real-world study

A Phase 4 observational study called ENABLE is enrolling adults with relapsing forms of multiple sclerosis (MS) across the U.S. to better understand the safety, tolerability, and efficacy of Briumvi (ublituximab-xiiy) in the real world. At least 500 patients are expected to enter ENABLE (NCT06433752) at some…

A 14-week regimen of physical therapy combined with PoNS — a neurostimulator device used to improve mobility — led to significant gait improvements in people with multiple sclerosis (MS), with evidence that its benefits are sustained over time, according to new data from the real-world PoNSTEP clinical study.

Achieving NEDA — no evidence of disease activity — after two years of treatment was not common among people with relapsing-remitting multiple sclerosis (RRMS) at a center in Italy. NEDA more often was reached, however, when researchers didn’t include the first few months of treatment in their analysis, suggesting…

People with multiple sclerosis (MS) who switch between more than two disease-modifying therapies (DMTs) have a higher risk of relapses compared with those who never switch, regardless of how well these patients adhere to their prescribed medications, according to real-world study in Canada. These findings are consistent with…

Octave Bioscience plans to test its precision care program in an observational, real-world study with people with multiple sclerosis (MS). The program, called MS Precision Care Solution, uses blood biomarkers to monitor disease activity alongside MRI scans of the brain and spinal cord. An app tracks…

Disability progression in people with multiple sclerosis (MS) significantly reduces their quality of life, affects their ability to work, and represents a major socioeconomic cost, according to real-world data collected from a German MS registry. These results suggest that the use of disease-modifying therapies to slow MS progression…

A generic equivalent of oral Gilenya (fingolimod) significantly lowers relapse rates, slows disability progression, and works against new lesions developing in people with relapsing multiple sclerosis (MS), according to a real-world study in Turkey. Feedback from patients also was favorable, with most being satisfied with the generic treatment…

Treatment with Tecfidera (dimethyl fumarate) provides a similar long-term benefit for Black and Hispanic people with multiple sclerosis (MS) as is found in other racial and ethnic populations, according to five years of data from the real-world ESTEEM study. The study — which assessed the long-term safety and…

Outcomes are better for people with relapsing-remitting multiple sclerosis (RRMS) initially treated with higher efficacy disease-modifying therapies (DMTs) than for those who begin with lower efficacy DMTs and escalate to more effective treatments as the disease progresses, according to a real-world analysis of patient registry data. Findings also…

Nearly 80% of adults with highly active relapsing-remitting multiple sclerosis (RRMS) were free of relapses or confirmed disability worsening two years after receiving stem cell transplant, according to a real-world study in Denmark. Moreover, more than two-thirds (69%) of these RRMS patients achieved a clinical outcome called NEDA-3, or…

Tysabri (natalizumab) is generally safe and effectively lowers disease activity in people with multiple sclerosis (MS), according to a real-world study of patients over a 13-year period in Denmark. “Most patients treated with [Tysabri] are clinically stable with few adverse events,” researchers wrote. In more recent years, doctors…

One year of treatment with Lemtrada (alemtuzumab) significantly improved cognitive abilities, particularly with processing speed, and eased depression in people with relapsing forms of multiple sclerosis (MS), a small real-world study reported. Most of the 39 patients (92%) evaluated after that treatment year showed either stable or improved…

Almost two-thirds of a group of 108 secondary progressive multiple sclerosis (SPMS) patients being treated with Mayzent (siponimod) remained stable for at least one year, and about 1 in 5 of them showed improvements, a real-world study from Germany found. Nearly one-third of the total 227 SPMS patients evaluated…

The safety and efficacy of the approved multiple sclerosis (MS) therapy Mavenclad (cladribine) in a real-world group of patients were similar to what had been demonstrated in clinical trials, a new study reports. Among 243 people with relapsing-remitting multiple sclerosis (RRMS), more than 60% showed no…

Tecfidera (dimethyl fumarate) appears to have similar benefits to Gilenya (fingolimod) in preventing relapses and the loss of motor function and cognition in people with multiple sclerosis (MS), a study with real-world data found. The two medications also led to similar findings on MRI scans, including in…

Long-term treatment with Gilenya (fingolimod) in routine clinical practice is safe and effective for relapsing-remitting multiple sclerosis (RRMS), a five-year study in Germany of more than 4,000 patients reported. Over time, relapses in the majority of study patients who continued with Gilenya became less common and less severe,…

A real-world study confirmed the effectiveness and safety of interferon beta-1b in treating older adults with multiple sclerosis (MS), those over the age of 40. “These findings from a real-world setting are promising and demonstrate the positive benefit-risk ratio for [interferon beta-1b] in this study population of middle-aged and…

PicnicHealth and Komodo Health have agreed to combine their databases of patient medical records to support research based on real-world evidence. Together, the companies hope to unlock new insights into complex diseases like multiple sclerosis (MS). “Komodo Health and PicnicHealth share a mission to utilize health data…

Measurements of the thickness of the eye’s retina — the layer of nerve cells lining the back of the eye — could be used to predict disability progression and relapses in people with multiple sclerosis (MS), a real-world study from Austria suggests. “Our study shows that both crossectional and…

Patients with multiple sclerosis (MS) switching from Tysabri (natalizumab) to moderate-efficacy disease-modifying therapies (DMTs) are at a higher risk of showing signs of MS activity and experiencing disability progression than those switching to high-efficacy DMTs, a real-world study found. Based on these findings, the researchers are arguing that,…

Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are similarly effective at lowering the frequency of relapses and delaying disability progression in people with relapsing-remitting multiple sclerosis (RRMS), a real-world study from Switzerland reported. These efficacy measures were also consistent whether patients were new to a disease-modifying therapy (DMT)…

Mavenclad (cladribine) prevents relapses and disease progression in more than half of patients with relapsing forms of multiple sclerosis (MS) for at least five years after the last dose, according to a real-life study from Italy. These findings, based on real-world data from Italian MS patients previously treated…

Tecfidera (dimethyl fumarate) is as safe and effective in Hispanic/Latino multiple sclerosis (MS) patients as it is in their non-Hispanic and non-Latino peers, three-year data from a real-world study show. These interim findings, based on the largest group of Tecfidera-treated Hispanic and Latino MS patients studied to date, support the therapy’s…

Tysabri (natalizumab) is safe and shows robust, real-world effectiveness at reducing the frequency of relapses in people  with relapsing-remitting multiple sclerosis (RRMS), 10 years of data from a large, observational study report. Findings were reported in “Long-term safety and effectiveness of natalizumab treatment…

In clinical practice, relapse events dropped by roughly half over a four-year period in relapsing-remitting multiple sclerosis (RRMS) patients treated with Aubagio (teriflunomide), a real-world study reports. The study, “Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study,” also examined patients’ perspectives in…

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.

Tecfidera (dimethyl fumarate) and Gilenya (fingolimod) are equally effective in treating multiple sclerosis (MS), but Tecfidera shows higher rates of discontinuation, according to a real-world study. The study, “Discontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers,” was published in the journal Neurology Clinical…