Session Title: Quick Fire Free Paper 4
Session Date/Time: Sunday 14/09/2014 | 08:00-10:00
Paper Time: 08:25
Venue: Boulevard B
First Author: : G.Menon UK
Co Author(s): : S. Mahmood N. Patel S.P. Kelly R. Gale J. Warburton C. Brand
Understanding the ocular and systemic safety profile of ranibizumab when used in real world settings will allow appropriate evaluation of the potential risks associated with treatment. The objective of this country-level pre-specified interim analysis is to describe the safety profile of ranibizumab in the first 866 patients from the UK with neovascular AMD (nAMD) who completed 1 year of follow-up.
Patients with neovascular AMD receiving 0.5mg ranibizumab in NHS eye services in England, Scotland and Wales
The prospective LUMINOUS program is a 5‐year, multicenter, global, observational, registry study initiated to describe the long‐term safety of ranibizumab 0.5mg in nAMD within routine clinical practice. Prospective collection of patient demographics, visual acuity, injection frequency, visit frequency and safety data was undertaken on eligible patients who consented to study enrolment. Patients were excluded if involved in any investigational drug or procedure study, and if treated with other VEGF inhibitors in the prior 90 days. The first pre-specified interim analysis occurred in March 2013, when patients enrolled in the first year of recruitment completed one year of follow up. Patients are described according to whether treatment naïve (TN) or previously treated with ranibizumab (TP). The UK data are described in the context of the LUMINOUS global dataset for patients with nAMD. Data are shown as mean±SD or percentages unless otherwise indicated. Data for adverse events (AEs) and serious adverse events (SAEs) are presented. Ocular AEs are shown for the primary treated eye.
A total of 2112 patients with nAMD were included in the global dataset of whom 866 (41.0%) were from the UK. Patients in the UK population were elderly (age 79.4±8.22), with 46% aged 75-<85 and 28.2% >85. There were more women (61.1%) than men. Few patients discontinued treatment during the 12 months (6.7%); 2.1% died and 1.4% withdrew consent. Few patients were lost to follow-up (n=3, 0.3%). By 12 months, a total of 3517 injections were administered in the UK. TN and TP patients in the UK received 4.6±2.15 and 4.0±3.15 injections compared to 5.2±3.27 and 5.2±3.32 injections, respectively per annum in the global population. Ocular AEs occurred in a similar proportion of TN and TP patients in the UK (13.5% vs 15.0%). There were only 5 ocular SAEs; 1 patient developed endophthalmitis. The incidence of ocular SAEs in the UK was comparable to the global dataset (0.6% vs 0.5%). Non-ocular SAEs occurred less frequently in TN compared to TP patients in the UK (5.8% vs 10.8%) although the overall incidence of non-ocular SAEs in the UK was similar to global (10.1% vs 7.7%). UK rates of atherothrombotic SAEs were low (MI 0.69%, Angina 0.69%, CVA 0.23%, TIA 0.23%).
The LUMINOUS study includes more diverse patients than those recruited to pivotal trials and is therefore more representative of real world outcomes for nAMD patients. Safety data from the initial 1 year interim analysis reinforces the well-known safety profile of ranibizumab in nAMD patients. No new safety signals were observed in this real world UK population. LUMINOUS is the largest observational study following patients treated for multiple medical retina indications in a clinical practice setting and will provide an invaluable source of long term patient safety data both globally and for the UK.