LOW INCIDENCE OF CLEAN INTERMITTENTCATHETERIZATION WITH ONABOTULINUMTOXINA IN DIVERSE AGE GROUPS OFFEMALE PATIENTS WITH OVERACTIVE BLADDER AND CORRESPONDINGIMPROVEMENTS IN URINARY SYMPTOMS AND QUALITY OF LIFE IN A POOLED POSTHOC ANALYSIS OF PHASE 3 TRIALS
D. ROBINSON1, V. W.NITTI 2, E. ROVNER 3, R. DMOCHOWSKI 4,C. R. CHAPPLE 5, D. GINSBERG 6, T. ABOUSHWAREB7, C. CHANG 8, D. S. HALE 9;
1King's Coll. Hosp. NHS Fndn. Trust, London, UnitedKingdom, 2New York Univ. Langone Med. Ctr., New York, NY,3Med. Univ. of South Carolina, Charleston, SC, 4VanderbiltUniv. Med. Ctr., Nashville, TN, 5Royal Hallamshire Hosp.,Sheffield, United Kingdom, 6Univ. of Southern California,Los Angeles, CA, 7Allergan plc, Irvine, CA, 8Allerganplc, Bridgewater, NJ, 9Urogynecology Associates, pc,Indianapolis, IN.
Introduction: OnabotulinumtoxinA(onabotA) has been previously associated with the potential need forclean intermittent catheterization (CIC) in patients with overactivebladder (OAB). In two randomized, phase 3, placebo-controlled trialsof onabotA 100U, 6.1-6.9% of patients initiated CIC.1,2 Apossible correlation of CIC risk with age has been suggested with nosupporting evidence.
Objective: We examined the risk of CICand assessed the efficacy and quality of life (QOL) outcomes aftertreatment with onabotA in different age groups in a post hoc analysisof a large cohort of female patients with OAB.
Methods:Data from the female subpopulation of three randomized,placebo−controlled, phase 3 trials evaluating onabotA (the twophase 3 trials and a post−marketing study) were pooled for analysis(N=1031; intent-to-treat [ITT] population). Patients treated withonabotA 100U in treatment 1 and patients initially in the placebogroup who received open−label onabotA 100U in treatment 2 weregrouped by age: <40 (n=80), 40−49 (n=136), 50−59 (n=239),60−69 (n=300) and ≥70 (n=276) years. Assessments at week 12 aftertreatment were: incidence and duration of CIC, mean and % change frombaseline in urinary incontinence (UI) episodes, proportion ofpatients with reductions in UI of ≥50% and 100% (“dry”), meanchange from baseline and proportion of patients with an achievementof at least the minimally important difference (MID; -5 points) inthe King’s Health Questionnaire (KHQ) domain scores of RoleLimitations (RL) and Social Limitations (SL), and proportion ofpatients with a positive response (urinary symptoms‘improved’/’greatly improved’) on the treatment benefit scale(TBS). Adverse events (AEs) were recorded. AEs, including CIC ratesand duration were analyzed in the safety population (N=1028; allpatients who received treatment); efficacy and QOL outcomes wereanalyzed in the ITT population (all randomized patients).
Results:CIC rate after onabotA treatment was 4.8% (49/1028) in the overallpooled female subpopulation; the rate was lowest (1.3%) in the <40group and showed small increases with age (3.7%, 5.0%, 4.3% and 6.6%in the 40−49, 50−59, 60−69 and ≥70 groups, respectively)(Table). Younger patients <40 and 40-49 years of age had a shortermean duration of CIC (3 and 44 days, respectively) than the othergroups; a similar trend was seen for the median duration (Table). Atbaseline, mean UI episodes/day were 4.0, 4.8, 5.2, 5.9, and 6.0 inthe <40, 40−49, 50−59, 60−69 and ≥70 groups. All agegroups showed substantial reductions in mean UI episodes/day (−2.3,−2.6, −3.2, −3.6 and −3.1) and % change in UI (−57.9%,−49.7%, −64.5%, −63.5% and −49.4%). High proportions ofpatients in all groups achieved ≥50% UI reduction; 42.5% of thepatients in the <40 group achieved 100% UI reduction, which wasthe highest among all groups (Table). Additionally, 21.4% of elderlypatients ≥70 years of age achieved 100% UI reduction aftertreatment with onabotA (Table). All age groups showed substantialimprovements from baseline in KHQ RL and SL domain scores that were3-6 times the MID (Table). High proportions of patients in all agegroups achieved ≥MID improvements in KHQ domains and reportedtreatment benefit (urinary symptoms “improved”/”greatlyimproved” on the TBS; Table). Overall AEs were consistent among thegroups; urinary tract infection was most common (10.0%, 9.6%, 12.1%,17.7% and 17.9% in the <40, 40-49, 50-59, 60-69 and ≥70 groups,respectively).
Conclusions: In this large, pooledpopulation of female OAB patients treated with onabotA, the risk ofCIC was low overall but showed small increases with age. The <40group had the lowest rate of CIC (1.3%), with a mean duration of 3days and the ≥70 group had a rate of 6.6% with a duration of 87days. Patients in all groups exhibited substantial reductions in UI,improvements in QOL, and treatment benefit, which were similar acrossthe age groups. OnabotA was well tolerated in all agegroups.
References: 1. J Urol 2013; 189: 2186. 2. Eur Urol2013; 64: 249.