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The benefit is robust across a variety of demographics and baseline disease characteristics, according to data.
A post-hoc analysis of data from the Phase 3 PANORAMA trial investigating aflibercept (Regeneron Pharmaceuticals) treatment in eyes with moderately-severe to severe nonproliferative diabetic retinopathy (NPDR) shows that its benefit for reducing DR severity is robust across a variety of demographics and baseline disease characteristics, noted Nathan Steinle, MD, at the 2020 virtual meeting of the American Society of Retina Specialists.
“The true take-home message from this post-hoc analysis is that greater proportions of eyes treated with intravitreal aflibercept compared with sham had a two-step or greater improvement from their baseline Diabetic Retinopathy Severity Score (DRSS) regardless of baseline age, body mass index (BMI), ethnicity, hemoglobin A1c (HbA1c), duration of diabetes, or baseline DRSS level,” said Steinle, California Retina Consultants, Santa Barbara, CA.
“Aflibercept performed extremely well across all six of these baseline factors," Steinle added. "Therefore, retina specialists do not have to spend time during a busy clinic reviewing a variety of factors to determine whether a particular patient with moderately-severe to severe NPDR is an appropriate candidate for aflibercept. Instead, aflibercept worked well across the board, regardless of the baseline factor investigated. Thus, we can treat confidently with aflibercept for advanced NPDR regardless of which patient is in front of us.”
The PANORAMA study enrolled patients with type 1 or 2 diabetes mellitus, DRSS level 47 or 53 diabetic retinopathy, and ETDRS BCVA ≥69 letters (approximate Snellen equivalent 20/40 or better).
Patients were randomized equally into three groups to receive aflibercept 2 mg every 8 weeks following five monthly doses (n = 134), aflibercept every 16 weeks following 3 monthly doses, and one 8-week interval (n = 135), or sham (n = 133). The aflibercept treatment schedules were followed through week 52.
Patients in the 2 mg every 8 weeks arm were then treated on an as-needed basis after week 52 out to week 100, while the 2 mg every 16 weeks arm continued at q 16 weeks dosing to week 100.
The topline data from PANORAMA showed that a significantly greater proportion of patients in both aflibercept arms achieved a two-step or greater reduction (improvement) from baseline DRSS level at weeks 24, 52, and 100 versus the sham arm.
The post-hoc analysis investigating whether there was a difference in treatment effect between aflibercept and sham by baseline factors divided patients into age by tertiles (≤52 years, >52 to ≤61 years, >61 years), ethnicity (Hispanic/Latino or not), three BMI subgroups (≤30 kg/m2, >30 to ≤35 kg/m2, >35 kg/m2), HBA1c tertiles (≤7.6%, >7.6 to ≤9.1%, >9.1%), duration of diabetes tertiles (≤10.3 years, >10.3 to ≤17.6 years, >17.6 years), and baseline DRSS level (47 or 53).
Adjusted Mantel-Haenszel weight scheme was used to evaluate differences between treatment groups across all baseline factors, and treatment-by-subgroup interactions were evaluated by logistic regression.
In analyses of data from both week 52 and week 100, there were no treatment-by-subgroup interactions for any of the baseline factors.
In addition, both dosing regimens of aflibercept maintained statistical superiority over sham in all baseline factor subgroups.