Study Supports Fingolimod Use vs. iDMTs in Early Relapsing-Remitting MS
VANCOUVER, BC—“The advantages of fingolimod over injectable disease-modifying therapies (iDMTs) in patient retention and treatment satisfaction support use of fingolimod in early relapsing-remitting multiple sclerosis (MS) in the real world,” Heidi Crayton, MD, a neurologist with Multiple Sclerosis Center of Greater Washington, Vienna, VA, reported at the 68th AAN Annual Meeting.
That's the conclusion of PREFERMS, the first large randomized, prospective, real-world study of treatment retention with disease-modifying therapies and other outcomes in patients with early relapsing-remitting MS.
The 12-month Phase 4 open-label PREFERMS study enrolled patients who were treatment-naïve or who had received only one iDMT class, interferon beta or glatiramer acetate. Before patients were randomly assigned to oral fingolimod 0.5mg or iDMT, the investigators selected an iDMT for each. After a minimum of 3 months on treatment, one switch was allowed, unless an adverse event occurred that necessitated a change in therapy.
The primary endpoint was the percentage of patients who were retained on randomized treatment.
“Treatment satisfaction was assessed for both randomized and switched populations, using the Medication Satisfaction Questionnaire (MSQ) at all assessments,” they noted. “Sample-size and power calculations were based on retention rates only.”
A total of 875 patients were randomized, 436 to fingolimod 0.5mg and 439 to an iDMT.
“At baseline, mean time since diagnosis was 4.3 years, Expanded Disability Status Scale score was 2.4, and treatment-group characteristics were similar,” Dr. Crayton noted.
Among the 861 patients (98.4%) who completed the study, comprising the full analysis set, a significantly greater percentage completed on fingolimod, 81.3% (n=352) than on iDMT, 29.2% (n=125) (P<0.001), with 254 patients switching from iDMT to fingolimod, and 28 to iDMT.
“Patients receiving fingolimod experienced greater treatment satisfaction at all assessments than those on iDMT (P<0.001),” she stated. In addition, among patients who switched to fingolimod, satisfaction levels increased compared with iDMTs (P<0.05 at Months 6, 9, and last assessment) and fewer discontinued fingolimod, 5 (1.1%), vs. the 43 (9.8%) who discontinued iDMT.
Most of the switches from randomized treatment occurred in the iDMT group (90.5%) where the majority cited injection-related reasons, including injection-site reactions and influenza-like symptoms; this comprised 59.9% of the total switches made.