Real-World Data Shows Tecfidera, Tysabri Improve Outcomes in MS Patients


New analyses show the benefits of early treatment with Tefidera (dimethyl fumarate) and Tysabri (natalizumab).

Biogen recently announced positive, real-world data showing dimethyl fumarate (Tecfidera) and natalizumab (Tysabri) improved outcomes for patients with relapsing multiple sclerosis (MS).

MS is a chronic, disabling condition that attacks the central nervous system. Initiating treatment early after diagnosis has been observed to slow disease progression and may prevent future disability, which may allow patients to remain active, according to a press release. These recent findings suggest that early treatment with dimethyl fumarate and natalizumab could improve patient outcomes.

Dimethyl fumarate is an oral treatment for relapsing MS that has been used by more than 240,000 patients. It is the most commonly prescribed treatment for MS worldwide.

According to a comparison of real-world data, dimethyl fumarate showed efficacy in treatment-naïve and treatment-experienced patients with MS compared with other treatments.

In the study, the researchers used insurance claims to compare time to first relapse among patients treated with dimethyl fumarate, fingolimod (Gilenya), or teriflunomide (Aubagio).

They discovered that dimethyl fumarate reduced the risk of relapse by 30% compared with teriflunomide. The risk of relapse between dimethyl fumarate and fingolimod were comparable. These findings are consistent with other data showing similar results to oral drugs and increased efficacy to interferon beta and glatiramer acetate, according to the release.

Another analysis of the PROTECT and RESPOND clinical trials examined the efficacy of dimethyl fumarate in early MS and early switch patients. The investigators found that dimethyl fumarate reduced the 1-year annual relapse rate among early MS subgroups, including those who switched from a disease-modifying therapy, Biogen reported.

Natalizumab is a targeted MS treatment with more than 10 years of clinical use. New data from an observational program highlight the proven efficacy of natalizumab and show that early, continuous treatment results in optimal patient outcomes.

A new subgroup analysis compared outcomes for treatment-naïve patients who initiated natalizumab less than 1 year after symptom onset with patients with initiated treatment after many years.

The investigators analyzed annualized relapse rate and disability status, as indicated by the Expanded Disability Status Scale. Over 3 years, 49.3% of patients who initiated treatment within 1 year of symptom onset experienced disability improvement, compared with 38.1% of patients who initiated treatment between 1 to 5 years, according to the release. Only 26.3% of patients who started treatment more than 5 years after symptom onset saw disability improvement.

Treatment with natalizumab was also found to significantly reduce the annualized relapse rate compared with baseline among all patients. The investigators also found that patients who remained on natalizumab experienced better outcomes than patients who switched, according to the release.

Additional data will be presented at the annual meeting of the American Academy of Neurology (AAN).

“The new real-world Tecfidera and Tysabri data presented at AAN emphasize the importance of effective treatment early in the course of one’s disease,” said Kate Dawson, MD, vice president, US Medical at Biogen. “Timely treatment with appropriate therapies can help mitigate damage caused by MS and delay long-term disability for people with the disease.”

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