Real World Use of Teriflunomide in South Africa: A Medium Prevalence Multiple Sclerosis Area

Abstract

Back ground: South Africa, which has a multi-ethnic population of over fifty million, is considered to have a medium (5-30/100 000) prevalence rate of Multiple Sclerosis. Teriflunomide is one of two oral disease modifying agents that have been registered in this country. We describe the real-world experience of this drug in South Africa with respect to efficacy, tolerability and side effects. Methods: A retrospective analysis was undertaken of the demographics, clinical presentation, number of preceding relapses, date of last relapse, degree of disability (Expanded Disability Status Scale–EDSS- score) and the magnetic resonance imaging (MRI) changes at initiation of therapy with teriflunomide (14 mg daily orally) and the subsequent course. Tolerability and side effects were recorded. Any preceding disease modifying therapy was recorded. The treating neurologists were asked about the effectiveness of teriflunomide in the patients under their care. Results: Data for 32 patients was analysed. The majority were women (75%) and of white race (78.1%). The mean age (±SD) was 41.1 (11.5) years at the time of initial assessment. Twenty six of the 32 (81%) patients were on prior disease modifying therapy (DMT) which consisted of an interferon-beta 1a or 1b and glatiramer acetate. One patient was on teriflunomide at initiation of the study. The duration on treatment with DMTs prior to teriflunomide ranged from 7.0 to 236.6 months with a mean (±SD) of 96.5 (71.2) months. The duration of therapy with teriflunomide varied from 3 to 24 months with a mean (±SD) of 12.3 (5.0) months. Fourteen patients experienced mild to moderate relapses while on teriflunomide treatment, with 56% remaining relapse free over the study period. The mean (±SD) EDSS score on teriflunomide was 2.5 (1.6), remaining relatively stable compared to the baseline score 2.6 (1.3). The drug was well tolerated in 24 patients, satisfactorily tolerated in 7 and not tolerated in 1. The treating neurologists’ assessment was that the drug was an effective treatment choice in 87.1% of patients, with 96.9% of patients remaining on therapy at the time of analysis. One patient experienced 2 relapses in the year of treatment and one experienced a relapse and progression of the gait disturbance. Conclusions: This small “real world” study confirms that teriflunomide is an effective DMT for patients with mild to moderate MS, prolonged disease duration and switching from other DMTs. It has a tolerable side effect profile. The oral administration compared to the interferons will appeal to many patients. The drug was also effective in patients who were on previous DMTs.