Cyltezo (adalimumab-admb) is a drug from Boehringer Ingelheim Pharmaceuticals for the treatment of chronic inflammatory diseases, including juvenile arthritis (JA). Cyltezo is a biosimilar to Humira, which has been approved by the U.S. Food and Drug Administration (FDA) since 2002. Biosimilars are biologic medical products that are nearly identical to an original product developed by another company.
It has been approved by the FDA but is not yet commercially available.
How Cyltezo works
It is a monoclonal antibody against tumor necrosis factor alpha (TNF-alpha). TNF alpha is a small protein that binds to TNF receptors found on immune cells to trigger an inflammatory response. Cyltezo reduces inflammation by blocking TNF from stimulating the immune system.
Cyltezo in clinical trials
The FDA requires manufacturers to provide evidence of biosimilarity through clinical trials to confirm that they are as safe and effective as the original product. On August 25, 2017, the FDA approved Cyltezo based on both the long history of safety, efficacy, and tolerability of Humira and on clinical studies of Cyltezo itself as a biosimilar.
On Oct. 28, 2015, BI announced results from a Phase 1 study of Cyltezo, called VOLTAIRE PK (NCT02045979). The main aim of this study was to study the pharmacokinetics of Cyltezo, or how the drug moves in the body, to show that it was similar to Humira. It also evaluated its safety. The trial involved 327 healthy men who were randomized to receive one under-the-skin injection of Cyltezo or Humira. The results, published in 2016 in the journal Expert Opinion on Investigational Drugs, showed that Cyltezo was comparable to Humira on all measures.
In October 2016, BI announced results from a Phase 3 study (NCT02137226) involving 645 patients with moderate to severe rheumatoid arthritis. Results of this study confirmed that Cyltezo was as safe and effective as Humira.
An additional study, called VOLTAIRE X (NCT03210259), is underway to show that Cylteza is interchangeable with Humira. It will include 240 patients with psoriasis, a chronic autoimmune skin condition, randomized to receive either Humira continuously or Humira alternating with Cyltezo. If the two groups show the same clinical result it will be concluded that Cylteza works as well as Humira, and can be substituted for Humira by a pharmacist without consulting the doctor who wrote the original prescription. The VOLTAIRE X study is still recruiting participants.
Although the clinical studies were conducted in patients with other types of inflammatory diseases, the drug is also approved for use in children with JA. It is given as an injection under the skin at a dose of 40 mg every other week for children weighing more than 30 kg (66 pounds). The most important adverse effect is the risk of serious infections.
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