Multiple sclerosis treatment with fingolimod: profile of non-cardiologic adverse events

Fragoso, Yára Dadalti

doi:10.1007/s13760-017-0794-7

Cited by 16 publications

(7 citation statements)

References 66 publications

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“…To conclude, this 5-year follow-up of PANGAEA confirmed the known and manageable safety profile of fingolimod but the identification of specific AEs potentially affecting treatment adherence might further increase the clinical benefit of fingolimod [36].…”

Section: Discussionsupporting

confidence: 61%

Long-term real-world effectiveness and safety of fingolimod over 5 years in Germany

Ziemssen

Lang²,

Schmidt

et al. 2022

J Neurol

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Objective To evaluate the 5-year real-world benefit–risk profile of fingolimod in patients with relapsing–remitting MS (RRMS) in Germany. Methods Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) is a non-interventional real-world study to prospectively assess the effectiveness and safety of fingolimod in routine clinical practice in Germany. The follow-up period comprised 5 years. Patients were included if they had been diagnosed with RRMS and had been prescribed fingolimod as part of clinical routine. There were no exclusion criteria except the contraindications for fingolimod as defined in the European label. The effectiveness and safety analysis set comprised 4032 and 4067 RRMS patients, respectively. Results At the time of the 5-year follow-up of PANGAEA, 66.57% of patients still continued fingolimod therapy. Annualized relapse rates decreased from baseline 1.5 ± 1.15 to 0.42 ± 0.734 at year 1 and 0.21 ± 0.483 at year 5, and the disability status remained stable, as demonstrated by the Expanded Disability Status Scale mean change from baseline (0.1 ± 2.51), the decrease of the Multiple Sclerosis Severity Score from 5.1 ± 2.59 at baseline to 3.9 ± 2.31 at the 60-months follow-up, and the percentage of patients with ‘no change’ in the Clinical Global Impression scale at the 60-months follow-up (78.11%). Adverse events (AE) occurring in 75.04% of patients were in line with the known safety profile of fingolimod and were mostly non-serious AE (33.62%) and non-serious adverse drug reactions (50.59%; serious AE 4.98%; serious ADR 10.82%). Conclusions PANGAEA demonstrated the sustained beneficial effectiveness and safety of fingolimod in the long-term real-world treatment of patients with RRMS.

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Section: Discussionsupporting

confidence: 61%

Long-term real-world effectiveness and safety of fingolimod over 5 years in Germany

Ziemssen

Lang²,

Schmidt

et al. 2022

J Neurol

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“…PML, Cryptococcus infection, hemophagocytic syndrome, Kaposi’s sarcoma, vasculopathy, or encephalopathy have been individually reported and reviewed recently by Fragoso. 56 These rare occurrences have (to our knowledge) not been captured in the long-term studies discussed herein. The primary end point of the international observational PASSAGE study (NCT01442194) is the incidence of collected adverse events.…”

Section: Discussionmentioning

confidence: 89%

Long-term safety and real-world effectiveness of fingolimod in relapsing multiple sclerosis

Druart¹,

Sankari²,

Pesch³

2017

PROM

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With a growing number of disease-modifying therapies becoming available for relapsing multiple sclerosis, there is an important need to gather real-world evidence data regarding long-term treatment effectiveness and safety in unselected patient populations. Although not providing as high a level of evidence as randomized controlled trials, and prone to bias, real-world studies from observational studies or registries nevertheless provide crucial information on real-world outcomes of a given therapy. In addition, evaluation of treatment satisfaction and impact on quality of life are increasingly regarded as complementary outcome measures. Fingolimod was the first oral disease-modifying therapy approved for relapsing multiple sclerosis. This review aims to summarize current knowledge on the long-term effectiveness and safety outcomes of multiple sclerosis patients on fingolimod. Impact on treatment satisfaction and quality of life will be discussed according to available data.

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“…Headache referred by patients treated with IFN-β has often migraine-like features and some of the patients compelling headache then develop medication-overuse headache and seek help from a physician due to the severity and frequency of headache [92]. Headache has also been reported as a side effect of fingolimod, teriflunomide and alentuzumab treatment, but reports from clinical trials investigating efficacy and safety on these immunomodulatory/immunosuppressive agents did not clarify the clinical characteristics of headache referred by patients [68,93,94]. Conversely, a longitudinal analysis of MS patients cohort revealed a significant reduction in migraine frequency for the subgroup of patients who were switched from IFN-β to natalizumab, irrespective of their level of fatigue, anxiety, depression, alexithymia or other clinical variables as well as Migraine Disability Assessment questionnaire scores [95,96].…”

Section: Effect Of Disease-modifying Treatment On Headache/ Migrainementioning

confidence: 99%

Headache and immunological/autoimmune disorders: a comprehensive review of available epidemiological evidence with insights on potential underlying mechanisms

Biscetti

Vanna

Cresta

et al. 2021

J Neuroinflammation

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Several lines of evidence support a role of the immune system in headache pathogenesis, with particular regard to migraine. Firstly, alterations in cytokine profile and in lymphocyte subsets have been reported in headache patients. Secondly, several genetic and environmental pathogenic factors seem to be frequently shared by headache and immunological/autoimmune diseases. Accordingly, immunological alterations in primary headaches, in particular in migraine, have been suggested to predispose some patients to the development of immunological and autoimmune diseases. On the other hand, pathogenic mechanisms underlying autoimmune disorders, in some cases, seem to favour the onset of headache. Therefore, an association between headache and immunological/autoimmune disorders has been thoroughly investigated in the last years. The knowledge of this possible association may have relevant implications in the clinical practice when deciding diagnostic and therapeutic approaches. The present review summarizes findings to date regarding the plausible relationship between headache and immunological/autoimmune disorders, starting from a description of immunological alteration of primary headaches, and moving onward to the evidence supporting a potential link between headache and each specific autoimmune/immunological disease.

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Multiple sclerosis treatment with fingolimod: profile of non-cardiologic adverse events

Cited by 16 publications

References 66 publications

Long-term real-world effectiveness and safety of fingolimod over 5 years in Germany

Long-term real-world effectiveness and safety of fingolimod over 5 years in Germany

Long-term safety and real-world effectiveness of fingolimod in relapsing multiple sclerosis

Headache and immunological/autoimmune disorders: a comprehensive review of available epidemiological evidence with insights on potential underlying mechanisms

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