Low immunogenicity of emicizumab in persons with haemophilia A.
Christophe SchmittThomas EmrichSammy ChebonElena FernandezClaire PetryKoichiro YoneyamaAnna KiialainenMonet HowardMarkus NiggliIdo Paz-PrielTiffany ChangPublished in: Haemophilia : the official journal of the World Federation of Hemophilia (2021)
The immunogenicity risk of emicizumab in phase 3 studies was low. ADAs, including in vitro neutralising ADAs, were not associated with a change in safety profile. Routine surveillance is, therefore, not warranted; however, in cases where a loss and/or waning of efficacy are observed, prompt evaluation by a healthcare provider should be sought.