Aflibercept Monotherapy or Bevacizumab First for Diabetic Macular Edema

Jhaveri, Chirag; Glassman, Adam R.; Ferris, Frederick L.; Liu, Danni; Maguire, Maureen G.; Allen, J. R. L.; Baker, Carl W.; Browning, David J.; Cunningham, Maureen; Friedman, Scott M.; Jampol, Lee M.; Marcus, Dennis M.; Martín, Daniel; Preston, Carin M.; Stockdale, Cynthia R.; Sun, Jennifer K.

doi:10.1056/nejmoa2204225

Cited by 48 publications

(27 citation statements)

References 14 publications

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“…Detailed procedures, protocol, and statistical methods have been reported previously. 6 In summary, participants were aged 18 years or older with center-involved DME on optical coherence tomography (OCT) and clinical examination and bestcorrected visual acuity (Snellen fraction) of 20/50 to 20/320 (electronic Early Treatment Diabetic Retinopathy Study letter score 69-24) in the study eye. Participants were followed up every 4 weeks through 1 year and every 4 to 16 weeks in year 2.…”

Section: Participantsmentioning

confidence: 99%

“…Results from DRCR Retina Network Protocol AC have now demonstrated that in eyes with center-involved DME and starting visual acuity of 20/50 or worse, 6 no clinically meaningful differences in visual acuity outcomes over 2 years exist between eyes treated with aflibercept monotherapy vs bevacizumab first, with eyes receiving aflibercept if needed (mean [SD] improvement in visual acuity over 2 years was 15.0 (8.5) letters in the aflibercept monotherapy group and 14.0 (8.8) letters in the bevacizumab-first group [P = .37]). 6 During follow-up, aflibercept treatment was received in approximately 70% of eyes in the bevacizumab-first group. Given the respective costs of the treatments and the results of Protocol AC, it is important to evaluate the relative cost-effectiveness of these different management strategies for treating DME.…”

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confidence: 99%

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Cost-effectiveness of Aflibercept Monotherapy vs Bevacizumab First Followed by Aflibercept If Needed for Diabetic Macular Edema

et al. 2023

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ImportanceThe DRCR Retina Network Protocol AC showed no significant difference in visual acuity outcomes over 2 years between treatment with aflibercept monotherapy and bevacizumab first with switching to aflibercept for suboptimal response in treating diabetic macular edema (DME). Understanding the estimated cost and cost-effectiveness of these approaches is important.ObjectiveTo evaluate the cost and cost-effectiveness of aflibercept monotherapy vs bevacizumab-first strategies for DME treatment.Design, Setting, and ParticipantsThis economic evaluation was a preplanned secondary analysis of a US randomized clinical trial of participants aged 18 years or older with center-involved DME and best-corrected visual acuity of 20/50 to 20/320 enrolled from December 15, 2017, through November 25, 2019.InterventionsAflibercept monotherapy or bevacizumab first, switching to aflibercept in eyes with protocol-defined suboptimal response.Main Outcomes and MeasuresBetween February and July 2022, the incremental cost-effectiveness ratio (ICER) in cost per quality-adjusted life-year (QALY) over 2 years was assessed. Efficacy and resource utilization data from the randomized clinical trial were used with health utility mapping from the literature and Medicare unit costs.ResultsThis study included 228 participants (median age, 62 [range, 34-91 years; 116 [51%] female and 112 [49%] male; 44 [19%] Black or African American, 60 [26%] Hispanic or Latino, and 117 [51%] White) with 1 study eye. The aflibercept monotherapy group included 116 participants, and the bevacizumab-first group included 112, of whom 62.5% were eventually switched to aflibercept. Over 2 years, the cost of aflibercept monotherapy was $26 504 (95% CI, $24 796-$28 212) vs $13 929 (95% CI, $11 984-$15 874) for the bevacizumab-first group, a difference of $12 575 (95% CI, $9987-$15 163). The aflibercept monotherapy group gained 0.015 (95% CI, −0.011 to 0.041) QALYs using the better-seeing eye and had an ICER of $837 077 per QALY gained compared with the bevacizumab-first group. Aflibercept could be cost-effective with an ICER of $100 000 per QALY if the price per dose were $305 or less or the price of bevacizumab was $1307 per dose or more.Conclusions and RelevanceVariability in individual needs will influence clinician and patient decisions about how to treat specific eyes with DME. While the bevacizumab-first group costs still averaged approximately $14 000 over 2 years, this approach, as used in this study, may confer substantial cost savings on a societal level without sacrificing visual acuity gains over 2 years compared with aflibercept monotherapy.

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Section: Participantsmentioning

confidence: 99%

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confidence: 99%

Cost-effectiveness of Aflibercept Monotherapy vs Bevacizumab First Followed by Aflibercept If Needed for Diabetic Macular Edema

et al. 2023

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“…In patients with central involvement of DME, it was discovered that vitreous injections of aflibercept, bevacizumab, and ranibizumab enhanced visual acuity and decreased retinal thickness, although the proportionate benefit depended on baseline eyesight ( 154 ).. At a lower initial level of vision, aflibercept was more effective at improving vision. In the DRCR Retina Network trial, which involved moderate vision loss due to DME, the team did not find that over a two-year period, there was a significant difference in visual outcome between aflibercept monotherapy and bevacizumab treatment, and in the event of a poor response, aflibercept may be preferred ( 155 ).…”

Section: Therapies Targeting Inflammation In Drmentioning

confidence: 99%

The role of inflammation in immune system of diabetic retinopathy: Molecular mechanisms, pathogenetic role and therapeutic implications

et al. 2022

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Diabetic retinopathy is one of the most common complications of diabetes mellitus and the leading cause of low vision and blindness worldwide. Mounting evidence demonstrates that inflammation is a key mechanism driving diabetes-associated retinal disturbance, yet the pathophysiological process and molecular mechanisms of inflammation underlying diabetic retinopathy are not fully understood. Cytokines, chemokines, and adhesion molecules interact with each other to form a complex molecular network that propagates the inflammatory and pathological cascade of diabetic retinopathy. Therefore, it is important to understand and elucidate inflammation-related mechanisms behind diabetic retinopathy progression. Here, we review the current understanding of the pathology and pathogenesis of inflammation in diabetic retinopathy. In addition, we also summarize the relevant clinical trials to further suggest inflammation-targeted therapeutics for prevention and management of diabetic retinopathy.

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“…Bevacizumab (Avastin; Genentech, Inc., South San Francisco, CA, USA) is a 149 kDa recombinant immunoglobulin G1 humanized monoclonal antibody that was originally approved by the U.S. Food and Drug Administration for the treatment of colorectal cancer in 2004, and its off-label intraocular use at doses of 1.25 to 2.50 mg in 0.05 mL had demonstrated good visual results and efficacy in the treatment of DME [ 13 , 14 , 27 ]. Bevacizumab binds and neutralizes the three biologically active isoforms of VEGF-A: VEGF 165 , VEGF 121, and VEGF 110 ; the vitreous half-life is 9.8 days with a mean (SD) serum half-life of 18.7 (5.8) days in non-vitrectomized patients [ 28 , 29 , 30 ].…”

Section: Treatment Optionsmentioning

confidence: 99%

“…Half the patients in each group had a ≥2-step improvement from baseline on the ETDRS-DRSS. However, it should be noted that approximately 70% of the patients in the bevacizumab-first switched to aflibercept during the 2-year trial [ 27 ]. These data demonstrate that even if it is not FDA-approved, bevacizumab keeps being a safe, effective, and cost-effective option for DME and DR management, at least at the beginning of the disease.…”

Section: Treatment Optionsmentioning

confidence: 99%

Current Treatments and Innovations in Diabetic Retinopathy and Diabetic Macular Edema

et al. 2022

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Diabetic retinopathy (DR) is one of the leading causes of blindness worldwide. Multiple treatment options have been used over time to attempt to modify the natural progression of the disease in both proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME). These two retinal complications are the result of microvascular occlusions and vascular hyperpermeability and are considered one of the leading causes of irreversible blindness in patients of working age. It is now well demonstrated that PDR and DME are associated with increased levels of inflammatory and pro-angiogenic factors in the ocular compartment. To date, laser photocoagulation, vascular endothelial growth factor (VEGF) inhibitors, and corticosteroids have demonstrated efficacy in their treatment in large randomized controlled trials and in real-life observational studies. This manuscript aims to provide a comprehensive review of current treatments, including the main drugs used in diabetic pathologic manifestations, as well as new therapeutic alternatives, such as extended-release intraocular devices.

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Aflibercept Monotherapy or Bevacizumab First for Diabetic Macular Edema

Cited by 48 publications

References 14 publications

Cost-effectiveness of Aflibercept Monotherapy vs Bevacizumab First Followed by Aflibercept If Needed for Diabetic Macular Edema

Cost-effectiveness of Aflibercept Monotherapy vs Bevacizumab First Followed by Aflibercept If Needed for Diabetic Macular Edema

The role of inflammation in immune system of diabetic retinopathy: Molecular mechanisms, pathogenetic role and therapeutic implications

Current Treatments and Innovations in Diabetic Retinopathy and Diabetic Macular Edema

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