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Predictors of hospitalization due to infection in rituximab-treated MS patients
Jakob Rishovd Karlowicz1, Mattias Klakegg1, Jan Harald Aarseth2
1Department of clinical medicine, University of Bergen, Norway.
Background:
Rituximab is extensively used off-label to treat multiple sclerosis (MS), and long-term vigilance for adverse events is needed. This study was conducted to determine frequencies and predictors of hematological adverse events, including hypogammaglobulinemia, severe lymphopenia, neutropenia, and infections leading to hospitalization.
Methods:
This retrospective cohort study included all patients with MS initiating rituximab treatment at Haukeland University Hospital between January 1st, 2017, and July 1st, 2021. Patients were followed by clinical monitoring and repeated blood sampling every six months. Clinical outcomes and laboratory results were retrieved from the Norwegian MS Registry and Biobank and the patient administrative system at Haukeland University Hospital.
Results:
Five hundred and fifty-six patients were included, 515 with relapsing-remitting MS (RRMS) and 41 with progressive MS. Overall, 33 patients (5.9%) experienced 56 episodes of infections requiring hospital admission. Sixty patients (10.8%) had confirmed hypogammaglobulinemia, 17 (3.1%) had confirmed severe lymphopenia, and 10 (1.8%) had confirmed severe neutropenia. Predictors of infection requiring hospital admission were progressive MS (adjusted OR (aOR): 4.81; 95%CI: 1.25-18.48), duration of treatment with rituximab (aOR: 1.52; 95%CI: 1.11-2.09) and confirmed severe lymphopenia (aOR: 13.58; 95%CI: 3.41-54.06) and neutropenia (aOR: 13.40; 95%CI: 2.93-61.25). Of the hematological abnormalities, only hypogammaglobulinemia was associated with treatment duration (aOR: 1.35; 95%CI: 1.09-1.69).
Conclusion:
The risk of hospitalization due to infection is associated with time on rituximab treatment, in patients with lympho- or neutropenia, and in patients with primary progressive MS. We observed a time-dependent decline in IgG values, in contrast to neutrophil and lymphocyte count, suggesting a cumulative dose-dependent response. These predictors can assist clinicians in assessing and monitoring MS patients receiving rituximab.
Insights
Long-term rituximab treatment for multiple sclerosis increases infection risk, particularly in progressive MS patients with lymphopenia or neutropenia. Monitoring these adverse events is crucial for patient safety.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Rituximab is frequently used off-label for multiple sclerosis (MS) treatment.
- Long-term monitoring for adverse events associated with rituximab therapy is essential.
Purpose of the Study:
- To determine the frequency of hematological adverse events in MS patients treated with rituximab.
- To identify predictors of hypogammaglobulinemia, severe lymphopenia, neutropenia, and treatment-related hospitalizations due to infection.
Main Methods:
- Retrospective cohort study of 556 MS patients initiating rituximab between 2017 and 2021.
- Data collected from clinical monitoring, blood sampling every six months, the Norwegian MS Registry and Biobank, and hospital administrative systems.
Main Results:
- 5.9% of patients experienced infections requiring hospitalization.
- Predictors for hospitalization included progressive MS, longer rituximab treatment duration, severe lymphopenia, and neutropenia.
- Hypogammaglobulinemia showed a time-dependent increase with treatment duration.
Conclusions:
- Hospitalization risk due to infection correlates with treatment duration, lymphopenia/neutropenia, and primary progressive MS.
- A cumulative, dose-dependent response is suggested by the time-dependent decline in IgG.
- Identified predictors aid clinicians in assessing and monitoring MS patients on rituximab.
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