At UEG 2019, Data Shed Light on Monitoring of Biosimilar Adalimumab, Imraldi, in IBD

Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti—tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis’ biosimilar adalimumab, Imraldi, in patients with IBD.

First, a research team from the Czech Republic will present data from a study in 87 patients with IBD, 77 of whom had Crohn disease (CD) and 10 of whom had ulcerative colitis (UC) who were switched from the reference adalimumab, Humira, to the biosimilar.¹ These patients all had 3 previous measurements of adalimumab trough levels from their treatment with the originator drug, and their biosimilar adalimumab trough levels were measured at week 10 after the switch using an adalimumab-validated ELISA assay.

The researchers report that there was “excellent” quantitative agreement between adalimumab trough levels before and after the switch to the biosimilar (Spearman’s rank coefficient values, R = .756, P <.0001).

Moreover, there were no differences in C-reactive protein or fecal calprotectin values before and after the switch, and no significant differences in disease activity scores using the Harvey-Bradshaw Index or partial Mayo score.

Another research team, also from the Czech Republic, will report on the use of 2 different monitoring assays—a TNF-based ELISA kit and a monoclonal antibody-based ELISA kit&mdash;for monitoring trough levels of the biosimilar.²

The research team obtained 62 samples of sera from patients (54 of whom had CD and 8 of whom had UC) who were receiving maintenance therapy with Imraldi at a dose of 40 mg every 2 weeks. Adalimumab trough levels were measured by both the standard TNF-based assay and by the monoclonal antibody assay, and the data were analyzed, with a Kruskal-H test used to compare the 2 cohorts of concentration values.

The researchers report that quantitative agreement was observed between the 2 measurement kits (R = .804, P <.0001), and the non-parametric Kruskal Wallis test showed that the median tough level concentrations did not differ (P =.363), and they add that these data should be valuable in determining the potential to use the kits as tools for drug monitoring during biosimilar adalimumab treatment.

These new data, said Ian Henshaw, vice president and head of the global biosimilars unit at Biogen, which together with Samsung BioLogics comprises Samsung Bioepis, are part of continued research “with the goal of generating data that will enable us to deliver value to patients with high unmet needs.”

References

1. Lukas M, Pesinová V, Bortlik M, et al. Impact of the switch from original adalimumab to biosimilar adalimumab SB5 on serum drug trough levels, clinical and biological disease activity in patients with IBD. Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.

2. Malícková K, Bortlík M, Duricová D, et al. Serum trough SB5 levels: A comparison of two different immunoassays for the monitoring of biosimilar adalimumab treatment in patients with inflammatory bowel disease. Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.