By VETTAPHARMA reporter – Derek Roche: UCB presented new data at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress demonstrating that CIMZIA® (certolizumab pegol) delivered a consistent effect in rheumatoid arthritis (RA) regardless of rheumatoid factor (RF) levels. The findings provide mechanistic support for previous clinical observations showing CIMZIA efficacy across RF subgroups.
The in vitro study showed that RF antibodies bind to Fc-containing biologic disease-modifying antirheumatic drugs (bDMARDs), leading to immune complex formation and stimulation of pro-inflammatory cytokine release from peripheral blood mononuclear cells. In contrast, RF did not bind to Fc-free certolizumab pegol, and no immune complex formation or cytokine induction was observed.
According to UCB, elevated RF levels remain common in clinical practice, with approximately one in four patients receiving biologic therapies having high RF levels. High RF has previously been associated with lower drug exposure and reduced responses to certain Fc-containing TNF inhibitors. The new data help explain why CIMZIA may maintain consistent concentrations and clinical effects regardless of RF status.
The findings are further supported by a recent update to the European Union Summary of Product Characteristics (SmPC) for CIMZIA, which states that the medicine is not bound by rheumatoid factor, does not form immune complexes with RF, and is not subject to RF-dependent macrophage clearance in vitro. The update is also reflected in UK product information maintained by the Medicines and Healthcare products Regulatory Agency (MHRA).
Professor James Galloway of King’s College London noted that rheumatoid factor can meaningfully influence treatment response and said the data help explain differences observed in patients with high RF while supporting RF-informed treatment decision-making. UCB Chief Medical Officer Donatello Crocetta said the results reinforce the company’s commitment to generating evidence that supports personalized treatment decisions for people living with immune-mediated diseases.
UCB reported that it will present a total of 27 abstracts across its immunology portfolio at EULAR 2026, covering psoriatic arthritis, psoriasis, axial spondyloarthritis, rheumatoid arthritis, and systemic lupus erythematosus.
Quick FAQs
1. What Is CIMZIA®?
CIMZIA® (certolizumab pegol) is an Fc-free TNF inhibitor approved for multiple inflammatory conditions, including rheumatoid arthritis.
2. What Did UCB Present at EULAR 2026?
UCB presented new in vitro data demonstrating that rheumatoid factor binds Fc-containing biologics but does not bind Fc-free CIMZIA, supporting consistent treatment effects across RF levels.
3. What Was the Study About?
The study evaluated interactions between rheumatoid factor and biologic therapies, assessing immune complex formation and inflammatory cytokine release in vitro.
4. What Is Rheumatoid Arthritis?
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that can cause joint damage, pain, and disability. Rheumatoid factor is a commonly measured biomarker in the disease.
5. What Were the Key Results?
RF antibodies bound Fc-containing biologics and induced immune complex formation and cytokine release, while no RF binding, immune complex formation, or cytokine induction was observed with Fc-free certolizumab pegol.
6. Why Is This Important?
The findings provide mechanistic support for previously observed consistent CIMZIA efficacy across rheumatoid factor levels and further differentiate its Fc-free molecular structure.
