title: Positive outcomes with first onabotulinumtoxinA treatment persist in the long term with repeat treatments in patients with neurogenic detrusor overactivity.
abstract: To examine whether response to first treatment with onabotulinumtoxinA is predictive of long-term treatment outcome in patients with neurogenic detrusor overactivity (NDO).
  
  
  
  Patients with NDO who were enrolled in a 3-year extension study (after a 52-week phase III study) received onabotulinumtoxinA 'as needed', based on fulfilment of prespecified retreatment criteria. This post hoc analysis included patients who received only the 200-U dose during the phase III and extension studies. Data on mean percent reduction from baseline in urinary incontinence (UI) episodes at week 6 after the first treatment were analysed, and the patients were stratified into three response groups: <50% (group 1; n = 33), 50-74% (group 2; n = 23), and 75-100% (group 3; n = 139). The following were assessed: change from baseline in mean percent UI reduction; proportions of patients who achieved ≥50% and 100% UI reduction after each subsequent treatment, and patients who achieved ≥50% UI reduction after all subsequent treatments; change from baseline in Incontinence Quality of Life (I-QOL) total summary score; and the proportion of patients who achieved or exceeded the minimally important difference (MID; +11 points) in I-QOL score. Adverse events (AEs) were also assessed.
  
  
  
  The majority of the patients (83.1%; 162/195) experienced a ≥50% UI reduction after onabotulinumtoxinA treatment 1. Baseline characteristics were largely similar across the groups. After treatment 1, the mean percent reduction in UI remained consistent in subsequent treatments 2-6 for patients in response group 2 (range: 64.5-83.5%) and group 3 (range: 79.4-88.0%), but increased for those in the low response group (range: 36.3-60.3%). After treatment 1, the proportion of patients who achieved ≥50% reduction in UI episodes was consistent with subsequent treatments 2-6 in group 2 (range: 75.0-100%) and group 3 (range: 87.3-97.1%), but increased in the low response group (range: 48.3-72.7%). Even among those who achieved a low response after treatment 1, 37.9% of patients achieved ≥50% UI reduction in all subsequent treatments. Improvements in I-QOL scores in groups 2 and 3 were consistently 2-3 times the MID. In the low response group, at least 50% of the patients achieved or exceeded the MID with treatments 2-6. AEs were similar across all response groups and consistent across repeated treatments.
  
  
  
  Patients with NDO with a ≥50% UI reduction after their first onabotulinumtoxinA treatment continued to experience consistent improvements in UI and quality of life with subsequent treatments over the duration of 4 years. A <50% UI reduction after first treatment did not necessarily predict low response with subsequent treatments. Thus, these results underscore the importance of attempting at least a second treatment with onabotulinumtoxinA before deeming patients unsuitable for onabotulinumtoxinA therapy.
authors.affiliation: Hôpital Raymond Poincaré, Garches, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Denys
authors.affiliation: Vanderbilt University Medical Center, Nashville, TN, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Dmochowski
authors.affiliation: Western New York Urology Associates, LLC, Cheektowaga, NY, USA.
authors.forename: Philip
authors.initials: P
authors.lastname: Aliotta
authors.affiliation: Hospital Universitario de Canarias, Universidad de La Laguna, Santa Cruz de Tenerife, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Castro-Diaz
authors.affiliation: Erasmus Medical Centre, Rotterdam, The Netherlands.
authors.forename: Bertil
authors.initials: B
authors.lastname: Blok
authors.affiliation: University of Manitoba, Winnipeg, MB, Canada.
authors.forename: Karen
authors.initials: K
authors.lastname: Ethans
authors.affiliation: Allergan plc, Irvine, CA, USA.
authors.forename: Tamer
authors.initials: T
authors.lastname: Aboushwareb
authors.affiliation: Allergan plc, Bridgewater, NJ, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Magyar
authors.affiliation: Carolinas Rehabilitation, Charlotte, NC, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Kennelly
mesh_terms: D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
chemical_list: D019274:Botulinum Toxins, Type A
keywords: botulinum toxins; long-term efficacy; neurogenic detrusor overactivity; onabotulinumtoxinA; quality of life; repeat treatments; urinary incontinence