Use of oral DMTs grew substantially since their launch: US study

Since their launch in the 2010s, the use of oral disease-modifying treatments (DMTs) for multiple sclerosis (MS) has increased substantially, while injectable DMTs have become less popular, according to a study based on U.S. commercial health insurance data.

“While two injectable therapies known as platform injectables, were once the mainstay of multiple sclerosis treatment, our study showed oral therapies became the predominate treatment for multiple sclerosis by 2020,” Mackenzie Henderson, the study’s first author and a postdoctoral researcher at the Rutgers Institute for Health, Health Care Policy, and Aging Research, said in a university press release.

This study “offers an important step in understanding the evolving treatment landscape for MS among U.S. adults and children,” Henderson added.

The study, “Initiation Patterns of Disease-Modifying Therapies for Multiple Sclerosis Among US Adults and Children, 2001 Through 2020,” was published in JAMA Neurology.

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DMTs available since 1990s, with first oral treatment approved in 2010

The first disease-modifying treatments for MS were approved in the 1990s, and in the following decades many more have been approved — about two dozen DMTs are currently available to treat MS in the U.S.

“Specifically, oral DMTs became available in 2010 and have provided an alternative, more convenient form of administration compared with injectable and infusion therapies,” the researchers wrote.

With an increasing number of available DMTs for MS, “treatment decisions revolve around shared decision-making between patients and clinicians regarding the need to balance convenience, safety and tolerability, efficacy, and costs,” they added.

However, how the patterns of their use have changed over time in the U.S., especially among pediatric MS patients, remains largely unknown.

“Understanding how real-world treatment patterns in MS have shifted can provide insight into patients’ and clinicians’ evolving priorities in making these decisions,” the researchers wrote.

Now, a team of scientists looked at data from a U.S. health insurance database to analyze patterns of DMT initiations from 2001 to 2020 among adult and pediatric MS patients with employer-based insurance.

The analysis included data on 113,095 adults with MS, as well as 488 children and adolescents with the disease, who started on at least one new DMT in the time period analyzed. More than 70% of these patients were female.

Results showed that, in the early 2000s, virtually all adult patients were started on platform injectable DMTs, which include interferon-beta-based therapies such as Avonex (interferon beta-1a) and glatiramer acetate (sold as Copaxone and generics). These therapies were some of the first to be approved for MS in the 1990s.

While two injectable therapies known as platform injectables, were once the mainstay of multiple sclerosis treatment, our study showed oral therapies became the predominate treatment for multiple sclerosis by 2020.

Use of injectable medications for MS has declined over the years

However, the use of injectable medications declined significantly in the years since. By 2020, about one in four DMT initiations among adult patients were with these therapies.

The reduced use of injectable DMTs “corresponded strongly with the market introduction of oral therapies in 2010,” the researchers wrote. Oral DMTs include Tecfidera (dimethyl fumarate), Aubagio (teriflunomide), Gilenya (fingolimod), and Mavenclad (cladribine).

When the first oral DMT was introduced in 2010, about 1.1% of DMT initiations were with oral medications. But by 2020, oral therapies accounted for nearly two-thirds (62.3%) of treatment initiations.

Therapies that are administered via infusion into the bloodstream were generally less common during the study period. These accounted for 3.2% of all treatment initiations since the first infusible therapy, Tysabri (natalizumab), was approved in 2004. The researchers noted that the use of infusible therapies increased slightly since 2017, when Ocrevus (ocrelizumab) was approved.

“Despite the availability and efficacy of infusion therapies for multiple sclerosis, we found that their utilization remained relatively low throughout the study period,” said Chintan Dave, PhD, the study’s senior author and an assistant professor with Rutgers Ernest Mario School of Pharmacy.

“This may be due to several factors contributing to this treatment decision by patients and clinicians, including the preference for more convenient oral therapies, the relatively recent introduction of infusion options, and considerations of safety and cost,” Dave added.

Patterns seen in children with MS were generally similar to those seen for adult patients, the researchers noted. The exception was in the preferred oral DMT, with the most commonly initiated oral therapy between 2019 and 2020 being Tecfidera for adults (23.3% to 27.2%) and Gilenya for children (34.8% to 68.8%).

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Study included only patients on commercial health insurance in US

Among the study’s limitations, the scientists highlighted the inclusion of only patients with commercial insurance, representing about 55% of MS patients in the U.S. As such, it’s unclear whether these findings would also apply to patients who are on government-funded insurance programs like Medicare and Medicaid, or to people who are uninsured.

They also noted that data on important factors such as race and socioeconomic status, which may influence patients’ choices about treatment, were not available for this analysis.

“As new DMTs continue to enter the market, future research should evaluate the impact that these approvals will have on MS treatment patterns,” the team wrote.

Of note, one of the study authors has received grants and personal fees from Novartis and Biogen, companies that market both oral and non-oral DMTs for MS.