Bayer HealthCare reports that real-world data from a UK wide National Aflibercept Audit and Moorfields Aflibercept Audit have been presented at The Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting showcasing the efficacy of EYLEA® (aflibercept solution for injection) for the treatment of wet age-related macular degeneration (wAMD). The results from both audits highlight that treatment with aflibercept in NHS clinical practice has resulted in stabilised or improved visual and/or anatomical outcomes in treatment-naïve and pre-treated patients; (1–4) reflecting the results seen in the pivotal VIEW clinical trials. (5)
Commenting on the data, Luis-Felipe Graterol, Medical Director, Bayer HealthCare said, ‘It is encouraging to see that large centres from across the UK have a continued enthusiasm to audit the use of EYLEA in NHS clinical practice. This is the first time in the treatment of wet AMD that results from real-world NHS clinical audits have begun to approach those seen in randomised clinical trials, demonstrating the benefits to patients and ophthalmologists of a proactive fixed dosing regime in the first year of treatment. These data therefore further cement it as valuable treatment option for wet AMD.’
National Aflibercept Audit
Amongst the highlights of data presented at ARVO, were data from the UK wide National Aflibercept Audit assessing the use of aflibercept in NHS clinical practice. Sixteen NHS hospitals contributed over 3000 patient records to the audit via Medisoft, an electronic patient record. The aim of the audit was to assess visual acuity outcomes with aflibercept in treatment naïve and pre-treated wAMD patients. Further data presentations from the audit are anticipated at scientific congresses later in the year.
Mr James Talks, Consultant in Ophthalmology, Royal Victoria Infirmary, Newcastle, presented data from the National Aflibercept Audit assessing the use of aflibercept in NHS clinical practice for treatment naïve wAMD patients. The results at one year, within the published abstract, showed a mean improvement in visual acuity from baseline of six EDTRS letters. Those results compare reasonably to the mean visual acuity gain of 8.4 letters seen in the pivotal VIEW clinical trials for aflibercept. (1) Additional data analysis based on more than 4000 treatment naïve eyes were included within the poster presented at the meeting.
Mr James Talks commented: ‘The positive results seen in this large UK clinical audit further demonstrate that the clearly defined treatment plan in the first year of treatment with EYLEA enables clinics to achieve significant visual improvements similar to those seen in the clinical trials; something that has not historically been seen with other treatment options for wet AMD.’
Results from the National Aflibercept Audit assessing the outcomes associated with switching patients from other anti-VEGF treatments to aflibercept in the NHS clinical setting were also presented. (2) Mr Talks commented: ‘The observed results demonstrate that switching patients from ranibizumab to aflibercept can be a viable and effective option in real life clinical practice; meaning patients and clinicians can be confident in the efficacy of aflibercept in the switch setting while benefitting from its fixed treatment regimen in the first year.’
Moorfields Aflibercept Audit
Researchers from Moorfields Eye Hospital, the leading provider of eye services in the UK and a world-class centre of excellence, presented data from a retrospective review of 250 consecutive patient records assessing the use of aflibercept in NHS clinical practice for treatment naïve wAMD. (3) The results showed that there was a rapid visual acuity improvement in treatment naïve wAMD patients following initiation of aflibercept, independent of baseline central subfield thickness; these results reflected those seen in the VIEW clinical trials.
Miss Sobha Sivaprasad, Consultant in Ophthalmology, Moorfields Eye Hospital and Kings College Hospital, London, commented: ‘At Moorfields we are dedicated to building clinical evidence to ensure patients with ophthalmic conditions are treated effectively. The results from this audit further support the use of EYLEA in clinical practice and demonstrate that results seen in clinical trials can be replicated in NHS clinics. The audit results showed a significant increase from baseline in the percentage of patients with legal driving vision after the first year of treatment; highlighting the impact that EYLEA can have on patients’ lives in terms of helping them to maintain their independence and quality of life.’
Researchers from Moorfields Eye Hospital also presented data from a retrospective, observational study of one-year treatment outcomes with aflibercept in 52 treatment-naïve wAMD patients. These results further confirm that visual outcomes with aflibercept in NHS clinical practice can reflect those seen at one year in the pivotal VIEW clinical trials; 96.2% of patients maintained vision at the end of follow-up with a mean of 7.2±1.6 injections. (4)
Further data from Moorfields Eye Hospital included results from a retrospective analysis of 120 eyes switched from a reactive ranibizumab regimen, associated with four weekly monitoring, to a fixed eight weekly aflibercept regimen (off-label). These results suggest that macular thickness decreases significantly when patients are switched to aflibercept. (5)
- Paul B et al. UK outcomes of providing aflibercept, according to the VIEW protocol, for treatment naïve neovascular AMD. National Aflibercept Audit. Poster. ARVO 2015 Annual Meeting. Available at: http://www.arvo.org/webs/am2015/abstract/Section%20Retina.pdf. Last accessed April 2015.
- Manjunath V. UK outcomes of switching patients with neovascular age-related macular degeneration from ranibizumab to aflibercept. National Aflibercept Audit. Poster. ARVO 2015 Annual Meeting. Available at: http://www.arvo.org/webs/am2015/abstract/Section%20Retina.pdf. Last accessed April 2015.
- Roxanne R et al. Real-world rapid mean visual acuity improvement in patients initiated on aflibercept therapy for treatment-naïve neovascular age-related macular degeneration. Moorfields Aflibercept Audit. Poster. ARVO 2015 Annual Meeting. Available at: http://www.arvo.org/webs/am2015/abstract/Section%20Retina.pdf. Last accessed April 2015.
- Vazquez-Alfageme C, Patel PJ, Hamilton R. Efficacy of Aflibercept in Treatment-naïve Neovascular Agerelated Macular Degeneration: One-Year Real World Outcomes. Poster. ARVO 2015 Annual Meeting. Available at: http://www.arvo.org/webs/am2015/abstract/Section%20Retina.pdf. Last accessed April 2015.
- Citu, MC, Roxanne R, Crosby-Nwaobi R, Hykin P G, Hamilton R, Sivaprasad S. Real-world UK NHS outcomes of a switch to alfibercept from ranibizumab in neovascular age-related macular degeneration. Moorfields Aflibercept Audit. Poster. ARVO 2015 Annual Meeting. Available at: http://www.arvo.org/webs/am2015/abstract/Section%20Retina.pdf. Last accessed April 2015.
- EYLEA® summary of product characteristics (SmPC) March 2015.