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

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.

Biological and nonbiological complex drugs for multiple sclerosis in Latin America: regulations and risk management.

Biological drugs and nonbiological complex drugs with expired patents are followed by biosimilars and follow-on drugs that are supposedly similar and comparable with the reference product in terms of quality, safety and efficacy. Unlike simple molecules that can be copied and reproduced, biosimilars and follow-on complex drugs are heterogeneous and need specific regulations from health and pharmacovigilance agencies. A panel of 14 Latin American experts on multiple sclerosis from nine different countries met to discuss the recommendations regarding biosimilars and follow-on complex drugs for treating multiple sclerosis. Specific measures relating to manufacturing, therapeutic equivalence assessment and pharmacovigilance reports need to be implemented before commercialization. Physical, chemical, biological and immunogenic characterizations of the new product need to be available before clinical trials start. The new product must maintain the same immunogenicity as the original. Automatic substitution of biological and complex drugs poses unacceptable risks to the patient.

Management of relapsing-remitting multiple sclerosis in Latin America: practical recommendations for treatment optimization.

The Latin American MS Experts' Forum has developed practical recommendations on the initiation and optimization of disease-modifying therapies in patients with relapsing-remitting multiple sclerosis (RRMS). The recommendations reflect the unique epidemiology of MS and the clinical practice environment in Latin American countries. Treatment response may be evaluated according to changes in relapses; progression, as assessed by the Expanded Disability Status Scale and the Timed 25-foot Walk; and lesion number on magnetic resonance imaging. Follow-up assessments are recommended every six months, or annually for stable patients. Cognitive function should be evaluated in all RRMS patients at baseline and annually thereafter. These recommendations are intended to assist clinicians in Latin America in developing a rational approach to treatment selection and sequencing for their RRMS patients.

Optimizing outcomes in multiple sclerosis: consensus guidelines for the diagnosis and treatment of multiple sclerosis in Latin America.

OBJECTIVE: The prevalence of multiple sclerosis (MS) in Latin America varies across different studies but an intermediate risk and increased frequency of the disease have been reported in recent years. The circumstances of Latin American countries are different from those of Europe and North America, both in terms of differential diagnoses and disease management. METHODS: An online survey on MS was sent to 855 neurologists in nine Latin American countries. A panel of nine experts in MS analyzed the results. RESULTS: Diagnostic and therapeutic recommendations were outlined with special emphasis on the specific needs and circumstances of Latin America. The experts proposed guidelines for MS diagnosis, treatment, and follow up, highlighting the importance of considering endemic infectious diseases in the differential diagnoses of MS, the identification of patients at high risk of developing MS in order to maximize therapeutic opportunities, early treatment initiation, and cost-effective control of treatment efficacy, as well as global assessment of disability. CONCLUSIONS: The experts recommended that healthcare systems allocate a longer consultation time for patients with MS, which must be conducted by neurologists trained in the management of the disease. All drugs currently approved must be available in all Latin American countries and must be covered by healthcare plans. The expert panel supported the creation of a permanent forum to discuss future clinical and therapeutic recommendations that may be useful in Latin American countries.