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BOTOX® has safety and tolerability experience from +30 years of use in a range of conditions5-7*

BOTOX® is generally well-tolerated in overactive bladder (OAB)7

Adapted from BOTOX® Summary of Product Characteristics. Last accessed April 2022.7

Elevated PVR not requiring catheterisation. Procedure-related adverse reactions.


Clean intermittent catheterisation (CIC) rates that are low and predominantly transient8,9

CIC requirements and duration in two 24-week phase 3 trials of OAB patients treated with 100U BOTOX®8

Adapted from Sievert KD, et al. 2014.8

Study context: A prespecified pooled analysis of two placebo-controlled, phase 3 trials evaluated whether the number of prior anticholinergics used or reason for their discontinuation affected the treatment response to BOTOX® 100U in OAB patients with urinary incontinence. The co-primary endpoints were change from baseline at week 12 in urinary incontinence episodes/day and proportion of patients reporting a positive response on the treatment benefit scale. The most common AEs were localised urologic events. UTI was the most frequently reported AE in the pooled safety population and all but one case of UTI was uncomplicated.8

§Patients requiring CIC at any point during the treatment cycle. CIC was initiated if the PVR urine volume was ≥ 200ml and < 350ml with associated symptoms or if the PVR urine volume was ≥ 350ml, regardless of symptoms.8


BOTOX® is generally well-tolerated in OAB7

  • 93.5% (516 out of 552) of patients did not have to initiate CIC after one full treatment cycle (placebo=99.6%; 540 out of 542 patients)8
  • Significantly improved QOL in BOTOX®-treated patients compared to placebo group (p<0.001)9
  • Only 6.5% of patients (n=552) treated with BOTOX® had to self-catheterise (placebo=0.4%; n=542)7

CIC does not impact upon QoL improvement9

Adapted from Everaert K, et al. 2015.9

Study context: A pooled analysis of two randomised controlled trials, to evaluate the impact of BOTOX® on quality of life and practical aspects of daily living. 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.9

¥Change from baseline in I-QoL total summary score in the subgroups by CIC use. p<0.001 vs. placebo. Error bars represent 95% confidence intervals. The n values denote the number of patients with data available at Week 12.9 


CIC: clean intermittent catheterisation; MID, minimal important difference; OAB: overactive bladder; QoL: quality of life; I-QoL: incontinence quality of life; PVR: post-void residual volume.

*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.7

 

References

  1. Allergan. Data on file. INT/0423/2016
  2. 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
  3. 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
  4. Allergan Ltd. Data on file 014
  5. Allergan. Data on file. INT/0423/2016(1). 2018
  6. Allergan. Data on file. INT/0572/2016(2). 2019
  7. BOTOX® Summary of Product Characteristics. www.medicines.org.uk. Accessed April 2022
  8. Sievert K D, Chapple C et al. OnabotulinumtoxinA 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
  9. Everaert K, Gruenenfelder J et al. Impact of onabotulinumtoxinA on quality of life and practical aspects of daily living: A pooled analysis of two randomized controlled trials. Int J Urol 2015;22(12):1131-1137

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 2022. UK-BUO-220013.