Author: Se Joon Woo (Korea, Republic of)
Co-authors: Neil Bressler, Jin Ah Jung, Taehyung Kim, Inkyung Oh, Mercy Yeeun Kim
Purpose
The clinical equivalence between SB11, a proposed ranibizumab biosimilar, and the reference ranibizumab (rRBZ) in terms of change from baseline in optical coherence tomography (OCT) central subfield thickness (CST) and in best-corrected visual acuity (BCVA) in patients with neovascular age-related macular degeneration (nAMD) was previously reported to show equivalency with rRBZ. To provide additional confidence regarding the equivalency of this biosimilar product, the results of an ad hoc analysis was undertaken to identify baseline factors associated with visual acuity and anatomic outcomes in SB11 vs rRBZ, specifically OCT CST at week 52, as well as a subgroup analysis based on baseline factors judged relevant.
Setting/Venue
subgroup post hoc analysis of a randomized, double-masked, parallel-group, multicenter, 52-week phase III clinical trial conducted in 75 centers across 9 countries.
Methods
Patients were randomized to receive monthly 0.05 mL intravitreal injections of either 0.5 mg SB11 or 0.5 mg rRBZ. The primary endpoint was change from baseline in BCVA at week 8 and change in CST at week 4 with both endpoints then followed through week 52. Associations between baseline factors and treatment responses of BCVA and CST at week 52 were assessed by linear regression analyses, then multivariable analysis on baseline factors that were identified to have a pre-specified P value of <.001. Additionally, a subgroup analysis based on associated baseline factors was conducted on week 52 change from baseline for BCVA outcomes.
Results
A total of 634 (89.9%) participants completed the 52-week study visit (SB11: n=307; RBZ: n=327), whose median (min, max) age was 75 (51, 96) years. From an ad hoc regression analysis, baseline age, BCVA and total lesion size were associated with mean change from baseline improvement in BCVA at week 52. Similarly, baseline age, BCVA and CST were associated with reduction in mean change from baseline CST at week 52. For every year of participant age, the mean change from baseline BCVA improvement was reduced by 0.19 letters (95% CI, -0.29 to -0.08; P<.001) and CST showed additional thickness reduction by 1.26 μm (95% CI, -1.87 to -0.66; P<.001). For every 1 letter increment of BCVA at baseline, the mean BCVA improvement was reduced by 0.22 letters (95% CI, -0.31 to -0.14; P <.001). For every 1 μm increment of baseline CST, CST showed additional thickness reduction by 0.71 μm (95% CI, -0.76 to -0.66; P<.001). Overall, the subgroup analysis of change from baseline in BCVA by associated baseline factors showed comparable treatment effects within each subgroup between SB11 and rRBZ across important baseline characteristics, supporting the robustness of the previously reported primary and secondary outcomes.
Conlusions
Baseline age, BCVA, CST, and total lesion size were identified to be associated with visual acuity and anatomical outcomes when managing nAMD with SB11 or rRBZ. Similarity in the change from baseline in BCVA between SB11 and rRBZ in each subgroup further support equivalent clinical efficacy between the products, reinforcing confidence in the biosimilarity of SB11 with its reference product.
Financial Disclosure
NMB: grants from Samsung Bioepis to Johns Hopkins University during the conduct of the study and receiving grants from Bayer, Biogen, F. Hoffman-LaRoche, Novartis, Regeneron outside the submitted work; SW: consultant for Samsung Bioepis, Janssen, Allergan, Novartis, Curacle, Novelty Nobility, Alteogen, Philophos, Panols Bioscience, is equity owner of Retimark and Panolos Bioscience, is Board Member of Novartis and Novelty Nobility, received grants from Samsung Bioepis, Novelty Nobility, Novartis, Abbvie, Alteogen and Curacle and received lecture fee from Novartis, Bayer, Allergan, Abbvie, Alcon, and Taejoon; JJ, TK, IO, and MYK are employees of Samsung Bioepis
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