Quality of life and tolerability of B-cell directed therapy of multiple sclerosis with ofatumumab in a patient-centered real-world observational study

Abstract

Introduction: Ofatumumab (Kesimpta^®) is a subcutaneous CD20-targeting antibody approved in Germany in 2021 for the treatment of relapsing multiple sclerosis (RMS). After careful instruction, patients can administer the treatment themselves. We previously reported data of 101 patients (Klimas et al. in Nervenarzt 94:923-933, 2023). The objective of this longitudinal study is to explore the tolerability and acceptability of ofatumumab from a patient perspective over a follow up period of 6 months.

Methods: In this prospective observational real-world study, we report follow up data of 81 patients. We evaluated sociodemographic data, disease duration, duration and side effects of ofatumumab use, expanded disability status scale (EDSS), Beck Depression Inventory II (BDI-II), Short-Form 36 (SF-36), Fatigue Scale of Motor and Cognitive Functions (FSMC), and modified Multiple Sclerosis Functional Composite Test (MSFC). In addition, we asked for subjective treatment outcomes, such as impact on quality of life, walking distance, concentration, mood, medication adherence, fatigue and the subjective course of MS on a numerical rating scale (1 = very negative; 5 = very positive). Furthermore, treatment discontinuations were recorded.

Results: The average duration of ofatumumab treatment was 10 months. In comparison to previous published data of our cohort, patients reported a significant increase in headache (10% up to 26%, p = 0.004) and limb pain (5% up to 26%, p < 0.001) as persistent side effects after the injections. More patients reported a very positive effect (p < 0.0001) on quality of life. 4 confirmed relapses occurred but no EDSS worsening, and no treatment discontinuations were documented during the observation period.

Discussion: As previously described, our prospective study indicates that patients have a good tolerability of ofatumumab, precisely because of the mild and few side effects at the first administration. However, the longer the observation period, the more headaches and limb pain occurred after the injections. Despite this, patients' subjective quality of life improved. There were no discontinuations during the follow-up period, with the limitation of a high loss to follow-up.

Keywords: Anti-CD20 monoclonal antibody; B-cell depletion; Multiple sclerosis; Ofatumumab.

Fig. 1

Study design. 118 patients were enrolled in the study after medical adjustment. 17 patients did not want participate in the study, leaving 101 patients in the study. At baseline, patients were required to complete a questionnaire and provide their disease and current medical history. Furthermore, a physical examination and MSFC were conducted. Following baseline assessments, 20 of the 101 patients either withdraw from the study for the personal reasons or could not be contacted. Subsequently, a second appointment was scheduled after a period of 6 months. 81 patients have already completed this appointment

Fig. 2

Application questions. Impact of ofatumumab on various patient-Reported outcomes over time. Figure illustrates the changes in the patient-reported outcomes over the course of ofatumumab treatment during a 6 month observation period. Parameters accessed include quality of life, walking distance, concentration, mood, medication adherence, and fatigue from a patients subjective perspective. Statistically significant differences were determined using the chi-squared test. Drug-handling: p = 0.099. Quality of life: p = 0.002. Walking distance p < 0.001. Concentration: p < 0.001. Mood: p = 0.010. Fatigue: p < 0.001. Disease course: p < 0.001. Compliance: p = 0.085. Ofatumumab side effects: p < 0.001. The symbols within the bars indicate significance after post-hoc testing with Bonferroni correction