SIGNIFICANT, PROVEN REDUCTION IN WEEKLY UI EPISODES AT WEEK 6:

BOTOX® cut leakage episodes by more than half1

Uncomfortable pulling or drawing in the neck

Reduction in UI Episodes at Week 6(1,2,*)

*Double-blind, placebo-controlled, randomized, multicenter, phase 3, 52-week clinical studies in patients with UI associated with OAB due to SCI or MS, who had an inadequate response to or were intolerant of at least 1 anticholinergic medication. Primary end point was the mean change from baseline in weekly UI episodes at week 6.2

*Least squares (LS) mean change from baseline.

Study 1 and 2 design: Double-blind, placebo-controlled, randomized, multicenter, phase 3, 52-week clinical studies in patients with urinary incontinence (UI) associated with OAB due to SCI or MS who had an inadequate response to or were intolerant of at least 1 anticholinergic medication. These patients were randomized to receive either BOTOX® 200 Units (n = 227), BOTOX® 300 Units (n = 223), or placebo (n = 241). Primary end point was the mean change from baseline in weekly UI episodes at week 6. ANCOVA model with last-observation-carried-forward (LOCF) imputation was used. No additional benefit of BOTOX® 300 Units over 200 Units was demonstrated.2

MANY PATIENTS WERE SEEN TO ACHIEVE:

50% to 100% Reduction in Weekly Leakage Episodes2

36% to 38% of BOTOX® patients stopped weekly leakage episodes completely2

36% to 38% of BOTOX® patients stopped weekly leakage episodes completely2

Study 1 and 2 design: Double-blind, placebo-controlled, randomized, multicenter, phase 3, 52-week clinical studies in patients with urinary incontinence (UI) associated with OAB due to SCI or MS who had an inadequate response to or were intolerant of at least 1 anticholinergic medication. These patients were randomized to receive either BOTOX® 200 Units (n = 227), BOTOX® 300 Units (n = 223), or placebo (n = 241). Primary end point was the mean change from baseline in weekly UI episodes at week 6. ANCOVA model with last-observation-carried-forward (LOCF) imputation was used. Study 1 mean baseline UI frequency: BOTOX® 200 Units = 32.3/week, 4.7/day, placebo = 28.3/week, 4.0/day. Study 2 mean baseline UI frequency: BOTOX® 200 Units = 32.7/week, 4.6/day, placebo = 36.8/week, 5.3/day.1,2

No additional benefit of BOTOX® 300 Units over 200 Units was demonstrated.2

BOTOX® Achieved More Than 2 Times the Improvement in QOL2,*

Change from baseline in overall I-QOL score vs placebo at week 62

Documented with I-QOL, a validated incontinence-related QOL questionnaire2,3

I-QOL is a validated incontinence-related questionnaire that measures 3 domains3:

  • Avoidance and limiting behavior (physical impact)
  • Psychosocial impact
  • Social embarrassment (social impact)

UI-Specific QOL Instrument (I-QOL) total score was a prespecified secondary efficacy measure in pivotal studies of BOTOX® in NDO. I-QOL is a validated, disease-specific, health-related quality-of-life (HRQOL) questionnaire scored as 4 variables: total I-QOL summary score and its 3 domains (Avoidance and Limiting Behavior, Psychosocial Impacts, and Social Embarrassment). Each is transformed to a 0-100 scale: Scale score = [(Sum of items minus lowest possible score)/possible raw score range] × 100. Higher scores indicate better HRQOL. Published estimates of minimally important differences in total I-QOL scores in the neurogenic OAB population have included 11 points.2,3

IN AN OPEN-LABEL, 3-YEAR EXTENSION STUDY, CONSISTENT WITH PIVOTAL TRIAL RESULTS

BOTOX® Demonstrated Efficacy With Each Treatment Over 3 Years4

BOTOX® 200-UNIT TREATMENT CYCLE*
 

1

2

3

4

5

6

BASELINE UI EPISODES PER DAY
MEAN CHANGE FROM BASELINE (UI EPISODES/DAY)
PERCENT CHANGE FROM BASELINE
SWIPE

 

-3.2

-75%

 

-3.3

-77%

4.5

-3.5

-78%

 

-3.5

-79%

 

-3.6

-82%

 

-4.1

-84%

Study design: Open-label, 3-year extension of 2 double-blind, placebo-controlled, randomized, multicenter clinical studies in patients with urinary incontinence (UI) associated with OAB due to SCI or MS who had an inadequate response to or were intolerant of side effects on anticholinergic therapy. Eligible patients had to have completed the double-blind portion, have 12 or more weeks since their last treatment, and at least 1 urge urinary incontinence (UUI) episode within 3 days. Patients were re-treated with BOTOX® 200 Units as needed but no sooner than 12 weeks since their last treatment. Primary end point was the mean change from baseline in daily UI episodes at week 6 after each treatment. Data are presented in discrete subgroups of patients who received 1, 2, 3, 4, 5, or 6 treatments.4

NOTE: A total of 240 patients completed the 3-year extension. Patients in whom BOTOX® had a longer duration of effect received fewer treatments over the study period, whereas those with a shorter duration of effect received more treatments during the same study period. Data for patients who received up to 6 sequential BOTOX® treatments are presented herein, as the number of patients who needed 7 or more treatments during the study was not large enough to make meaningful comparisons.4

*Treatment 1, n = 195; 2, n = 175; 3, n = 164; 4, n = 141; 5, n = 99; 6, n = 68.

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