Impact of Fingolimod Discontinuation Strategy on Recurrence of Disease Activity in Individuals With Multiple Sclerosis.

Abstract

Background: For individuals with multiple sclerosis (MS), treatment interruption can result in relapse/recurrence of the disease activity. Currently, there are no consensus guidelines about whether an abrupt stop with a short washout period or gradual tapering is better for fingolimod (Gilenya) cessation. We investigated the impact of the fingolimod discontinuation strategy on the recurrence of disease activity and the rebound occurrence of symptoms during washout.

Methods: This was a retrospective, observational, multicenter study of individuals with MS in Egypt and Kuwait. The charts of patients on fingolimod therapy were screened to collect data on the impact of drug cessation strategies on disease activity and relapse occurrence. Disease relapse after cessation was defined as a relapse that occurred in the previous 12 months despite using a first-line treatment option or 2 relapses in the previous 12 months.

Results: In a cohort of 100 patients, 58 had an abrupt cessation and 42 had a gradual tapering. Compared with abrupt cessation, gradual tapering was associated with a significantly lower rate of disease relapse (4.8% vs 81%, respectively; P = .001). Abrupt cessation also resulted in increased MRI findings of new lesions (24.1%; P = .29), enhancing lesions (32.8%; P = .5), and enlarging lesions (6.9%; P = .59); however, none of the MRI findings were significant. Other risk factors showed no significant association with disease relapse after fingolimod cessation.

Conclusions: Gradual fingolimod tapering is highly recommended to decrease the risk of rebound and severe disease reactivation. A prolonged washout should be avoided for lymphocyte recovery.