New York—Repeated onabotulinumtoxinA 100 U (onabotA [Botox]) injections continue to provide benefit for patients with overactive bladder syndrome and urinary incontinence and without evidence of any new safety concerns, according to results of a pre-specified interim analysis in an open-label, 3-year extension study.
“The final, end-of-study complete dataset should be available soon. However, the messages from this third interim analysis are first, that the adverse events of onabotulinumtoxinA treatment for OAB syndrome with urinary incontinence have been well characterized, and second, that patients who start on this therapy and benefit can expect continued success with a consistent duration of response,” said co-author Victor W. Nitti, MD, professor of urology and obstetrics/gynecology, New York University Langone Medical Center, New York.
The analysis included data for 829 patients who entered the long-term study after completing one of two placebo-controlled phase III pivotal trials. To be eligible to participate in the phase III studies, patients had to have at least three urgency urinary incontinence (UI) episodes over 3 days, at least eight micturitions/day, and be inadequately managed with an anticholinergic agent. Repeat treatments were given at a minimum interval of 12 weeks upon patient request and if the patient was experiencing two or more urgency UI episodes/3 days and had a post-void 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, consistent benefits were observed in the co-primary endpoints of mean change from baseline in UI episodes/day (range, –3.2 to –3.9) and proportion of patients reporting a positive response (“greatly improved” or “improved”) on the Treatment Benefit Scale (range, 74% to 86%). There were also consistent mean reductions from baseline in micturition episodes/day (range, –2.4 to –2.9) and urgency episodes/day (range, –3.7 to –4.2). Median time to request for re-treatment was 24.0 weeks for cycle 1 and ranged from 23.9 to 31.6 weeks across cycles 2 to 5.
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