Experience with fingolimod in clinical practice

Abstract

Aim To report experience with fingolimod in clinical practice. Design/Methods Patients in an academic medical center who were prescribed fingolimod from October 2010 to August 2011 were identified through the electronic medical record and followed for 12 months after fingolimod initiation. Adverse effects, clinical measures, MRI data, and quality of life measures were assessed. Results Three hundred seventeen patients started fingolimod. Eleven patients were treatment naïve (3.5%) and 76 (24.0%) had remote disease modifying therapy use prior to fingolimod. One hundred fifty-one (47.6%) switched because of patient preference and 79 (24.9%) switched because of breakthrough disease. About 11.6% transitioned from natalizumab. Follow-up data were available for 306 patients (96.5%) with mean follow-up time 332 days. Fingolimod was discontinued in 76 of 306 patients (24.8%) at mean 248 days after fingolimod start. Discontinuation most often was due to adverse effects (n=40) or breakthrough disease (n=22). Among patients who started fingolimod with available 12 month follow-up data, 267 (87.3%) remained relapse free and 256 (83.7%) had no relapses or gadolinium enhancement. Time to first relapse occurred at mean 282 days after fingolimod initiation. Quality of life measures remained stable at follow-up. Conclusions Fingolimod was discontinued at a higher rate in clinical practice than in clinical trials. Discontinuation was primarily due to adverse effects or breakthrough disease. Disease activity was adequately controlled in most patients who started fingolimod. This clinical practice cohort is consistent with efficacy data from phase 3 trials and describes the most common tolerability issues in clinical practice.

A real world experience with fingolimod in active RRMS patients naïve to second-line agents: a 2 years, intention-to-treat, observational, single center study

“…Considering a more restrictive criterion, 63 and 37 % of patients presented NEDA-3 at 12th and 24th month. Our results about disability progression and percentage of relapsesfree patients are substantially in agreement with those of RCTs [2][3][4] and post-marketing observational studies [6][7][8][10][11][12]. Data from a post-hoc analysis of TRANS-FORMS showed that 46 % MS patients receiving FTY reached NEDA-3 status after 12 months [13].…”

“…However, drugs efficacy and safety need to be assessed outside the context of RCTs, in real world less selected populations. Until now only few studies have addressed this topic [10][11][12]. The aim of our study was therefore to better delineate the effectiveness and safety of FTY in a real life set.…”

Early safety and efficacy of fingolimod treatment in Denmark

“…It is important to identify and make further examinations and follow-up of patients with respiratory complains. Another report on the experience on fingolimod in clinical practice showed higher discontinuation rate, but this was due to other adverse effects or breakthrough disease (22). One of these studies reported less cardiopulmonary events but a higher rate of fingolimod discontinuation (21).…”

“…One of these studies reported less cardiopulmonary events but a higher rate of fingolimod discontinuation (21). Another report on the experience on fingolimod in clinical practice showed higher discontinuation rate, but this was due to other adverse effects or breakthrough disease (22). However, there are some casuistic reports of cardiovascular events raising new issues beyond 6 h of initial observation (23).…”

Sphingosine 1-Phosphate Receptor Modulators in Multiple Sclerosis

“…Hersh et al reported 306 patients treated at a large academic center with 12-month follow up after starting fingolimod [29]. About 72.6% were switched directly from another DMT, most due to intolerance, risk, convenience, or breakthrough disease.…”