UCB: New Data at EULAR 2026 Reinforces Cimzia's Profile
UCB presented new mechanistic data on Cimzia (certolizumab pegol) at EULAR 2026 on Friday, showing that its lack of an Fc domain allows it to maintain consistent efficacy in patients with rheumatoid arthritis, regardless of rheumatoid factor levels.
In Vitro Data Explains Rheumatoid Factor-Independent Efficacy
The data presented at EULAR 2026 demonstrates that the rheumatoid factor (RF) binds to biologics containing an Fc domain, forming immune complexes that trigger the release of pro-inflammatory cytokines. In contrast, certolizumab pegol, which lacks an Fc domain, is not bound by the rheumatoid factor and does not generate immune complexes or induce cytokine production. These observations provide an explanatory mechanism for the previously reported clinical effects of certolizumab pegol, which remains effective regardless of the level of rheumatoid factor.
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The Summary of Product Characteristics (SmPC) for Cimzia in the European Union has been updated in section 5.1 to better describe its mechanism devoid of an Fc domain, reinforcing the mechanistic differences compared to biologics containing one. This update is also reflected in the product information in the United Kingdom, maintained by the Medicines and Healthcare products Regulatory Agency (MHRA). Together, these regulatory elements and emerging in vitro data support the differentiation of certolizumab pegol in patients with varying rheumatoid factor profiles.
High Rheumatoid Factor and Therapeutic Implications
High rheumatoid factor remains common in clinical practice and has been associated with lower exposure and reduced responses to TNF inhibitors containing an Fc domain (e.g., adalimumab). It is estimated that about one in four patients treated with biologic therapies presents high levels of rheumatoid factor, historically associated with a poorer prognosis and reduced efficacy of certain biologics containing one. James Galloway, professor of rheumatology at King's College London and honorary consultant at King's College Hospital in London, emphasized that the rheumatoid factor goes beyond its role as a mere diagnostic marker and can significantly influence patient responses to therapy.
SectorPharmacie et biotechnologies›Vaccins et laboratoires de recherche
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Context
Period
Period: S1 2026
Key reported figures
Revenue: 4 270 millions d'euros
Quarterly revenue: 4 270 millions d'euros
Revenue growth: 22,5 %
EBITDA: 1 685 millions d'euros
EBITDA margin: 40,7 %
Net income: 1 111 millions d'euros
2 821 millions d'euros
Guidance from the release
Based on the continued strong growth, revenue is expected to grow in the low-teens to mid-teens percentage range; Reflecting our strong execution and confidence in the outlook
Risks mentioned
Perte d'exclusivité de BRIVIACT aux États-Unis depuis février 2026 et en Europe attendue en août 2026
Ventes de VIMPAT au Japon affectées par l'arrivée de génériques fin 2025
Expiration en 2026 de la protection brevetaire de CIMZIA au Japon
Opportunities identified
Objectif de ventes maximales de BIMZELX relevé à au moins 7 milliards d'euros
Supériorité de BIMZELX sur risankizumab dans le rhumatisme psoriasique (étude BE BOLD)
FINTEPLA déposé dans le syndrome CDKL5 auprès de la FDA et de l'EMA, Phase 3 lancée dans le syndrome de Rett
Outlook / guidance
Management commentary: revenue is expected to grow in the low-teens to mid-teens percentage range at constant exchange rates (CER). Adjusted EBITDA² is expected to grow in the mid-teens to low-twenties percentage range at CER. Excluding other operating one-offs in 2025, adjusted EBITDA² growth is expected to be in the mid-twenties to low-thirties percentage range at CER.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.
