Clinical Efficacy of Biosimilar Switch of Adalimumab for Management of Uveitis

ABSTRACT

Background

Adalimumab has demonstrated efficacy in non-infectious uveitis. With the introduction of biosimilar agents such as Amgevita, we aimed to quantify efficacy and tolerability compared to Humira in a multi-centre UK cohort

Methods

Patients identified from tertiary uveitis clinics in 3 centres, after institution-mandated switching was implemented.

Results

Data collected for 102 patients, aged 2–75 years, with 185 active eyes. Following switch, rates of uveitis flare were not significantly different (13 events before, 21 after, p = .132). Rates of elevated intraocular pressure were decreased (32 before, 25 afterwards, p = .006) and dosing of oral and intra-ocular steroids was stable. Twenty-four patients (24%) requested to return to Humira, commonly due to pain from injection or technical difficulty with the device.

Conclusion

Amgevita is safe and effective for inflammatory uveitis with non-inferiority to Humira. Significant numbers of patients requested to switch back due to side effects including injection site reactions.

KEYWORDS:

• Adalimumab
• biosimilar
• clinical efficacy
• TNF-alpha
• uveitis

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/09273948.2023.2172591

Acknowledgments

GMM is funded by an Arthritis Australia and Australian Paediatric Rheumatology Group of the Australian Rheumatology Association Paediatric Rheumatology Advanced Training Scholarship. The authors wish to acknowledge the contributions of Ms Katharine Sears, Professor Ian Rennie, Mr Fahd Quhill and Mr Christopher Brand, and special thanks to the Ophthalmic pharmacist Miss Priya Boparal in the Sheffield Teaching Hospital and Ms Gisella Cooper, and Ms Rebekkah Coles, paediatric uveitis nurse specialists.

Author contributions

GMM: design, data collection and analysis, drafting and editing of the article

NG: contributed to the data collection, analysis, and review of manuscript

PS, DAJ: contributed to data analysis, literature search for relevant articles and contributed to the discussion section of the manuscript

SLNC: contributions to data analysis and critical analysis of manuscript

JC: contributed to the design and data collection and critical analysis of the manuscript

DPH, CMG, AVR: contributed to the design and critically analysed the manuscript

All authors read and approved the final version of the article

Disclosure statement

GMM, NG, PS, DAJ, SLNC, JC, DPH, CMG declare no conflict of interest. AVR declares Speaker fees/Honoraria/Consulting: Abbvie, Eli Lilly, Pfizer, Roche, Novartis, Alimera, GSK, UCB, and SOBI

Ethics statement

This work was deemed a service evaluation and so formal ethical approval and consent from participants was not required, following discussion with the ethics department in the relevant institutions.

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This research was funded in whole, or in part, by the Wellcome Trust [grant reference 211030/Z/18/Z to SLNC as part of grant reference 203918/Z/16/Z]. For the purpose of Open Access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. No other specific funding was received from any funding bodies in the public, commercial, or non-for-profit sectors to carry out the work described in this article