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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Adalimumab biosimilars have similar efficacy to originator adalimumab when treating non-infectious uveitis
Oren Tomkins-Netzer1,2, Rachael L Niederer3, Radgonde Amer4,5
1Department of Ophthalmology, Lady Davies Carmel Medical Center, Haifa, Israel orentn@clalit.org.il.
Aims:
To compare the efficacy in achieving and maintaining control of inflammation between adalimumab biosimilars and originator adalimumab as initial biologic treatment among patients with non-infectious uveitis (NIU).
Methods:
This is a multicentre retrospective cohort study. Events of uveitis relapse were noted per eye following initiation of adalimumab treatment. Relapses were defined as the clinical diagnosis of intraocular inflammation, requiring an increase or change in local or systemic immunosuppression. Relapse rates and time to first relapse by 12 months were compared between eyes treated with originator adalimumab or a biosimilar.
Results:
260 eyes of 148 patients diagnosed with NIU were treated with either originator adalimumab (n=193, 74.23%) or a biosimilar (n=67, 25.77%). Median follow-up from baseline for patients who did not relapse was 24.0 months (IQR 18.0, 24.0). Uveitis relapses occurred in 97 eyes (37.31%, 76 in the originator adalimumab group and 21 in the biosimilar group). By 12 months, the estimated relapse rate was 24.2% in the originator adalimumab group versus 28.3% in the biosimilar group (relative risk=1.17, 95% CI 0.58 to 1.77). The average time to relapse by 12 months follow-up for the originator adalimumab group was 4.91 months compared with 5.04 months in the biosimilar group (mean difference 0.13 months, 95% CI -1.33 to 1.54 months).
Conclusion:
Our study suggests that by 12 months of use, biosimilar adalimumab agents were not inferior to originator adalimumab in preventing disease relapse among patients with refractory NIU. These results support the use of biosimilar adalimumab for treating NIU.
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