Treatment Satisfaction After Switching To Fingolimod Directly From An Injectable Therapy (P7.218)

OBJECTIVE: To assess patient-reported treatment satisfaction after switching to oral fingolimod from an injectable disease-modifying therapy (iDMT) without an intervening washout period, thereby reflecting a real-world treatment switch scenario. BACKGROUND: Clinical trial data have shown that fingolimod treatment (0.5mg oral capsules) is associated with significant clinical efficacy benefits in relapsing-remitting multiple sclerosis (RRMS). Patients may switch to fingolimod from an iDMT, owing to a suboptimal previous treatment response or tolerability, but little is known about the impact of this switch on patient-reported outcomes. DESIGN/METHODS: In the phase 4, multicenter, open-label Evaluate Patient OutComes study, patients with RRMS were randomized to receive fingolimod or continue iDMT for 6 months, in a 3:1 ratio. The primary endpoint was change in global satisfaction subscale score at month 6 versus baseline on the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4. Secondary endpoints included change at month 6 versus baseline in TSQM subscale score for effectiveness, side effects and convenience. Between-group differences were calculated using ANCOVA models that included baseline score and treatment as exploratory variables. Adverse events (AEs) were assessed via physical examination and patient-reporting, and were summarized descriptively. RESULTS: Of 1053 randomized patients, 790 received fingolimod and 263 received iDMT. Global treatment satisfaction improved significantly in patients switched to fingolimod; month 6, least-squares (LS) mean scores increased by 20.4 in fingolimod, and 2.9 in iDMT groups (LS mean ± SE treatment difference, -17.5±1.7; P<0.001). For TSQM effectiveness, side effects and convenience subscales, LS mean ± SE treatment differences at month 6 were -12.5±1.7 (P<0.001), -18.5±1.6 (P<0.001) and -37.6±1.0 (P<0.001), respectively, in favor of fingolimod versus iDMT. The most common fingolimod AEs were headache (12.4%), fatigue (11.5%) and upper respiratory tract infection (6.5%). No unexpected immune complications were observed in patients who switched directly to fingolimod. CONCLUSIONS: Patient-reported treatment satisfaction improved significantly in patients who switched from iDMT to fingolimod, compared with those who continued iDMT. Study Supported by: Novartis Pharmaceuticals Corporation. Disclosure: Dr. Fox has received personal compensation for activities with Bayer Pharmaceuticals Corp., Biogen Idec, EMD Serono, Genzyme Corp., Novartis, Opexa Therapeutics, and Teva Neuroscience. Dr. Fox has received research support from Biogen Idec, Eli Lilly & Co., EMD Serono, Genzyme Corp., GlaxoSmithKline Inc., Novartis, Ono Pharmaceutical, Roche Diagnostics Corp., Sanofi-Aventis Pharmaceuticals Inc., and Teva Neuroscience. Dr. Edwards has received personal compensation for activities with Novartis, Biogen Idec, Acorda Therapeutics, and EMD Serono. Dr. Edwards has received research support from Biogen Idec, Novartis, Actelion, Janssen Pharmaceutica, Acorda Therapeutics, Genzyme Corp., Eli Lilly & Co., EMD Serono, and Sanofi-Aventis Pharmaceuticals, Inc. Dr. Burch has nothing to disclose. Dr. McCague has received personal compensation for activities with Novartis as an employee. Dr. Barbato has received personal compensation for activities with Novartis as an employee.