Real-World Data of First 12-Months of Ofatumumab Treatment in Multiple Sclerosis Patients-A Multicenter Experience...

Background and Objectives: Ofatumumab (OFA) is the first fully human anti-CD20 monoclonal antibody approved for the treatment of RRMS classified as a high-efficacy treatment agent. Real-world evidence is essential for evaluating the effectiveness and safety of OFA. Materials and Methods: A total of 184 patients (72.3% women, mean age 38 years (±10.9), 51 naïve patients and 133 after switch. Among them, 142 patients were evaluated after first 12-months of treatment according to relapse rate, neurological status expressed by Expanded Disability Status Scale (EDSS), new T2-weighted (T2-w) lesions and gadolinium-enhancing lesions (GELs) in magnetic resonance imaging (MRI), confirmed disability progression, as well as adverse events. Logistic regression identified factors associated with disease activity at ofatumumab initiation, including age, sex, disease duration, prior treatment, and baseline EDSS. Results: After the first 12 months of OFA treatment, relapses occurred in 12.0% of patients; new or enlarging T2-w lesions were observed in 12.7%; GELs in 3.5%; EDSS progression in 12.7%; and EDSS improvement in 14.2%. The No Evidence of Disease Activity-3 (NEDA-3) status was achieved in 76.1% of patients overall-75.8% in those who switched from another disease-modifying therapy (DMT), and 76.6% in treatment-naïve individuals. No significant differences were observed between the naïve and switch groups. Baseline EDSS at ofatumumab initiation was a significant predictor of relapse activity, while age was significantly associated with MRI activity (GELs) at 12 months. Conclusions: Real-world data confirmed high efficacy and safety of ofatumumab in RRMS. NEDA-3 was achieved more often than in registration trials. No efficacy differences between naïve and switch patients were observed.