Gottlieb Alice B, Kang Sewon, Linden Kenneth G, Lebwohl Mark, Menter Alan, Abdulghani Ahsan A, Goldfarb Michael, Chieffo Nicole, Totoritis Mark C
Clinical Research Center, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ 08901-0019, USA.
Clin Immunol. 2004 Apr;111(1):28-37. doi: 10.1016/j.clim.2004.01.006.
Reduction in lesional, activated T cells induces improvement in psoriatic plaques. Galiximab (IDEC-114), an IgG(1) anti-CD80 antibody, binds to CD80, a costimulatory molecule involved in T-cell activation.
A Phase I/II, multidose, multischedule, dose-finding study of galiximab to evaluate safety, pharmacokinetics, and clinical activity was conducted in 35 patients with moderate to severe plaque psoriasis.
Seven cohorts of five patients received galiximab intravenously on three different schedules at different dose levels.
Adverse events (AEs) commonly occurred as mild and self-limiting. Improvements were observed in most cohorts without evidence of a dose response in Psoriasis Area and Severity Index (50% or greater reduction in PASI score in 40% of patients), Physician's Global Psoriasis Assessment (PGA rating of Good or above in 57% of patients), and Psoriasis Severity Scale (PSS, baseline mean of 7.6 decreased by Study Day 127 to 5.0). An association was observed between reduction in CD3(+) cell count in histologic studies and reduction in PASI score. No antibodies to galiximab were detected.
Galiximab appears to be safe and well tolerated with preliminary evidence of clinical and histologic response.
减少皮损处活化的T细胞可改善银屑病斑块。加利昔单抗（IDEC-114）是一种IgG(1)抗CD80抗体，可与参与T细胞活化的共刺激分子CD80结合。
对35例中度至重度斑块状银屑病患者进行了一项关于加利昔单抗的I/II期、多剂量、多方案、剂量探索性研究，以评估其安全性、药代动力学和临床活性。
7个队列，每个队列5例患者，按照三种不同方案、不同剂量水平静脉注射加利昔单抗。
不良事件通常为轻度且具有自限性。在大多数队列中观察到病情改善，在银屑病面积和严重程度指数（40%的患者PASI评分降低50%或更多）、医生整体银屑病评估（57%的患者PGA评分为良好或更高）和银屑病严重程度量表（PSS，基线平均值为7.6，到研究第127天降至5.0）方面均无剂量反应证据。在组织学研究中观察到CD3(+)细胞计数减少与PASI评分降低之间存在关联。未检测到抗加利昔单抗抗体。
加利昔单抗似乎安全且耐受性良好，有临床和组织学反应的初步证据。
