Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study

Abstract

Background/aimsTo monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.MethodsRAINBOW (Real life use of intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT-AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.ResultsSafety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)µm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p<0.001 vs baseline). The mean (SD) CRT reduction was –108.7 (146.8)µm and –116.4 (150.4)µm (loading dose) at month 12 (p<0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.ConclusionThis 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.Trial registration numberNCT02279537 Pre-results.

Impact of intravitreal aflibercept dosing regimens in treatment-naïve patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study

“…Variability in the treatment protocols used with IVT-AFL is likely due to the option of anti-VEGF administration using either a reactive (PRN) or proactive treatment approach. Although both approaches incorporate three initial monthly injections, our observation that this does not occur in all patients, is not unique and has been seen previously with IVT-AFL and ranibizumab (with both a fixed-dose or treat-and-extend dosing) 23–25. This, therefore, provides the rationale to evaluate the impact of any differences in treatment protocols on patient outcomes in clinical practice.…”

“…Consequently, intervals between injections may have varied substantially. In addition, we have also previously shown that not all patients receive the approved three initial doses of IVT-AFL 23…”

“…The ongoing Real life of intravitreal Aflibercept In FraNce: oBservatiOnal Study in Wet AMD (RAINBOW) study was initiated in 2014, with the objective of monitoring the outcomes achieved with IVT-AFL in treatment-naïve patients with neovascular AMD treated in routine clinical practice 23. The aim of this interim analysis of the RAINBOW study was to monitor treatment outcomes in patients with neovascular AMD stratified by IVT-AFL dosing regimen (identified retrospectively) over the first 12 months of treatment: a regular cohort of patients who received the indicated posology of three initial monthly injections of IVT-AFL followed by regular injections every 2 months, with ≥6 injections given during the 12 months; and two irregular cohorts who received <6 injections of IVT-AFL, either with or without three initial monthly injections.…”

Real-World Effectiveness and Real-World Cost-Effectiveness of Intravitreal Aflibercept and Intravitreal Ranibizumab in Neovascular Age-Related Macular Degeneration: Systematic Review and Meta-Analysis of Real-World Studies

“…Treatment effectiveness inputs used in the model were derived primarily from the metaanalysis and meta-regression, except for effectiveness at week 12, because the meta-analysis did not provide a pooled estimate for this time point. To overcome this limitation, the data were derived from two real-world studies of intravitreally administered aflibercept (RAIN-BOW [12]) and RBZ (ORACLE [29]). The impact of this assumption was tested in a sensitivity analysis.…”

“…Because of its later approval, there are fewer observational studies evaluating intravitreally administered aflibercept in patients with nAMD; however, these studies indicate that the implementation of a proactive treatment regimen with intravitreally administered aflibercept and an injection frequency consistent with the approved label are associated with RCT-like outcomes in clinical practice [12][13][14][15][16]. In a recent meta-analysis of studies on intravitreally administered aflibercept, researchers included subgroup analyses describing outcomes in RCTs and observational studies [17].…”