Long-term management of natalizumab discontinuation in a large monocentric cohort of multiple sclerosis patients

Abstract

Background: Several pPivotal and post-marketing studies showed demonstrated the efficacy and

ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis

“…After a full-text review and removal of duplicates, 19 studies met the eligibility criteria for this review. One study was an RCT; 120 12 were prospective cohort studies; [121][122][123][124][125][126][127][128][129][130][131][132] and six were retrospective cohorts. [133][134][135][136] In 15 studies, participants were receiving natalizumab before discontinuing treatment due to safety issues, whereas in one study, 127 participants were receiving fingolimod.…”

“…At 24 weeks after natalizumab cessation, there was a significant reduction in the annualized relapse rate between the pre-natalizumab period and the post-natalizumab period (2 vs 0.3; p = 0.009), 128 and a reduction in the mean number of relapses (1.1 vs 0.07), although no p values were reported, 120 according to fair quality evidence. At 52 weeks after natalizumab discontinuation, several studies of fair to poor quality reported a statistically significant reduction in the annualized relapse rate compared with that during the pre-natalizumab period 131,135,137,138 or described a reduction without statistical calculations. 123,126 However, other studies of fair quality reported no change in the annualized relapse rate and mean number of relapses between the two time periods.…”

“…Of these, 3771 studies were excluded based on their title/abstract and 82 studies were subjected to a full-text appraisal. After a full-text review and removal of duplicates, four studies met the eligibility criteria; three were prospective cohorts; 131,139,140 one was an RCT 141 and participants in all the studies were receiving natalizumab before switching to other DMTs. The number of included participants ranged from 110 to 214 (mean: 166), and the length of the follow-up post-switch ranged from 28 to 52 weeks (mean: 44 weeks).…”

“…Across 11 studies, 2 reported no evidence of rebound 123,135 and 1 reported no evidence of immune reconstitution inflammatory syndrome. 128 The proportion of participants showing evidence of rebound ranged, in most of the studies, from 9% to 12%, 126,127,131,132,137 whereas other authors reported higher rebounds, including 14%, 136 21.2% 134 and 38.3%. 138 Relapse outcomes.…”

“…121 Various studies reported an increase in the mean number of GAD lesions in all participants as a group during the pre-natalizumab period compared to that during the post-natalizumab period. 126,128,131,138 Quality assessment. The study quality was assessed with the 'Quality Assessment of Before-After (PrePost) Studies With No Control Group' tool developed by the National Heart, Lung, and Blood Institute and the Research Triangle Institute International.…”