Long-term treatment with prolonged-release fampridine (PR-FAM) in the LIBERATE study showed clinical benefits consistent with those previously reported . No new safety signals were identified in this real-world study, suggesting that routine risk minimisation measures were effective.
PR-FAM 10 mg twice-daily is indicated for the improvement of walking in adult multiple sclerosis (MS) patients with walking disability (Expanded Disability Status Scale [EDSS] 4-7). The observational LIBERATE study recruited patients newly prescribed PR-FAM at 201 sites in 13 countries.
MS Impact Scale-29 (MSIS-29) physical impact score improved significantly for patients on-treatment for 12 months versus those who discontinued (mean change from baseline to 12 months: 9.99 vs -0.34 points; P<0.001). Results were similar for MSIS-29 psychological impact. At 12 months, 61% of patients on treatment had improvement in walking ability rated by Clinical Global Impression of Improvement (CGI-I) versus 11% of those who discontinued (P<0.001).
The safety analysis included 4,646 patients. Median age was 52.6 (range 21–85), 65.7% were female; 24.9% (n=1,158) of patients discontinued treatment due to lack of efficacy. The rate of treatment-emergent adverse events (TEAEs) was 52.7%, the rate of serious TEAEs 6.0% (see Table).
Table. Overall adverse events and adverse events of special interest .
UTI, urinary tract infection
- Castelnovo G, et al. Abstract EPR1160, EAN 2020.
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