Author: Michel Giunta (Canada)
Co-authors: Ananda Kalevar, Pierre Trottier, Louis Caron, Sohel Somani, Raman Tuli, Ghassan Cordahi
Purpose
Studies have shown that switching anti-vascular endothelial growth factors (anti-VEGFs) can help improve outcomes in diabetic macular edema (DME) patients with inadequate response to ongoing anti-VEGF therapy. However, real-world data are limited on switching from aflibercept (AFL) to ranibizumab (RBZ) and no study thus far has been reported on treatment switch to RBZ prefilled syringe (RBZ-PFS). PRECISE is the first study to evaluate treatment outcomes in DME patients with an inadequate response to ongoing AFL treatment who were switched to RBZ-PFS in a routine clinical setting. Here, we present the final results of DME patients in Canada who were switched from AFL to RBZ-PFS in real-world practice.
Setting/Venue
PRECISE is a prospective, observational, multicenter, real-world switch study of previously AFL-treated Canadian DME patients to RZB-PFS.
Methods
Eligible consenting patients, aged ≥18 years, who received ≥3 AFL intravitreal injections for DME, switched to RBZ-PFS based on clinician’s discretion, and treated as per the product label, were enrolled into the study. Primary endpoint was mean change from baseline to day 90 in central retinal thickness (CRT). Secondary endpoints included change in best-corrected visual acuity (BCVA), reasons for treatment switch, functional outcomes, treatment injection interval, and safety. The study enrolled 48 eyes with DME from 15 clinical centers across Canada.
Results
Patients presented with a mean (SD) age of 67.4 (10.6) years, 47.8% were Caucasian, and 30.4% female; 6.5%/93.5% had Type1/Type 2 diabetes, 100% were medication-controlled, and 82.6% had hypertension. At baseline, mean (SD) CRT was 353.7 (84.4) µm and mean (SD) baseline visual acuity was 65.1 (12.5) ETDRS letters; 84.8% had presence of macular fluid (94.9% intraretinal fluid [IRF]; 5.1% IRF and subretinal fluid) with no pigment epithelial detachments. Median time since diagnosis to first RBZ-PFS was 1.9 years. Prior to study entry, patients received median of 12 injections of any anti-VEGF, with median of 8.5 AFL injections. Median time from last AFL to first RBZ-PFS was 1.3 months. Key reasons for treatment switch were due to a lack of response to AFL treatment (82.6% persistent fluid, 2.2% loss of vision, 2.2% unsatisfactory vision gains), unable to extend dosing (6.5%), ocular safety concerns (2.2%), and other (2.2%). Results demonstrated significant CRT reduction of -23.3 (57.5) µm (p=0.0063), 69.4% with continued presence of macular fluid, and significant improvement of visual acuity (+2.7 letters; p=0.0209) at Day-90 post-switch, with average treatment interval of 4.7 weeks during the study and average next planned interval of 5.2 weeks. There were no new safety signals.
Conlusions
Real-world evidence from the PRECISE study provides useful information on the baseline characteristics of DME patients who required the treatment switch from AFL to RZB-PFS. Results demonstrated a significant reduction in CRT and improvement of visual acuity, and maintenance of safety. The key real-world reason for treatment switch from AFL to RBZ-PFS was lack of response to AFL treatment, primarily due to presence of fluid in the macula. These results will further our current understanding and enhance routine clinical care of DME patients.
Financial Disclosure
Advisory Board: Abbott, Alcon, Novartis; Research Grants: Allergan, Bayer AG, Chengdu Kanghong Biotechnology, F. Hoffmann-La Roche, Novartis; Speaker: Abbott, Alcon, Bausch & Lomb, Bayer AG, Novartis
Comments
Please include extra co-authors below: Co-author 7:Joanne Gavalakis Novartis Pharma Canada Inc Co-author 8: Eser Adiguzel Novartis Pharma Canada Inc
