Immunogenicity of Adalimumab Reference Product vs. Adalimumab-adbm
Study Overview
This analysis looked at the immunogenicity of a biosimilar drug, adalimumab-adbm (Cyltezo), compared to the original adalimumab (Humira) in patients with rheumatoid arthritis, Crohn’s disease, and chronic plaque psoriasis.
Study Details
In the VOLTAIRE trials, researchers measured the presence of antidrug antibodies (ADAs) and neutralizing antibodies (nAbs) at various times. They used a sensitive testing method to ensure accurate results.
Key Findings
- There were minor differences in immunogenicity between adalimumab-adbm and the reference product.
- The number of patients with ADAs and nAbs increased over time across all trials.
- The psoriasis trial showed higher rates of ADA and nAb positivity compared to the rheumatoid arthritis and Crohn’s disease trials.
Conclusion
The study confirms that adalimumab-adbm is similar to the original adalimumab across different diseases. It suggests that adalimumab-adbm can be used interchangeably with the reference product, providing consistent clinical results.
Clinical Implications
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