Real-World Patient Retention and Satisfaction on Fingolimod Versus Platform Injectable Disease-Modifying Therapies in Early RRMS: Results from PREFERMS

Thursday, June 2, 2016
Exhibit Hall
Heidi Crayton, MD , MS Center of Greater Washington, Vienna, VA
Brian Steingo, MD , Sunrise Medical Group, Sunrise, FL
DeRen Huang, MD, PhD , Neurology and Neuroscience Associates, Akron, OH
Xiangyi Meng, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Lesley Schofield, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Kristen Johnson, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Nadia Tenenbaum, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
* on behalf of the PREFERMS investigators, **please delete** , **please delete**, **please delete**, NJ
Jeremy Bright, PhD , Oxford Pharmagenesis, Tubney, United Kingdom
Terence Smith, PhD , Oxford Pharmagenesis, Tubney, United Kingdom

Background: Suboptimal adherence to injectable disease-modifying therapy (iDMT) classes is well established. PREFERMS is the first large study of treatment retention with disease modifying therapies and other outcomes in patients with relapsing–remitting multiple sclerosis (RRMS).

Objectives: To examine therapeutic retention and satisfaction on fingolimod versus iDMTs in PREFERMS, a randomized, prospective real-world study of patients with early RRMS.

Methods: PREFERMS was a 12-month, phase 4, open-label, active-controlled, randomized, multicenter study. At enrollment, patients were treatment-naïve, or had received only one iDMT class (interferon beta or glatiramer acetate). Investigators selected an iDMT for each patient, before subjects were randomized (1:1) to fingolimod 0.5 mg or the selected iDMT. One treatment switch was allowed on study after a minimum 3 months of treatment, unless required by an adverse event. The primary endpoint was percent retained on randomized treatment. Treatment satisfaction was assessed for both randomized and switched populations, using the Medication Satisfaction Questionnaire (MSQ) at all assessments. Sample-size and power calculations were based on retention rates only.

Results: 875 patients were randomized (fingolimod, n=436; iDMT, n=439). At baseline, mean time since diagnosis was 4.3 years, Expanded Disability Status Scale score was 2.4 and treatment-group characteristics were similar. Among 861 patients (98.4%) who completed the study (full analysis set), significantly more completed on fingolimod than on iDMT (352 [81.3%] vs 125 [29.2%]; p<0.001); 254 patients switched 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). Among those who switched, satisfaction levels increased with fingolimod versus iDMTs (p<0.05 at months 6, 9 and last assessment). After treatment switch, fewer patients discontinued fingolimod (5 [1.1%]) than iDMT (43 [9.8%]).

Conclusions: The advantages of fingolimod over iDMTs in patient retention and treatment satisfaction support use of fingolimod in patients with early RRMS in the real world.