Efficacy Of onabotulinumtoxinA Research Articles

Efficacy and safety of onabotulinumtoxinA for the treatment of overactive bladder in men and women: A pooled analysis.

This pooled analysis of randomized controlled studies investigated the safety and efficacy of onabotulinumtoxinA in male and female patients with overactive bladder (OAB). Data were pooled from four similarly designed trials in North America and Europe. Adults with idiopathic OAB for ≥6 months inadequately managed by at least one anticholinergic were randomized 1:1 or 2:1 to receive onabotulinumtoxinA 100 U or matched placebo in Cycle 1 and could request open-label retreatment with onabotulinumtoxinA 100 U at ≥12 weeks. Efficacy outcomes at Week 12 included the primary endpoint of mean urinary incontinence (UI) episodes per day and other variables, such as the proportion of patients with ≥50% reduction in daily UI episodes. Safety was assessed by monitoring treatment-emergent adverse events (TEAEs). Analyses by sex were descriptive. Males were further analyzed by benign prostatic hyperplasia (BPH) diagnosis status. In the pooled population (N = 1564), there were 194 males (12.4%) and 1370 females (87.6%). Mean number of baseline UI episodes per day was 4.9 in males and 5.5 in females. At Week 12, numerically greater mean reductions from baseline in number of daily UI episodes were observed with the onabotulinumtoxinA 100 U group (females: -3.0; males: -2.2) versus placebo (females: -1.1; males: -1.3). Achievement of ≥50% reduction in daily UI episodes was numerically greater with onabotulinumtoxinA 100 U (females: 64.8%; males: 61.2%) versus placebo (females: 30.6%; males: 44.8%), and numerically higher in males without BPH (onabotulinumtoxinA: 65.1%; placebo: 50.9%) versus with BPH (onabotulinumtoxinA: 54.3%; placebo: 36.6%). A total of 34.7% of males and 39.4% of females experienced at least one TEAE in the first 12 weeks during treatment Cycle 1. Urinary tract infection rate was 13.1% in females and 4.2% in males; incidence of hematuria was 6.8% in males and 1.1% in females. Incidence of urinary retention (defined as incomplete emptying, requiring catheterization) was 2.7% in females and 4.7% in males. OnabotulinumtoxinA 100 U was efficacious and well tolerated in men and women with OAB, including in males with and without BPH. No new safety findings were identified when data were analyzed by sex.

Reduction of masseter muscle prominence after treatment with onabotulinumtoxinA: primary results from a randomized phase 2 study

OnabotulinumtoxinA is used to treat masseter muscle prominence (MMP). To assess the safety and efficacy of onabotulinumtoxinA for MMP in a randomized study. This 12-month, multicenter, double-blind, placebo-controlled, phase 2 study randomized adults (18-50 years of age) with marked/very marked bilateral MMP (≥4 on the Masseter Muscle Prominence Scale [MMPS]) to onabotulinumtoxinA (24, 48, 72, or 96 U) or placebo; retreatment occurred at day 180 if MMPS ≥4. Lower facial volume at day 90 was measured using Vectra 3-dimensional photography. Safety assessments included computed tomography and dental exams. Evaluations occurred monthly through day 360. Among 187 randomized subjects, significant lower facial volume reductions and percentage of responders (MMPS grade ≤3) were greater with onabotulinumtoxinA versus placebo at day 90 (P < .001 and ≤ .008, respectively). Similar efficacy was observed with retreatment. No dose-related safety trends or clinically relevant changes in the mandible or teeth occurred. Localized impact on smile was reported with 96 U onabotulinumtoxinA (n=4). Limited sample size per individual treatment group. OnabotulinumtoxinA administered in 1 or 2 treatments over 1 year was associated with significant reductions in masseter muscle volume and MMP severity, with an acceptable safety profile.

Improving Neck and Jawline Aesthetics With OnabotulinumtoxinA by Minimizing Platysma Muscle Contraction Effects: Efficacy and Safety Results in a Phase 3 Randomized, Placebo-Controlled Study.

Platysma prominence (PP) describes the noticeable appearance of the platysma muscle upon contraction, causing less defined jawline contour and vertical neck bands. To assess safety and efficacy of onabotulinumtoxinA for improvement of PP in adults. Participants with moderate-to-severe (Grade 3 to 4) PP at maximum contraction received onabotulinumtoxinA or placebo on Day 1 and were monitored for 120 days. OnabotulinumtoxinA dosage (26, 31, or 36 U) was customized based on baseline PP severity on each side of the neck. Efficacy analyses were conducted in the intent-to-treat (ITT) population (all randomized participants), and modified ITT population (mITT; psychosocially impacted by PP appearance). Results from ITT and mITT populations were comparable. As assessed by investigators, 76.7% of onabotulinumtoxinA mITT participants achieved ≥1-grade improvement versus 21.2% in the placebo group, and 41.0% versus 2.2% (P < 0.0001) achieved ≥2-grade improvement at Day 14. As assessed by participants, 79.9% of onabotulinumtoxinA mITT participants versus 21.8% in the placebo group and 40.8% versus 3.9% (P < 0.0001) achieved ≥1- or ≥2-grade improvement, respectively, at Day 14. OnabotulinumtoxinA responder rates remained higher than placebo through Day 120, gradually declining over time. OnabotulinumtoxinA participants reported significantly higher satisfaction with treatment effect, lower bother from jawline and vertical neck bands, and lower psychosocial impact from PP than placebo at Day 14 (P < 0.0001). OnabotulinumtoxinA effectively improved self-perceived jawline definition and was well tolerated. OnabotulinumtoxinA was well tolerated and effective in improving moderate-to-severe PP, including neck bands and jawline definition.

Improvement of Platysma Prominence With OnabotulinumtoxinA: Safety and Efficacy Results From a Randomized, Double-Blinded, Placebo-Controlled Phase 3 Trial

Platysma prominence (PP) refers to the undesirable effects that may occur with platysma muscle contraction. Evaluate safety and efficacy of onabotulinumtoxinA for improving Moderate (Grade 3) to Severe (Grade 4) PP in adults. Participants were randomized 1:1 to receive a total dose of onabotulinumtoxinA 26, 31, or 36 U or placebo on Day 1 and monitored for 120days. Dosage was administered via superficial intramuscular injections into the platysma muscle based on baseline PP severity. At Day 14, 32.3% of onabotulinumtoxinA-treated participants in the intent-to-treat population versus 1.9% who received placebo achieved investigator- and participant-rated Grade 1 or 2 (Minimal or Mild) and ≥2-grade improvement from baseline in PP severity, while 56.9% and 51.7% achieved Grade 1 or 2 on investigator's and participant's assessments, respectively (all P<.0001). OnabotulinumtoxinA-treated participants reported higher satisfaction, less bother from jawline and vertical neck band appearance, and reduced psychosocial impact versus placebo (all P<.0001). Adverse event incidence was similar between onabotulinumtoxinA and placebo. No events of dysphagia or muscular weakness were reported. A single onabotulinumtoxinA treatment was evaluated. OnabotulinumtoxinA showed favorable tolerability and significantly improved PP severityand patient-reported outcomes in participants with moderate-to-severe PP.

54285 Evaluating the Safety and Efficacy of OnabotulinumtoxinA for the Treatment of Platysma Prominence: Results from a Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

54285 Evaluating the Safety and Efficacy of OnabotulinumtoxinA for the Treatment of Platysma Prominence: Results from a Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Adverse Effects of Intravesical OnabotulinumtoxinA Injection in Patients with Idiopathic Overactive Bladder or Neurogenic Detrusor Overactivity: A Systematic Review and Meta-Analysis of Randomized Controlled Studies.

Despite the efficacy of onabotulinumtoxinA, its safety profile remains a concern. This meta-analysis reviewed the major adverse events (AEs) associated with intravesical onabotulinumtoxinA treatment in patients with neurogenic detrusor overactivity (NDO) and idiopathic overactive bladder (iOAB). Randomized controlled trials (RCTs) conducted between January 2000 and December 2022 were searched for adult patients administered different onabotulinumtoxinA dosages or onabotulinumtoxinA vs. placebo. Quality assessment was performed using the Cochrane Collaboration tool, and statistical analysis was performed using Review Manager version 5.3. A total of 26 RCTs were included in the analysis, including 8 on NDO and 18 on iOAB. OnabotulinumtoxinA vs. placebo significantly increased the urinary tract infection (UTI) incidence in patients with NDO (relative risk, or RR, 1.54) and iOAB (RR, 2.53). No difference in the RR with different onabotulinumtoxinA dosages was noted. Urinary retention was frequent with onabotulinumtoxinA use in the NDO (RR, 6.56) and iOAB (RR, 7.32) groups. Similar observations were made regarding the risks of de novo clean intermittent catheterization (CIC). The risk of voiding difficulty increased with onabotulinumtoxinA use in patients with iOAB. Systemic AEs of onabotulinumtoxinA, including muscle weakness (RR, 2.79) and nausea (RR, 3.15), were noted in patients with NDO; most systemic AEs had a low incidence and were sporadic.

Comparative study between the efficacy of prabotulinum toxin-A versus onabotulinum toxin-A for the treatment of upper facial expression lines.

Botulinum Toxin (BoNTA) is the most used nonsurgical aesthetic procedure to treat facial expression lines. This study compared the efficacy of Prabotulinum toxin-A, a novel BoNTA that originates from Clostridium botulinum Hall-A, with onabotulinum toxin-A in treating facial expression lines using the Facial Wrinkle Scale (FWS) and FACE-Q questionnaires. This was an experimental, comparative, longitudinal, open-label, and prospective study. Patients aged between 25 and 40 years with upper-third facial expression lines were included. Follow-ups were made at three, seven, 30, and 120 days. A total of 26 patients were included: 20 female, and six males, with a mean age of 28.26 years. An average of 31.00 IU and 31.38 IU were administered to the onabotulinum and prabotulinum groups, respectively. The prabotulinum group demonstrated superiority in FWS and Face-Q scores between the first and third days (p ≤ 0.001, p < 0.001, respectively), which continued on day 7. By day 30, there were no differences in the scores of the two questionnaires. Prabotulinum toxin-A is a safe and effective treatment for upper-third facial wrinkles. On day three and seven, the results suggest that prabotulinum toxin-A has a quicker onset of action than onabotulinum toxin-A. On days 30 and 120, both groups showed similar FWS and Face-Q scores.

Onabotulinumtoxina in the Prevention of Migraine in Pediatric Population: A Systematic Review.

Migraine is a leading cause of disability worldwide, yet it remains underrecognized and undertreated, especially in the pediatric and adolescent population. Chronic migraine occurs approximately in 1% of children and adolescents requiring preventive treatment. Topiramate is the only FDA-approved preventative treatment for children older than 12 years of age, but there is conflicting evidence regarding its efficacy. OnabotulinumtoxinA is a known and approved treatment for the management of chronic migraine in people older than 18 years. Several studies examine its role in the pediatric population with positive results; however, the clear-cut benefit is still unclear. OnabotulinumtoxinA seems not only to improve disability scores (PedMIDAS) but also to improve the quality, characteristics, and frequency of migraines in the said population. This systematic review aims to summarize the evidence on the efficacy, dosing, administration, long-term outcomes, and safety of onabotulinumtoxinA in pediatric and adolescent migraine. Eighteen studies met the eligibility criteria and were included in this review. The mean monthly migraine days (MMDs), decreased from of 21.2 days per month to 10.7 after treatment. The reported treatment-related adverse effects were mild and primarily injection site related and ranged from 0% to 47.0%. Thus, this review provides compelling evidence suggesting that OnabotulinumtoxinA may represent a safe and effective preventive treatment option for pediatric migraine.

"Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study".

With aging, repetitive contraction of the platysma leads to an increase in platysma prominence (PP) characterized by the accentuation of vertical neck bands and blunting of the jawline's contour. This multicenter, double-blind, phase 2 study evaluated onabotulinumtoxinA (onabotA) treatment in adults with Moderate to Severe PP. Participants were randomized to receive 1 treatment of onabotA low dose (LD), onabotA high dose (HD), or placebo, and were followed for 4 months. Efficacy endpoints were the achievement of a ≥ 1-grade improvement on both the left and right sides at Day 14 at maximum contraction as assessed by the investigator (primary) or by participants (secondary) using validated scales. Safety was evaluated throughout. Participants in the modified intent-to-treat population (N = 164) had a mean age of 50 years; 95.1% were female and 93.9% were White. The primary endpoint was met for both onabotA groups, with investigator-assessed ≥ 1-grade improvement in 77.8% (LD) and 88.2% (HD) vs 12.0% (placebo) of participants on Day 14 (P < 0.0001 vs placebo). Based on participant self-assessment, 75.9% (LD) and 88.2% (HD) vs 18.0% (placebo) achieved ≥ 1-grade improvement on Day 14 (P < 0.0001 vs placebo). Most treatment-related adverse events (AEs) were procedure-related, transient, and mild in severity. The most frequent onabotA-related AE was neck muscle weakness, reported in the HD group. OnabotA was effective in improving the appearance of PP based on both investigators' and participants' ratings. Treatment was well tolerated.

OnabotulinumtoxinA as a promising treatment for primary trochlear headache: A retrospective case series.

To report the efficacy of onabotulinumtoxinA (BoNTA) injections in relieving pain in patients with primary trochlear headache (PRTH). Examination of medical records for patients diagnosed with PRTH according to the International Classification of Headache Disorders, 3rd edition criteria and treated with BoNTA. Data were collected for variables related to pain relief, duration of effectiveness, and adverse effects. Six patients were included in the study. All had previously undergone standard care interventions, including infiltrations or oral treatments, yet experienced treatment failure or symptom recurrence. All patients received 20 units of BoNTA, administered in the corrugator and procerus muscles. Subsequent to the BoNTA injections, all six patients reported substantial pain relief, with five achieving complete remission of symptoms. The analgesic effect persisted for a duration of 3 months. No adverse events were reported in any of the cases. Our case series presents the first evidence of the potential of BoNTA as a safe and effective treatment option for PRTH. From a clinical standpoint, having a safer alternative is of paramount significance for patients with limited treatment options, such as those with PRTH. Further research is warranted to validate these findings and explore the long-term efficacy of BoNTA in PRTH management.

A Retrospective Comparison of Onabotulinum Toxin A and Incobotulinum Toxin A in Terms of Efficacy, Tolerability, Duration of Effect, and Pain on Injection Administration Site for the Treatment of Chronic Migraine.

Background Onabotulinum toxin A (OnA) is a well-tolerated and effective treatment for chronic migraine (CM). However, based on research indications that incobotulinum toxin A (InA) would be equally effective, a VeteransHealth Administration medical center mandated a two-year trial of InA as a more cost-effective alternative to OnA. Although InA is used for many similar indications as OnA, it is not Food and Drug Administration-approved for treating CM, and complications occurred in several patients with CM following this treatment change. We conducted this retrospective analysis to evaluate differences in the efficacy of OnA and InA and identify the reasons for the adverse effects of InA in some of these patients. Methods We performed a retrospective review of 42 patients who had been effectively treated with OnA and were then switched to InA. The differences between treatment responses to OnA and InA were assessed through the evaluation of pain on injection, number of headache days, and duration of action. Patients received injections at 10- to 13-week intervals. Those who reported severe pain on injection of InA were switched back to OnA. Results Severe burning pain on InA injection was reported by 38% of patients (nine males and seven females, i.e., a total of 16 patients out of 42 patients). One male patient reported the same degree of pain fromboth InA and OnA injections. A total of 66.7% of women with obesity and 83.3% of men with obesity or diabetes experienced severe pain on injection. Neither migraine suppression nor the duration of effect was significantly different between OnA and InA. Conclusions OnA isbetter toleratedthan InA in the treatment of CM. InA appears to effectively suppress migraines, but some patients complain of a severe localized burning sensation during the injections. Some of these patients, all of whom were previously treated with OnA, requested to switch back to OnA. This suggested that InA is not equivalent to OnA in terms of tolerability and effectiveness.The present studyfound 2.38% of patients experienced an insufficient duration of effect withInA, and none withOnA. However, these lower rates may, in part, be due to variability in injection intervals in this sample, which could be because of scheduling considerations at the Harry S. Truman Veterans Health Administration Medical Center. In cases where OnA fails because of the development of antibodies, it might be reasonable to switch to InA treatment. Reformulation of InA with a pH-buffered solution may eliminate the difference in pain on injection. InA would then be a good alternative to OnA for treating CM.

Efficacy and safety of onabotulinumtoxinA in the treatment of medication overuse headache: a systematic review.

Medication overuse headache (MOH) is a chronic headache caused by regular overuse of medications. OnabotulinumtoxinA (BoNTA) is used for preventive treatment of MOH. However, its efficacy and safety remain controversial. Seven online databases (Cochrane Library, Embase, Medline, PubMed, China National Knowledge Infrastructure, Wanfang data, and Chinese BioMedical Literature Database) were searched for relevant articles published between January 2002 and March 2024. We included randomized controlled trials (RCTs) and cohort studies on the treatment of MOH using BoNTA versus a placebo or other active treatments. We retrieved 487 articles in the database search. Of these, four eligible RCTs were identified after detailed screening. A total of 1,259 patients with MOH (622 patients treated with BoNTA, 607 with placebo, and 30 with topiramate) were included in the four RCTs. We found that BoNTA significantly reduced headache frequency compared with placebo (mean difference, 1.89; 95% confidence interval (CI), 1.11-2.67; I 2 = 0%; p < 0.001). There was no significant difference between BoNTA and the placebo in terms of secondary outcomes, which included reductions in acute medication intake (MD, 1.30; 95% CI, -1.18-3.78; I 2 = 0%; p = 0.30), Migraine Disability Assessment questionnaire scores (MIDAS, MD, -4.04; 95% CI, -29.36-21.28; I 2 = 0%; p = 0.75), and Headache Impact Test scores (HIT-6, MD, 0.03; 95% CI, -1.77-1.83; I 2 = 0%; p = 0.97). BoNTA was more likely to cause adverse events (OR, 1.87; 95% CI, 1.45-2.42; I 2 = 0%; p < 0.001) than placebo. The results of this study show that BoNTA reduces headache frequency and is effective for the treatment of MOH. https://www.crd.york.ac.uk/prospero/, identifier CRD42022315845.

Therapeutic Benefit of Sensory Trick in Cervical Dystonia.

Sensory tricks (STs) are voluntary maneuvers that dampen the abnormal movement in cervical dystonia (CD). To investigate the effect of ST on CD severity and treatment. Data on 1039 individuals with a modified Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score were extracted from the CD Patient Registry for Observation of OnabotulinumtoxinA (onabotA) Efficacy study. Univariate and multivariate models evaluated the direct and indirect impact of ST on CD severity and treatment, while controlling for confounds. Complete ST was associated with a 10% lower mean onabotA dose. Absence of complete ST was associated with a higher onabotA dose after controlling for dystonia severity (OR = 1.37, P = 0.04). ST moderated the relationship between dystonia severity and toxin dose (β = -0.16, P = 0.02). ST is related to lower CD severity and toxin dose. It may have a direct effect on lowering toxin dose, independent of CD severity.

Botulinum Toxin for Pediatric Migraine: A Retrospective Multisite Cohort Study

BackgroundOnabotulinum toxin A is effective in adult chronic migraine, but the efficacy is not well established in adolescent patients. The objective of this study is to describe the safety and efficacy of onabotulinum toxin A and incobotulinum toxin A for adolescent chronic migraine headache. MethodsWe performed a chart review of adolescents who received onabotulinum toxin A or incobotulinum toxin A for headache prevention. Demographic information and baseline headache characteristics were collected. The primary end point was a 50% reduction in headache frequency. Secondary outcome measures included reduction in headache frequency, repeat appointments for injections, reduction in other migraine medications, and adverse events. ResultsWe included 51 adolescents who received at least one injection of either incobotulinum toxin A or onabotulinum toxin A for chronic migraine. Mean age at first dose was 16.0 (1.1; 13 to 17), (S.D. and range). Patients averaged 24.0 headache days per month (7.6; 4 to 28), (S.D. and range) before injection. In addition, 36 of the 51 adolescents (71%) were experiencing continuous headaches. Thirty-five (69%) adolescents had experienced 50% reduction in headache days by the time of first follow-up, which occurred on average at 16.6 weeks from initial injection (11.5; 2 to 55.7) (S.D. and range). Adolescents reported an average decrease of 13.1 headaches days per month. Only two adolescents reported side effects (4%), which were neck soreness and headache following injection. ConclusionsBotulinum toxin had better efficacy in our adolescent migraine population than has been demonstrated in other studies.

OnabotulinumtoxinA improves oral aperture in patients with scleroderma: A small clinical trial

Reduced oral aperture (ROA), resulting from systemic sclerosis (SSc), is a debilitating condition with limited treatment options. Improvement in oral function has been reported with perioral administration of botulinum toxin type A. To prospectively evaluate the efficacy of onabotulinumtoxinA (onabotA) injection in improving oral opening and quality of life in SSc patients with ROA. Seventeen women with SSc and ROA were treated with 16 units of onabotA in 8 different sites around the cutaneous lips. Measurements of maximum mouth opening were taken before treatment, at 2weeks posttreatment, and at 3months posttreatment. Function and quality of life were also assessed via surveys. Interincisor and interlabial distances were significantly increased 2weeks after treatment with onabotA (P<.001) but not 3months after. Subjective improvement in quality of life was noted. This single-institution study enrolled 17 patients and did not have a placebo control group. OnabotA appears to have a strong short-term symptomatic benefit in patients with ROA due to SSc, with possible benefit to quality of life.

Quantitative and Qualitative Pain Evaluation in Response to OnabotulinumtoxinA for Chronic Migraine: An Observational Real-Life Study.

(1) Background: Randomized controlled trials and real-life studies demonstrated the efficacy of OnabotulinumtoxinA (OBT-A) for CM prevention. However, no studies specifically addressed its effect on pain's quantitative intensity and qualitative characteristics. (2) Methods: This is an ambispective study: a post-hoc retrospective analysis of real-life prospectively collected data from two Italian headache centers on CM patients treated with OBT-A over one year (i.e., Cy1-4). The primary endpoint was the changes in pain intensity (Numeric Rating Scale, NRS; the Present Pain Intensity (PPI) scale, the 6-point Behavioral Rating Scale (BRS-6)) and quality scale (the short-form McGill Pain Questionnaire (SF-MPQ)) scores. We also assessed the relationship between changes in intensity and quality of pain and disability scale (MIDAS; HIT-6) scores, monthly headache days (MHDs), and monthly acute medication intake (MAMI) (3) Results: We retrieved 152 cases (51.5 years SD 11.3, 80.3% females). From baseline to Cy-4, MHDs, MAMI, NRS, PPI, and BRS-6 scores decreased (consistently p < 0.001). Only the throbbing (p = 0.004), splitting (p = 0.018), and sickening (p = 0.017) qualities of pain collected in the SF-MPQ were reduced. Score variations in MIDAS related to those in PPI scales (p = 0.035), in the BRS-6 (p = 0.001), and in the NRS (p = 0.003). Similarly, HIT-6 score changes related to PPI score modifications (p = 0.027), in BRS-6 (p = 0.001) and NRS (p = 0.006). Conversely, MAMI variation was not associated with qualitative or quantitative pain score modifications except BRS-6 (p = 0.018). (4) Conclusions: Our study shows that OBT-A alleviates migraine by reducing its impact on multiple aspects, such as frequency, disability, and pain intensity. The beneficial effect on pain intensity seems specific to pain characteristics related to C-fiber transmission and is associated with a reduction in migraine-related disability.

Double-Blind, Placebo-Controlled Study of Onabotulinumtoxin A for the Treatment of Hailey-Hailey Disease.

Hailey-Hailey disease (HHD) can be treated with topical steroids, antibiotics, and invasive surgical procedures. Since sweating often exacerbates HHD lesions, the use of onabotulinumtoxin A could serve as an adjunctive treatment. The goal of this study was to evaluate the safety and efficacy of onabotulinumtoxin A for the treatment of HHD. A double-blind, placebo-controlled single center study was conducted. Six HHD patients who successfully completed this trial in addition to 1 patient who exited early are reported and discussed. Four of these patients received an initial injection of Btx-A and 3 received the placebo initially. All patients except 1 who received an initial or reinjection of Btx-A decreased 2 levels on a 4-point clinical severity scale at weeks 8 or 12 after treatment. Patient 6 received an initial placebo injection and maintained clearance for 6 months, while patients 5 and 7 did not have any improvement in their target lesions after a placebo injection. All patients who received a reinjection of Btx-A at the week 4 follow-up decreased by at least 1 level on the HHD severity scale. Btx-A is a safe treatment that is effective for most cases of HHD. The most severe cases of HHD may not respond to Btx-A as sole treatment. J Drugs Dermatol. 2023;22(4): doi:10.36849/JDD.6857 Citation: Saal R, Oldfield C, Bota J, et al. Double-blind, placebo-controlled study of Onabotulinumtoxin A for the treatment of Hailey-Hailey disease. J Drugs Dermatol. 2023;22(4):339-343. doi:10.36849/JDD.6857.

A Novel 3-Point Injection Technique for OnabotulinumtoxinA in the Upper Depressor Anguli Oris.

To evaluate the efficacy and safety of onabotulinumtoxinA (ONA) injections to the depressor anguli oris (DAO) to improve downturned mouth. This prospective, placebo-controlled, study enrolled subjects aged 18 to 65 years. Injections were performed using a novel 3-point technique in the upper DAO (1.5 U/injection site). The primary end point was a DAO contraction scale 1-grade improvement. Subjective evaluation was performed using the Global Aesthetic Improvement Scale (GAIS). Ten subjects received ONA and 10 placebo (saline) injections. In ONA-treated subjects, DAO scores showed significant improvements at Weeks 4 and 12 ( p < .001) compared with baseline. No significant difference between visits was observed for placebo-injected subjects. Global Aesthetic Improvement Scale scores showed that 100% of subjects were improved compared with baseline at Week 4% and 90% at Week 12. By contrast, 90% and 80% of placebo-treated subjects had "no change" in their DAO appearance at Weeks 4 and 12. Subject GAIS assessments matched the live evaluator at Week 4; 60% continued to report improvement at Week 12. Treatment was well tolerated. OnabotulinumtoxinA injections to the DAO using a 3-point technique provide clinically meaningful improvements in appearance. Treatment was well tolerated and in most individuals lasted at least 12 weeks. ClinicalTrials.gov NCT04240535.

Efficacy of abobotulinumtoxinA versus onabotulinumtoxinA for the treatment of refractory neurogenic detrusor overactivity: a systematic review and indirect treatment comparison

AimsTo compare the efficacy and safety of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) for the treatment of refractory neurogenic detrusor overactivity (NDO), using an indirect treatment comparison (ITC).Materials and methodsA systematic literature review was used to identify randomized controlled trials (RCTs) that evaluated botulinum toxin type A for the treatment of refractory NDO. Treatments were compared using a Bucher ITC approach. Efficacy outcomes were reduction in number of weekly urinary incontinence (UI) episodes at 6, 12, and 24 weeks of follow-up. The safety outcome was the proportion of patients with treatment-emergent urinary tract infections (TE-UTIs) during follow-up. Subgroup/sensitivity analyses were performed to investigate the impact of heterogeneity.ResultsFifteen studies of botulinum toxin type A were identified. Among these, onaBoNT-A 200 U was the only botulinum toxin type A considered an appropriate comparator for aboBoNT-A 600 U and 800 U. As such, six RCTs that evaluated onaBoNT-A or aboBoNT-A were included in the ITC. In base-case analyses, there were no statistically significant differences between aboBoNT-A and onaBoNT-A in terms of UI episodes or TE-UTIs. Numerically, the trend favored aboBoNT-A (either dose) for all endpoints and time points. At 12 and 24 weeks, the difference in reduction of UI episodes per week was considered clinically relevant when comparing aboBoNT-A 800 U with onaBoNT-A 200 U, but not when comparing the lower dose of aboBoNT-A (600 U) with onaBoNT-A 200 U. Results from subgroup/sensitivity analyses were consistent with the base case.LimitationsHeterogeneity across studies was observed; however, strong consistency of trends across analyses suggests the impact of heterogeneity is low.ConclusionsThere may be potential advantages of aboBoNT-A over onaBoNT-A, in terms of UI reduction, in patients with refractory NDO. More confirmatory studies are needed owing to the sparsity of current evidence.

Comparative assessment of the efficacy of onabotulinumtoxinA as monotherapy and combined therapy with propiverine in female refractory overactive-bladder syndrome

Comparative assessment of the efficacy of onabotulinumtoxinA as monotherapy and combined therapy with propiverine in female refractory overactive-bladder syndrome