent efficacy and great safety in moderate-to-severe plaque psoriasis, but long-term safety remained to be determined.
研究 Guselkumab 在治疗中重度斑块状银屑病中的疗效和安全性。
系统检索了 2020 年 3 月 1 日前发表的 PubMed、Web of Science、Cochrane 图书馆、EMBASE 和 Google Scholar 数据库中的双盲随机对照试验（RCT）。计算优势比（OR）及其 95%置信区间（CI）。所有分析均基于意向治疗原则进行。进行了一系列敏感性分析。
共纳入 7 项研究，包含 1206 例接受 Guselkumab 治疗、585 例接受安慰剂治疗和 1250 例接受阿达木单抗治疗的斑块状银屑病患者。结果表明，与安慰剂或阿达木单抗相比，Guselkumab 能更显著地降低患者的银屑病面积与严重程度指数（PASI 75）评分（OR = 61.37，95%CI = 31.15-120.91；OR = 3.08，95%CI = 2.35-4.06）、改善研究者全球评估（IGA）评分（OR = 65.75，95%CI = 45.54-94.95；OR = 2.79，95%CI = 2.17-3.59）和皮肤病生活质量指数（DLQI）评分（OR = 29.64，95%CI = 18.80-46.73；OR = 1.86，95%CI = 1.50-2.31）。Guselkumab 与安慰剂或阿达木单抗相比，不良事件（AE）（OR = 1.05，95%CI = 0.86-1.29；OR = 0.97，95%CI = 0.79-1.19）和严重不良事件（SAE）（OR = 1.03，95%CI = 0.47-2.27；OR = 0.91，95%CI = 0.44-1.87）的发生率相似，安全性相当。同时，与安慰剂或阿达木单抗组相比，Guselkumab 组的感染和严重感染发生率无统计学差异。Guselkumab 在中重度斑块状银屑病中疗效显著且安全性良好，但长期安全性仍需进一步确定。
