Infection risk in a real-world cohort of patients treated with long-term B-cell depletion for autoimmune neurologic disease

Abstract

Background: B-cell depleting medications are effective disease-modifying therapies for multiple sclerosis. Prior studies have demonstrated that use of these medication is associated with infections and immunologic changes. Limited data suggest that infectious adverse effects may be more common with long-term use. We aimed to investigate rates of infections and laboratory abnormalities in a real-world cohort of patients treated with long term B-cell depletion and identify clinical factors associated with these outcomes.

Methods: In this retrospective, single-center observational study, patients with MS and other autoimmune neurologic disorders treated with rituximab or ocrelizumab for ≥2 years were identified. Linear regression analyses identified factors associated with increased risk of minor and severe infections. Rates of total and severe infections were compared between the first two years of treatment and years three and beyond.

Results: 291 patients, treated with rituximab or ocrelizumab for an average of 46 months, were included. Total infections and infections requiring hospitalization occurred at rates of 25.0 and 3.03 per 100 person-years, respectively. Female gender and current or former smoking status were associated with a higher rate of total infections. Hypogammaglobulinemia and higher BMI were associated with increased risk of hospitalization. Rates of total and serious infections were higher in years three and beyond compared to the first two years.

Conclusions: Infections in patients with MS treated with long-term B-cell depletion may be more common with longer duration of therapy. This study provides additional information to help personalize care.

Keywords: Adverse events; Disease modifying therapy; Multiple sclerosis; infections.