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Jasmine Uchi, PharmD

Hidden Risk in Stelara and Cetuximab for Alpha-gal Syndrome

Biologics are transformative treatments for autoimmune diseases, chronic inflammation, and certain cancers. However, some biologics carry hidden triggers that can cause severe allergic reactions in certain patients. One such trigger is alpha-gal (galactose-α-1,3-galactose). Notable examples are Stelara (ustekinumab) and Cetuximab—monoclonal antibodies produced using mouse cell lines. These drugs can carry alpha-gal on their surfaces, posing a risk for those with Alpha-gal Syndrome.


The Alpha-gal Connection

Stelara and Cetuximab are produced in cell cultures that can incorporate alpha-gal into their molecular structure. Stelara, used for inflammatory bowel diseases such as Crohn’s and ulcerative colitis, and Cetuximab, used in treating certain colorectal and head-and-neck cancers, are both generated from the murine Sp2/0 cell line—an environment where alpha-gal can “decorate” the protein. When introduced into a patient with Alpha-gal Syndrome (AGS), these antibodies can trigger the release of histamines and other inflammatory chemicals, resulting in an immediate infusion reaction, even at the very first dose.


Current Research 

Researchers have looked into patient cases to understand this phenomenon better. Cetuximab has a well-documented history of causing severe first-infusion reactions in alpha-gal patients, especially in certain U.S. regions. Meanwhile, Stelara reactions, although less potent, have also been observed. Interestingly, when Stelara is given subcutaneously (under the skin) rather than intravenously, these reactions appear milder and often manageable, suggesting that the route and concentration might influence the body’s response.


The Future of Biologics 

Patients deserve transparency in their medications, including the origin of biologic therapies. Many biologics are produced using mammalian cell lines, raising concerns for those with dietary restrictions (vegan, halal, kosher) or allergies like Alpha-gal Syndrome. However, animal-free alternatives exist! PlantForm's vivoXPRESS® platform offers a compelling solution by leveraging plant-based production methods. This innovative approach not only addresses the concerns of patients with dietary restrictions or allergies but also presents potential advantages such as reduced production costs, faster development timelines, and improved safety profiles. VeganMed plays a vital role in driving change from pharmaceutical companies by advocating for greater transparency. We aim to foster partnerships to improve the disclosure of crucial information about the origin and production of their medications, ultimately empowering patients to make informed healthcare choices.


 

Disclaimer: The product and/or information provided on VeganMed is of a general nature and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. We do not lab test the products to confirm that they are free from animal ingredients, and it is possible that the formulation and ingredients could have changed. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or product. The information provided in this post is accurate and up to date as of the date it was written. However, please note that circumstances and facts may change over time, and new information may become available that could alter the accuracy or relevance of the content. We encourage readers to verify and cross-reference any information provided here with trusted sources or consult relevant professionals for the most current and accurate updates.


 

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