DX16
Treatment Retention and Satisfaction in Patients Randomized to Fingolimod or Injectable Disease-Modifying Therapies in PREFERMS: Effect of Previous Treatment
PREFERMS was a 12-month, phase 4, active-controlled, open-label, multicenter study that compared treatment retention and related outcomes in 875 patients with relapsing multiple sclerosis. Understanding the impact of previous treatment status on retention could help inform treatment decision-making in the early stages of the disease.
Objectives:
To assess the impact of previous treatment status (naïve or previously treated) in patients randomized to oral fingolimod or injectable disease-modifying therapies (iDMTs) in PREFERMS on treatment retention, medication satisfaction and occurrence of adverse events.
Methods:
At enrollment, patients were either treatment-naïve (n=404, 46.2%) or had been treated with one class of iDMT (n=471, 53.8%). Patients were randomized (1:1) to fingolimod 0.5 mg/day or a pre-selected iDMT; patients previously treated with iDMT received an alternative iDMT class if randomized to iDMT. The primary endpoint was retention on randomized treatment. Secondary endpoints included medication satisfaction (measured using the Medication Satisfaction Questionnaire), reasons for treatment discontinuation, and occurrence of adverse events. These post hoc analyses and p values are for hypothesis generation only.
Results: Retention rates over 12 months were higher for fingolimod than for iDMTs in both subgroups (treatment-naïve, 78.7% [n/N=166/211] vs 38.1% [n/N=72/189], p<0.0001; treated, 83.8% [n/N=186/222] vs 22.2% [n/N=53/239], p<0.0001, respectively). A similar trend in favor of fingolimod compared with iDMTs was also observed for treatment satisfaction (treatment-naïve, 75.1% [n/N=157/209] vs 49.2% [n/N=93/189], p<0.0001; treated, 79.6% [n/N=176/221] vs 45.9% [n/N=107/233], p<0.0001, respectively). Rates of adverse events leading to study discontinuation were lower for fingolimod than for iDMTs, regardless of previous treatment status (treatment-naïve, 9.5% [n/N=20/211] vs 24.3% [n/N=46/189]; treated, 9.0% [n/N=20/222] vs 22.6% [n/N=54/239], respectively).
Conclusions:
In PREFERMS, fingolimod was associated with higher treatment retention and satisfaction rates and lower rates of adverse events leading to drug discontinuation than iDMTs, in both previously treated and treatment-naïve patients.