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Introduction:Here we present the final results from an extension study assessing long-term onabotulinumtoxinA treatment (3.5 years) in patients with overactive bladder syndrome (OAB).
Materials & Methods:Patients who completed either of 2 Phase III trials were eligible to enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100U) treatments. Data were analyzed for the overall population of patients who received 100U in any treatment cycle (N=829) and within discrete subgroups of patients who received exactly 1 (n=105), 2 (n=118), 3 (n=117), 4 (n=83), 5 (n=46), or 6 (n=33) treatments of the 100U dose throughout the study (n=502).
Results:Of the 829 patients enrolled, 51.7% completed the study. Discontinuations due to AEs/lack of efficacy were low (5.1/5.7%); other reasons were not treatment-related. Mean reductions from baseline in urinary incontinence (UI) episodes/day (week 12; co-primary endpoint) were consistent among discrete subgroups who received 1 (-3.1), 2 (-2.9, -3.2), 3 (-4.1 to -4.5), 4 (-3.4 to -3.8), 5 (-3.0 to -3.6), or 6 (-3.1 to -4.1) treatments. A consistently high proportion of patients reported improvement/great improvement on the Treatment Benefit Scale (week 12; co-primary endpoint) in the discrete subgroups across all treatments (70.0-93.5%). Median time to request retreatment was ≤6 months for 34.2%, >6-≤12 months for 37.2%, and >12 months for 28.5% of patients. Most common AE was UTI, with no changes in safety profile over time.
Conclusions:Long-term onabotulinumtoxinA treatment resulted in consistent reductions in UI and high proportions of patients reporting improvement after each treatment, with no new safety findings.