incobotulinumtoxinA Injections Research Articles

Benefit of Repeated Injections of IncobotulinumtoxinA for Pain Reduction in Adults with Cervical Dystonia and Moderate or Severe Baseline Pain: An Analysis of Pooled Data (P8-3.004)

Benefit of Repeated Injections of IncobotulinumtoxinA for Pain Reduction in Adults with Cervical Dystonia and Moderate or Severe Baseline Pain: An Analysis of Pooled Data (P8-3.004)

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.

Pain Reduction After Repeated Injections of IncobotulinumtoxinA for Pain Reduction in Adults With Cervical Dystonia and Moderate or Severe Baseline Pain

Pain Reduction After Repeated Injections of IncobotulinumtoxinA for Pain Reduction in Adults With Cervical Dystonia and Moderate or Severe Baseline Pain

Incobotulinum Toxin-A in Professional Musicians with Focal Task-Specific Dystonia: A Double Blind, Placebo Controlled, Cross-Over Study.

Musician's focal task-specific dystonia is a complex disorder of fine motor control, with incomplete understanding of its etiology. There have been relatively few trials of botulinum toxin in upper limb task-specific dystonia, and prior studies have yielded variable results, leading to skepticism regarding the utility of this approach in elite performers. We conducted a double-blind, placebo-controlled, randomized, cross-over study of incobotulinum toxin-A in 21 professional musicians with focal upper extremity task-specific dystonia affecting performance on their instrument, using a novel paradigm of initial injections followed by booster injections at two- and four-week intervals. The primary outcome measure was the change in blinded dystonia rating of the active arm by two expert raters using a Clinical Global Impression numeric scale at week 8 compared to enrollment. 19 men and 2 women with musicians' dystonia were enrolled over a six-year period. Nineteen patients completed the study. Analysis of the primary outcome measure in comparison to baseline revealed a change in dystonia severity of P = 0.04 and an improvement in overall musical performance of P = 0.027. No clinically significant weakness was observed, and neutralizing antibodies to toxin were not found. Despite its small sample size, our study demonstrated a statistically significant benefit of incobotulinum toxin-A injections as a treatment for musicians' task-specific dystonia. Tailoring the use of toxin with booster injections allowed refinement of dosing strategy and outcomes, with benefits that were meaningful to patients clearly visible on videotaped evaluations. In addition to its application to musicians' dystonia, this approach may have relevance to optimize application of botulinum toxin in other forms of focal dystonia such as blepharospasm, cervical dystonia, writer's cramp, and spasmodic dysphonia.

Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: protocol for a phase II, single-centre, double-blind, randomised, placebo-controlled trial (the PINBOT study)

IntroductionDiabetic neuropathic pain (DNP) is a debilitating complication affecting 15–20% of people with diabetes and is a predictor of depression, poor sleep and decreased quality of life. Current pharmacological treatments...

Benefit of Multiple IncobotulinumtoxinA Injections for Pain Reduction in Adults With Cervical Dystonia: An Analysis of Pooled Data

Benefit of Multiple IncobotulinumtoxinA Injections for Pain Reduction in Adults With Cervical Dystonia: An Analysis of Pooled Data

Injections of incobotulinumtoxina at intervals less than 10 weeks are effective and safe for cervical dystonia patients with inadequate benefit from standard injection intervals

Injections of incobotulinumtoxina at intervals less than 10 weeks are effective and safe for cervical dystonia patients with inadequate benefit from standard injection intervals

Benefit of repeated injections of incobotulinumtoxina for pain reduction in adults with cervical dystonia and moderate or severe baseline pain: An analysis of pooled data

Benefit of repeated injections of incobotulinumtoxina for pain reduction in adults with cervical dystonia and moderate or severe baseline pain: An analysis of pooled data

Benefit of multiple incobotulinumtoxina injections for pain reduction in adults with cervical dystonia: An analysis of pooled data

Benefit of multiple incobotulinumtoxina injections for pain reduction in adults with cervical dystonia: An analysis of pooled data

Treatment of cervical dystonia using shorter incobotulinumtoxina injection intervals improves patient-reported outcomes in those with inadequate benefits from standard intervals

Treatment of cervical dystonia using shorter incobotulinumtoxina injection intervals improves patient-reported outcomes in those with inadequate benefits from standard intervals

Global facial rejuvenation with one treatment of incobotulinumtoxinA, hyaluronic acid, and calcium hydroxyapatite results in long-term patient-reported satisfaction.

Global facial rejuvenation using injectables (neuromodulators and fillers) has reported patient satisfaction after 2 treatments: an initial and touch-up treatment at 2-4 weeks afterward. In practice, patients typically receive only 1 treatment and do not return for a touch-up treatment within a month. The purpose of this study was to assess patient-reported satisfaction after only 1 treatment, thus mimicking real-world scenarios. Patients with facial photoaging (Glogau facial aging scale ≥2) were treated with calcium hydroxyapatite, hyaluronic acid 22.5 mg/mL, and incobotulinumtoxinA injections for full facial rejuvenation, with no touch-up treatments. Patients completed the FACE-Q Satisfaction with Facial Appearance survey at baseline and 1- and 3-month post-treatment. The treating physician completed the Global Aesthetic Improvement Scale at 1- and 3-month post-treatment. Twenty-two patients were enrolled in the study, with 1 patient lost to follow-up. There was a significant improvement in mean FACE-Q scores at 1-month (80.1, P = .01) and 3-month (77.9, P = .02) compared to baseline (71.4). Mean Global Aesthetic Improvement Scale scores at 1-month (2.1) and 3-month (2.2) were not statistically significant, indicating sustained improvement at 3 months. The product amount used per patient varied and was not correlated with either score. Limitations included a lack of a control group and follow-up ending at 3 months. Strengths included assessment of patient satisfaction after only 1 treatment, compared to other studies allowing 2 treatments. Limitations include a small sample size and lack of a control group. Global full facial rejuvenation using 1 treatment of calcium hydroxyapatite, hyaluronic acid 22.5 mg/mL, and incobotulinumtoxinA provides sustained patient-reported satisfaction at 3 months.

IncobotulinumtoxinA injections at intervals

IncobotulinumtoxinA injections at intervals <10 weeks are effective and safe for cervical dystonia patients with inadequate benefit from standard intervals

Pain reduction in adult patients with limb spasticity following single incobotulinumtoxinA injection: analysis of pooled data from phase 2/3 studies

Pain reduction in adult patients with limb spasticity following single incobotulinumtoxinA injection: analysis of pooled data from phase 2/3 studies

Benefit of multiple incobotulinumtoxinA injections for pain reduction in adult patients with limb spasticity: pooled analysis of phase 2/3 studies

Benefit of multiple incobotulinumtoxinA injections for pain reduction in adult patients with limb spasticity: pooled analysis of phase 2/3 studies

Treatment of cervical dystonia using shorter incobotulinumtoxinA injection intervals improves patient-reported outcomes in those with inadequate benefits from standard intervals

Treatment of cervical dystonia using shorter incobotulinumtoxinA injection intervals improves patient-reported outcomes in those with inadequate benefits from standard intervals

Treatment of Vestibulodynia with Submucosal Injections of IncobotulinumtoxinA into Targeted Painful Points: An Open-Label Exploratory Study.

The studies carried out to date on vulvodynia treatment with botulinum neurotoxin type A (BoNT/A) have followed generic injection protocols and reported contradictory outcomes on its effects. The aim of the present study was thus to propose a protocol for injecting BoNT/A into targeted painful points, to comprehensively assess the clinical effect of BoNT/A treatment and identify the risk/protective factors for successful treatment. Thirty-five vestibulodynia patients were treated with submucosal injections of incobotulinumtoxinA and assessed 8, 12 and 24 weeks after their treatment. Their clinical and pelvic statuses were assessed from self-reported questionnaires (Visual Analogue Scale (VAS), Female Sexual Function Index (FSFI), Marinoff's Dyspareunia Scale (MDS), Hospital Anxiety and Depression Scale (HADS), Catastrophizing Scale (CS)), physical examinations and surface electromyography (sEMG). The patients reported a reduction in provoked vestibulodynia (<VAS, p < 0.01), improved sexual function (>FSFI, p < 0.01; <MDS, p = 0.01) and psychological status (<HADS, p < 0.01), and lower pelvic floor hyperactivity at rest (<sEMG amplitude, p = 0.01). Factors such as smoking, painful comorbidities, vulvar pain sensitivity and sexual function were significantly associated with successful treatment. The results indicate the beneficial effects of BoNT/A in treating vestibulodynia and reinforce the importance of adapting the treatment according to its clinical presentation and the patient's medical background.

Benefit of Multiple IncobotulinumtoxinA Injections for Pain Reduction in Adult Patients with Limb Spasticity: an Analysis of Pooled Data from Phase 2 and 3 Studies (P12-11.009)

<h3>Objective:</h3> To assess pain relief after multiple incobotulinumtoxinA (incoA) injections in a large sample of patients (pts) with limb spasticity-associated pain (SAP) using pooled data from six phase 2/3 studies (four placebo-controlled). <h3>Background:</h3> Repeated treatment with incoA has shown pain-relieving benefits in pts with limb spasticity in individual studies. <h3>Design/Methods:</h3> Adults with upper limb SAP received up to 4 incoA injections (total dose ≤400U) administered at 12- to 14-week intervals (injection cycles [ICs] 1–4; total observation period up to 56 weeks). Only IC 1 was placebo-controlled. Pain severity was assessed at control visits (CVs; 4 weeks after each injection) using the Disability Assessment Scale (DAS; pain scores ranging from 0 [no pain] to 3 [severe pain]). The proportions of pts with a response (defined as a reduction by ≥1 point in the DAS score from baseline to each CV) and with a complete response (DAS pain score=0) were assessed at every CV. Data were descriptively analyzed. As placebo-treated pts in IC 1 received incoA in subsequent cycles, they contributed data to the appropriate incoA CVs 1–4. <h3>Results:</h3> 515 pts with SAP at baseline were included in this analysis (515, 297, 263, and 181 pts at CVs 1–4, respectively). Response rates increased over time, being 53.0%, 63.3%, 66.9%, and 72.4% at CVs 1–4, respectively. Likewise, the proportion of pts with complete response increased over time, being 27.6%, 38.4%, 39.5%, and 43.6% at CVs 1–4, respectively. <h3>Conclusions:</h3> In pts with upper limb SAP, treatment response rates were sustained and showed a cumulative effect over 56 weeks after multiple incoA injections, with a complete pain relief in &gt;40.0% of pts. Results support the use of incoA in reducing upper limb SAP in affected adults. <b>Disclosure:</b> Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merz. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Camoes-Barbosa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MERZ, ABBVIE, IPSEN. Dr. Camoes-Barbosa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for MERZ, ABBVIE, IPSEN. Mr. Comes has received personal compensation for serving as an employee of Merz Pharmaceuticals GmbH. Michael Althaus has received personal compensation for serving as an employee of Merz Pharmaceuticals. Astrid Scheschonka has received personal compensation for serving as an employee of Merz Therapeutics. Dr. Simpson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Simpson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz.

Pain Reduction in Adult Patients with Limb Spasticity Following a Single IncobotulinumtoxinA Injection: an Analysis of Pooled Data from Phase 2 and 3 Studies (P14-11.008)

<h3>Objective:</h3> To assess pain relief in a large cohort of incobotulinumtoxinA-treated pts with spasticity-associated pain (SAP) using pooled data from mostly placebo-controlled phase 2/3 studies. <h3>Background:</h3> IncobotulinumtoxinA (incoA) has shown pain-relieving benefits in patients (pts) with limb spasticity in individual studies; data from large pt cohorts are lacking. <h3>Design/Methods:</h3> Pain severity was assessed with the Disability Assessment Scale (DAS; 0–3) in adults with upper limb SAP. A ≥1 point reduction in the DAS pain score from baseline [BL] to 4 weeks was defined as response. Between-treatment group response rates (overall and by BL pain severity – DAS mild, moderate, severe) and the proportion of pts with complete pain relief (DAS pain score=0) at 4 weeks after 1 injection of incoA (total dose ≤400U) or placebo were analyzed using <i>χ</i>² test. Overall between-group response rate differences were analyzed using logistic regression (presented as odds ratio [OR] and 95% confidence interval [CI]). <h3>Results:</h3> 542 (incoA: 413, placebo: 129) pts reported SAP at BL. At 4 weeks, a significantly higher proportion of incoA- vs placebo-treated pts achieved a response (52.1% vs 28.7%; p&lt;0.0001). IncoA-treated pts were more likely to achieve pain response vs placebo-treated pts (OR 2.7 [95% CI: 1.6–4.3]; p&lt;0.0001). Irrespective of BL pain severity, significantly higher response rates were observed with incoA vs placebo at 4 weeks (p&lt;0.02 all comparisons). Complete pain relief was achieved by significantly more incoA- vs placebo-treated pts at 4 weeks (26.9% vs 12.4%; p=0.0007). <h3>Conclusions:</h3> Pts receiving incoA vs placebo are significantly, by 2.7 times, more likely to achieve reduced upper limb SAP, irrespective of baseline pain severity, at 4 weeks post-injection thus supporting use of incoA in this setting. <b>Disclosure:</b> Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merz. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Camoes-Barbosa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MERZ, ABBVIE, IPSEN. Dr. Camoes-Barbosa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for MERZ, ABBVIE, IPSEN. Mr. Comes has received personal compensation for serving as an employee of Merz Pharmaceuticals GmbH. Michael Althaus has received personal compensation for serving as an employee of Merz Pharmaceuticals. Astrid Scheschonka has received personal compensation for serving as an employee of Merz Therapeutics. Dr. Simpson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Simpson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz.

Spasticity-related pain in children/adolescents with cerebral palsy. Part 2: IncobotulinumtoxinA efficacy results from a pooled analysis.

This pooled analysis of data from three Phase 3 studies investigated the effects of incobotulinumtoxinA on spasticity-related pain (SRP) in children/adolescents with uni-/bilateral cerebral palsy (CP). Children/adolescents (ambulant and non-ambulant) were evaluated for SRP on increasingly difficult activities/tasks 4 weeks after each of four incobotulinumtoxinA injection cycles (ICs) using the Questionnaire on Pain caused by Spasticity (QPS; six modules specific to lower limb [LL] or upper limb [UL] spasticity and respondent type [child/adolescent, interviewer, or parent/caregiver]). IncobotulinumtoxinA doses were personalized, with all doses pooled for analysis. QPS key item responses were available from 331 and 155 children/adolescents with LL- and UL-spasticity, respectively, and 841/444 (LL/UL) of their parents/caregivers. IncobotulinumtoxinA efficacy was evident with the first IC. Efficacy was sustained and became more robust with further subsequent ICs. By Week 4 of the last (i.e. fourth) IC, 33.8-53.3% of children/adolescents reported complete SRP relief from their baseline pain for respective QPS items. Children/adolescents reported reductions in mean LL SRP intensity at levels that surpassed clinically meaningful thresholds. Similarly, parents/caregivers observed complete SRP relief and less frequent SRP with incobotulinumtoxinA. Similar results were found for UL SRP. These findings indicate that incobotulinumtoxinA could bring considerable benefit to children/adolescents with spasticity by reducing SRP, even during strenuous activities.

Quantitative assessment of botulinum toxin injection on blink rate in blepharospasm

ABSTRACT Purpose To objectively measure the blink rate in patients with blepharospasm managed by botulinum toxin type-A injections. Methods In this prospective, non-interventional case series, the complete blink rates of subjects were measured before incobotulinumtoxina injection and at follow-up within 4 weeks using slow-motion video-taping. Additionally, subjects graded the frequency of blinking, the severity of light-sensitivity, and the severity and frequency of dry eye symptoms on a categorical visual analog scale. The results are reported as median (range). Results Ten subjects were enrolled, with nine females. The total duration of treatment was 70 (5–116) months with total of 27.5 (2–51) injections. The subjects were grouped as short-time (<52w) or long-time (>52w) treatments. The median age, follow-up time, and injected doses were 73.5 (49–81) years, 21 (14–28) days, and 38 (8–47) units, respectively, with no significant difference between groups. The total complete blinks per minute before incobotulinumtoxina injection was 39 (23–64) which decreased to 18.5 (1–60) at follow-up (p = 0.004). The average change in complete blink rate was −67.4 ± 23.7% in long-time and −45.2 ± 31.2% in short-time groups (mean ± SD, p = 0.01). The total self-graded frequency of blinking and light-sensitivity decreased significantly at follow-up (p = 0.004, p = 0.047, respectively). Similar patterns of subject reported grades were seen in both groups. Conclusion Videotaping is a low-cost method for objective measurement of blink rate in blepharospasm patients after incobotulinumtoxina injection. There was a significant reduction in blink rate after incobotulinumtoxina injections with higher percentage of change in the long-time treatment group. Incobotulinumtoxina injection also significantly improves subjective photophobia.