Repeated injections of onabotulinumtoxinA (onabotA [Botox]), 100 U, continue to provide benefit in patients with overactive bladder syndrome and urinary incontinence and without any new safety concerns, according to results of a pre-specified interim analysis in an open-label, 3-year extension study.
Repeated injections of onabotulinumtoxinA (onabotA [Botox]), 100 U, continue to provide benefit in patients with overactive bladder syndrome (OAB) and urinary incontinence and without any new safety concerns, according to results of a pre-specified interim analysis in an open-label, 3-year extension study.
The analysis included data for 829 patients who entered the long-term study after completing one of two placebo-controlled phase III pivotal trials. Eligibility for participation in the phase III studies required that patients have three or more urgency incontinence episodes over 3 days, eight or more micturitions/day, and be inadequately managed with an anticholinergic agent. Repeat treatments were given as needed at a minimum interval of 12 weeks if patients had two or more urgency incontinence episodes/3 days and postvoid residual volume <200 mL.
At the time of the interim analysis, median follow-up was 2.4 years and 544 patients had been followed at least 2 years. Numbers of patients receiving 2, 3, 4, and 5 treatment cycles were 580, 310, 178, and 104, respectively.
Outcomes were assessed at 12 weeks post-injection, and across all five treatment cycles, there was consistent reduction in mean change from baseline in urinary incontinence episodes/day (range, -3.2 to -3.9), micturition episodes/day (range, -2.4 to -2.9), and urgency episodes/day (range, -3.7 to -4.2). Proportions of patients reporting a positive response to onabotA also remained consistently high across all treatment cycles (74% to 86%), and improvements in health-related quality of life were stable and clinically relevant.
Median time to request for re-treatment was 24 weeks for cycle 1 and ranged from 23.9 to 31.6 weeks across cycles 2 to 5.
There was no change in the types of adverse events reported over time, rates of urinary tract infection and clean intermittent catheterization decreased with increasing treatment cycle number, and there were low rates of withdrawal for lack of efficacy (4.9%) and adverse events (4.5%).
“The complete dataset should be available soon, but the messages from this third interim analysis are that the adverse events of onabotulinumtoxinA treatment for OAB syndrome with urinary incontinence have been well characterized, and patients needing repeat injections can expect continued success with a consistent duration of effect,” said lead author Victor Nitti, MD, of NYU Langone Medical Center, New York.
Dr. Nitti has consulted for and been an investigator in studies funded by Allergan.
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