METHODS: A broad SLR was conducted to identify randomised controlled trials to ensure all relevant potential comparators were captured. Identified studies were refined to those appropriate for inclusion in the NMA. A Bayesian NMA was conducted comparing brolucizumab 6 mg (every 12 [Q12W]/every 8 weeks [Q8W]) with relevant aflibercept 2 mg and ranibizumab 0.5 mg regimens.
RESULTS: Fourteen studies were included in the NMA. At 1-year follow-up, the various aflibercept 2 mg and ranibizumab 0.5 mg regimens were mostly comparable with brolucizumab 6 mg Q12W/Q8W across key visual and anatomical outcomes, except brolucizumab 6 mg was favoured over ranibizumab 0.5 mg every 4 weeks (Q4W) for the change from baseline (CFB) in best-corrected visual acuity (BCVA), and BCVA loss/gain of pre-specified numbers of letters, and over ranibizumab 0.5 mg pro re nata for CFB in diabetic retinopathy severity scale, and retinal thickness. At year 2, where data were available, brolucizumab 6 mg showed similar results across efficacy outcomes versus all other anti-VEGFs. In most cases, discontinuation rates (all cause, and due to adverse events [AE]) and serious and overall rates of AEs excluding ocular inflammatory events were similar (in unpooled and pooled-treatment analyses) versus comparators.
CONCLUSIONS: Brolucizumab 6 mg Q12W/Q8W was comparable or superior to aflibercept 2 mg and ranibizumab 0.5 mg regimens for various visual and anatomical efficacy outcomes and discontinuation rates.
方法:进行广泛的SLR以确定随机对照试验,以确保捕获所有相关的潜在比较者。已确定的研究被细化为适合纳入NMA的研究。进行了贝叶斯NMA,比较了6mg的brolucizumab(每12[Q12W]/每8周[Q8W])与相关的阿柏西普2mg和雷珠单抗0.5mg方案。
结果:14项研究纳入了NMA。在1年的随访中,各种阿柏西普2mg和雷珠单抗0.5mg方案在主要视觉和解剖学结局方面与布罗珠单抗6mgQ12W/Q8W相当,除了在最佳矫正视力(BCVA)中相对于基线(CFB)的变化方面,每4周(Q4W)6mg的brolucizumab优于0.5mg的雷珠单抗,和BCVA预先指定的字母数的损失/收益,在糖尿病视网膜病变严重程度量表中,超过雷珠单抗0.5mg前再纳塔用于CFB,和视网膜厚度。在第二年,有数据的地方,与所有其他抗VEGF相比,布罗珠单抗6mg在疗效结局中显示相似的结果。在大多数情况下,停药率(所有原因,并且由于不良事件[AE]),并且不包括眼部炎症事件的AE的严重和总体发生率(在未合并和合并治疗分析中)与比较者相似。
结论:Brolucizumab6mgQ12W/Q8W在各种视觉和解剖学疗效结果和停药率方面与阿柏西普2mg和雷珠单抗0.5mg方案相当或更好。