+30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4
UROLOGY
UK-BUO-220048. DOP: April 2022.
Reduce the impact of overactive bladder (OAB) on your patients' lives
BOTOX®: Significant improvements for overactive bladder patients5,6*
reductions from baseline in UI episodes at Week 12 (BOTOX® 100U: n=557)5†
reductions from baseline in urgency episodes at Week 12 (BOTOX® 100U: n=557)5†
of OAB patients were completely dry‡ at Week 12 (BOTOX® 100U: n=557)5†
Study context: Two double-blind, placebo-controlled, randomised, 24-week phase 3 clinical studies were conducted in 1105 patients with overactive bladder, with symptoms of urge urinary incontinence, urgency and frequency, whose symptoms had not been adequately managed with at least one anticholinergic therapy. To evaluate the impact of efficacy, safety and health-related quality of life of BOTOX® in patients with OAB with UI. Patients were randomised to receive either 100 U of BOTOX® (n=557) or placebo (n=548). The co-primary end points were the mean reduction in UI episodes per day and the proportion of patients reporting a positive response on the TBS at week 12. Secondary end points were the change from baseline in daily frequency of micturition episodes, urgency episodes and health related quality of life. Mean baseline for daily UI episodes: BOTOX® 100 U 5.49/day, placebo 5.39/day. Mean baseline for daily urgency episodes: BOTOX® 100mU 8.82/day, placebo 8.31/day.5
†P<0.001 vs placebo.
‡Dry patients over a 3-day diary.
BOTOX® provides 50% reduction at week 12 in daily UI episodes from a single treatment5
Adapted from BOTOX® Summary of Product Characteristics. Last accessed April 2022.5
Study context: Two double-blind, placebo-controlled, randomised, 24-week phase 3 clinical studies were conducted in 1105 patients with overactive bladder, with symptoms of urge urinary incontinence, urgency and frequency, whose symptoms had not been adequately managed with at least one anticholinergic therapy. Patients were randomised to receive either 100U of BOTOX® (n=557) or placebo (n=548).5 Co-primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the TBS at post treatment week 12. Secondary end points were the change from baseline in daily frequency of micturition episodes, urgency episodes and health related quality of life.
‡Mean baseline score: BOTOX® 100U 5.49/day, placebo 5.39/day. †p<0.001 vs. placebo
UK-BCM-220070. DOP: April 2022.
UK-BCM-220070. DOP: April 2022.
BOTOX® provides 35% reduction at week 12 in urgency from a single treatment5
Adapted from BOTOX® Summary of Product Characteristics. Last accessed April 2022
Study context: Two double-blind, placebo-controlled, randomised, 24-week phase 3 clinical studies were conducted in 1105 patients with overactive bladder, with symptoms of urge urinary incontinence, urgency and frequency, whose symptoms had not been adequately managed with at least one anticholinergic therapy. Patients were randomised to receive either 100U of BOTOX® (n=557) or placebo (n=548).5
‡Secondary endpoint. Mean baseline score: Placebo = 8.31/dey: BOTOX® 100U = 8.82/day. p<0.001 vs placebo. Co-primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at post-treatment week 12.5
Secondary end points were the change from baseline in daily frequency of micturition episodes, urgency episodes and health related quality of life.5
27% of patients were completely dry with BOTOX® at week 125‡
Adapted from BOTOX® Summary of Product Characteristics. Last accessed April 2022
Study context: Two double-blind, placebo-controlled, randomised, 24-week phase 3 clinical studies were conducted in 1105 patients with overactive bladder, with symptoms of urge urinary incontinence, urgency and frequency, .hose symptoms had not been adequately managed with at least one anticholinergic therapy. Patients were randomised to receive either 100U of BOTOX® (n= 557) or plocebo (n=548).5
‡Dry patients over a 3-day diary. †p<0.001 vs. placebo.
BOTOX® in OAB: Treatment benefit sustained over time6
BOTOX® sustained reductions in daily episodees of UI and urgency from baseline, throughout the entire 3.5 year study period§6
Adapted from Nitti VW, et al. 20166
- Approximately 52% of patients completed the entire 3.5 year study6
- The most common reasons for discontinuation were related to study burden, personal reasons, loss to follow up and other non-treatment related reasons6
- Only 5.7% discontinued due to lack of efficacy and 5.1% due to adverse events efficacy and 5.1% due to adverse events6
Study context: The final results of the prospective, multicentre, long-term (3.5 year) study of the efficacy/safety of BOTOX® for overactive bladder syndrome. The co-primary endpoints were the mean reduction in UI episodes per day and the proportion of patients reporting a positive response on the TBS, both at Week 12. In the overall population the most common AEs within the first 12 weeks of BOTOX® treatment were localised to the urinary tract. There was no evidence of increasing occurence of these AEs with repeat treatments, UTI was the most frequently reported AE.6
§n values denote the number of patients with data avalable at Week 12. Error bars represent 95% confidence intervals.
Overall median duration of effect was 7.6 months6
Duration of botulinum toxin type A effect based on time to patient request for re-treatment¥6
Adapted from Nitti VW, et al. 20166
Study context: The final results of the prospective, multicentre, long-term (3.5 year) study of the efficacy/safety of BOTOX® for overactive bladder syndrome. The co-primary endpoints were the mean reduction in UI episodes per day and the proportion of patients reporting a positive response on the TBS, both at Week 12. In the overall population the most common AEs within the first 12 weeks of BOTOX® treatment were localised to the urinary tract. There was no evidence of increasing occurence of these AEs with repeat treatments, UTI was the most frequently reported AE.6
¥Median duration in patients (n=438) who received 100U BOTOX® only throughout study with complete treatment cycles, with 1 month defined as 4 weeks. Total study duration 3.5 years. Patients received up to 6 treatment cycles.6
AE: adverse event; BL: baseline; OAB: overactive bladder; TBS: treatment benefit scale; UI: urinary incontinence; UTI: urinary tract infection.
*BOTOX® is indicated for the management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics: overactive bladder with symptoms of urinary incontinence, urgency and frequency.5
References
- Allergan Ltd. Data on file 014
- Allergan. Data on file. INT/0423/2016
- Aurora S K, Winner P et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358-1373
- Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
- BOTOX® Summary of Product Characteristics. Available from: www.medicines.org.uk. Accessed April 2022
- Nitti V W, Ginsberg D et al. Durable efficacy and safety of long-term onabotulinumtoxinA treatment in patients with overactive bladder syndrome: final results of a 3.5-year study. The Journal of Urology 2016;196(3),791-800
Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/
Adverse events should also be reported to AbbVie on [email protected]
Date of preparation: April 2022. UK-BUO-220012.
