Two studies presented at the American Academy of Ophthalmology (AAO) annual meeting in Chicago, Illinois, showed that a ranibizumab biosimilar (SB11; BioViz) could impact patient outcomes.
Post hoc analysis to define baseline factors for clinical outcomes
A post-hoc analysis of a phase 3 trial found that baseline age, best-corrected visual acuity (BCVA), and central subfield thickness (CST) were the best baseline predictors of visual acuity and physiologic outcomes when managing neovascular age-related macular degeneration. because wet AMD) with biosimilar or reference product (Stellara).1
The objective of the study was to determine factors associated with efficacy outcomes after 1 year of a phase 3 trial comparing Stellara with SB11 in patients with wet AMD. The phase 3 study was randomized and double-masked. During post-hoc analysis, associations between baseline factors of BCVA and CST at week 52 and treatment responses were examined using a linear regression model. A multivariable analysis was used to judge the relevance of each baseline factor.
The linear regression model estimated that patients would experience a 1.9 letter less gain in BCVA and a 12.6 mcm greater CST reduction at 52 weeks for each 10-year increase in participant age. For every 5-year increase in age, the model predicted 1.1 fewer letters of BCVA improvement.
For every 50-mcm greater baseline CST, the model predicted approximately 35.5 mcm more CST reduction at 52 weeks. In addition, a subgroup analysis of BCVA change by the respective baseline factors demonstrated similar therapy effects between SB11 and the reference product within each subgroup.
Correlation analysis between immunogenicity, clinical outcomes
A correlation analysis showed that the immunogenicity profile of SB11 was low and very similar to the reference product in wet AMD patients.2
The analysis examined a double-masked phase 3 trial that included 705 patients who were randomized to receive monthly intravitreal injections of the biosimilar or reference product for up to 48 weeks. Efficacy data were assessed based on patients’ antidrug antibody (ADA) status through week 52.
The cumulative incidence of an ADA-positive reaction was low and similar across treatment arms, with immunogenicity results at 52 weeks falling to 14 (4.2%) for the biosimilar and 18 (5.5%) for the reference product.
Changes in BVCA and CST from baseline to week 52 were not associated with ADA status, while the difference between ADA-positive and ADA-negative status was 1.6 (95% CI, -2.7 to 5.8; p = .46) for BCVA and 2.9 (95% CI, –22.8 to 28.5; p = .83) for CST.
1. Woo SJ, Kim T, Oh IK, et al. A post-hoc analysis of a phase 3 trial to define baseline factors associated with treatment outcome of SB11 (ranibizumab biosimilar). Presented at: AAO 2022; September 30-October 3, 2022; Chicago, IL. Poster PO385.
2. Bressler NM, Kim T, Oh IK, et al. Correlation analysis between immunogenicity and clinical outcomes of an approved ranibizumab biosimilar, BioViz (SB11). Presented at: AAO 2022; September 30-October 3, 2022; Chicago, IL. Poster PO376.