#ACTRIMS2017 – Novantrone Lowers Relapse Rates over Long Term, But Carries Cancer Risk

Ten years after completing treatment with Novantrone (mitoxantrone), a chemotherapy drug, multiple sclerosis (MS) patients showed evidence of markedly lower annualized relapse rates, but the therapy’s effects began to wane after five years, a study presented at ACTRIMS 2017 Forum reported.

The study also assessed how Novantrone affects disease progression in primary and secondary progressive MS patients, but results here were not reported. Although the treatment is effective in relapsing MS patients, it is linked to severe side effects, including heart problems, leukemia and other cancers.

Findings in the study, “Clinical follow-up of 411 patients with multiple sclerosis ten years after mitoxantrone treatment,” were given by Dr. Guillaume Mathey with Nancy University Hospital Center in France during the Poster Session 1 and Opening Networking Event at ACTRIMS, which ran from Feb. 23–25 in Florida.

Novantrone is approved for aggressive relapsing MS, as well as secondary progressive and relapsing-progressive disease. It is not indicated for primary progressive MS patients.

Researchers followed 411 patients, of which 155 had relapsing and 256  had progressive disease (both primary and secondary). The patients had been treated with Novantrone before Jan. 1, 2006, and the research team collected information detailing follow-up evaluations after 10 years from the European Database for Multiple Sclerosis (EDMUS).

By then, 117 relapsing and 186 progressive patients were still being followed. Among relapsing patients, the mean annualized relapse rate decreased from 2.0 to 0.5 at two years. This lower rate was maintained at five years, but rose to 0.7 at 10 years. But this annualized relapse rate still significantly lower than that recorded before the treatment’s start. No specific patient characteristics could be linked to a shorter time to first relapse.

In this group, disability levels, as measured by the Expanded Disability Status Scale (EDSS), increased from 2.8 at study start to 4.8 after 10 years. Higher annualized relapse rates at study start predicted a greater increase in disability.

At the time of analysis, 66.4 percent of relapsing patients had converted to secondary progressive disease. High relapse rates and disability scores at study start were linked to a higher likelihood of conversion.

Researchers reported that the progressive patients increased their average EDSS scores from 4.9 to 6.5 during the 10 years, but did not provide information as to whether disability progression rates differed before and after treatment. A low EDSS score at study start was, however, linked to a greater likelihood of increased disability levels.

Among all patients analyzed, four developed leukemia and 25 developed other cancers (including seven cases of breast cancer), and one patient had heart trouble.

Based on the findings, Mathey concluded that Novantrone “is a powerful induction therapy in MS, with a sustained effect at ten years, even if vanishing after year 5. Less active and disabled relapsing patients are more likely to benefit from this treatment.”