Most Tysabri patients see no disease activity after 6 years: Study
Real-world study of RRMS patients shows majority reach NEDA-3
A large majority of people with relapsing-remitting multiple sclerosis (RRMS) who received Tysabri (natalizumab) in a real-world setting experienced no evidence of disease activity for as long as six years, according to a study from a single center in Hungary.
No evidence of disease activity, known as NEDA-3, means that patients experienced no relapses, no new or enlarging lesions, and no disability progression events during a period. The therapy also stabilized dexterity and walking function, and significantly improved cognition in these patients, the study found.
The study, “NEDA-state, psychological symptoms and quality of life are stable in natalizumab-treated multiple sclerosis patients: An up to 6-years long follow-up study,” was published in Heliyon.
In multiple sclerosis, the immune system launches an inflammatory attack against the myelin sheath, a protective coating around nerve fibers. The immune cells that drive the attack must cross the from bloodstream into the brain and spinal cord, where they cause inflammation.
Tysabri is an antibody marketed by Biogen, which was not involved in the study. It works by blocking a protein that helps immune cells cross blood vessel walls. By preventing their crossing into the brain and spinal cord, Tysabri is expected to reduce inflammation and the resulting damage to nerve cells.
Disease activity over time
While Tysabri has been approved for nearly two decades in the U.S. and Europe, not many studies have looked at its ability to sustain NEDA-3 over several years of treatment.
Researchers in Hungary examined the outcomes of 121 RRMS adults who received Tysabri at its standard every-four-week dosing at periods from 2010 to 2022. More than three-quarters of patients had high disease activity before starting Tysabri. The median follow-up was three years, with 38 participants observed for six years.
At some point during the follow-up period, a total of 97 participants (80.2%) reached NEDA-3 while on treatment with Tysabri. For those who didn’t, the main reason was disability progression on the Expanded Disability Status Scale (EDSS).
The proportion of patients who reached NEDA-3 was highest in the first year (95.9%). While that decreased steadily to 78.9% by year six of follow-up, at least three-quarters of patients reached NEDA-3 in each year of follow-up, indicating sustained benefits.
Looking at factors that could predict a higher chance of reaching NEDA-3, the team found that patients with an EDSS score up to 3, indicating no to moderate disability, were twice as likely to reach that outcome than patients with more significant disability levels (EDSS scores of 3.5-6.5).
In turn, patients who had received injectable therapies before switching to Tysabri were 50% less likely to reach NEDA-3 compared with those who had been prescribed oral medications or who received Tysabri as their first MS therapy.
Both hand dexterity and walking speed remained stable over the six-year period, as did fatigue and depression scores. Several measures of cognitive function also showed significant improvements over time.
Consistent with recent research showing that fatigue and depression are important predictors of quality of life in MS, patients continued to experience the same level of quality of life, or better, across various aspects of daily life.
Tysabri “not only [halts] clinical and MRI activity, it significantly reduces disease progression, effectively protects from the worsening of limb function, cognitive and other psychological impairment, and stabilizes the patients’ quality of life in basically every measurable aspect as well,” the researchers wrote.
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