Real-world data of treatment with Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) in relapsing multiple sclerosis (MS) patients suggest that treatment at early disease stages improves outcomes and prevents disability development.
The studies, presented by Biogen at the American Academy of Neurology 2017 Annual Meeting in Boston, might challenge the view that more potent disease-modifying drugs should be reserved for later disease stages.
“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,” Kate Dawson, MD, vice president of U.S. Medical at Biogen, said in a press release.
Biogen researchers compared the time to first relapse in patients who started Tecfidera, Gilenya (fingolimod), or Aubagio (teriflunomide). Compared to Aubagio, Tecfidera reduced the risk of relapse by 30%. There was no difference between Tecfidera and Gilenya in the time to first relapse. The results were seen in both newly treated patients and those previously treated with another disease-modifying drug.
Data also showed that Tecfidera was more effective than interferon-beta and glatiramer acetate.
Subgroup analyses of early-stage MS patients included in the PROTEC (NCT01930708) and RESPOND (NCT01903291) clinical trials showed that Tecfidera reduced annualized relapse rates over one year. This also was seen in patients who switched to Tecfidera from another disease-modifying treatment.
In addition, long-term data confirmed that Tecfidera continued being safe after seven years of treatment.
Tysabri also was seen to improve patient outcomes when used in early stages of disease. Biogen used data from the real-world Tysabri Observational Program (TOP; NCT00493298) to analyze how treatment initiation timing impacted disease development.
The study showed that those who initiated treatment one year or sooner after the first symptoms appeared were more likely to experience disability improvement than those who started treatment later.
Improvement was seen in 49.3% in those treated early, in 38.1% in those who started treatment between one and five years, and in 26.3% in those who started treatment after more than five years after symptom onset.
Researchers, however, pointed out that Tysabri also reduced annualized relapse rates when treatment was started later.
An analysis of reasons for Tysabri discontinuation showed that the majority of patients stopped the treatment because of concerns of PML (progressive multifocal leukoencephalopathy). The study also showed that those who continued Tysabri treatment fared better than those who switched treatments.
“Timely treatment with appropriate therapies can help mitigate damage caused by MS and delay long-term disability for people with the disease,” Dawson concluded.