Safety and efficacy of fingolimod in clinical practice: The experience of an academic center in the Middle East

Yamout, Bassem; Zeineddine, Maya; Tamim, Hani; Khoury, Samia J.

doi:10.1016/j.jneuroim.2015.10.015

Cited by 25 publications

(16 citation statements)

References 19 publications

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“…Two studies examining the safety and efficacy of fingolimod in Kuwait [20] and Lebanon [21] have been published. However, no large-scale studies comparing oral and injectable medications or examining use of different MS medications have been performed.…”

Section: Resultsmentioning

confidence: 99%

The Rapidly Changing Landscape of Multiple Sclerosis Immunomodulatory Therapy: A Retrospective Chart Review in the United Arab Emirates

Schiess¹,

Holroyd²,

Aziz³

et al. 2017

J Mult Scler

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The past 6 years have demonstrated a dramatic change in the landscape of immunomodulatory treatment for multiple sclerosis. Prior to 2010, there were no approved FDA oral immunomodulatory medications available. Since then, three new oral medications have been approved in addition to the newly approved alemtuzumab and ocrelizumab. This has dramatically changed the treatment options for MS patients. The older injectable agents -beta-interferons and glatiramer acetate are slowly being replaced. While data exists in the literature regarding the use of new medications in the west, there is little published data about the use of these new medications in the Middle East and, none, to our knowledge, in the United Arab Emirates (UAE). We conducted a retrospective chart review of four major government hospitals in Abu Dhabi looking at the types of MS in the Emirate, the use of different immunomodulatory treatment and the changes in prescribed medications between 2014 and 2016. A total of 328 people with MS were identified for the study. The proportion of participants receiving injections or infusions significantly (p=0.0013) dropped from 53% (128) in 2014 to 42.7% (102)

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Section: Resultsmentioning

confidence: 99%

The Rapidly Changing Landscape of Multiple Sclerosis Immunomodulatory Therapy: A Retrospective Chart Review in the United Arab Emirates

Schiess¹,

Holroyd²,

Aziz³

et al. 2017

J Mult Scler

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“…The sociodemographic and disease variables associated with better health outcomes were younger age, female gender, current employment, higher level of education, shorter disease duration, and non-progressive type of MS. DMD use was associated with higher odds of being fatigued or depressed, which may be common side effects of DMDs (29, 30), but lower odds for inability to walk unassisted. Lifestyle factors, of special interest given their modifiable character, associated with better health outcomes were non-smoking status, moderate alcohol use (vs. low), high level of physical activity (vs. low), normal BMI, healthier diet, vitamin D supplementation, and having several support people, in line with current literature (1, 2, 7).…”

Section: Discussionmentioning

confidence: 99%

International Differences in Multiple Sclerosis Health Outcomes and Associated Factors in a Cross-sectional Survey

et al. 2017

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Multiple sclerosis (MS) is a major cause of disability and poor quality of life (QOL). Previous studies have shown differences in MS health outcomes between countries. This study aimed to examine the associations between international regions and health outcomes in people with MS. Self-reported data were taken from the Health Outcomes and Lifestyle In a Sample of people with Multiple Sclerosis online survey collected in 2012. The 2,401 participants from 37 countries were categorized into three regions: Australasia, Europe, and North America. Differences were observed between regions in disability, physical and mental health QOL, fatigue, and depression, but most of these disappeared after adjusting for sociodemographic, disease, and lifestyle factors in multivariable regression models. However, adjusted odds for disability were higher in Europe [odds ratio (OR): 2.17, 95% confidence interval (CI): 1.28 to 3.67] and North America (OR: 1.79, 95% CI: 1.28 to 2.51) compared to Australasia. There may be other unmeasured factors that vary between regions, including differences in access and quality of healthcare services, determining disability in MS. When assessing differences in MS health outcomes, lifestyle factors and medication use should be taken into consideration.

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“…For example, data of an Italian study assessing the safety and tolerability of fingolimod after first dose ( n = 906) revealed that the concomitant use of drugs which may cause bradycardia or otherwise influence cardiac conduction was not associated with cardiac events during the first-dose observation [12]. Other studies in real-life settings also demonstrate the rare occurrence of cardiac events after the first dose of fingolimod and their self-limited character [2, 3, 12–17], thus corroborating the very favorable cardiac safety profile of fingolimod.…”

Section: Discussionmentioning

confidence: 99%

Cardiac Safety Profile of First Dose of Fingolimod for Relapsing-Remitting Multiple Sclerosis in Real-World Settings: Data from a German Prospective Multi-Center Observational Study

Linker

Wendt

2016

Neurol Ther

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IntroductionFingolimod was the first oral therapy approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). Due to its action on cardiac sphingosine 1-phosphate receptors, fingolimod is leading to a transient decrease in heart rate (HR) and the occurrence of rare and asymptomatic self-limited atrioventricular (AV) blocks. This German non-interventional clinical study aimed to assess the cardiac safety profile in RRMS patients during at least 6 h after the initial treatment or restart after interruption of fingolimod in real-world settings.MethodsThe GoCARD study (German National Health Authorities, BfArM, CFTY720DDE18, NIS334) was a prospective, multi-center non-interventional study which was conducted in neurological and other medical practices or hospitals, qualified to routinely assess electrocardiogram (ECG) findings. Data were collected through interviews, clinical evaluations (notably ECGs), and laboratory tests. Medical history, vital signs, and a 12-lead ECG were assessed before fingolimod administration. After the first dose, a 6 h ECG was performed and vital signs (blood pressure and HR) were measured hourly. The occurrence of bradycardia (HR ≤45 beats per minute [BPM]), AV blocks (2nd degree Mobitz type I or higher), and corrected QT interval (QTc) intervals was also documented.ResultsMore than 95% of physicians adhered to the cardiac monitoring recommendations. The observation of 217 patients in 42 study centers showed that while 35.9% of the patients had any cardiac risk profile, none of them experienced a bradycardia during the 6 h post-dose observation. Overall, only 1.8% of all patients displayed bradycardia (HR ≤45 BPM) during 6 h after treatment initiation. Moreover, in this cohort, none of the patients showed a new or persistent onset AV block (2nd degree Mobitz type I or higher) or QTc ≥500 ms.ConclusionAltogether, these data confirm that the first-dose observation after fingolimod initiation is usually uneventful (even in patients with pre-existing cardiovascular risk factors of this cohort) and that the rarely observed events remained asymptomatic and self-limited.FundingNovartis Pharma GmbH, Nürnberg, Germany.

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Safety and efficacy of fingolimod in clinical practice: The experience of an academic center in the Middle East

Cited by 25 publications

References 19 publications

The Rapidly Changing Landscape of Multiple Sclerosis Immunomodulatory Therapy: A Retrospective Chart Review in the United Arab Emirates

The Rapidly Changing Landscape of Multiple Sclerosis Immunomodulatory Therapy: A Retrospective Chart Review in the United Arab Emirates

International Differences in Multiple Sclerosis Health Outcomes and Associated Factors in a Cross-sectional Survey

Cardiac Safety Profile of First Dose of Fingolimod for Relapsing-Remitting Multiple Sclerosis in Real-World Settings: Data from a German Prospective Multi-Center Observational Study

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