Long-Term Utilization of OnabotulinumtoxinA for the Treatment of OAB

Objectives: OnabotA is approved for the treatment of OAB with symptoms of urgency urinary incontinence, urgency, and frequency in adults who have an inadequate response to or are intolerant of oral medications (i.e. anticholinergics or beta-3 agonists), according to the AUA/SUFU guidlines.1,2 OAB is a chronic condition that requires long-term treatment.2 Currently there is limited data on real-world long-term utilization of onabotA in patients receiving repeated treatments for OAB beyond 3 years.3 The purpose of this study is to contextualize real world data on long- term utilization of onabotulinumtoxinA (onabotA) for ≥4 years for the treatment of overactive bladder (OAB).

Methods: This retrospective study collected data from January 1, 2013 to June 30, 2023, from the Optum Clinformatics Data Mart (CDM). The study included patients age ≥18 years who had continuous health plan enrollment (gap < 60 days was allowed) on or after the date of first onabotA treatment (index date) and who received onabotA for the treatment of OAB for ≥ 4 consecutive years. Patients were considered to be on continuous therapy if they received ≥1 onabotA treatment for OAB every 18 months starting from the index date. Patients were excluded if they had any diagnosis code for a neurologic condition that may be related to voiding dysfunction.

Results: A total of 186 patients met inclusion criteria for analysis. Mean age was 69.7 years ± 9.6. Patients were predominantly female (94.6%) with Medicare insurance (88.7%) and were mostly from the Midwest region (45.7%). Common comorbidities evaluated 1 year prior or on the index date included diabetes (26.3%) and menopause (19.9%). The year of index date varied from 2013-2019. Patients had an average of 9.2 (SD 3.2) onabotA treatments with an average of 7.2 (SD 3.3) months between two consecutive treatments. 77.4% of patients received treatment with onabotA in the office/clinic setting followed by 32.8% who received treatment in the outpatient hospital setting. Common diagnostic evaluations at any time during the 90-day period prior to or on the index date included: urinalysis (98.4%), urine culture (76.9%), complex uroflowmetry (59.1%), and urodynamics (19.4%). Diagnostic evaluations decreased for subsequent injection cycles except for urinalysis. Use of oral medications in combination with onabotA, defined as at least 1 day of oral medication overlap with onabotA plus 90 days included, mirabegron (15.6%), oxybutynin (8.6%), and solifenacin (5.4%). 4.3% of patients were on more than 1 oral medication for OAB. Use of oral medications generally decreased over subsequent onabotA treatments.

Conclusions: This study describes long-term real-world use of onabotA (≥4 years) for the treatment of OAB. Most patients received consecutive treatments every 7.2 months, in the office/clinic setting, and oral medication use decreased over subsequent treatment cycles.