Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm

Background: XCiDaBLE is a large, prospective, observational &ldquo;naturalistic&rdquo; study evaluating Xeomin&reg; for Cervical Dystonia or BLEpharospasm in the United States. We report the interim results from the blepharospasm cohort of XCiDaBLE.Methods: Subjects (&ge;18 years old) with blepharospasm were followed for two treatment cycles of incobotulinumtoxinA and monitored for 4 weeks after injection via interactive voice/web response system (IVRS/IWRS). The investigator‐reported scale includes the Clinical Global Impression Scale‐Severity subscale (CGI‐S). Patient‐reported outcome measures include the Patient Global Impression Scale‐Severity (PGI‐S) and ‐Improvement (PGI‐I) subscales, Jankovic Rating Scale (JRS), SF‐12v2&reg; health survey, and Work Productivity and Activity Impairment questionnaire. Subjects are seen by the investigator at baseline (including the first injection), during the second injection, and at a final study visit (12 weeks after the second injection).Results: One hundred seventy subjects were included in this interim analysis. The majority of subjects were female (77.1%) and white (91.8%), and had previously been treated with botulinum toxins (96.5%). The mean total dose (both eyes) was 71.5 U of incobotulinumtoxinA for the first injection. PGI‐S, PGI‐I, and JRS scores were significantly improved 4 weeks after treatment (all p&lt;0.0001). No differences were noted in either quality of life (QoL) or work productivity in this short assessment period. No unexpected adverse events occurred.Discussion: This is an interim study and assessment method based on an IVRS/IWRS. In this predominantly toxin‐experienced cohort, significant benefits in specific and global measures of disease severity were seen in the immediate post‐incobotulinumtoxinA injection period. It will be interesting to see if there are improvements in QoL with consistent individualized injections over a longer period.</p

Effect of botulinum toxin pretreatment on laser resurfacing results: a prospective, randomized, blinded trial.

BACKGROUND: Facial laser resurfacing and chemodenervation with botulinum toxin type A are used independently as means of nonsurgical facial rejuvenation. Recent reports in the literature have described combining these 2 therapies, claiming improved and longer-lasting laser resurfacing results. To date, no scientific investigation has been undertaken to prove or disprove this theory. DESIGN: Institutional review board-approved, prospective, randomized, blinded study at university-affiliated outpatient cosmetic surgery offices. INTERVENTION: Patients had one side of their face injected, at specific anatomic subsites (crow\u27s feet, horizontal forehead furrows, and glabellar frown lines), with botulinum toxin 1 week before laser resurfacing. After receiving an injection, patients underwent cutaneous laser exfoliation on both sides of the face with either a carbon dioxide or an erbium dual-mode laser. MAIN OUTCOME MEASURES: Patients\u27 injected (experimental) and noninjected (control) sides were compared after laser resurfacing. Follow-up was documented at 6 weeks, 3 months, and 6 months after laser resurfacing. Subjective evaluation, based on a visual analog scale, was performed in person by a blinded observer. Furthermore, a blinded panel of 3 expert judges (1 facial plastic surgeon, 1 oculoplastic surgeon, and 1 cosmetic dermatologist) graded 35-mm photographs taken during postoperative follow-up visits. RESULTS: Ten female patients were enrolled in the study. A 2-tailed t test showed that all sites that were pretreated with botulinum toxin showed statistically significant improvement (P\u3c or =.05) over the nontreated side, with the crow\u27s feet region showing the greatest improvement. Comparing results between the carbon dioxide and erbium lasers did not result in any statistically significant differences. CONCLUSIONS: Hyperdynamic facial lines, pretreated with botulinum toxin before laser resurfacing, heal in a smoother rhytid-diminished fashion. These results were clinically most significant in the crow\u27s feet region. We recommend pretreatment of movement-associated rhytides with botulinum toxin before laser resurfacing. For optimum results, we further recommend continued maintenance therapy with botulinum toxin postoperatively

Outcomes of Patients With Thyroid Eye Disease Partially Treated With Teprotumumab

In response to the coronavirus (COVID-19) pandemic, teprotumumab production was temporarily halted with resources diverted toward vaccine production. Many patients who initiated treatment with teprotumumab for thyroid eye disease were forced to deviate from the standard protocol. This study investigates the response of teprotumumab when patients receive fewer than the standard 8-dose regimen. This observational cross-sectional cohort study included patients from 15 institutions with active or minimal to no clinical activity thyroid eye disease treated with the standard teprotumumab infusion protocol. Patients were included if they had completed at least 1 teprotumumab infusion and had not yet completed all 8 planned infusions. Data were collected before teprotumumab initiation, within 3 weeks of last dose before interruption, and at the visit before teprotumumab reinitiation. The primary outcome measure was reduction in proptosis more than 2 mm. Secondary outcome measures included change in clinical activity score (CAS), extraocular motility restriction, margin reflex distance-1 (MRD1), and reported adverse events. The study included 74 patients. Mean age was 57.8 years, and 77% were female. There were 62 active and 12 minimal to no clinical activity patients. Patients completed an average of 4.2 teprotumumab infusions before interruption. A significant mean reduction in proptosis (-2.9 mm in active and -2.8 mm in minimal to no clinical activity patients, P < 0.01) was noted and maintained during interruption. For active patients, a 3.4-point reduction in CAS ( P < 0.01) and reduction in ocular motility restriction ( P < 0.01) were maintained during interruption. Patients partially treated with teprotumumab achieve significant reduction in proptosis, CAS, and extraocular muscle restriction and maintain these improvements through the period of interruption