Abstract
The PROFILE study measured patient reported outcomes (PROs) in the real world in fingolimod-treated patients with relapsing remitting multiple sclerosis (RRMS); the first study to do so specifically in the UK real world setting. This abstract presents data comparing adherence to previous treatment with adherence to fingolimod at three months (M). A prospective observational study of 144 consenting outpatients with RRMS in 14 secondary care National Health Service (NHS) centres. Eligibility: aged 18-55 years at first initiation of fingolimod (‘baseline’) and treated within the European product licence. Disease modifying therapy (DMT) history was collected from medical records at baseline and PROs were collected at baseline, three, six, and 12 M. A planned interim analysis of the 8-item ©Morisky Medication Adherence Scale (MMAS-8-item) for 75 patients is presented for patients who were on previous treatment at baseline (excluding those on infusions, de-risking from natalizumab). Mean (standard deviation [SD]) MMAS-8-item score at baseline/3M: 5.8 (1.6)/7.1 (0.9); mean change: +1.4 (95% confidence interval: 1.0; 1.7). 8/35 patients reporting low adherence (MMAS-8-item score: <6) at baseline and 19/33 reporting medium adherence (MMAS-8-item score: ≥6<8) at baseline, reported high adherence (MMAS-8-item score: 8) at 3M. At 3M, the largest proportions of patients reporting non-adherence were in the categories not taking medication yesterday: 53/75 (70.7%) compared to 17/75 (22.7%) at baseline; sometimes forgetting to take medication: 11/75 (14.7%) compared to 28/75 (37.3%) at baseline; and feeling hassled about sticking to treatment plan: 10/75 (13.3%) compared to 22/75 (29.3%) at baseline. Overall, patients reported improved adherence after three months of fingolimod therapy compared to baseline. In particular, notable improvements in adherence levels from medium or low at baseline, to high at 3M were observed. Therefore, it will be of interest to evaluate patients’ responses to MMAS-8-item assessment in the longer term.
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