Real‐life long‐term effectiveness of fingolimod in Swiss patients with relapsing‐remitting multiple sclerosis

Abstract

Background and purposeIn 2011, fingolimod was approved in Switzerland for the treatment of relapsing‐remitting multiple sclerosis (RRMS). The aim of the present study was to assess the effectiveness and retention of fingolimod in a real‐life Swiss setting, in which patients can receive fingolimod as both first‐ and second‐line treatment for RRMS.MethodsThis cross‐sectional, observational study with retrospective data collection was performed at 19 sites that comprised both hospitals and office‐based physicians across Switzerland. Sites were asked to document eligible patients in consecutive chronological order to avoid selection bias. Demographic and clinical data from 274 consenting adult patients with RRMS who had received treatment with fingolimod were analyzed.ResultsMean treatment duration with fingolimod was 32 months. Under fingolimod, 77.7% of patients remained free from relapses and 90.3% did not experience disability progression. The proportion of patients who were free from any clinical disease activity, i.e. without relapses and disability progression, was 72.1%. A total of 28.5% of patients had been RRMS treatment‐naïve prior to fingolimod therapy. High long‐term treatment retention rates ranging between 95.7% at 24 months and 87.8% at 36 months were observed.ConclusionIn this Swiss cohort of naïve and pre‐treated subjects with RRMS, the majority of patients under fingolimod treatment showed freedom from relapses and disability progression. In addition, treatment retention rate over 2 and 3 years was high, irrespective of previous treatment.

Macular oedema and changes in macular thickness in multiple sclerosis patients treated with fingolimod

“…The findings that none of our patients developed macular oedema is in agreement with other studies showing a frequency of macular oedema of 0.3% in patients treated with the 0.5 mg dose used in RRMS [4]. The rare occurrence is supported by several post marketing studies emerging in recent years mentioning a total of eight cases of macular oedema amongst almost 2000 patients [11][12][13][14][15][16][17][18][19][20]. The finding of small increases in macular thickness and volume is also in line with a previous study of Nolan et al that showed a small but significant difference in macular volume between MS patients treated with fingolimod and patients never treated with fingolimod [21].…”

Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study

“…To our knowledge, this is one of the largest real-world series of patients with RRMS treated with FNG with composite outcomes assessment and for which composite effectiveness outcomes assessment data are available for the 2 years before and after FNG treatment initiation. Similarly to other real-world studies [ 6 , 7 , 11 , 12 , 24 ], patients under FNG treatment maintained a low ARR and thus a high proportion of relapse-free patients, as compared to the pre-FNG period, with a high rate of treatment persistence. Regarding the subgroup analysis, our data showed that FNG brings a benefit on MS patients regardless of the previous DMT used, although to a lesser extent in the NTZ+.…”

“…Fingolimod (FNG), proven efficacious in three large phase III trials [1][2][3] and in their extensions [4,5], is a widely used oral medication licensed in the USA for the first-line treatment of relapsing-remitting form of multiple sclerosis (RRMS) and in the European Union (EU) for patients with highly active RRMS defined as either high disease activity despite treatment with at least one disease-modifying treatment (DMT) or rapidly evolving severe RRMS. A large number of postmarketing studies have confirmed the efficacy of FNG in a real-world setting, with data substantially overlapping those of pivotal trials [6][7][8][9][10][11][12][13]. All this despite patients are included in observational studies being on average older, with longer disease duration and more severe neurological disability [14].…”

Safety and Temporal Pattern of the Lymphocyte Count During Fingolimod Therapy in Patients With Multiple Sclerosis: Real-World Korean Experience

“… 6 19 Acceptable tolerance was observed in the current study. The discontinuation rate was quite low in the current cohort (14.5%) compared with those in previous studies (10.6%–43.8%), 27 28 29 and grade-4 lymphopenia was not considered the main reason for discontinuation.…”