Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)

BMC Ophthalmology

Research Article

Dominic Muston¹  Richard Birnie²  Gill Worthy²  Kate Misso²  Regina M Leadley²  Shona H Lang²  Jos Kleijnen³  Diana V Do⁴  Jean-Francois Korobelnik⁵ 

[1] Global Health Economics and Outcomes Research, Bayer HealthCare Pharmaceuticals Inc., 100 Bayer Boulevard, 07981, New Jersey, Whippany, USA;Kleijnen Systematic Reviews Ltd., Escrick Business Park, YO19 6FD, England, Escrick, York, UK;School for Public Health and Primary Care (CAPHRI), Maastricht University, Limburg, Maastricht, the Netherlands;Truhlsen Eye Institute, University of Nebraska Medical Center, 985540 Nebraska Medical Center, 68198-5540, Omaha, Nebraska, USA;Université Bordeaux, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux; Service d’Ophtalmologie, CHU de Bordeaux, Bordeaux, France;

关键词: Intravitreal aflibercept;    Diabetic macular edema (DME);    Intravitreal ranibizumab;    Meta-analysis;    Systematic review;   

DOI  :  10.1186/s12886-015-0035-x

 received in 2014-12-17, accepted in 2015-04-22,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundThis was an indirect comparison of the effectiveness of intravitreal aflibercept (IVT-AFL) 2 mg every 8 weeks after 5 initial monthly doses (or if different periods, after an initial monthly dosing period) (2q8) and other diabetic macular edema (DME) therapies at doses licensed outside the USA.MethodsA comprehensive search was undertaken to source relevant studies. Feasibility networks were prepared to identify viable comparisons of 12-month outcomes between IVT-AFL 2q8 and therapies licensed outside the USA, which were assessed for clinical and statistical homogeneity. Pooled effect sizes (mean difference [MD] and relative risk/risk ratio [RR]) were calculated using fixed- and random-effects models. Indirect comparisons were performed using Bucher analysis. If at least one ‘head-to-head’ study was found then a mixed treatment comparison (MTC) was performed using Bayesian methods. Two 12-month comparisons could be undertaken based on indirect analyses: IVT-AFL 2q8 versus intravitreal ranibizumab (IVR) 0.5 mg as needed (PRN) (10 studies) and IVT-AFL 2q8 versus dexamethasone 0.7 mg implants (three studies).ResultsThere was an increase in mean best-corrected visual acuity (BCVA) with IVT-AFL 2q8 over IVR 0.5 mg PRN by 4.67 letters [95% credible interval (CrI): 2.45–6.87] in the fixed-effect MTC model (10 studies) and by 4.82 letters [95% confidence interval (CI): 2.52–7.11] in the Bucher indirect analysis (four studies). IVT-AFL 2q8 doubled the proportion of patients gaining ≥ 10 Early Treatment Diabetic Retinopathy Study letters at 12 months compared with dexamethasone 0.7 mg implants (RR = 2.10 [95% CI: 1.29–3.40]) in the fixed-effect model. There were no significant differences in safety outcomes between IVT-AFL 2q8 and IVR 0.5 mg PRN or dexamethasone 0.7 mg implants.ConclusionsStudies of IVT-AFL 2q8 showed improved 12-month visual acuity measures compared with studies of IVR 0.5 mg PRN and dexamethasone 0.7 mg implants based on indirect comparisons. These analyses are subject to a number of limitations which are inherent in indirect data comparisons.

【 授权许可】

Unknown   
© Korobelnik et al. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.