Arch Ophthalmol. 1997 Dec;115(12):1528-36.
To evaluate the efficacy and safety of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis.
Two hundred nine patients with acquired immunodeficiency syndrome and active CMV retinitis were enrolled in a multicenter, phase 2/3, randomized, placebo-controlled clinical trial. Patients received adjuvant treatment with MSL-109, 60 mg intravenously every 2 weeks, or placebo. Randomization was stratified on the basis of whether patients had untreated or relapsed retinitis. Primary drug therapy for CMV retinitis was determined by the treating physician.
The rates of retinitis progression, as evaluated in a masked fashion, were 3.04/person-year in the MSL-109-treated group and 3.05/person-year in the placebo-treated group (P=.98; Wald test); the median times to progression were 67 days in the MSL-109-treated group and 65 days in the placebo-treated group. No differences between the 2 groups were noted in the rates of increase in retinal area involved by CMV, visual field loss, or visual acuity outcomes. The mortality rate in the MSL-109-treated group was 0.68/person-year, and in the placebo-treated group, 0.31/person-year (P=.01). The mortality difference was not explained by differences in baseline variables or in concurrent antiretroviral therapy. Among patients with newly diagnosed retinitis, mortality rates were similar (MSL-109, 0.41/person-year; placebo, 0.42/person-year; P=.95), whereas among patients with relapsed retinitis the MSL-109-treated group had a greater mortality rate (MSL-109, 0.83/person-year; placebo, 0.24/person-year; P=.003). However, the mortality rate in the placebo-treated patients with relapsed CMV retinitis was lower than that in the placebo-treated patients with newly diagnosed CMV retinitis and lower than that in other trials of patients with relapsed CMV retinitis.
Intravenous MSL-109, 60 mg every 2 weeks, appeared to be ineffective adjuvant therapy for CMV retinitis. The mortality rate was higher in the MSL-109-treated group, but the reasons for this difference remain uncertain.
评估静脉注射人巨细胞病毒（CMV）单克隆抗体MSL - 109作为CMV视网膜炎辅助治疗的疗效和安全性。
209例获得性免疫缺陷综合征合并活动性CMV视网膜炎患者参与了一项多中心、2/3期、随机、安慰剂对照临床试验。患者接受MSL - 109辅助治疗（每2周静脉注射60 mg）或安慰剂治疗。随机分组根据患者是否患有未经治疗的视网膜炎或复发性视网膜炎进行分层。CMV视网膜炎的主要药物治疗由主治医生决定。
以盲法评估，MSL - 109治疗组视网膜炎进展率为3.04/人年，安慰剂治疗组为3.05/人年（P = 0.98；Wald检验）；进展的中位时间在MSL - 109治疗组为67天，在安慰剂治疗组为65天。两组在CMV累及的视网膜面积增加率、视野损失或视力结果方面未发现差异。MSL - 109治疗组的死亡率为0.68/人年，安慰剂治疗组为0.31/人年（P = 0.01）。死亡率差异无法通过基线变量或同时进行的抗逆转录病毒治疗的差异来解释。在新诊断视网膜炎的患者中，死亡率相似（MSL - 109，0.41/人年；安慰剂，0.42/人年；P = 0.95），而在复发性视网膜炎患者中，MSL - 109治疗组的死亡率更高（MSL - 109，0.83/人年；安慰剂，0.24/人年；P = 0.003）。然而，安慰剂治疗的复发性CMV视网膜炎患者的死亡率低于安慰剂治疗的新诊断CMV视网膜炎患者，且低于其他复发性CMV视网膜炎患者试验中的死亡率。
每2周静脉注射60 mg的MSL - 109似乎是CMV视网膜炎无效的辅助治疗方法。MSL - 109治疗组的死亡率较高，但这种差异的原因仍不确定。
