Switch Analysis of Teriflunomide from Other Multiple Sclerosis Disease Modifying Therapies

Background: Teriflunomide is an oral immunomodulatory agent that blocks the proliferation of activated B and T lymphocytes. Although the effects of teriflunomide on relapse-related neurologic sequelae are known, there is no published study evaluating the effectiveness and safety of teriflunomide when switched from other multiple sclerosis (MS) disease modifying therapies (DMTs).

Objectives: Evaluate the effectiveness and safety of teriflunomide in the first switch analysis study.

Methods: Subjects included MS patients (n=87) who had been treated with other DMTs and switched to teriflunomide for at least six months.  Prior DMTs included:  glatiramer acetate (n=70), interferon-beta 1a IM (n=7), natalizumab (n=8), and fingolimod (n=2).  No ‘wash out’ period was used for conversion from natalizumab to teriflunomide and no immune inflammatory reconstitution syndrome was noted in any of those patients.  Analysis included reasons for switching, side effects, relapse rate , MS Disease Activity-free (absence of relapse, 12-week SAD, and MRI changes), and discontinuation rate on teriflunomide.

Results: Over 80% of patients were female, age ranged from 24 to 80 years, and baseline EDSS scores ranged from 2.0 to 7.0. Reasons for switching to teriflunomide included:  injection exhaustion (predominant factor), injection site reactions, lipoatrophy, JCV Elisa positivity, increase in relapse rate on prior DMT, NABs to interferon and natalizumab, and preference for an oral agent.  Nine patients (10.3%) reported side effects early in the treatment course (within 2 months). Of these, five (5.7%) required discontinuation and resumed prior DMT: nausea (2), hypotension (1), anxiety (1), and elevated liver function tests (1).  Side effects in the other 4 patients resolved while remaining on teriflunomide.  Four patients (4.6%) experienced relapses (2 pseudo and 2 required methylprednisolone treatment) and all returned to baseline while remaining on teriflunomide.  Ninety-five percent of patients were free of MS disease activity.

Conclusions: Teriflunomide is a well tolerated oral medication for the management of MS. Side effects were mild and rarely led to medication discontinuation (only 5.7% discontinued and returned to their prior DMT).  A 95% MS disease-activity free rate during the first year of treatment with teriflunomide compares favorably to other DMTs in our clinical practice and makes it a logical choice for first line switch therapy in the management of MS.