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Observational Study of Switching from Natalizumab to Immunomodulatory Drugs
Ramón Villaverde-González1, Julia Gracia Gil, Angel Pérez Sempere
1Department of Neurology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
Objective:
To determine the effect of disease-modifying drugs (DMDs) on disease activity rebound in patients discontinuing natalizumab (NTZ).
Methods:
Twenty-one patients with relapsing-remitting multiple sclerosis (RRMS) treated with NTZ for ≥1 year and who switched to DMDs (glatiramer acetate [GA] or interferon) were followed up for 12 months in clinical practice. Clinical outcomes after NTZ cessation were assessed every 3 months for 1 year and MRI was performed at 12 months.
Results:
Twelve months after switching from NTZ to DMDs, there were no significant differences in the annualized relapse rate (ARR) compared to the days that NTZ was used (0.3 vs. 0.1; p = 0.083); and the ARR never reached similar values to those prior to NTZ use (1.61; p < 0.001). The percentage of relapse-free patients after switching from NTZ was 71.4%. These patients did not have lower disease activity before NTZ compared with those with clinical relapses (1.3 vs. 1.7; p = 0.302), but they had lower Expanded Disability Status Scale scores (3.4 vs. 5.7; p = 0.001). DMDs had beneficial effects on MRI parameters, as 10 of 16 patients (62.5%) presented no evidence of radiological activity 12 months after NTZ discontinuation.
Conclusions:
Patients with RRMS and moderate disability who discontinued NTZ for safety reasons may benefit from the DMDs GA and interferon with no known risk for progressive multifocal leukoencephalopathy.
Insights
Switching from natalizumab (NTZ) to disease-modifying drugs (DMDs) like glatiramer acetate or interferon maintained low relapse rates in multiple sclerosis (MS) patients. DMDs also showed beneficial effects on MRI, indicating sustained disease control without progressive multifocal leukoencephalopathy risk.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Natalizumab (NTZ) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS).
- Discontinuation of NTZ can lead to disease activity rebound.
- Disease-modifying drugs (DMDs) such as glatiramer acetate (GA) and interferon are alternative treatments for MS.
Purpose of the Study:
- To evaluate the impact of switching from natalizumab (NTZ) to disease-modifying drugs (DMDs) on disease activity rebound in patients with RRMS.
- To assess the efficacy of GA and interferon in maintaining disease control after NTZ cessation.
Main Methods:
- A cohort of 21 RRMS patients treated with NTZ for at least one year were switched to GA or interferon.
- Patients were followed for 12 months, with clinical assessments every 3 months and MRI at 12 months post-discontinuation.
- Annualized relapse rate (ARR) and MRI outcomes were compared to pre-NTZ and during-NTZ periods.
Main Results:
- After switching to DMDs, the ARR remained low (0.3 vs. 0.1 during NTZ use; p=0.083) and did not return to pre-NTZ levels (1.61; p<0.001).
- 71.4% of patients remained relapse-free.
- 62.5% of patients showed no evidence of radiological activity on MRI 12 months after NTZ discontinuation.
- Patients on DMDs had lower Expanded Disability Status Scale scores compared to those who relapsed.
Conclusions:
- Switching from natalizumab to glatiramer acetate or interferon is a viable strategy for managing RRMS in patients with moderate disability.
- DMDs effectively control disease activity and MRI progression after NTZ cessation.
- This switch offers a safe alternative, avoiding the risk of progressive multifocal leukoencephalopathy associated with NTZ.
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