Abstract Details

Title First-Hand Experience With Ofatumumab at ASCLEPIOS Study Sites In Germany

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 104

Objective To evaluate physician’s first hand experience with ofatumumab, to identify unmet needs regarding the usage of ofatumumab and to describe the physician’s intention how to use ofatumumab in real life in Germany

Background Ofatumumab, a human anti-CD20 monoclonal antibody, was approved by the FDA for the treatment of RMS. Ofatumumab can be self-administered subcutaneously once monthly at home via an autoinjector pen and is expected to address significant unmet needs for people living with RMS.
The Phase III ASCLEPIOS I and II studies demonstrated superior efficacy of ofatumumab versus teriflunomide. Data on convenience and satisfaction as well as on implementation of ofatumumab as a therapy for RMS in real life are not part of the pivotal ASCLEPIOS trials.

Design/Methods Data was collected via an online questionnaire from investigators of the ASCLEPIOS trials in Germany. The investigators were asked to share their personal view on ofatumumab mode of action, route of administration and implementation of ofatumumab therapy in real life (e.g. premedication, first dose observation, at home administration).

Results An interim analysis shows that the majority of investigators consider ofatumumab’s benefit-risk ratio as (very) good and rate the subcutaneous self-injection of ofatumumab as user-friendly, timesaving for patients and as a relief for high-occupancy clinics and office-based practices. Most of them intent to give steroids, antihistamines and acetaminophen as premedication prior to the first ofatumumab injection only. Mean duration of planned first dose observation was specified as 2 hours. By April 2021 we will present comprehensive data describing convenience and planned implementation of ofatumumab from the treating physician’s view.

Conclusions After gaining experience with ofatumumab within clinical trials, German neurologists consider ofatumumab a very efficient and safe treatment option. They rate the self-administered subcutaneous injection once a month as offering high convenience for patients and as facilitating processes at high-occupancy clinics and office-based practices.

Authors/Disclosures
Carola Wagner PRESENTER	Carola Wagner has received personal compensation for serving as an employee of Novartis Pharma GmbH.
	No disclosure on file
Benjamin Ettle (Novartis Pharma GmbH)	Benjamin Ettle has received personal compensation for serving as an employee of Novartis Pharma GmbH.

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