A majority of relapsing-remitting multiple sclerosis (RRMS) patients at a Swedish clinic who initiated treatment with Tecfidera (dimethyl fumarate; DMF) either stopped or switched to another therapy within two years, a study reports.
Researchers in the observational study were not able to determine exact reasons for discontinuation. But, they wrote, “it is likely that lack of effectiveness, lack of tolerability, or a combination of the two contributed to the low persistence rates observed.”
When Tecfidera was approved to treat RRMS patients in the European Union in 2014 (in the U.S. in 2013), expectations promoted its rapid use. But high discontinuation rates seen among patients in pivotal clinical trials and a lack of real-world data on persistance in use of the treatment, marketed by Biogen, encouraged this study. (Lack of persistence was measured as treatment discontinuation for 60 or more days, or a decision to switch therapies)
“DMF was the first oral first-line DMT [disease-modifying therapy] introduced, and the initial market uptake was relatively rapid compared to that of other recently introduced DMTs, suggesting that the expectations for DMF were high at the time of introduction,” the researchers wrote.
The high expectations were linked to the therapy’s ease of use (oral administration) and potential effectiveness, such as in overcoming intolerance and preventing disease relapses.
Researchers collected data on 400 RRMS patients who initiated Tecfidera treatment in Stockholm County from May 2014 through May 2017. A majority (61 percent or 244 people) had used other DMTs, and patients were observed for a median of 2.5 years.
Results revealed that 124 patients (31 percent) stopped treatment during that time, and 114 patients (29 percent) switched to another disease-modifying therapy. Mean time to discontinuation was 366 days; mean time to switching was 372 days. One-third of all patients had stopped using Tecfidera within one year, and only 43 percent continued using Tecfidera at two years, the researchers reported.
Rituximab, a commonly used off-label MS treatment, was the therapy chosen by most patients who switched from Tecfidera — by 78 percent of those who had never used a DMT previously, and by 62 percent of those who had.
“The rapidly changing MS treatment landscape poses a challenge for clinicians to select the most optimal DMT for their patients,” the research team wrote. “Even though risk-benefit profiles of the new DMTs have been assessed in clinical trials, there are uncertainties about their effectiveness and safety as well as long-term outcomes when used in routine clinical practice.”
While researchers could not determine from the data exact reasons for discontinuation, they noted a rising use of off-label rituximab among RRMS patients in Stockholm County between 2014 and 2017, and the likely role of Tecfidera’s “lack of effectiveness, lack of tolerability, or a combination of the two” in influencing patients’ choices.