Author: Sobha Sivaprasad (United Kingdom)
Co-authors: James Talks, Simon P Kelly, Faruque Ghanchi, Ajay Kotagiri, Peter Scanlon, Moneeb Saddiq
The DRAKO study aimed to evaluate the effectiveness and safety of standard-of-care intravitreal aflibercept (IVT-AFL) injections for the treatment of patients with diabetic macular edema (DME) within the UK over a 2-year follow-up period. Here we describe the change from baseline at Month 12 (M12) for best-corrected visual acuity (BCVA) and central subfield thickness (CST) when local standard-of-care posologies were applied. We also assess patient quality of life (QoL), summary of product characteristics (SmPC) adherence, and fellow eye involvement at M12. All results pertain to the anti-vascular endothelial growth factor (VEGF) treatment-naïve patient cohort.
DRAKO (NCT02850263) is a prospective, non interventional, non-comparative study conducted in 35 National Health Service centers across the UK. Adult patients with type 1 or type 2 diabetes diagnosed with center-involving DME were enrolled. Data related to the routine clinical care and QoL for patients were collected over the 2-year follow-up period.
Data were analyzed following an interim database lock at M12 (19 Jun 2019) for patients with BCVA or CST results available at baseline and M12 within a ±1-month window. Summary statistics were used to describe the change from baseline at M12 for all outcomes. The primary endpoints were change from baseline at M12 in BCVA and CST. Secondary endpoints included change from baseline at M12 in QoL assessed using the National Eye Institute Visual Function Questionnaire 25-item version (NEI VFQ-25), evaluation of the number of injections and SmPC adherence, and evaluation of fellow eye involvement. Where both eyes were affected with DME, the study eye was defined as the eye with worse baseline visual acuity. Where appropriate, outcomes were stratified by baseline measures. Safety events were coded using the Medical Dictionary for Regulatory Activities and summarized. All analyses were conducted using SAS 9.4.
A total of 507 anti-VEGF treatment-naïve patients were enrolled. Subsequently, 388 patients were included in this analysis based on predefined criteria. Fellow eye involvement was confirmed for 53.9% patients. At baseline, mean (standard deviation [SD]) BCVA was 71.4 (12.0) letters and CST was 448.7 (88.7) µm. At M12, mean (SD) change from baseline gain of 2.5 (12.2) BCVA letters and reduction of 119.1 (116.4) µm in CST was reported. Patients with baseline BCVA <70 letters (36.9%) experienced a mean (SD) gain of 7.3 (12.9) letters at M12. At site initiation, 27 of 35 sites (77.1%) intended to adhere to DME SmPC for 5 initial monthly injections, and 21 of 35 sites (60.0%) planned to subsequently perform bi-monthly injections in Year 1 (as per SmPC). At M12, the mean number (SD) of injections administered was 6.4 (2.1). A mean gain of 4.2 letters was observed in patients receiving 5 initial injections (30.2% patients), with mean 1.1-letter gain in those being treated as per SmPC (2.3% patients). The mean number (SD) of fellow eye injections was 4.5 (2.5), with 69.3% occurring on the same day as study eye treatment. The safety profile of IVT-AFL was noted as consistent with previous studies.
The DRAKO study 12-month results indicate that IVT-AFL was effective for the treatment of anti-VEGF treatment-naïve DME in this UK real-world population by maintaining or improving functional and anatomical outcomes, despite patients being under-treated compared with SmPC, and a wide range of treatment posologies being applied. Patients adhering to SmPC posology initial dosing experienced vision gains above the mean for the study. Of note, mean baseline BCVA was high for most patients, supporting the effectiveness of the UK diabetic retinopathy screening program. The potential increased burden on the patient and the center for patients with bilateral disease was also ameliorated, with over two-thirds of bilateral treatments conducted on the same day. In addition, a trend towards improvement from baseline in QoL was seen, with similar outcomes for patients with or without fellow eye involvement.
Sivaprasad S has been a consultant for Bayer, Allergan, Novartis Pharma AG, Roche, Boehringer Ingelheim, Optos, and Heidelberg Engineering. Talks J has been a consultant for Bayer and Novartis; received travel support from Bayer; and received research grants from Bayer, Novartis, and Roche. Kelly S P has received travel support from Bayer; research support from Bayer and Novartis Pharma AG; and has been a consultant for Novartis Pharma AG and Polyphotopics. Ghanchi F has been a consultant and speaker for Novartis, Bayer, Allergan, Alimera, and Roche; and has received travel support from Bayer and Novartis. Kotigiri A has received travel support from Novartis, Bayer, and Allergan; and speaker fees from Allergan and Bayer. Scanlon P has been a consultant for Pfizer, Allergan, Boehringer, Roche, and Bayer; and has received research grants from Allergan, Boehringer Ingelheim, Novartis, and Bayer. Saddiq M is an employee of O4 Research. Napier J is an employee of Bayer Plc.
Important add below co-authors: 9. - Jackie Napier: Department of Medical Affairs, Bayer Plc, Reading, United Kingdom 8. - on behalf of the DRAKO study group