Ranibizumab in diabetic macular oedema - A benefit-risk analysis of ranibizumab 0.5 mg PRN versus laser treatment

Focke Ziemssen; Alan Cruess; Cornelia Dunger-Baldauf; Philippe Margaron; Howard Snow; William David Strain

doi:10.17925/EE.2017.13.02.91

Ranibizumab in diabetic macular oedema - A benefit-risk analysis of ranibizumab 0.5 mg PRN versus laser treatment

Focke Ziemssen, Alan Cruess, Cornelia Dunger-Baldauf, Philippe Margaron, Howard Snow, William David Strain

Medicine

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

Introduction: The structured Benefit-risk Action Team (BRAT) approach aims to assist healthcare decision makers in treatment assessments. We applied BRAT to compare the benefit-risk profile of ranibizumab 0.5 mg versus laser photocoagulation for the treatment of diabetic macular oedema (DMO). Methods: One-year data for the ranibizumab 0.5 mg pro re nata (PRN) and laser arms of the phase III trials RESPOND (NCT01135914; n=220), RESTORE (NCT00687804; n=345), and REVEAL (NCT00989989; n=396) were included in the analysis. The benefit measures included =10 letters gain/avoidance of loss in best-corrected visual acuity (BCVA), achieving central retinal thickness (CRT) <275 μm, and 25-item Visual Function Questionnaire (VFQ-25) outcomes. The risks measures included endophthalmitis, intraocular pressure increase, hypertension, proteinuria, arterial/venous thromboembolic events and deaths. Results: Ranibizumab treatment provided significant benefits compared with laser for =10 letter BCVA gain at month 12 (387/1,000 versus 152/1,000 patients), CRT <275 μm at 12 months (474/1,000 versus 348/1,000 patients), and improvement of =6.06 on the VFQ-25 near activities subscale (325/1,000 versus 245/1,000 patients). Results for the risk measures were similar for both treatments. Conclusions: Superior clinically relevant outcomes were observed with ranibizumab 0.5 mg PRN compared with laser without compromising on safety. This analysis further supports the positive benefit-risk profile of ranibizumab 0.5 mg PRN.

Original language	English
Pages (from-to)	91-98
Number of pages	8
Journal	European Endocrinology
Volume	13
Issue number	2
DOIs	https://doi.org/10.17925/EE.2017.13.02.91
Publication status	Published - 2017

Bibliographical note

Funding Information:
Acknowledgements: The authors acknowledge Claire Bailey for her significant contribution towards the design and conduct of the analysis and for the development of this manuscript. Writing support was provided by Jennifer Green (Green Ink Communications) and was funded by Novartis. William David Strain would like to acknowledge the support of the National Institute for Health Research (NIHR) Exeter Clinical Research Facility and the NIHR Biomedical Research Centre scheme. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR Exeter Clinical Research Facility, the NHS, the NIHR or the Department of Health in England.

Funding Information:
Support: The publication of this article was supported by Novartis.

ASJC Scopus Subject Areas

Endocrinology, Diabetes and Metabolism
Endocrinology
Endocrine and Autonomic Systems

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.17925/EE.2017.13.02.91

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title = "Ranibizumab in diabetic macular oedema - A benefit-risk analysis of ranibizumab 0.5 mg PRN versus laser treatment",

abstract = "Introduction: The structured Benefit-risk Action Team (BRAT) approach aims to assist healthcare decision makers in treatment assessments. We applied BRAT to compare the benefit-risk profile of ranibizumab 0.5 mg versus laser photocoagulation for the treatment of diabetic macular oedema (DMO). Methods: One-year data for the ranibizumab 0.5 mg pro re nata (PRN) and laser arms of the phase III trials RESPOND (NCT01135914; n=220), RESTORE (NCT00687804; n=345), and REVEAL (NCT00989989; n=396) were included in the analysis. The benefit measures included =10 letters gain/avoidance of loss in best-corrected visual acuity (BCVA), achieving central retinal thickness (CRT) <275 μm, and 25-item Visual Function Questionnaire (VFQ-25) outcomes. The risks measures included endophthalmitis, intraocular pressure increase, hypertension, proteinuria, arterial/venous thromboembolic events and deaths. Results: Ranibizumab treatment provided significant benefits compared with laser for =10 letter BCVA gain at month 12 (387/1,000 versus 152/1,000 patients), CRT <275 μm at 12 months (474/1,000 versus 348/1,000 patients), and improvement of =6.06 on the VFQ-25 near activities subscale (325/1,000 versus 245/1,000 patients). Results for the risk measures were similar for both treatments. Conclusions: Superior clinically relevant outcomes were observed with ranibizumab 0.5 mg PRN compared with laser without compromising on safety. This analysis further supports the positive benefit-risk profile of ranibizumab 0.5 mg PRN.",

author = "Focke Ziemssen and Alan Cruess and Cornelia Dunger-Baldauf and Philippe Margaron and Howard Snow and Strain, {William David}",

note = "Funding Information: Acknowledgements: The authors acknowledge Claire Bailey for her significant contribution towards the design and conduct of the analysis and for the development of this manuscript. Writing support was provided by Jennifer Green (Green Ink Communications) and was funded by Novartis. William David Strain would like to acknowledge the support of the National Institute for Health Research (NIHR) Exeter Clinical Research Facility and the NIHR Biomedical Research Centre scheme. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR Exeter Clinical Research Facility, the NHS, the NIHR or the Department of Health in England. Funding Information: Support: The publication of this article was supported by Novartis.",

year = "2017",

doi = "10.17925/EE.2017.13.02.91",

language = "English",

volume = "13",

pages = "91--98",

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T1 - Ranibizumab in diabetic macular oedema - A benefit-risk analysis of ranibizumab 0.5 mg PRN versus laser treatment

AU - Ziemssen, Focke

AU - Cruess, Alan

AU - Dunger-Baldauf, Cornelia

AU - Margaron, Philippe

AU - Snow, Howard

AU - Strain, William David

N1 - Funding Information: Acknowledgements: The authors acknowledge Claire Bailey for her significant contribution towards the design and conduct of the analysis and for the development of this manuscript. Writing support was provided by Jennifer Green (Green Ink Communications) and was funded by Novartis. William David Strain would like to acknowledge the support of the National Institute for Health Research (NIHR) Exeter Clinical Research Facility and the NIHR Biomedical Research Centre scheme. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR Exeter Clinical Research Facility, the NHS, the NIHR or the Department of Health in England. Funding Information: Support: The publication of this article was supported by Novartis.

PY - 2017

Y1 - 2017

N2 - Introduction: The structured Benefit-risk Action Team (BRAT) approach aims to assist healthcare decision makers in treatment assessments. We applied BRAT to compare the benefit-risk profile of ranibizumab 0.5 mg versus laser photocoagulation for the treatment of diabetic macular oedema (DMO). Methods: One-year data for the ranibizumab 0.5 mg pro re nata (PRN) and laser arms of the phase III trials RESPOND (NCT01135914; n=220), RESTORE (NCT00687804; n=345), and REVEAL (NCT00989989; n=396) were included in the analysis. The benefit measures included =10 letters gain/avoidance of loss in best-corrected visual acuity (BCVA), achieving central retinal thickness (CRT) <275 μm, and 25-item Visual Function Questionnaire (VFQ-25) outcomes. The risks measures included endophthalmitis, intraocular pressure increase, hypertension, proteinuria, arterial/venous thromboembolic events and deaths. Results: Ranibizumab treatment provided significant benefits compared with laser for =10 letter BCVA gain at month 12 (387/1,000 versus 152/1,000 patients), CRT <275 μm at 12 months (474/1,000 versus 348/1,000 patients), and improvement of =6.06 on the VFQ-25 near activities subscale (325/1,000 versus 245/1,000 patients). Results for the risk measures were similar for both treatments. Conclusions: Superior clinically relevant outcomes were observed with ranibizumab 0.5 mg PRN compared with laser without compromising on safety. This analysis further supports the positive benefit-risk profile of ranibizumab 0.5 mg PRN.

AB - Introduction: The structured Benefit-risk Action Team (BRAT) approach aims to assist healthcare decision makers in treatment assessments. We applied BRAT to compare the benefit-risk profile of ranibizumab 0.5 mg versus laser photocoagulation for the treatment of diabetic macular oedema (DMO). Methods: One-year data for the ranibizumab 0.5 mg pro re nata (PRN) and laser arms of the phase III trials RESPOND (NCT01135914; n=220), RESTORE (NCT00687804; n=345), and REVEAL (NCT00989989; n=396) were included in the analysis. The benefit measures included =10 letters gain/avoidance of loss in best-corrected visual acuity (BCVA), achieving central retinal thickness (CRT) <275 μm, and 25-item Visual Function Questionnaire (VFQ-25) outcomes. The risks measures included endophthalmitis, intraocular pressure increase, hypertension, proteinuria, arterial/venous thromboembolic events and deaths. Results: Ranibizumab treatment provided significant benefits compared with laser for =10 letter BCVA gain at month 12 (387/1,000 versus 152/1,000 patients), CRT <275 μm at 12 months (474/1,000 versus 348/1,000 patients), and improvement of =6.06 on the VFQ-25 near activities subscale (325/1,000 versus 245/1,000 patients). Results for the risk measures were similar for both treatments. Conclusions: Superior clinically relevant outcomes were observed with ranibizumab 0.5 mg PRN compared with laser without compromising on safety. This analysis further supports the positive benefit-risk profile of ranibizumab 0.5 mg PRN.

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Ranibizumab in diabetic macular oedema - A benefit-risk analysis of ranibizumab 0.5 mg PRN versus laser treatment

Abstract

Bibliographical note

ASJC Scopus Subject Areas

UN SDGs

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