Comparison of the Efficacy of Brolucizumab with Natural Disease Progression in Wet AMD Using Clinical Data from the Phase III HAWK and HARRIER Trials and Modelled Placebo Data

Autor:	Miltiadis K. Tsilimbaris, Andreas Clemens, Zufar Mulyukov, Etienne Pigeolet, Valeria Colafrancesco, David Gaucher, Hansjürgen Agostini, Felicitas Bucher, Pilar Calvo
Rok vydání:	2020
Předmět:	Male Vascular Endothelial Growth Factor A medicine.medical_specialty Visual acuity genetic structures Visual Acuity Angiogenesis Inhibitors Antibodies Monoclonal Humanized Placebo Placebos 03 medical and health sciences Cellular and Molecular Neuroscience 0302 clinical medicine Double-Blind Method Ophthalmology medicine Humans Treatment effect Aged Aged 80 and over Age differences biology business.industry Disease progression Harrier Diabetic retinopathy Macular degeneration medicine.disease biology.organism_classification Choroidal Neovascularization Sensory Systems Treatment Outcome Intravitreal Injections Disease Progression Wet Macular Degeneration 030221 ophthalmology & optometry Female medicine.symptom business 030217 neurology & neurosurgery
Zdroj:	Zaguán: Repositorio Digital de la Universidad de Zaragoza Universidad de Zaragoza Zaguán. Repositorio Digital de la Universidad de Zaragoza instname
ISSN:	1460-2202 0271-3683
DOI:	10.1080/02713683.2020.1731832
Popis:	Aim: To compare the treatment effect of brolucizumab, a novel anti-vascular endothelial growth factor therapeutic, with a putative placebo in patients with wet age-related macular degeneration. Materials and Methods: Clinical treatment-effect data from patients receiving brolucizumab 6 mg in the HAWK and HARRIER studies were compared with modelled placebo data using a previously developed and validated indirect response, non-linear, mixed effects model describing the natural visual acuity decline in wet age-related macular degeneration. The placebo model incorporated patient-level data from the sham injection arms of the MARINA and PIER studies, corrected for baseline best corrected visual acuity and age difference between these studies and the HAWK and HARRIER studies. Results: Compared with a modelled placebo, brolucizumab treatment was associated with an overall best corrected visual acuity gain of approximately 22 Early Treatment Diabetic Retinopathy Study letters at Week 48 and 28 letters at Week 96. Conclusions: As anti-vascular endothelial growth factor therapy is now a standard of care for wet age-related macular degeneration, it is not feasible to conduct placebo-controlled trials for new wet age-related macular degeneration treatments. By allowing comparison with the natural decline in visual acuity without treatment, this analysis conveys the clinical importance of brolucizumab for the treatment of wet age-related macular degeneration.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::917d4c67b1909966f7bed4448946dd86 https://doi.org/10.1080/02713683.2020.1731832 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
Nepřihlášeným uživatelům se plný text nezobrazuje	K zobrazení výsledku je třeba se přihlásit.