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Interim Analysis of the Long-term Efficacy and Safety of Repeat OnabotulinumtoxinA in the Treatment of Overactive Bladder and Urinary Incontinence, Median 2.4 Years’ Follow up
Victor Nitti, MD1, Christopher Chapple, MD2, David Sussman, MD3, Sidney Radomski, MD4, Peter Sand, MD5, Steven Guard, PhD6, Jihao Zhou, PhD7, Karl-Dietrich Sievert, MD8.
1NYU Langone Medical Center, New York, NY, USA, 2Royal Hallamshire Hospital, Sheffield, United Kingdom, 3NJ School of Osteopathic Medicine, Newark, NJ, USA, 4University of Toronto, Toronto, ON, Canada, 5University of Chicago, Evanston, IL, USA, 6Allergan, Ltd., Marlow, United Kingdom, 7Allergan, Inc., Bridgewater, NJ, USA, 8University of Tuebingen, Tuebingen, Germany.
BACKGROUND:
Long-term efficacy/safety of repeated onabotulinumtoxinA treatments were assessed for patients with overactive bladder (OAB) symptoms including urinary incontinence (UI) who had been inadequately managed by an anticholinergic (ACH). The results are from a third interim analysis.
METHODS:
Patients who completed either of two phase 3 studies could enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100U) treatments. Data were analyzed by treatment cycle. Change from baseline (BL) in OAB symptoms, proportions of patients with a positive response on the Treatment Benefit Scale (TBS; co-primary endpoint), health-related quality of life (HRQOL), duration of effect, adverse events (AEs), and clean intermittent catheterization (CIC) initiation were assessed.
RESULTS:
829 patients entered this extension study; median follow-up was 126 weeks (2.4 years). Discontinuation rates due to AEs/lack of efficacy were low (4.5%/4.9%). OnabotulinumtoxinA reduced mean UI episodes/day (co-primary endpoint; BL=5.55) at week 12 by -3.26, -3.70, -3.87, -3.20, and -3.22 (cycles 1-5, respectively). Improvements in other OAB symptoms and HRQOL (exceeding minimally important differences; ≥2.5X) were consistently observed with repeat onabotulinumtoxinA. Positive TBS responses were reported (74.0, 80.9, 80.4, 79.4, 86.1%). Median duration was 24.0, 31.6, 27.9, 24.3, and 23.9 weeks. Most common AE was urinary tract infection, with no changes in overall AE profile. CIC rates were 4.6, 4.0, 4.3, 4.6, and 2.9%.
CONCLUSIONS:
Patients with OAB and UI inadequately managed by an ACH showed sustained improvements in OAB symptoms, perception of their condition, and HRQOL after repeated onabotulinumtoxinA treatment, with no new safety concerns.
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