Purpose: Due to risks of prolonged higher efficacy therapy exposure, it is unclear how long to treat people with MS. There is little data on treatment de-escalation, which may fill the gap between higher efficacy therapy and discontinuation. The aim of this study is to determine outcomes of DMT de-escalation.
Methods: Data was obtained retrospectively from medical records. Annualized relapse rate (ARR) was evaluated using Poisson generalized linear mixed effect models (GLMM), while MRI activity and disability were assessed using logistic GLMM. Non-inferiority tests were used to determine whether ARR and MRI activity were not clinically meaningfully higher after de-escalation.
Results: A total of 163 patients were identified who de-escalated from high efficacy therapy (HET) to moderate efficacy therapy (MET), and 71 % remained free from relapses after de-escalation to MET. There were 127 patients de-escalating from MET to low efficacy therapy (LET), with 77 % remaining relapse-free after de-escalating to LET. Freedom from both relapses and MRI activity were higher on those de-escalating from ocrelizumab or fumarates compared to natalizumab or s1p modulators. Non-inferiority for de-escalation was not demonstrated in either cohort.
Conclusions: Our study provides real world evidence on de-escalation strategies. De-escalation from ocrelizumab and fumarates appear to be safer strategies than from natalizumab and s1p modulators. De-escalation requires further investigation, and decisions regarding treatment should be based on the patient's individual disease characteristics.
Keywords: De-escalation; Disease-modifying therapy; Multiple sclerosis; Non-inferiority; Treatment strategies.
Copyright © 2025 The Author(s). Published by Elsevier B.V. All rights reserved.
