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JU INSIGHT Safety and Tolerability of OnabotulinumtoxinA in Children With Neurogenic Detrusor Overactivity
By: Israel Franco, MD, Yale New Haven Children’s Hospital, Connecticut; Piet B. Hoebeke, MD, Ghent University Hospital, Belgium; Eric Dobremez, MD, PhD, Hôpital Pellegrin Enfants, Bordeaux, France; Wilson Titanji, PhD, AbbVie Inc, Irvine, California; Till Geib, PhD, AbbVie Inc, Irvine, California; Brenda Jenkins, BS, AbbVie Inc, Irvine, California; Irina Yushmanova, MD, AbbVie Inc, Irvine, California; Paul F. Austin, MD Texas Children’s Hospital, Houston | Posted on: 20 Apr 2023
Franco I, Hoebeke PB, Dobremez E, et al. Long-term safety and tolerability of repeated treatments with onabotulinumtoxinA in children with neurogenic detrusor overactivity. J Urol. 2023;209(4):774-784.
Study Need and Importance
Studies on intradetrusor botulinum toxin A injections in pediatric patients with neurogenic detrusor overactivity (NDO) have been limited in size and duration. This long-term extension study was conducted to establish the safety of onabotulinumtoxinA (50 U, 100 U, or 200 U; not to exceed 6 U/kg) following repeat treatment on an as-needed basis for up to 60 weeks in eligible patients (aged 5-17 years) with NDO from a previous 48-week, single-treatment, phase 3 study (potential overall follow-up of ∼2 years). This study complements the initial single-treatment study and supports the Food and Drug Administration approval of onabotulinumtoxinA for the treatment of children aged ≥5 with NDO.
What We Found
The safety profile was similar across doses and after repeat treatments. The most common treatment-emergent adverse event during cycles 1, 2, and 3 was urinary tract infection (UTI; 31%, 34%, 22%). Annualized UTI rates for each treatment group following onabotulinumtoxinA treatment in successive cycles were similar to the rates during the 24 weeks before study entry. The lack of a dose-response effect, and similar annualized UTI rates prescreening and posttreatment, suggests that onabotulinumtoxinA did not contribute to UTIs. There were no cases of autonomic dysreflexia, neutralizing antibodies, and treatment-emergent adverse events related to distant spread of toxin.
Limitations
The study lacked a placebo control group due to ethical concerns in children, and it was only possible to use descriptive statistics for the efficacy analysis, which precluded the reporting of any statistically significant improvements.
Interpretation for Patient Care
Taken together with the efficacy findings from the initial dose-finding study, these long-term safety results suggest that repeat treatments with onabotulinumtoxinA 200 U (not to exceed 6 U/kg), the approved dose in the United States, are well tolerated and effective, and fulfill the unmet need in pediatric patients with NDO who had not been adequately managed with anticholinergics.
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