• Neurology Clinical Trials
• Demyelinating Diseases

• Neurology Clinical Trials
• Neurology
• Demyelinating Diseases

A long-term extension trial demonstrated improvement in urinary incontinence (UI) as a result of neurogenic detrusor overactivity (NDO) caused by multiple sclerosis (MS). Philip J. Aliotta, MD, Western New York Urology Associates, Cheektowaga, New York, USA, presented data from A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis trial [NCT00876447; Aliotta PJ et al. ACTRIMS/ECTRIMS 2014; (poster P905)].

NDO can occur in patients with MS, which results in UI [de Sèze M et al. Mult Scler. 2007]. Two randomized trials demonstrated that intradetrusor onabotulinumtoxinA was effective and well tolerated for the treatment of NDO in patients with spinal cord injury or MS who did not achieve adequate relief with an anticholinergic agent [Ginsberg D et al. J Urol. 2012; Cruz F et al. Eur Urol. 2011]. According to Dr Aliotta, the purpose of this 3-year extension study was to evaluate the use of onabotulinumtoxinA for the treatment of UI as a result of NDO in patients with MS over a long-term follow-up of up to 4 years.

In the 3-year extension study, 231 patients received ≥ 1 treatment of the same dose of onabotulinumtoxinA (200 U or 300 U) as that administered in the core trials; however, an amendment to the extension trial allowed a change in the treatment from 300 U to 200 U of onabotulinumtoxinA, if requested. Patients received treatment as needed over 4 years and the change in baseline UI episodes per day was evaluated, as were the incidence of adverse events (AEs) and the initiation of clean intermittent catheterization (CIC). At baseline, the mean number of UI episodes per day ranged from 4.6 to 4.8, and CIC was in use in 33% to 46% of patients.

Treatment with onabotulinumtoxinA resulted in a decrease in the number of UI episodes per day, and 45.2% to 61.9% of patients achieved complete continence at 6 weeks with the 200 U dose. The efficacy was similar in patients who switched from the 300 U to 200 U dose of onabotulinumtoxinA. The median duration of the anti-UI effect was 9.1 months for patients who received 200 U of onabotulinumtoxinA and 9.6 months for patients who received 300 U. After the first treatment cycle of onabotulinumtoxinA, de novo use of CIC was highest but declined after the second and third treatment cycles for both doses of the drug.

Common AEs included urinary tract infections and urinary retention. Retreatment with onabotulinumtoxinA did not increase the rate of AEs. Discontinuation of the study drug as a result of AEs or lack of efficacy occurred in 3% and 1.7% of patients, respectively.

In conclusion, Dr Aliotta stated that the results from this long-term extension trial indicate that the efficacy of onabotulinumtoxinA was maintained over 4 years, with no new safety signals.

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