Assessment of confirmed urinary tract infection in patients treated with dalfampridine for multiple sclerosis

Area of Science:

• Neurology
• Pharmacology
• Infectious Diseases

Background:

• Previous studies indicated a higher incidence of urinary tract infections (UTIs) with dalfampridine extended-release (dalfampridine-ER) 10 mg compared to placebo in multiple sclerosis (MS) patients.
• The association between dalfampridine-ER and confirmed UTIs in MS patients requires further investigation.

Purpose of the Study:

• To determine if dalfampridine-ER is associated with an increased incidence of confirmed UTIs in patients with multiple sclerosis.
• To compare the rates of confirmed UTIs across different doses of dalfampridine-ER and placebo.

Main Methods:

• A post hoc analysis of UTI data from a 4-week study comparing dalfampridine-ER 5 mg, 10 mg, and placebo in MS patients.
• Confirmed UTIs were determined using urinalysis, urine culture (≥100,000 and ≥10,000 CFUs/mL), and symptomatology.
• Statistical significance was assessed using Fisher's exact test.

Main Results:

• The proportion of patients reporting UTIs as adverse events was 5.6% (placebo), 6.3% (dalfampridine-ER 5 mg), and 9.9% (dalfampridine-ER 10 mg).
• Rates of laboratory-confirmed UTIs (≥100,000 CFUs/mL) were 4.2% (placebo), 2.8% (5 mg), and 2.8% (10 mg).
• Rates of laboratory-confirmed UTIs (≥10,000 CFUs/mL) were 4.2% (placebo), 3.5% (5 mg), and 4.9% (10 mg), with no significant statistical differences across treatment groups.

Conclusions:

• The incidence of confirmed UTIs was similar between dalfampridine-ER treated groups and the placebo group.
• Dalfampridine-ER treatment does not appear to increase the risk of confirmed urinary tract infections in multiple sclerosis patients.