Patients with RRMS Discontinue Dimethyl Fumarate Earlier Than Fingolimod
VANCOUVER, BC—At 12 months, patients with relapsing-remitting multiple sclerosis (MS) treated with dimethyl fumarate (DMF) and fingolimod had similar rates of overall efficacy and adherence, according to findings from a "real-world” study presented in a poster session at the 68th AAN Annual Meeting.
However, DMF “may have greater gadolinium-enhancing (GdE) lesions and side effects early after treatment initiation, leading to early discontinuation and relapses," the coauthors cautioned.
"Results indicate that DMF and fingolimod have comparable ARR [annualized relapse rates], overall brain MRI activity, and discontinuation at 12 months," reported Carrie Hersh, DO, of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, NV, and coauthors.
Both DMF and fingolimod are approved oral disease-modifying therapies for relapsing-remitting MS. However, based on the existing evidence base, “comparative adherence and efficacy remain unknown,” the authors noted.
In order to compare these agents, Dr. Hersh and colleagues conducted an analysis using propensity scores to help “lessen effects of potential confounders on outcomes in observational studies.”
They identified 458 patients with relapsing forms of MS including secondary progressive MS with relapses, who were treated with DMF and 317 with fingolimod in a large academic center. Using unadjusted comparisons and propensity score weighting, they assessed discontinuation rates and measures of disease activity.
In the propensity score model, covariates included demographics and baseline clinical and MRI characteristics within 12 months of initiation of dimethyl fumarate or fingolimod. Outcome measures included the annualized relapse rate (ARR), drug discontinuation, and new brain MRI lesions at 12 months.
Prior to propensity score analysis, no significant differences were observed in the discontinuation rate (odds ratio [OR] 1.39; 95% confidence interval [CI] 0.99–1.92), annualized relapse rate (ARR: OR 1.28; 95% CI 0.85–1.91), GdE lesions (OR 1.52; 95% CI 0.78–2.95), or new T2 lesions (OR 1.54; 95% CI 0.93–2.55).
Propensity score weighting confirmed a lack of differences between groups for discontinuation rate (OR 1.30; 95% CI 0.84–1.99), ARR (OR 1.63; 95% CI 0.82–3.25), and new T2 lesions (OR 1.33; 95% CI 0.71–2.49).
However, after propensity score weighting, a greater proportion of patients treated with DMF than fingolimod had GdE lesions (OR 2.90; 95% CI 1.24–6.57; P<0.05), the authors reported. Patients treated with DMF also had earlier time to first clinical relapse (OR 1.64; 95% CI: 1.10–2.46; P<0.01) and discontinuation (OR 1.35; 95% CI 1.05–1.74; P<0.01).