Istituto di Dermatologia, Università Cattolica, Largo Francesco Vito, 1, 00168 Rome, Italy, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo Agostino Gemelli 8, 00168 Rome, Italy.
Dermatology Unit Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini, 20089 Pieve Emanuele (MI) Italy, Skin Pathology Laboratory, Humanitas Research Hospital IRCCS, Via Manzoni 56, 20089 Rozzano, (MI) Italy.
Eur J Dermatol. 2021 Feb 1;31(1):3-16. doi: 10.1684/ejd.2021.3965.
Guselkumab, a subcutaneously administered fully human IgG1λ monoclonal antibody that selectively inhibits the p19 subunit of interleukin 23, is approved in both the USA and the EU for the treatment of adult patients with moderate-to-severe plaque psoriasis. The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability. Guselkumab was shown to be efficacious in patients with prior failure of other biologics, including adalimumab and ustekinumab, and was superior to both adalimumab and secukinumab in head-to-head trials. Guselkumab efficacy was also observed in the treatment of psoriasis localized in difficult-to-treat body regions including the scalp, palms and/or soles, and fingernails. Treatment with guselkumab improved health-related quality of life and patient-reported signs and symptoms. Guselkumab has a consistently favourable safety profile and is well tolerated over the long-term. Clinical development of guselkumab as a treatment is ongoing for other immune-mediated inflammatory diseases, including psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the overall management of patients with plaque psoriasis, guselkumab is a robust treatment option with durable maintenance of response over time.
古塞库单抗是一种皮下注射用全人源 IgG1λ 单克隆抗体，可选择性抑制白细胞介素 23 的 p19 亚单位，已获美国和欧盟批准，用于治疗成人中重度斑块型银屑病。古塞库单抗在四项随机、双盲、III 期临床试验（VOYAGE1 和 2、NAVIGATE 和 ECLIPSE）中显示出疗效和安全性，无论性别、年龄、体重和种族如何，在三年的连续治疗中均显示出较高的临床应答水平，保持了良好的安全性和长期耐受性。古塞库单抗对先前使用其他生物制剂（包括阿达木单抗和乌司奴单抗）治疗失败的患者有效，且在头对头试验中优于阿达木单抗和司库奇尤单抗。古塞库单抗在治疗头皮、手掌和/或足底以及指甲等难以治疗的身体部位的银屑病时也具有疗效。古塞库单抗治疗可改善患者的健康相关生活质量和患者报告的体征和症状。古塞库单抗具有一致的安全性，长期耐受性良好。古塞库单抗作为一种治疗药物，其在其他免疫介导的炎症性疾病（包括银屑病关节炎、克罗恩病和溃疡性结肠炎）方面的临床开发正在进行中。在斑块型银屑病患者的整体管理中，古塞库单抗是一种有效的治疗选择，随着时间的推移可持久维持应答。
