OnabotulinumtoxinA is a well tolerated and effective treatment for refractory overactive bladder in real-world practice

Rizwan Hamid, Maria-Fernanda Lorenzo-Gomez, Heinrich Schulte-Baukloh, Amin Boroujerdi, Anand Patel, Elisabeth Farrelly, Rizwan Hamid, Maria-Fernanda Lorenzo-Gomez, Heinrich Schulte-Baukloh, Amin Boroujerdi, Anand Patel, Elisabeth Farrelly

Abstract

Introduction and hypothesis: In randomized clinical trials onabotulinumtoxinA was demonstrated to be an effective and well-tolerated treatment for overactive bladder (OAB) with urinary incontinence (UI). However, data reporting onabotulinumtoxinA use in everyday clinical practice are limited. Here, we present the results from a large, first-of-its-kind real-world study in patients with OAB.

Methods: This was a prospective, observational, multinational study (GRACE; ClinicalTrials.gov , NCT02161159) performed in four European countries. Patients (N = 504) aged ≥ 18 years with OAB inadequately managed with ≥ 1 anticholinergic received onabotulinumtoxinA per their physician's normal clinical practice.

Results: Physicians primarily used rigid cystoscopes for onabotulinumtoxinA injection; anesthesia/analgesia was utilized during most treatment procedures. Significant reductions in UI episodes/day from baseline to weeks 1 and 12 were observed as well as in micturition, urgency, and nocturia episodes/day. These improvements in urinary symptoms corresponded to higher scores on the treatment benefit scale at week 12. The use of other OAB medications dropped from baseline to weeks 1 and 12 and was sustained to week 52, which paralleled a reduction in the number of incontinence products used during that time frame. Adverse reactions were reported in 2.6% of patients throughout the study.

Conclusions: In this real-world study, significant improvements in urinary symptoms were seen following onabotulinumtoxinA treatment as early as week 1 and sustained to at least week 12. This was accompanied by a reduced reliance upon incontinence products and reduction in concomitant OAB medication use. OnabotulinumtoxinA was well tolerated with no new safety signals.

Keywords: OnabotulinumtoxinA; Overactive bladder; Quality of life; Urinary incontinence.

Conflict of interest statement

Rizwan Hamid has served as a consultant for Allergan Plc.

Maria-Fernanda Lorenzo-Gomez has no financial conflicts of interest to disclose.

Heinrich Schulte-Baukloh has received travel expenses/honoraria from Allergan Plc.

Amin Boroujerdi and Anand Patel are employees of Allergan Plc.

Elisabeth Farrelly has served as a consultant for Allergan Plc.

Figures

Fig. 1
Fig. 1
a Change from baseline in UI episodes over time. b Proportion of patients with a positive (improved/greatly improved) response and no change/worsened response on the TBS at week 12. *Statistically significant (p < 0.001 vs. baseline). TBS, treatment benefit scale; UI, urinary incontinence
Fig. 2
Fig. 2
Reduction in incontinence product use from baseline over time. aWeek 52: only patients without reinjection of onabotulinumtoxinA. *Statistically significant (p < 0.05) vs. baseline
Fig. 3
Fig. 3
OAB medication use: Baseline: at enrollment; week 1: during the last week; week 12, 20, 28, 36, 52: during the last 4 weeks. Data at week 52 were only in patients without reinjection of onabotulinumtoxinA. Patients could receive more than one medication

References

    1. Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21(1):5–26. 10.1007/s00192-009-0976-9.
    1. Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011;108(7):1132–1138. doi: 10.1111/j.1464-410X.2010.09993.x.
    1. Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000;6(11 Suppl):S580–S590.
    1. Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, et al. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012;39(1):61–74. 10.1097/WON.0b013e31823fe246.
    1. Soliman Y, Meyer R, Baum N. Falls in the elderly secondary to urinary symptoms. Rev Urol. 2016;18(1):28–32. doi: 10.3909/riu0686.
    1. Reeves P, Irwin D, Kelleher C, Milsom I, Kopp Z, Calvert N, et al. The current and future burden and cost of overactive bladder in five European countries. Eur Urol. 2006;50(5):1050–7. 10.1016/j.eururo.2006.04.018.
    1. Durden E, Walker D, Gray S, Fowler R, Juneau P, Gooch K. The direct and indirect costs associated with overactive bladder within a commercially-insured population in the United States. J Occup Environ Med. 2018;60(9):847–852. doi: 10.1097/JOM.0000000000001367.
    1. Staskin DR, MacDiarmid SA. Using anticholinergics to treat overactive bladder: the issue of treatment tolerability. Am J Med. 2006;119(3 Suppl 1):9–15. doi: 10.1016/j.amjmed.2005.12.011.
    1. Coupland CAC, Hill T, Dening T, Morriss R, Moore M, Hippisley-Cox J. Anticholinergic drug exposure and the risk of dementia: a nested case-control study. JAMA Intern Med. 2019;179(8):1084–1093. doi: 10.1001/jamainternmed.2019.0677.
    1. Bragg R, Hebel D, Vouri SM, Pitlick JM. Mirabegron: a beta-3 agonist for overactive bladder. Consult Pharm. 2014;29(12):823–837. doi: 10.4140/TCP.n.2014.823.
    1. Highlights of prescribing information: BOTOX (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use. . Accessed 22 Nov 2019.
    1. Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013;64(2):249–56. 10.1016/j.eururo.2013.04.001.
    1. EMBARK Study Group. Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, et al. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013;189(6):2186–93. 10.1016/j.juro.2012.12.022.
    1. Colman S, Chapple C, Nitti V, Haag-Molkenteller C, Hastedt C, Massow U. Validation of Treatment Benefit Scale for assessing subjective outcomes in treatment of overactive bladder. Urology. 2008;72(4):803–807. doi: 10.1016/j.urology.2008.05.033.
    1. Avallone MA, Sack BS, El-Arabi A, Guralnick ML, O'Connor RC. Less is more-a pilot study evaluating one to three intradetrusor sites for injection of OnabotulinumtoxinA for neurogenic and idiopathic detrusor overactivity. Neurourol Urodyn. 2017;36(4):1104–1107. doi: 10.1002/nau.23052.
    1. Herschorn S, Kohan A, Aliotta P, McCammon K, Sriram R, Abrams S, et al. The efficacy and safety of onabotulinumtoxinA or solifenacin compared with placebo in solifenacin naïve patients with refractory overactive bladder: results from a multicenter, randomized, double-blind phase 3b trial. J Urol. 2017;198(1):167–75. 10.1016/j.juro.2017.01.069.
    1. Papanicolaou S, Pons ME, Hampel C, Monz B, Quail D, Schulenburg MG, et al. Medical resource utilisation and cost of care for women seeking treatment for urinary incontinence in an outpatient setting. Examples from three countries participating in the PURE study Maturitas. 2005;52 Suppl 2:S35–47. 10.1016/j.maturitas.2005.09.004.
    1. Freemantle N, Khalaf K, Loveman C, Stanisic S, Gultyaev D, Lister J, et al. OnabotulinumtoxinA in the treatment of overactive bladder: a cost-effectiveness analysis versus best supportive care in England and Wales. Eur J Health Econ. 2016;17(7):911–21. 10.1007/s10198-015-0737-2.
    1. Murray B, Hessami SH, Gultyaev D, Lister J, Dmochowski R, Gillard KK, et al. Cost-effectiveness of overactive bladder treatments: from the US payer perspective. J Comp Eff Res. 2019;8(1):61–71. 10.2217/cer-2018-0079.
    1. Shepherd JP, Carter-Brooks CM, Chermanksy C. A cost-effectiveness analysis of Onabotulinumtoxin A as first-line treatment for overactive bladder. Int Urogynecol J. 2018;29(8):1213–9. 10.1007/s00192-018-3653-z.
    1. Patel DN, Jamnagerwalla J, Houman J, Anger JT, Eilber KS. What is the true catheterization rate after intravesical onabotulinumtoxinA injection? Int Urogynecol J. 2018;29(7):1005–1009. doi: 10.1007/s00192-017-3440-2.
    1. Bickhaus JA, Vaughan M, Truong T, Li YJ, Siddiqui NY. A comparison of antibiotic prophylaxis regimens to decrease the risk of post-procedure urinary tract infection after onabotulinum toxin A injection. Int Urogynecol J. 2020. 10.1007/s00192-020-04230-7.
    1. Houman J, Moradzadeh A, Patel DN, Asanad K, Anger JT, Eilber KS. What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens. Int Urogynecol J. 2019;30(5):701–704. doi: 10.1007/s00192-018-3721-4.
    1. Drake MJ, Nitti VW, Ginsberg DA, Brucker BM, Hepp Z, McCool R, et al. Comparative assessment of the efficacy of onabotulinumtoxinA and oral therapies (anticholinergics and mirabegron) for overactive bladder: a systematic review and network meta-analysis. BJU Int. 2017;120(5):611–22. 10.1111/bju.13945.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit