Self-injectable Therapies Tied to No Disease in 50% of Patients at 2 Years
More than half of multiple sclerosis (MS) patients treated with self-injectable therapies — namely, glatiramer acetate, marketed as Copaxone, among others, or any of a host of interferons — showed no evidence of disease activity after two years, according to a study out of Turkey.
Among patients treated for 10 years, nearly one in five was free of disease activity.
“Our study includes real-world data with the highest number of patients and the longest … follow-up, so far,” the researchers wrote, noting that more than half of the group continued treatment for 10 years.
This data, the team said, indicates that “self-injectable therapies may be considered relatively effective in these patients.”
The study, “Self-injectable DMTs in relapsing MS: NEDA assessment at 10 years in a real-world cohort,” was published in Acta Neurologica Scandinavia.
The efficacy of most injectable MS therapies traditionally was investigated in clinical trials by one of three measures: their ability to prevent relapses in the first years of treatment, their effectiveness in delaying disability worsening, and their efficacy in reducing the formation of new or enlarging brain lesions.
However, later studies suggested that a single outcome assessment that combined all three measures, called NEDA-3, for “No Evidence of Disease Activity,” could provide a better idea of treatment efficacy. NEDA-3 means that an individual has had no disease relapses, no worsening disability, and no signs of new brain inflammation as assessed on an MRI scan.
“Although lifelong NEDA-3 does not mean a cure for MS, it does mean optimal control of the disease,” the researchers wrote.
Aiming to determine the proportion of patients on NEDA-3 in the long-term, a quartet of scientists in Turkey examined data from 1,032 people with relapsing-remitting MS (RRMS) who were treated with self-injectable therapies from 1996 to 2005.
Specifically, 289 patients were treated with glatiramer acetate, which is sold as Copaxone, among other therapies, while the remaining 743 were treated with interferon. These interferon therapies included Betaseron, Avonex, Rebif, Extavia, and Plegridy.
The researchers assessed the proportion of participants with no evidence of disease activity, or NEDA-3, after two years of treatment. At two years, the NEDA-3 rate was 52.4% (321 total patients).
After 10 years, 613 patients (59.3%) were still being treated; the others either had stopped treatment or switched to other medications. Among those still on their therapies, 18.3% had NEDA-3 after a decade. The researchers noted that NEDA-3 rates at 10 years were generally higher among females, which is consistent with prior data that MS tends to be more severe in males. NEDA-3 after 10 years also was more common in patients with less disability and those who were younger at the time of treatment initiation.
“The disease was controlled two years after treatment in half of the patients, while NEDA-3 was achieved in one in five patients at the end of 10 years,” the team concluded. “Although this long-term rate may appear low, we think these therapies are effective if suitable patients are selected.”
In addition to supporting the effectiveness of these medications, this study “supports the idea that NEDA-3 can be an effective early predictor of progression-free status at treatment follow-up of up to 10 years,” the researchers wrote.
Of note, the average time to stop taking glatiramer acetate or interferon was 10.2 years.
“A lengthy adherence to self-injectable therapies may be interpreted as further evidence of their effectiveness and reliability,” the team wrote.