[P7.244] Dalfampridine Real World Utilization and Efficacy Assessment

Sylvia Klineova, Joshua Friedman, Colleen Farrell, Christine Hannigan, Fred Lublin, Stephen Krieger
New York, NY, USA


OBJECTIVE:
To assess utilization of dalfampridine and magnitude of walking speed improvement in clinical practice.
BACKGROUND:
Two phase 3 trials showed approximately 35% of patients receiving dalfampridine were Timed 25 Foot Walk (T25FW) responders, with average improvement in walking speed of 25%. We examined if T25FW response rate and magnitude differ in clinical practice.
DESIGN/METHODS:
Single-center retrospective study evaluating all patients for whom dalfampridine was prescribed since approval, from March 2010 through August 2013. Inclusion criteria for T25FW analyses: diagnosis of MS, dalfampridine treatment ≥ 3 months, and minimum of two T25FW measurements within one year pre- and post- treatment.
RESULTS:
Chart review identified 221 intention-to-treat (ITT) patients. Dalfampridine was shipped to 174 (78.7%), twelve of whom never began therapy. Thirty patients (13.5%) discontinued dalfampridine in < 3 months due to lack of subjective benefit. 67 patients (30.5%) had insufficient visits or documentation during the time window, and 6 patients (2.7%) were non-ambulatory at baseline. Fifty-three patients (23.9%) met our inclusion criteria for walking speed analysis, with mean T25FW of 9.5 seconds (range 3.8 to 66.3).
Twenty-nine of these patients (56.9%) showed improvement in T25FW speed, and 24 (53.8%) showed none. In 10 patients (18.9%), the T25FW improvement was < 10%. Eleven patients (20.8%) improved between 10 - 20%. Only 8 patients (15.1%) achieved a clinically meaningful threshold of > 20% improvement, comprising 3.6% of the 221 patients in the ITT population. Despite this, 47 of the 53 (88.7%) continued therapy at last point of follow up.
CONCLUSIONS:
Our real world cohort demonstrated a lower rate and magnitude of T25FW improvement than was seen in clinical trials. Given that only a small minority of patients who continued on dalfampridine showed a clinically meaningful T25FW improvement, the T25FW may be an insensitive measure of actual therapeutic response to dalfampridine.
Category - MS and CNS Inflammatory Disease: Clinical Science

Thursday, May 1, 2014 3:00 PM

P7: Poster Session VII: Treatment of Specific Multiple Sclerosis Symptoms (3:00 PM-6:30 PM)

 

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