REALMS study: real-world effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis in Portugal

Abstract

Background Fingolimod, an oral sphingosine 1-phosphate receptor modulator, is approved by EMA for relapsing-remitting multiple sclerosis (RRMS). Objectives To assess the effectiveness and safety of fingolimod in patients with RRMS in real-world clinical practice in Portugal. Methods Retrospective, multicentre, non-interventional study, reporting 3 years follow-up of data collected from October 2015 to July 2016. Sociodemographic data and previous treatments at baseline and data regarding disease evolution, including number of relapses, annualised relapse rates (ARR) and Expanded Disability Status Scale (EDSS), were collected. Results Two-hundred and seventy-five participants were enrolled in the REALMS study. Results showed that the main reason to switch to fingolimod was failure of previous treatment (56.7%) and only 3.6% were naïve patients. In the total population, there was a significant decrease in ARR of 64.6% in the first year of treatment, 79.7% in the second year and 82.3% in the third year, compared with baseline. More than 67.0% of patients had no relapses during the 3 years after switching to fingolimod. EDSS remained stable throughout the study. Conclusions Therapy with fingolimod showed a sustained effectiveness and safety over the 3 years, particularly on patients switched from first-line drugs (BRACE). No new safety issues were reported.

The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary

“…Furthermore, some studies employed patients with both progressive and relapsing-remitting disease type [37]. Most of our findings corroborate the outcomes of the biggest real-life studies conducted with fingolimod so far [37,[38][39][40][41][42][43][44][45][46][47][48][49][50][51]56]. Although several papers have been published evaluating the real-world effectiveness of fingolimod, most report outcomes are capped at 2 or 3 years.…”

“…Furthermore, apart from a select few [32,37,38], most of the studies examining fingolimod in a real-world practice published so far are heterogeneous in terms of the methodologies and/or the cohorts used. Some of them were conducted solely in a single centre [30,[39][40][41][42][43], some of them were posthoc analyses of the pivotal studies [44][45][46], some used a relatively small cohort [30,39,40,43,47,48]. Meanwhile, others have focused only on a single objective [49][50]; except a few studies [51,52], the follow-up period was surprisingly brief [43,[53][54][55] in several reports.…”

Review article: Risk of cardiovascular events in patients with inflammatory bowel disease receiving small molecule drugs

“…Within 6 h of the first dose, 19 patients experienced bradycardia, which was symptomatic in two; six patients had a second‐degree AV block, and one developed a third‐grade AV block 104 . Similar rates were also observed in other long‐term real‐world studies 105,106 …”

“…104 Similar rates were also observed in other long-term realworld studies. 105,106 Siponimod selectively modulates S1P1 and S1P5 receptors, and it is approved for the treatment of multiple sclerosis. 107 A phase 3, placebo-controlled RCT in which 1105 patients with multiple sclerosis were randomised to receive treatment with siponimod 2 mg or placebo.…”

Factors Influencing the Degree of Disability in Patients With Multiple Sclerosis

“…A long-term follow-up study by Healy et al found that interferon-beta (IFN-β) could appropriately extend the time for EDSS to reach 4 points and 6 points ( 11 ). Batista et al showed that fingolimod could significantly reduce the ARR of MS patients, and that the EDSS score remained stable during the use of fingolimod ( 12 ). Teliflunomide has a good effect on patients with mild disabilities (EDSS ≤ 2) initial treatment ( 13 ).…”