Low immunogenicity of emicizumab in persons with haemophilia A.

ABSTRACT:

Introduction

Emicizumab is a humanised, bispecific monoclonal antibody mimicking the cofactor function of activated factor (F)VIII. It is indicated for routine prophylaxis of bleeding episodes in persons with haemophilia A (PwHA) with/without FVIII inhibitors.

Aim

To evaluate the development of anti-emicizumab antibodies and their impact on pharmacokinetics (PK), pharmacodynamics (PD), efficacy and safety in PwHA.

Methods

Data from seven completed or ongoing phase 3 studies were pooled. The assessment of the immunogenicity profile of emicizumab included anti-drug antibody (ADA) measurement and the association of ADAs with PK, PD, bleeding events, and adverse events.

Results

Of 668 PwHA evaluable for immunogenicity analysis, 34 (5.1%) developed ADAs after exposu

SUBMITTER: Schmitt C 

PROVIDER: S-EPMC9292930 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature