Immunogenicity at the Heart of Chronic Inflammatory Treatments

The advent of biosimilars, such as adalimumab-adbm (Cyltezo), represents a significant advancement in the management and treatment of chronic inflammatory diseases such as rheumatoid arthritis, Crohn's disease, and chronic plaque psoriasis. However, immunogenicity, which can affect the efficacy and safety of these treatments, remains a critical concern.

This study compares the immunogenicity of adalimumab-adbm with that of its reference product (Humira) to provide valuable insights for healthcare professionals in their clinical practice.

Do Biosimilars Offer Comparable Immunogenicity to Their Reference Products?

The immunogenicity of adalimumab-adbm was compared with its reference product in patients with moderate-to-severe rheumatoid arthritis, Crohn's disease, and chronic plaque psoriasis. Immunogenicity was evaluated based on two key criteria:

• Anti-drug antibodies (ADAs): Measured at defined intervals.
• Neutralizing antibodies (nAbs): Studied for their impact.

The results showed differences in ADA and nAb levels between the treatments, but without a significant impact on clinical efficacy. The primary clinical responses, i.e., the main therapeutic objectives of the trials, were found to be comparable between the two groups.

It is also noteworthy that the incidence of antibodies varies by disease. The incidence of ADAs is lower in rheumatoid arthritis—thanks to the use of methotrexate—intermediate in Crohn's disease, and higher in chronic plaque psoriasis due to the frequent absence of background therapy.

Confirmed Biosimilarity and Future Opportunities

The findings of these trials confirm the biosimilarity between adalimumab-adbm and its reference product, demonstrating comparable immunogenicity and maintained clinical efficacy. These data support the adoption of biosimilars as interchangeable alternatives, paving the way for expanded treatment options, particularly for patients with rheumatoid arthritis, Crohn's disease, and chronic plaque psoriasis.