Kaohsiung Medical University Chung-Ho Memorial Hospital, Sanmin District, Kaohsiung City, Taiwan.
Tri-Service General Hospital, National Defense Medical Centre, Chenggong Road, Taipei City, Taiwan.
BMC Ophthalmol. 2020 Nov 25;20(1):462. doi: 10.1186/s12886-020-01715-3.
The current National Health Insurance scheme in Taiwan reimburses 3 initial plus 4 additional injections of ranibizumab 0.5 mg for eligible patients with neovascular age-related macular degeneration (nAMD). The Ranibizumab AMD Clinical Efficacy in Real-world practice (RACER) study aimed to observe the effectiveness of ranibizumab injections under this reimbursement system.
RACER was a 12-month, prospective, observational study conducted in treatment-naïve, adult Taiwanese patients with nAMD. Patients received intravitreal ranibizumab 0.5 mg injections in adherence with local prescribing information.
Of 161 patients enrolled, 114 (70.8%) completed the 12-month study. Overall, patients received a mean (standard deviation [SD]) of 4.3 (1.7) ranibizumab injections. The mean (SD, [95% confidence interval], P value) gain in best-corrected visual acuity (BCVA) from baseline at Month 3 was 5.2 (12.2, [3.1, 7.3] letters, P < 0.0001) and at Month 12 was 3.4 (15.4, [0.2-6.6] letters, P = 0.0352). Mean central retinal thickness also decreased from baseline at Months 3 and 12 (both P < 0.001). In subgroup analyses, better treatment outcomes at Months 3 and 12 were observed among patients who received a loading dose and those who had a shorter duration of nAMD at baseline. Adverse events were reported in 58.4% of patients; most (94.4%) were mild-to-moderate in severity and 98.8% were deemed unrelated to study treatment.
Treatment with ranibizumab 0.5 mg resulted in significant improvements in visual outcomes among treatment-naïve Taiwanese patients with nAMD. Early treatment and frequent dosing in the real-world setting may be the key to achieving better outcomes.
台湾现行的全民健保制度针对新生血管性年龄相关性黄斑变性（nAMD）患者，支付雷珠单抗 0.5mg 的前 3 次和另外 4 次注射的费用。雷珠单抗 AMD 临床疗效真实世界研究（RACER）旨在观察在此报销制度下雷珠单抗注射的疗效。
RACER 是一项为期 12 个月、前瞻性、观察性研究，纳入未经治疗的成年台湾 nAMD 患者。患者按照当地处方信息接受玻璃体内注射雷珠单抗 0.5mg。
161 例患者中，114 例（70.8%）完成了 12 个月的研究。总体而言，患者平均（标准差[SD]，[95%置信区间]，P 值）接受了 4.3（1.7）次雷珠单抗注射。从基线开始，第 3 个月最佳矫正视力（BCVA）的平均（SD，[95%置信区间]，P 值）增加了 5.2（12.2，[3.1，7.3]个字母，P<0.0001），第 12 个月增加了 3.4（15.4，[0.2-6.6]个字母，P=0.0352）。从基线开始，第 3 和第 12 个月时，中央视网膜厚度也均下降（均 P<0.001）。在亚组分析中，基线时接受负荷剂量的患者和 nAMD 持续时间较短的患者在第 3 和第 12 个月时观察到更好的治疗效果。58.4%的患者报告了不良事件；大多数（94.4%）为轻至中度，98.8%被认为与研究治疗无关。
在未经治疗的台湾 nAMD 患者中，雷珠单抗 0.5mg 治疗可显著改善视力结局。在真实环境中尽早治疗和频繁给药可能是实现更好结局的关键。
