The non-interventional study (NIS) AIOLOS evaluates ofatumumab, interferon β1 (IFN-β1) or glatiramer acetate (GA) in treatment-naïve RMS patients who do not meet the highly-active disease criteria in daily clinical routine in Germany.

Ofatumumab, a fully human monoclonal aCD20 antibody, showed superior efficacy and comparable safety versus teriflunomide in the Phase 3 ASCLEPIOS I/II overall population and in various subgroups, including recently diagnosed treatment-naive and in non-highly active participants. Furthermore, ofatumumab demonstrated sustained efficacy for up to 6 years in all those populations in the ALITHIOS open-label extension.

This prospective NIS enrolls treatment-naïve RMS patients who do not meet the highly-active disease criteria and either initiate ofatumumab or other self-administered injectable therapies (IFN-β1/GA). Primary data is collected via questionnaires and electronic case report forms and includes clinical parameters for effectiveness, safety, and tolerability as well as various patient reported outcomes.

The interim analysis included 302 ofatumumab patients and 82 patients treated with IFN-β1/GA as first-line treatment. Baseline and demographic parameters were balanced overall, but also show that ofatumumab patients tend to have higher disease activity before baseline compared to IFN-β1/GA patients. Fewer ofatumumab patients discontinued therapy, resulting in a higher retention rate at one year compared to the IFN-β1/GA cohort. Compared to IFN-β1/GA, fewer ofatumumab patients experienced serious adverse events (SAEs) and experienced AEs leading to study drug discontinuation. IFN-β1/GA patients experienced a higher proportion of injection site reactions, while ofatumumab patients experienced more injection systemic reactions, mostly within the first month of treatment.

This interim analysis on real-world use of ofatumumab in treatment-naive RMS patients who do not meet the highly-active disease criteria is in line with data from the pivotal ofatumumab trials and confirms the favorable benefit-risk profile of ofatumumab as first-line treatment. The data provide insights into the RMS patient population treated with different self-administered first-line therapies.