Cyltezo (adalimumab-adbm), by Boehringer Ingelheim Pharmaceuticals, is a tumor necrosis factor (TNF) blocker for the treatment of various chronic inflammatory diseases, including Crohn’s disease and ulcerative colitis, when other medications and treatments did not help or cannot be tolerated by a patient.
It is the first biosimilar to Humira to be approved by the U.S. Food and Drug Administration (FDA), a decision announced on Aug. 25, 2017. Biosimilar means that the biological product was approved based on data that demonstrates that it is highly similar to an already FDA-approved medicine, and that there are no clinically meaningful differences between them.
How Cyltezo works
TNF is a naturally occurring protein, involved in normal and inflammatory immune responses. Inflammation of the digestive tract, one of the main symptoms of Crohn’s disease, may be due to an overproduction of TNF. Cyltezo is an anti-TNF-alpha monoclonal antibody. It binds to TNF and blocks its action in the body, helping to reduce inflammation.
It also induces biological responses that are driven by TNF, including changes in the levels of adhesion molecules responsible for the migration of white blood cells to inflammation sites in inflammatory diseases such as inflammatory bowel disease (IBD).
Cyltezo in clinical trials
A Phase 1 study (NCT02045979) demonstrated the pharmacokinetic bioequivalence of Cyltezo with Humira in healthy volunteers. The study included 327 people, ages 18 to 55. Each participant was randomized to receive one dose of either Cyltezo or Humira as an under-the-skin injection. Results showed that Cyltezo’s safety, tolerability, and immunogenicity (the capacity to induce an immune response) was similar to Humira, marketed by Abbvie.
The safety and efficacy of different doses of Cyltezo were also assessed in people with moderate to severe Crohn’s disease. Results of these studies showed that a greater percentage of participants achieved clinical remission at the fourth week of treatment with Cyltezo compared to placebo.
A third study showed that more participants who were in clinical response at the fourth week achieved clinical remission in the Cyltezo maintenance group than in the placebo maintenance group.
It comes in a pre-filled syringe for under-the-skin injection. An auto-injector option is currently seeking approval.
The most common adverse reactions reported are upper respiratory tract infections, injection site reactions, headache, and rash. It may also cause severe side effects, including serious infections such as tuberculosis and infections caused by viruses, fungi, or bacteria that have spread throughout the body. The risk of getting lymphoma or other cancers may also increase in people who are taking TNF blockers like Cyltezo.
Cyltezo is not yet commercially available.
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