Abstract: PD26-10
Sources of Funding: Allergan plc

Introduction

OnabotulinumtoxinA (onabotA) 100U was shown to significantly reduce urinary incontinence (UI) and improve quality of life (QOL) at week (wk) 12 after treatment (tx) in overactive bladder (OAB) patients (pts) in 2 large, placebo (pbo)-controlled phase 3 trials. The earliest time for tx response was not assessed in the phase 3 trials. Here we present an interim analysis of an ongoing post-marketing study of onabotA tx response and QOL outcomes as early as wk 1 postinjection in OAB pts with UI.

Methods

OAB pts were randomized 1:1 to receive their 1st tx with onabotA 100U (n=129) or pbo (n=125). Pts could receive an additional tx with open-label onabotA 100U after fulfilling prespecified criteria. This interim analysis presents data up to wk 12 after tx 1. Assessments at wks 1, 2, 6 and 12 (primary timepoint) postinjection included the proportions of pts who achieved 100% UI reduction (ie, &[Prime]dry&[Prime]; co-primary endpoint) and ≥75% and ≥50% UI reduction, mean change from baseline in daily episodes of urgency UI, micturition, nocturia, and in the Incontinence-QOL (I-QOL) total score. Adverse events (AEs) were also assessed.

Results

Baseline mean UI episodes/day were 5.4 (onabotA) and 6.0 (pbo). As early as wk 1 after onabotA, significantly higher proportion of pts achieved 100% UI reduction vs pbo (24.0% vs 4.8%) and continued through wk 2 (25.6% vs 5.6%), wk 6 (32.6% vs 8.0%) and wk 12 (31.8% vs 7.2%) (P<.001 for all timepoints). Similarly, a significantly higher proportion of onabotA-treated vs pbo pts achieved ≥75% and ≥50% UI reduction as early as wk 1 (45.0% vs 20.8%, and 58.9% vs 36.0%, respectively; P<.001 for both) which continued through wk 12. Decreases were noted with onabotA vs pbo in other urinary symptoms as early as wk 1 and continued through wk 12. The early onset of onabotA response was also evidenced by the significantly greater improvements in I-QOL score at wk 1 (14.3 vs 5.6; P<.001) that were ~1.5x the minimally important difference (MID; +10 points). At wks 2-12 after onabotA, improvements in I-QOL score were consistently ~2-3x the MID and significantly greater than pbo (P<.001 for all timepoints). OnabotA was well tolerated; urinary tract infection was the most common AE (21.1% vs 6.4%).

Conclusions

This interim analysis showed a significant and consistent tx response with onabotA vs pbo in OAB pts as early as wk 1 postinjection, with significant reductions in UI episodes and improvements in OAB symptoms and QOL outcomes which continued through wk 12. OnabotA was well tolerated.

Funding

Allergan plc