Intravenous ofatumumab treatment of multiple sclerosis and related disorders: An observational study

• Published in: Multiple sclerosis and related disorders 2022-12, Vol.68, p.104246-104246, Article 104246
• Main Authors: El Mahdaoui, Sahla, Romme Christensen, Jeppe, Magyari, Melinda, Wandall-Holm, Malthe Faurschou, Sellebjerg, Finn
• Format: Article
• Language: English
• Subjects: Administration, Intravenous; Antibodies, Monoclonal - adverse effects; Antineoplastic Agents - therapeutic use; CD20 depleting therapies; Demyelinating disorders; Humans; Multiple Sclerosis; Neuromyelitis Optica - drug therapy; Ofatumumab; Retrospective Studies
• ISSN: 2211-0348; 2211-0356
• DOI: 10.1016/j.msard.2022.104246

•Annualized relapse rate was reduced from 1.03 at baseline to 0.38 during treatment.•Disability worsening was stabilized with a cumulated risk of 7% at 24 months.•Mild-moderate infusion-related reactions were common. Ofatumumab is an anti-CD20 monoclonal antibody approved for subcutaneous administration for the treatment of relapsing multiple sclerosis (MS), but intravenously administered ofatumumab has been investigated in a phase 2 trial and used off-label. The objective of the present study was to assess disease activity and side effects in relation to longer-term intravenous ofatumumab treatment of MS and related disorders. We conducted a retrospective study of patients treated off-label with intravenous ofatumumab for MS, neuromyelitis optica spectrum disease (NMOSD) and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) at the Danish Multiple Sclerosis Center. Data was retrieved from the Danish Multiple Sclerosis Registry and through medical chart review. Fifty patients were identified with a median treatment duration of 2.2 years. Annualized relapse rate decreased from 1.03 at baseline to 0.38 during ofatumumab treatment. At 24 months, the probability of having experienced a relapse was 55% and confirmed disability worsening 7%. Frequency of infusion-related reactions was 86% during the first infusion and 42% during the last infusion. Six experienced infections requiring hospitalization. Our data indicate a reduction of relapse frequency, stabilization of disability worsening and an acceptable safety profile, although we observed a higher frequency of infusion reactions compared to data from other intravenously administered anti-CD20 monoclonal antibodies. The study supports a class effect of anti-CD20 monoclonal antibodies and the hypothesis that complement activation may be associated to a higher frequency of infusion related reactions. [Display omitted]