Facing Real-World Challenges of Immunogenicity in Pediatric Inflammatory Bowel Disease

The advent of biological therapies drastically altered the landscape of inflammatory bowel disease (IBD) treatment, making long-term steroid-free remission possible for thousands of patients living with this chronic inflammatory condition that compromises the integrity of the gastrointestinal mucosa. Unfortunately, up to 65% of patients with IBD develop anti-drug antibodies to biologics (1). This is especially problematic for pediatrics, where treatment options are substantially more limited than for adult patients. Currently, only two biologics have approval from the United States (U.S.) Food and Drug Administration (FDA) for pediatric indications in IBD, anti-TNF-α agents infliximab (IFX), and adalimumab (ADM). The fear of losing these two agents to immunogenicity is very real for the providers and the families of the ~70,000 children affected by IBD in the U.S. (2)

Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Managing immunogenicity in clinical practice and during drug development was a recent topic at the ASCPT 2019 annual meeting. This commentary expands on the discussion to facilitate a broader engagement across the community. The intent is to provide a rationale for ongoing research into the current gaps in assessing and interpreting immunogenicity in drug development and managing clinical immunogenicity for an approved drug. The following are highlighted: (i) Immunogenicity Considerations in Clinical Practice, (ii) Immunogenicity Testing and Current Limitations, (iii) Immunogenicity Risk Assessment and Mitigation, and (iv) Quantitative Systems Pharmacology (QSP) models of Immunogenicity

Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Managing immunogenicity in clinical practice and during drug development was a recent topic at the ASCPT 2019 annual meeting. This commentary expands on the discussion to facilitate a broader engagement across the community. The intent is to provide a rationale for ongoing research into the current gaps in assessing and interpreting immunogenicity in drug development and managing clinical immunogenicity for an approved drug. The following are highlighted: (i) Immunogenicity Considerations in Clinical Practice, (ii) Immunogenicity Testing and Current Limitations, (iii) Immunogenicity Risk Assessment and Mitigation, and (iv) Quantitative Systems Pharmacology (QSP) models of Immunogenicity