Abstract Details

Both from the authorities and from the neurological community it is a matter of ongoing discussion, whether and to what extent investigator vs. patient-reported safety issues differ.

CONFIDENCE (EUPAS22951) is an open phase IV study, systematically collecting investigator-reported clinical data of ocrelizumab-treated patients.

PSPs such as “TrotzMS” accompany patients during lifelong MS therapy regardless of treatment. As part of the standard pharmacovigilance procedure, unsystematically reported safety data from patients of PSPs are captured.

CONFIDENCE: Adverse events (AEs) will be collected during the observation period starting from the first administration of ocrelizumab.

“TrotzMS” PSP: AEs reported freely by patients will be collected during regular consultations.

Updated safety data from both programs will be presented.

CONFIDENCE: Since April 2018, 1624 patients newly treated with ocrelizumab have been enrolled. Preliminary data as of 30 September 2019 show that approximately 80.0% were diagnosed with RMS and 20.0% with PPMS. Mean age at initiation of ocrelizumab therapy was 56 years (range 18–72), with a majority of female patients (64.0%). 55.1% of patients have experienced at least one AE. The most common AEs were infections and infestations, followed by nervous system disorders, general disorders and administration site conditions. Incidences of infections and serious infections were within expected ranges.

“TrotzMS” PSP: Since January 2018, approximately 536 ocrelizumab-treated patients have joined the PSP. 512 AEs were documented. Patients primarily reported disease-related symptoms such as nervous system disorders and infections. As safety data were captured unsystematically, calculations of incidences was not possible.

No new or unexpected safety-signals were observed in either program.

Patients and physicians have a different perception of safety. Both perspectives should be considered when describing the safety profile and optimizing MS treatment.