Journal Insights Into: Oral Therapy for MS-Related Walking Impairment Supplemental Slides.

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Journal Insights Into: Oral Therapy for MS-Related Walking Impairment Supplemental Slides

Dalfampridine Phase III Trials Responder Analysis Responder analysis = % of patients in each group who respond, not mean differences between groups Best means of capturing response when some individuals have a high level of response, while others have little or no response Facilitates assessing patient-perceived value of response Patients who respond to dalfampridine have both improved walking speed 1 and enhanced quality of life 2 1. Measured on timed 25-foot walk 2. Measured on the 12-item Multiple Sclerosis Walking Scale

Dalfampridine First Phase III Trial 14-wk study in 301 patients with RRMS, SPMS, PPMS, PRMS – 229: Dalfampridine 10 mg twice daily – 72: Placebo Proportion of TWRs: Dalfampridine (35%) vs placebo (8%) (P <.0001) Change from baseline TW: Dalfampridine TWRs (25.2%) vs placebo (4.7%) MSWS-12: TWRs 1 had significantly greater improvement compared to non-TWRs (P =.0002) Leg strength: Dalfampridine TWRs and non-TWRs had significantly greater improvement compared to placebo patients (.18 and.11 vs.04) (P =.0002 and P =.046, respectively) 1 Independent of treatment group Abbreviations: MSWS-12, 12-item MS Walking Scale; PPMS, primary progressive MS; PRMS, progressive relapsing MS; RRMS, relapsing-remitting MS; SPMS, secondary progressive MS; TW, Timed 25-foot walk; TWRs, Timed 25-foot walk responders. Goodman AD, et al. Lancet. 2009;373:

Dalfampridine Second Phase III Trial 9-wk study in 237 patients with RRMS, SPMS, PPMS, PRMS – 119: Dalfampridine 10 mg twice daily – 118: Placebo Proportion of TWRs: Dalfampridine (42.9%) vs placebo (9.3%) (P <.0001) Change from baseline TW: Dalfampridine TWRs (24.7%) vs placebo (7.7%) MSWS-12: TWRs 1 had significantly greater improvement than did non-TWRs (P <.001) Leg strength: Dalfampridine TWRs had significantly greater improvement (.145 U) compared to placebo patients (.042 U) (P =.028) 1 Independent of treatment group Abbreviations: MSWS-12, 12-item MS Walking Scale; PPMS, primary progressive MS; PRMS, progressive relapsing MS; RRMS, relapsing-remitting MS; SPMS, secondary progressive MS; TW, Timed 25-foot walk; TWR, Timed 25-foot walk responder. Goodman AD, et al. Ann Neurol. 2010;68:

Concluding Comments Dalfampridine is the first FDA-approved drug to specifically address gait disability in patients with MS. Benefit is seen in patients with progressive MS, as well as relapsing-remitting disease. Not all patients benefit from treatment. To date, there are no predictive factors that permit the identification of those in whom the drug will be effective. In those patients who benefit, dalfampridine results in a significant improvement in walking and quality of life. Care must be taken in administering dalfampridine as indicated in the prescribing information.