Fingolimod

Gilenya (fingolimod), which works to modulate immune system activity in multiple sclerosis (MS), may benefit people with severe respiratory disease associated with COVID-19, a case report highlights. The study, “Severe COVID-19 infection in a patient with multiple sclerosis treated with fingolimod,” was published in…

People with relapsing multiple sclerosis (MS) being treated with Gilenya (fingolimod) for eight or more years show smaller increases in disability over 10 years than those using this treatment for a shorter time, a long-term follow-up study reports. Longer use of Gilenya also resulted in lesser disability progression,…

Treatment with Gilenya (fingolimod) could make people with multiple sclerosis (MS) more vulnerable to the parasitic infection known as cryptosporidiosis, a case report suggests. The report, “Cryptosporidiosis after treatment with fingolimod: a case report and pharmacovigilance review,” was published in the jorunal BMC Infectious Diseases. Gilenya…

Zeposia’s recent approval in the U.S. is exciting news for all in the MS community. Unfortunately, we will need to table that excitement a bit longer. Despite its approval, the treatment’s commercial distribution will be delayed by the COVID-19 pandemic. I am confident, however, that it will be…

Oral treatment with Gilenya (fingolimod) is more effective than Avonex (interferon beta-1a) for controlling brain lesion activity and brain volume loss in children with pediatric-onset multiple sclerosis (POMS), two-year results of the PARADIGMS study show. That means Gilenya provides an effective treatment option for…

The risk of invasive cancer may be slightly higher in multiple sclerosis (MS) patients treated with Gilenya (fingolimod) compared with those treated with rituximab, and with people from the general population, a Swedish study suggests. The study, “Cancer Risk for Fingolimod, Natalizumab, and Rituximab…

Ocrevus Use Rises Among New Starters with RRMS, Loses Ground to Other Therapies in PPMS Ocrevus (ocrelizumab) bolted out of the starting gate after it was approved for use in the U.S. about three years ago. However, though its use by people with relapsing forms of multiple sclerosis continues…

Treating people with relapsing-remitting multiple sclerosis (RRMS) for one year with the immune-modulating therapy Gilenya (fingolimod) reduced the numbers of antibody-producing B-cells and of T helper cells, a study finds.  While the…

The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS). A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the…

Teva Canada announced that Teva-Fingolimod 0.5 mg capsules, a bioequivalent generic version of Novartis’ Gilenya (fingolimod), are now available in Canada and approved by the country’s national health system called Health Canada. Generic medicines are chemically identical to the original branded therapy, but carry a significantly lower cost. Canadian…

Interferon therapy (brand names Avonex, Betaseron, and others) is more effective than glatiramer acetate (sold as Copaxone, Glatopa and other generics) for reducing relapses…

Long-term treatment with Gilenya (fingolimod) in patients with relapsing forms of multiple sclerosis (MS) is safe and effective, results from a Phase 3 trial show. Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in…

The levels of the inflammatory molecule interleukin-22 (IL-22) may be used as a potential biomarker to evaluate disease severity and the effectiveness of treatments in patients with relapsing-remitting multiple sclerosis (RRMS), a new study shows. The study, “Impact of interferon β-1b, interferon β-1a and fingolimod therapies on serum…

This is the time of year when my wife and I start thinking about getting our flu shots. We’ve already had the pneumonia and the older shingles vaccine and hope to soon update with the new shingles vaccine, Shingrix (recombinant zoster vaccine). These vaccines are OK with my neurologist and…

Over the past several weeks, I’ve been using an app called Floodlight to track my ability to live with my multiple sclerosis (MS). It measures things such as my balance, finger dexterity, walking speed, and cognitive ability. It even knows if I’m keeping myself shuttered in my apartment or…

Early and continuous treatment with Gilenya (fingolimod) in young  people — those ages 30 years or younger — with relapsing-remitting multiple sclerosis (RRMS) decreases the risk of disability progression, and lowers annual relapse rates and brain lesions, new analysis from the FREEDOMS and FREEDOMS II trials show. The…

Gilenya (fingolimod) has been approved in China as a disease-modifying therapy to treat adults and children, ages 10 and older, with relapsing forms of multiple sclerosis (MS). Gilenya, marketed by Novartis, is an oral disease-modifying treatment for relapsing MS. It acts by binding and modulating receptors…

About 15 disease-modifying therapies (DMTs) are available to treat MS these days. So, choosing which to use can be daunting. I’ve been treated with four DMTs since I was first prescribed Avonex (interferon beta-1a) back in 1996. Each time I’ve switched treatments, my neurologist has suggested a number of…

Almost 1 in 5 People Wrongly Diagnosed with MS at Two Specialized Centers in US, Study Finds We know that MS is a difficult disease to diagnose, but is it really possible that 20 percent of the MS diagnoses are wrong? Apparently so. This study reports that…

Multiple sclerosis patients who began treatment with Gilenya and stayed with it continuously showed a more than 50 percent reduction in annual relapse rates, a real-world study following these people for up to three years found. Gilenya, marketed by Novartis, is an oral disease-modifying treatment for relapsing-remitting multiple sclerosis , approved in 2010. It acts by binding and modulating receptors — called sphingosine-1-phosphate receptor — on lymphocytes (adaptive immune cells). By binding to these receptors, Gilenya prevents lymphocytes from leaving the lymph nodes and reaching the brain and spinal cord, and so lower lymphocyte-induced inflammation and damage. Although several clinical trials have reported reduced annualized relapse rates (ARRs) upon treatment with Gilenya, few long-term real-life studies have examined the relapse rate reductions over a long term. A team, led by Novartis researchers and a scientist at Central Texas Neurology Consultants, collected MS patient data from the MarketScan database, a U.S. claims database including medical and pharmacy claims (bills submitted to health insurance providers), between 2009 and 2016. Among 9,312 MS patients in the database with at least one filled Gilenya prescription, 1,599 adults (mean age, 46) met the study's inclusion criteria, including having at least one inpatient or two outpatient claims, and a total of four years of continuous health plan enrollment. Among these 1,599 patients, all used Gilenya for one year (cohort 1), 1,158 (72.4%) took Gilenya continuously up to the start of year two (cohort 2), and 937 (58.6%) used the therapy up to the start of year three (cohort 3). Baseline analysis — measures taken at the study's start — showed that the most common MS-linked symptoms were disorders of the optic nerve and visual pathways (reported in 22-24%), followed by fatigue/malaise (20-21%). Hypertension (20-21%) and depression (15-16%) were the most common physical and mental comorbidities, respectively. The mean annualized relapse rates (AARs) at baseline in these three groups of patients — cohorts 1 to 3 — ranged between 0.48 and 0.51. A consistent reduction in ARRs was seen in all three groups: cohort 1 had a 0.25 ARR at the close of the first year, for a 51% reduction from the baseline rate; cohort 2 a 0.22 ARR at the start of year two, for a  54% lowering in relapse rates from baseline; and cohort 3 had 0.23 ARR at the third year, amounting to a 53% reduction. As expected, when researchers calculated ARRs among patients with continuous Gilenya use over these three years, they found a greater reduction in annual relapse rates. Mean ARRs in continuous-use patients were 0.19 (a 61% reduction) during the first year, 0.18 (a 62% reduction) during the second year, and 0.18 (a 61% reduction) at the start of the third year. “This retrospective claims database study found that patients with MS who received fingolimod [Gilenya] therapy experienced a durable and sustained reduction in relapse rates over a 3-year period,” the researchers wrote, with findings representing “a durable reduction in relapse rates by [more than] 50%.” Reasons that some patients discontinued treatment were not a focus of this study, they added.

The question of how quickly to start a disease-modifying therapy (DMT) after a multiple sclerosis (MS) diagnosis is one that I frequently see when I browse online. It goes hand in hand with questions about which DMT is best to start with. There are many things to consider when…

The U.S. Food and Drug Administration (FDA) has issued a safety alert, warning that people with relapsing multiple sclerosis (MS) who stop using Gilenya (fingolimod) may experience disease worsening beyond that when starting the medicine or while taking it. Reported cases of such increases in MS disability upon stopping treatment are…

Assessing changes in a person’s heart rate can help to predict the degree to which lymphocyte numbers will decrease in relapsing-remitting multiple sclerosis (RRMS) patients using Gilenya (fingolimod), according to a small study. The research, “Fingolimod-induced decrease in heart rate may predict subsequent decreasing degree of…

Up to half of women with multiple sclerosis (MS) who stop treatment with Gilenya (fingolimod) when planning to become pregnant will experience a relapse during pregnancy, according to a new study. The findings also revealed relapses over the first six months after giving birth in a quarter of…

Mouse studies of siponimod — a potential progressive multiple sclerosis (MS) treatment that’s up for approval in the U.S. and EU — were among presentations given by Novartis at the 34th European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held Oct. 10-12 in Berlin. Animal work might seem…

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended that Gilenya (fingolimod) be approved to treat children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS). If the CHMP opinion is accepted, Gilenya — marketed by…

Gilenya (fingolimod) influences the release and function of small membrane particles, called extracellular vesicles, that are involved in the development of multiple sclerosis — and these vesicles may serve a biomarker of treatment effectiveness in people with relapsing MS, researchers report. Extracellular vesicles (EVs) may also work…

Multiple sclerosis (MS) patients may experience severe disease exacerbation after switching from Novartis’ Gilenya (fingolimod) to Sanofi Genzyme’s Lemtrada (alemtuzumab), a case report suggests. This unexpected high disease activity raises questions about managing MS through the consecutive use of immunotherapies. The case report, “Unexpected high multiple…

African-Americans with relapsing–remitting multiple sclerosis (RRMS) show higher adherence and greater satisfaction when treated with oral Gilenya (fingolimod, by Novartis) than with injectable therapies, according to a new study. The research, “Treatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A…

Shortening the washout period to four weeks when switching from Biogen’s Tysabri to Novartis’ Gilenya is safe and reduces the chances of experiencing a disease flare in patients with relapsing-remitting multiple sclerosis (RRMS), a small Swiss study found. A four-week washout reduced the risk of having a disease relapse or an increase in disease activity, compared with an eight-week washout period, for two years after switching from Tysabri to Gilenya. Although Tysabri effectively slows worsening of MS symptoms and the appearance of disease flares, its use is under a strict risk management plan as it heightens the risk of developing a rare and life-threatening brain infection called progressive multifocal leukoencephalopathy, also known as PML. Some patients may switch to Gilenya, an alternative disease-modifying therapy for RRMS. Gilenya has been associated with a lower risk of PML infection and seen to reduce relapses, disability worsening, and the appearance of new brain lesions on clinical trials. It also is the only therapy approved by the U.S. Food and Drug Administration for children with MS as young as 10. When switching from Tysabri to Gilenya, it is important to consider the washout period, which is the period when the patient is taken off medications. If too long, it may lead to disease reactivation, which can be even stronger than before starting Tysabri. There is little evidence about the optimal length of washout periods, but a Phase 3 trial showed that an eight-week washout between Tysabri and Gilenya was beneficial compared with longer washouts of 12 or 16 weeks. The eight-week washout enabled more RRMS patients to become free from relapses and lowered disease activity. To study if a shorter washout period of four weeks further reduced the risk of MS reactivation, researchers conducted an open-label, observational study at the University Hospital, Basel, Switzerland. The study enrolled 25 RRMS patients who were appointed to switch from Tysabri to Gilenya. Participants were assigned to either a four-week or an eight-week washout period, and were followed for two years after switching to Gilenya. Although patients were older in the four-week washout group, disease activity and disability scoreswere not significantly different between groups at the beginning of the study. Relapses, disability scores, and disease activity on magnetic resonance imaging scans were recorded at baseline and weeks 8, 12, 16, 20 32, 56, and 108. In the first year (week 56) the proportion of patients with disease flare-ups or disease activity on MRI was not significantly different between the two washout groups, affecting 55.6% and 62.5% of the patients who had a four-week and an eight-week washout, respectively. However, at the end of the two-year follow-up (week 108), recurrent event analysis showed that patients who were on the four-week washout group were 77% less likely to experience relapses. The combined risk for relapse or disease activity on MRI also was 58% lower in the four-week group, compared with those who had an eight-week washout. In addition, researchers found that patients who had flares more frequently in the year before discontinuing Tysabri also had a nearly four times higher risk of experiencing relapses in the first year after switching to Gilenya. This suggests that the number of relapses before switching from Tysabri can predict disease reactivation once on other disease-modifying therapies. Both washout periods were deemed safe, with no serious adverse side effects or cases of opportunistic infections, including PML, being reported. Researchers emphasized, however, that the findings need to be confirmed in larger studies.