More at-home Tysabri dosing seen for RRMS patients in France: Study
From 2022 to 2023, home treatments increased from 2% to nearly 7%
From 2019 to 2023, people with relapsing-remitting multiple sclerosis (RRMS) in France on treatment with Tysabri (natalizumab) adopted more at-home dosing and longer periods between doses, according to a review by researchers of the French national hospital database.
An increasing use of the therapy during pregnancy also was observed.
“Despite the approval of several other highly effective [disease modifying therapies] and their use earlier and earlier in the disease, [Tysabri] remained substantially prescribed in France,” the researchers wrote.
The team attributed at least some of the therapy’s increased at-home use to two key factors: the COVID-19 pandemic, which led to more home healthcare, and a formulation change in late 2021 that allowed dosing of Tysabri by subcutaneous, or under-the-skin, injections in addition to intravenous, or into-the-vein, infusions.
Its use “was certainly facilitated by better therapeutic management with the development of at-home injections,” the team wrote, noting Tysabri dosing “was maintained and even increased in France” over this time period.
The researchers’ findings were detailed in “Trends in the real-world management of patients with active relapsing-remitting multiple sclerosis treated with natalizumab (TYSABRI) in France: An analysis of the PMSI database over five years (2019–2023),” a study published in the journal Revue Neurologique.
Number of patients using therapy at home jumped from 2 to 520
Tysabri is an antibody-based therapy that’s been approved for RRMS in Europe since 2006. It has been shown to lower relapse rates, slow disability progression, and reduce the formation of new active brain lesions among patients. The therapy works by preventing the entry of immune cells into the brain and spinal cord, ultimately decreasing the inflammation that drives disease progression and symptoms.
Since the treatment’s approval in the European Union, changes have been made in how RRMS is managed with Tysabri. This includes the change in its formulation, a shift to more frequent at-home dosing due to the COVID-19 pandemic, and longer times between dosing to reduce the risk of side effects. There’s also been an increase in its use during pregnancy.
Now, a team of scientists from France extracted data from a national hospital database to shed light on the real-world management of MS patients treated with Tysabri. The study was sponsored by Biogen, which markets the therapy; one of the five scientists works for the company.
The data showed that, in 2019, 5,708 MS patients received Tysabri. That number grew to 7,181 by 2023, marking an increase of 25%.
We have seen a marked shift [toward subcutaneous] injections, with the proportion of [intravenous] infusions declining rapidly over the last two years. … It is too early to say whether this result will be confirmed in the years to come.
Population characteristics remained consistent across each calendar year, with a mean age of patients between 39 and 40. Of those on the medication, 3 of every 4 patients consistently were women. Over time, the number of newly treated patients also remained relatively stable (14.8%-18.7%).
In 2019, two patients received at-home injections. By 2023, that number had risen substantially, to 520 patients who received 3,501 injections at home.
Also in 2023, 63,118 injections occurred in healthcare facilities, with that number comprising overnight stays, day hospitalization, and drug infusion sessions.
“We have seen a marked shift [toward subcutaneous] injections, with the proportion of [intravenous] infusions declining rapidly over the last two years,” the researchers wrote. “It is too early to say whether this result will be confirmed in the years to come.”
Tysabri formulation updated in 2021, allowing subcutaneous dosing
In October 2021, Tysabri’s formulation was updated in the European Union to add the subcutaneous injection to the intravenous (IV) infusion. From the following January to December 2023, the number of IV infusions dropped by more than half (71% vs. 29.2%). During the same period, at-home treatments grew steadily from 2.1% to 6.8%. By 2023, 60.7% of patients received the subcutaneous injection, 27% the IV formulation, and 12.3% received both.
Extending interval dosing, or periods longer than 28 days between doses, was introduced in France around 2021-2022 to reduce the risk of side effects, including progressive multifocal leukoencephalopathy (PML), a rare and severe brain infection.
In 2019, half of MS patients in the country received 12 or 13 injections per year, which dropped to about 1-3 in 2023. Accordingly, the mean time between doses became longer, extending from 30.6 to 33.5 days, and the proportion of patients who received doses between 36 and 42 days rose from 5.9% to 17%.
Among those who received Tysabri between 1.5 and 3.5 years before 2019, the overall mean time between doses became longer after 2019, a trend that was more evident with longer periods of previous treatment.
Regarding pregnancy, the annual number of women who gave birth, and were exposed to Tysabri during the same calendar year, grew from 117 to 179. In 2019, about 1 in 5 patients stopped treatment within three months of conception, which dropped by more than half in 2020.
The use of Tysabri as a maintenance therapy during pregnancy rose in the first (75% to 90%), the second (44% to 78%), and the third trimesters (25% to 36%). During the three months after giving birth, the resumption of Tysabri remained relatively stable, at about 85%. Over time, more women adopted extended dose intervals within the 12 months of giving birth.
“Neurologists’ enhanced knowledge about treatment specificities thanks to research developed in the last 15 years on the management of PML risk and the positive experience from a patient’s point of view certainly contributed to the increase of the population of [MS patients] treated by [Tysabri],” the scientists concluded.
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