Comparison of Treatment Retention and Satisfaction with Fingolimod, Interferons and Glatiramer Acetate in PREFERMS

Background: PREFERMSwas the first large randomized trial to measure treatment retention in relapsing–remitting multiple sclerosis (RRMS) and was designed to reflect treatment decisions in practice. The trial demonstrated higher therapy retention with fingolimod 0.5 mg/day than with injectable disease-modifying therapies (iDMTs). 

Objectives: To compare therapy retention with fingolimod versus specific iDMTs in patients with RRMS.

Methods: PREFERMS was a 12-month, open-label, active-controlled, randomized, multicenter, phase 4 study. Patients were either treatment-naïve or had received only one iDMT class. Before randomization (1:1; fingolimod:iDMT), investigators preselected an iDMT for each patient: intramuscular interferon beta (IFN beta-1a IM), subcutaneous IFN beta-1a (IFN beta-1a SC) or glatiramer acetate (GA). One treatment switch was allowed on-study: before 3 months of treatment for reasons of efficacy or safety only, and after 3 months for any reason. The primary endpoint was 12-month patient retention on randomized treatment. Treatment groups analyzed post hocfor this endpoint were IFN beta-1a IM, IFN beta-1a SC, all IFN betas combined and GA, compared with fingolimod. Secondary endpoints included clinical, radiological and patient-reported outcomes, and safety assessments. All subanalyses were for hypothesis generation only.

Results: Of 875 patients randomized, 861 (98.4%) were in the full analysis set (IFN beta-1a IM, n=76; IFN beta-1a SC, n=90; all IFN betas, n=197; GA, n=231; fingolimod, n=433). Significantly more patients receiving fingolimod (81.3%) completed randomized treatment than those receiving IFN beta-1a IM (34.2%), IFN beta-1a SC (34.4%), all IFN betas (33.5%) or GA (25.5%) (all p<0.0001), with little difference in retention between iDMT groups. Based on pooling of patients’ Medication Satisfaction Questionnaire responses of ‘somewhat satisfied’, ‘very satisfied’ and ‘extremely satisfied’, more patients expressed satisfaction with fingolimod (77.4%) than with IFN beta-1a IM (44.4%), IFN beta-1a SC (47.8%), all IFN betas (47.2%) or GA (47.6%) (all p<0.0001 at last assessment on randomized treatment). Safety outcomes were consistent with respective product labels.

Conclusions: Higher therapeutic retention and greater treatment satisfaction were observed with fingolimod than with each iDMT or iDMT class analyzed.