Safety and Effectiveness of Fingolimod in Real-World Multiple Sclerosis Portuguese Patients

Barros, Ariana; Sequeira, J.; Sousa, Ary Severino Lopes de; Capela, Carlos; Pedrosa, Rui; Manita, Manuel

doi:10.1097/wnf.0000000000000292

Cited by 6 publications

(9 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These results are in accordance with those reported by the PANGAEA study after 5 years of fingolimod therapy [22], a study conducted with similar methodological characteristics as the current study [23]. These results are also consistent with previously reported Portuguese studies whose results also showed a decrease in ARR in the first year of treatment with fingolimod [11,18] and with the MS NEXT study that reported a 76% decrease in ARR after 2 years of fingolimod [20].…”

Section: Discussionsupporting

confidence: 93%

“…However, in this last study, the percentage of relapse-free patients decreased from years 1 to 3 of fingolimod treatment. Nevertheless, the percentage of patients with no relapses during the 3 years of fingolimod treatment was 60.8% [18], similar to that observed in our study.…”

Section: Discussionsupporting

confidence: 91%

“…A multicentric study was necessary to contribute to the validation of the reported data. In these two studies, the reported discontinuation rate was 10.6% [11] and 15.6% (at 12 months) [18]. These attrition rates are similar to the ones found in the present study (9.8%), which are also similar to the ones reported by the real-word study with fingolimod from UK (approximately 8%) [13].…”

Section: Discussionsupporting

confidence: 90%

“…This study aimed to characterise the patients' profile treated with fingolimod in the Portuguese real-word clinical practice, as well as to assess its effectiveness and safety. In Portugal, the effectiveness and safety of fingolimod in a real-word population was previously studied in two singlecentre studies [11,18]. A multicentric study was necessary to contribute to the validation of the reported data.…”

Section: Discussionmentioning

confidence: 99%

“…The GENIUS study concluded that fingolimod appeared to be effective in naïve patients and after first-line treatment failure in reducing risk of relapse and disease activity throughout a 2-year follow-up [21]. In the two Portuguese real-world studies, the percentage of relapse-free patients at year 1 after switching to fingolimod was 75% [11] and 80.4% [18]. However, in this last study, the percentage of relapse-free patients decreased from years 1 to 3 of fingolimod treatment.…”

Section: Discussionmentioning

confidence: 99%

See 4 more Smart Citations

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

et al. 2020

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

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

et al. 2020

View full text Add to dashboard Cite

show abstract

A Prospective, Observational Study Assessing Effectiveness, Safety, and QoL of Greek Patients with Multiple Sclerosis Under Treatment with Fingolimod

et al. 2023

View full text Add to dashboard Cite

The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review

et al. 2021

View full text Add to dashboard Cite

In this narrative review, we analyze pre-registration and post-marketing data concerning hepatotoxicity of all disease-modifying therapies (DMTs) available for the treatment of relapsing-remitting multiple sclerosis, including beta interferon, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, cladribine, natalizumab, alemtuzumab, and ocrelizumab. We review the proposed causal mechanisms described in the literature and we also address issues like use of DMTs in patients with viral hepatitis or liver cirrhosis. Most data emerged in the post-marketing phase by reports to national pharmacovigilance agencies and published case reports or case series. Serious liver adverse events are rare, but exact incidence is largely unknown, as are predictive factors. Unfortunately, none of the DMTs currently available for the treatment of multiple sclerosis is free of potential hepatic toxic effects. Cases of acute liver failure have been reported for beta-interferon, fingolimod, natalizumab, alemtuzumab, and ocrelizumab by different mechanisms (idiosyncratic reaction, autoimmune hepatitis, or viral reactivation). Patients with multiple sclerosis should be informed about possible hepatic side effects of their treatment. Most cases of liver injury are idiosyncratic and unpredictable. The specific monitoring schedule for each DMT has been reviewed and the clinician should be ready to recognize clinical symptoms suggestive for liver injury. Not all DMTs are indicated in cirrhotic patients. For some DMTs, screening for hepatitis B virus and hepatitis C virus is required before starting treatment and a monitoring or antiviral prophylaxis schedule has been established. Beta interferon, glatiramer acetate, natalizumab, and alemtuzumab are relatively contraindicated in autoimmune hepatitis due to the risk of disease exacerbation.

show abstract

Safety and Effectiveness of Fingolimod in Real-World Multiple Sclerosis Portuguese Patients

Cited by 6 publications

References 18 publications

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

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

A Prospective, Observational Study Assessing Effectiveness, Safety, and QoL of Greek Patients with Multiple Sclerosis Under Treatment with Fingolimod

The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review

Contact Info

Product

Resources

About