First-line Tysabri better at reducing MS relapse rates, healthcare use
Treatment has traditionally started with low- to moderate-efficacy DMTs
Starting Tysabri (natalizumab) early in multiple sclerosis (MS) treatment may lead to better outcomes, including greater reductions in relapse rates and less use of MS-related healthcare services over starting it after other therapies.
That’s according to a U.S. healthcare claims analysis of more than 1,500 adults with MS. While those who switched to Tysabri later saw significant improvements, those who received it as a first-line treatment tended to have even greater benefits, the data shows.
“This suggests the potential advantages of commencing [Tysabri] early in the treatment plan for MS not only in managing the condition effectively, but also in reducing the overall utilization of healthcare resources,” the researchers wrote. The study, “Evaluating natalizumab first-line and later-line use in multiple sclerosis: a US claims database analysis,” was published in Therapeutic Advances in Neurological Disorders. The study was led by researchers at Biogen, which markets Tysabri, and also funded the research.
More than 20 disease-modifying therapies (DMTs) are approved for MS. These therapies help reduce inflammation, and seek to reduce disease activity and slow disease progression, but each comes with its own safety and efficacy profile.
Traditionally, MS treatment has followed a stepwise approach, starting with low- to moderate-efficacy DMTs, which are generally safer, but less effective at controlling the disease. More potent, higher-efficacy therapies have more safety risks and higher costs, so they’ve been reserved for patients who show signs of disease activity with less effective drugs.
Rethinking first-line MS treatment
This approach is being challenged, however. Several studies have shown that starting a high-efficacy DMT earlier in the disease course can lead to fewer relapses and less disability worsening in the long term, which should result in less use of healthcare services and costs.
“Healthcare resource utilization (HCRU) and costs increase as disability progresses, with higher disability scores and disease relapses resulting in more hospitalizations and outpatient consultations,” the researchers wrote.
Tysabri is a high-efficacy antibody-based therapy that works by preventing immune cells from getting into the brain and spinal cord where they can cause damage. It’s traditionally been a second-line therapy, but researchers examined data from the U.S. Komodo Health database, which contains medical and pharmacy claims from 325 million people in the U.S., to see in a real-world setting how its effectiveness compares with its recent use as a first-line therapy.
The researchers focused on 1,568 adults who received a MS diagnosis between 2016 and 2020, and were given Tysabri as part of their treatment. Of them, 1,174 received Tysabri as their first DMT, while 394 used it as a second or later therapy.
Most of those who took Tysabri as a second-line or later therapy received moderate-efficacy DMTs — oral or older injectable therapies — as their first-line treatment. But some switched to Tysabri after first-line treatment with Ocrevus (ocrelizumab) or Kesimpta (ofatumumab). Tysabri’s effectiveness in both groups was assessed with the annualized relapse rate (ARR), or the average number of relapses per year, and healthcare resource utilization during follow-up.
As a first-line treatment, Tysabri resulted in an 81% reduction in ARR compared with baseline values, that is, those collected up to a year before starting treatment. When Tysabri was a later treatment, ARR was reduced by 55% over baseline.
Patients who received Tysabri as a first-line treatment started off with a higher ARR at baseline (1.48 relapses per year vs. 0.92 relapses per year in the later-line group). But they took longer to have a relapse and their relapse rate ended up being 32% lower than those given Tysabri later in their disease course. The risk of relapse was also 27% lower.
Finally, the researchers found that Tysabri consistently reduced the use of healthcare resources, such as MS-related hospitalizations, length of hospital stay, and outpatient visits, in both groups. For most assessments, however, these reductions were more pronounced in those who received it as first-line therapy.
According to the researchers, the “decreased risk of relapse, lower ARR and longer time to relapse” for patients on first-line Tysabri compared with those receiving it later in the disease course “reinforces the importance of utilizing natalizumab as a [first-line] treatment.”
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