Improvement of fatigue, depression, and processing speed two weeks post Natalizumab infusion in Multiple Sclerosis: No difference between standard and extended interval dosing schedules.

Background: Fatigue, depression and slow processing speed are debilitating symptoms in people with Relapsing-Remitting Multiple Sclerosis (RRMS) that significantly impacts on the quality of life. Natalizumab, a disease-modifying treatment, improves clinical symptoms but questions remain about the comparative efficacy between its standard interval dosing (SID) and extended interval dosing (EID) schedules.
Objective: To examine the impact of short term natalizumab dosing schedules-SID versus EID-on the so called "invisible symptoms", specifically focusing on symptom exacerbation during the 'wearing-off' phase before infusion and the subsequent relief post-infusion.
Methods: Forty-two RRMS patients were assessed one week before (T0) and two weeks after pre-and post-natalizumab infusion (T1) for fatigue symptoms using the Fatigue Scale for Motor and Cognitive Functions (FSMC), the Modified Fatigue Impact Scale (MFIS), and the Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS). Processing speed and depression were measured by the symbol digit modality test (SDMT), and the Beck Depression Inventory-II (BDI-II). Participants were categorized into either the SID or EID dosing schedules of natalizumab, and their outcomes were compared.
Results: Forty-two patients (21 SID; 21 EID) completed the study. Fatigue severity scales, SDMT, and BDI-II scores improved from T0 to T1. No significant differences in fatigue symptoms were found between the SID and EID groups, whether during the "wearing-off" period (T0) or post-infusion (T1).
Conclusions: Both SID and EID dosing regimens of natalizumab are similarly effective in reducing fatigue symptoms, depression and improving processing speed in individuals with RRMS, with no observed differences during the "wearing-off" periods or after re-infusion.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Antonella Conte reports financial support was provided by Biogen Inc. Antonella Conte reports financial support was provided by Italian Ministry of Health. Antonella Conte reports a relationship with Roche that includes: funding grants and speaking and lecture fees. Antonella Conte reports a relationship with Sanofi that includes: funding grants and speaking and lecture fees. Antonella Conte reports a relationship with Almirall that includes: speaking and lecture fees. Antonella Conte reports a relationship with Bristol Myers Squibb Co that includes: speaking and lecture fees. Antonella Conte reports a relationship with Merck & Co Inc that includes: speaking and lecture fees. Antonella Conte reports a relationship with Novartis that includes: speaking and lecture fees. Carlo Pozzilli reports a relationship with Hoffmann-La Roche Limited that includes: consulting or advisory. Carlo Pozzilli reports a relationship with Merck that includes: consulting or advisory and speaking and lecture fees. Carlo Pozzilli reports a relationship with Novartis that includes: consulting or advisory and speaking and lecture fees. Carlo Pozzilli reports a relationship with Janssen that includes: consulting or advisory and speaking and lecture fees. Carlo Pozzilli reports a relationship with Almirall that includes: consulting or advisory and speaking and lecture fees. Carlo Pozzilli reports a relationship with Bristol Myers Squibb Co that includes: consulting or advisory and speaking and lecture fees. Carlo Pozzilli reports a relationship with Alexion that includes: consulting or advisory and speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Giorgio Leodori has nothing to declare, Marco Mancuso has nothing to declare, Davide Maccarrone has nothing to declare, Matteo Tartaglia has nothing to declare, Antonio Ianniello has nothing to declare, Viola Baione has nothing to declare, Gina Ferrazzano has nothing to declare, Leonardo Malimpensa has nothing to declare, Daniele Belvisi has nothing to declare, Alfredo Berardelli has nothing to declare.
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