Exposure-response assessment for key secondary endpoints
Results of the subgroup analysis in each of the three key secondary
endpoints, worsening from baseline to the last visit of the RCP in
Expanded Disability Severity Scale (Figure S2), cumulative total active
MRI lesions during the RCP (Figure S3), and number of NMOSD-related
in-patient hospitalizations during the RCP (Figure S4), by PK exposure
(AUC0-14d or CL) were generally consistent with that of
the primary endpoint: no apparent relationship between the PK exposure
and efficacy outcome in the RCP was observed. In addition, body weight
had no apparent effect on key secondary endpoints. The presence of ADA
had no observed impact on PK of inebilizumab or the B cell depletion in
subjects with NMOSD. Despite the small number of subjects who tested
positive for ADA during the RCP, there was no apparent effect of ADA on
the key secondary endpoints.