介绍需要有关真实世界雷珠单抗使用的信息,以优化视网膜静脉阻塞(RVO)继发黄斑水肿的治疗。BOREAL-RVO研究评估了治疗用途,在真实世界环境中,雷珠单抗0.5mg治疗因RVO继发黄斑水肿导致视力障碍的患者24个月的有效性和安全性.方法这是一个多中心,授权后,法国的观察研究,包括开始使用雷珠单抗治疗RVO的患者。主要终点是第6个月最佳矫正视力(BCVA)相对于基线的平均变化。次要终点是第24个月时BCVA和第6个月和第24个月时中央视网膜厚度(CRT)相对于基线的平均变化,以及在现实世界中的治疗用途。结果共纳入226例分支RVO(BRVO)和196例中央RVO(CRVO)患者;71.7%和70.9%完成24个月随访。分别。在BRVO,平均(SD)基线BCVA为55.2(18.7)个字母,收益为14.3(13.7),14.1(16.5),第3、6、12和24个月的13.0(17.5)和11.4(20.1)字母。在CRVO,平均(SD)基线BCVA为40.4(25.6)个字母,收益为16.0(21.2),9.5(25.4),第3、6、12和24个月的9.2(27.7)和8.3(23.8)封信。在第24个月,52%的BRVO和41%的CRVO患者增加了15个或更多字母。在BRVO,基线和第3、6、12和24个月的平均(SD)CRT值分别为550(175),315(104),343(122),335(137)和340(105)μm。在CRVO,基线和第3、6、12和24个月的平均(SD)CRT值分别为643(217),327(152),400(203),379(175)和348(161)μm。平均而言,到第6个月,BRVO患者进行3.8次注射,进行6.9次访问,到第24个月,进行7.2次注射,进行19.7次访问。到第6个月,CRVO患者进行2.7次注射,进行4.2次访问,到第24个月,进行7.1次注射,进行21.1次访问。预测6个月时BCVA增加更好的因素是基线时年龄在60岁以下,第3个月基线BCVA和BCVA增益较低。没有新的安全性发现。结论在诱导期后第3个月观察到BCVA和CRT的重大改善,然后持续到第24个月,略有下降,可能是由于治疗不足。这项研究表明,雷珠单抗在现实世界中是BRVO和CRVO的安全有效治疗方法,尽管更常规或更积极的治疗可以进一步改善结局.
BACKGROUND: Information about real-world ranibizumab use is needed to optimize treatment of macular edema secondary to retinal vein occlusion (RVO). The BOREAL-RVO
study assessed treatment use, effectiveness, and safety of 24-month treatment with ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to RVO in a real-world setting.
METHODS: This was a multicenter, post-authorization, observational
study in France, including patients starting ranibizumab for RVO. Primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 6. Secondary endpoints were mean changes from baseline in BCVA at month 24 and central retinal thickness (CRT) at months 6 and 24, and treatment use in real-world setting.
RESULTS: 226 branch RVO (BRVO) and 196 central RVO (CRVO) patients were enrolled; 71.7% and 70.9% completed the 24-month follow-up, respectively. In BRVO, mean (SD) baseline BCVA was 55.2 (18.7) letters, with gains of 14.3 (13.7), 14.1 (16.5), 13.0 (17.5), and 11.4 (20.1) letters at months 3, 6, 12, and 24, respectively. In CRVO, mean (SD) baseline BCVA was 40.4 (25.6) letters, with gains of 16.0 (21.2), 9.5 (25.4), 9.2 (27.7), and 8.3 (23.8) letters at months 3, 6, 12, and 24, respectively. At month 24, 52% of BRVO and 41% of CRVO patients had gains of 15 or more letters. In BRVO, mean (SD) CRT values at baseline and months 3, 6, 12, and 24 were 550 (175), 315 (104), 343 (122), 335 (137), and 340 (105) μm. In CRVO, mean (SD) CRT values at baseline and months 3, 6, 12, and 24 were 643 (217), 327 (152), 400 (203), 379 (175), and 348 (161) μm. On average, BRVO patients had 3.8 injections for 6.9 visits by month 6, and 7.2 injections for 19.7 visits by month 24. CRVO patients had 2.7 injections for 4.2 visits by month 6 and 7.1 injections for 21.1 visits by month 24. Factors predictive of better BCVA gain at month 6 were age under 60 at baseline, lower baseline BCVA and BCVA gain at month 3. There were no new safety findings.
CONCLUSIONS: Major improvements in BCVA and CRT were observed at month 3 after the induction phase and then were sustained up to month 24, with a slight decrease, probably due to under-treatment. This
study demonstrated ranibizumab to be a safe and effective treatment for BRVO and CRVO in the real-world setting, although more regular or proactive treatment could further improve outcomes.