UCB, a Belgium-based global biopharmaceutical company, announced on Thursday results from three studies supporting the value of CIMZIA(R) (certolizumab pegol), a PEGylated fragment crystalised (Fc)-free TNFi, for women of childbearing age living with chronic immune-mediated diseases and people with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels.

The company says that these results are as presented at the European Congress of Rheumatology, EULAR 2024, and that they provide important evidence to support informed, personalised treatment decisions for patient populations with high unmet need.

Results from the open-label, phase 1b CHERISH study in women with immune-mediated diseases, including psoriatic arthritis (PsA), axial spondyloarthritis (axSpA) and rheumatoid arthritis, found that the range of blood plasma concentrations of certolizumab pegol throughout and after pregnancy were similar to those observed in studies of non-pregnant women with PsA, axSpA and RA, suggesting that women may maintain stable therapeutic levels of certolizumab pegol throughout pregnancy and post-partum. While plasma levels were lower during pregnancy than post-partum, they remained consistent throughout pregnancy. These data build on the comprehensive suite of evidence exploring the use of certolizumab pegol for women of childbearing age living with chronic immune-mediated diseases. The safety profile observed in the CHERISH study was consistent with the known safety profile of certolizumab pegol, which includes extensive pharmacovigilance data.1

A further study presented at EULAR provided molecular insights into why individuals living with RA and high RF levels maintain consistent drug concentrations and may experience consistent clinical outcomes when treated with certolizumab pegol compared with Fc-containing TNFis.3,6 An in vitro study found that three different RF antibodies all bound to Fc-containing TNFi adalimumab and enabled the formation of large immune complexes. Conversely, the RFs were unable to interact with certolizumab pegol, due to its lack of Fc domain, and no complexes with RF were formed.

Insights into the effects of certolizumab pegol in people living with RA and high RF levels were investigated in a post hoc analysis of the double-blind, placebo-controlled, phase 3b REALISTIC trial - also accepted as an abstract at EULAR. Clinical response to certolizumab pegol was analysed according to the highest quartile RF level compared with the lowest and in people with a previous inadequate response to TNFi versus those with no prior TNFi exposure. Responses were greater with certolizumab pegol versus placebo in all groups

These certolizumab pegol data together demonstrate how tailored treatment approaches can support specific groups of patients.