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+30 YEARS' GLOBAL EXPERIENCE
ACROSS MULTIPLE INDICATIONS1-4

 

UROLOGY

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

+30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4

UROLOGY

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

Reduce the impact of overactive bladder (OAB) on your patients' lives

BOTOX® demonstrates significant and sustained improvements for overactive bladder patients5-7

Week 12 co-primary endpoint results:

BOTOX® demonstrated significant reductions from baseline in daily UI episodes compared with placebo (-2.74 vs -0.95; p<0.001 vs placebo).5

Significantly greater proportion of BOTOX® patients achieved a positive response on the TBS compared to placebo (61.8% vs 28.0%; p<0.001 vs placebo).7

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 100U of BOTOX® (n=557) or placebo (n=548). Mean baseline for daily UI episodes: BOTOX® 100U 5.49/day, placebo 5.39/day. Mean baseline for daily urgency episodes: BOTOX® 100U 8.82/day, placebo 8.31/day.5



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 period6

Botulinum toxin type A 100U Treatment Number

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 treatment benefit scale. 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-treatment6

Adapted from Nitti VW, et al. 20166

Study context: The final results of the prospective, multicenter, long-term (3.5 year) study of the efficacy/safety of BOTOX® for overactive bladder syndrome. 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.

 

References

  1. Allergan. Data on file. INT/0423/2016
  2. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
  3. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
  4. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
  5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/859/smpc. Accessed April 2024.
  6. Nitti V W, Ginsberg D et al. Durable efficacy and safety of long-term onabotulinum toxin A treatment in patients with overactive bladder syndrome: final results of a 3.5-year study. The Journal of Urology. 2016;196(3),791-800
  7. Sievert K D, Chapple C et al. Onabotulinum toxin A 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Practice. 2014;68:1246-1256

 

References

  1. Allergan. Data on file. INT/0423/2016
  2. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
  3. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
  4. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
  5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk /emc/product/859/smpc. Accessed April 2024.
  6. Nitti V W, Ginsberg D et al. Durable efficacy and safety of long-term onabotulinum toxin A treatment in patients with overactive bladder syndrome: final results of a 3.5-year study. The Journal of Urology. 2016;196(3),791-800
  7. Sievert K D, Chapple C et al. Onabotulinum toxin A 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Practice. 2014;68:1246-1256

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 GBPV@abbvie.com 

 

Date of preparation: April 2024. UK-BUO-240026.