Abstract
BackgroundNatalizumab (NTZ) discontinuation leads to multiple sclerosis reactivation.The objective of this study is to compare disease activity in MS patients who continued on NTZ treatment to those who were switched to subcutaneous interferon 1b (IFNB) treatment.Methods1-year randomized, rater-blinded, parallel-group, pilot study (ClinicalTrial.gov ID: NCT01144052). Relapsing remitting MS patients on NTZ for ≥12 months who had been free of disease activity on this therapy (no relapses and disability progression for ≥6 months, no gadolinium-enhancing lesions on baseline MRI) were randomized to NTZ or IFNB. Primary endpoint was time to first on-study relapse. Additional clinical, MRI and safety parameters were assessed. Analysis was based on intention to treat.Results19 patients (NTZ n=10; IFNB n=9) with similar baseline characteristics were included. 78% of IFNB treated patients remained relapse free (NTZ group: 100%), and 25% remained free of new T2 lesions (NTZ group: 62.5%). While time to first on-study relapse was not significantly different between groups (p=0.125), many secondary clinical and radiological endpoints (number of relapses, proportion of relapse free patients, number of new T2 lesions) showed a trend, or were significant (new T2 lesions at month 6) in favoring NTZ.ConclusionsDe-escalation therapy from NTZ to IFNB over 1 year was associated with some clinical and radiological disease recurrence. Overall no major safety concerns were observed.
Highlights
Natalizumab (NTZ) discontinuation leads to multiple sclerosis reactivation
No significant differences between treatment arms for baseline characteristics, including annualized relapse rate (ARR) during the 2 years prior to the NTZ run-in period, duration of run-in period of NTZ treatment and EDSS at randomization, were found (Table 1)
Median time to first on-study relapse was 103 days in the interferon 1b (IFNB) group; no relapses were observed in the NTZ group (p=0.125) (Table 2)
Summary
Natalizumab (NTZ) discontinuation leads to multiple sclerosis reactivation. Natalizumab (NTZ) is an effective treatment for relapsingremitting multiple sclerosis (RRMS), but is associated with an increased risk of progressive multifocal leucoencephalopathy (PML) in JC virus (JCV) sero-positive patients in function of treatment duration and pre-exposure to immunosuppressants [1]. Mean half-life of unbound NTZ after repeated administrations is 11 days, and the drug is fully cleaned from the circulation within approximately 2. The objective of this pilot study was to generate initial prospective data and hypotheses on the concept of deescalating NTZ-treated patients with RRMS to interferon beta-1b (IFNB)
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