Dataset Information

Use of Fingolimod in the Management of Relapsing-Remitting Multiple Sclerosis: Experience from Latin America.

ABSTRACT:

Unlabelled

Once-daily fingolimod 0.5 mg (FTY720; Gilenya(®), Novartis Pharma AG, Basel, Switzerland) is a sphingosine 1-phosphate receptor modulator that is approved for the treatment of relapsing multiple sclerosis (MS); currently, this includes approval in 13 Latin American countries. However, despite a well-characterized efficacy and safety profile in a large clinical development program, thus far there has been limited representation of patients from across the Latin American region. Differences in MS disease characteristics have been reported for the Latin American population compared with Caucasians, which may be additional to recent improvements in MS diagnosis. Furthermore, healthcare provision and regional socioeconomic factors exist that are unique to Latin America compared with other regions. Therefore, to optimize MS treatment pathways and improve patient clinical outcomes, it is important to investigate the efficacy and safety profile of fingolimod using ethnically relevant data. Here, we review key data from Hispanic patients enrolled in the fingolimod clinical trial program, summarize recent findings from the FIRST LATAM study, and appraise fingolimod data from real-world patient populations.

Funding

Novartis Pharma AG, Basel, Switzerland.

SUBMITTER: Correale J

PROVIDER: S-EPMC4522024 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionFingolimod 0.5 mg is an orally active sphingosine 1-phosphate receptor modulator approved for use in adults with relapsing multiple sclerosis (MS). The efficacy and safety profile of fingolimod has been well characterized in a large clinical development program. Here, we report the safety and tolerability of fingolimod in relapsing-remitting MS (RRMS) patients from Latin America.MethodsA total of 162 patients with RRMS, predominantly from Latin American countries (138/162), were enrolled in this 16-week, single treatment arm, open-label, multi-center study. Unlike the phase III pivotal studies, this study permitted enrollment of patients with controlled diabetes, certain cardiac and pulmonary conditions, older age, and higher baseline Expanded Disability Status Scale. All patients were monitored clinically for a minimum of 6 hours after the first dose. Safety and tolerability assessments were based on adverse events, clinically notable laboratory abnormalities, vital signs, ophthalmic examinations, and electrocardiograms.ResultsOverall, the safety and tolerability profile was consistent with that reported previously in phase 3 studies and the FIRST study. Adverse events (AEs) were predominantly mild (n = 49, 35.5%) or moderate (n = 27, 19.6%). Three patients (2.2%) discontinued fingolimod due to AEs. Infections were reported in 33 patients (23.9%) and were predominantly mild in nature (n = 28, 20.3%). Increases in alanine aminotransferase enzymes of ≥3, ≥5 and ≥10 upper limit of normal were reported in five (3.7%), three (2.2%) and one (0.7%) patients, respectively. Hypertension cases (n = 3; 2.2%) did not result in treatment discontinuation and were controlled with antihypertensive therapy. Following first-dose administration, the majority of patients (90.6%) were discharged at 6 h. During the first-dose monitoring, 5 cases of bradycardia were reported; none required extended monitoring or treatment for symptomatic bradycardia.ConclusionThe first dose of fingolimod 0.5 mg was well tolerated in RRMS patients from Latin America. The overall safety profile was clinically manageable and consistent with previous fingolimod studies.FundingNovartis.Trial registrationClinicalTrials.gov #NCT01497262.

Dataset Information

Use of Fingolimod in the Management of Relapsing-Remitting Multiple Sclerosis: Experience from Latin America.

Unlabelled

Funding

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets