Treatment of Adult Spasticity With Botox (onabotulinumtoxinA): Development, Insights, and Impact

Upper and lower limb spasticity (ULS, LLS) often occur following a stroke or in patients with other neurological disorders, leading to difficulties in mobility and daily living and decreased quality of life. Prior to the use of onabotulinumtoxinA, antispastic medications had limited efficacy and often caused sedation. Phenol injections were difficult for physicians to perform, painful, and led to tissue destruction. The success of onabotulinumtoxinA in treating cervical dystonia led to its use in spasticity. However, many challenges characterized the development of onabotulinumtoxinA for adult spasticity. The wide variability in the presentation of spasticity among patients rendered it difficult to determine which muscles to inject and how to measure improvement. Another challenge was the initial refusal of the Food and Drug Administration to accept the Ashworth Scale as a primary endpoint. Additional scales were designed to incorporate a goal-oriented, patient-centered approach that also accounted for the variability of spasticity presentations. Several randomized, double-blind, placebo-controlled trials of post-stroke spasticity of the elbow, wrist, and/or fingers showed significantly greater improvements in the modified Ashworth Scale and patient treatment goals and led to the approval of onabotulinumtoxinA for the treatment of ULS in adult patients. Lessons learned from the successful ULS trials were applied to design an LLS trial that led to approval for the latter indication. Additional observational trials mimicking real-world treatment have shown continued effectiveness and patient satisfaction. The use of onabotulinumtoxinA for spasticity has ushered in a more patient-centered treatment approach that has vastly improved patients\u27 quality of life

Treatment of Chronic Migraine with Botox (Onabotulinumtoxina): Development, Insights, and Impact

Chronic migraine (CM) is a neurological disease characterized by frequent migraine attacks that prevent affected individuals from performing daily activities of living, significantly diminish quality of life, and increase familial burden. Before onabotulinumtoxinA was approved for CM, there were few treatment options for these seriously disabled patients and none had regulatory approval. The terminology and recognition of CM evolved in parallel with the onabotulinumtoxinA clinical development program. Because there were no globally accepted classification criteria for CM when onabotulinumtoxinA was in development, the patient populations for the trials conducted by Allergan were determined by the Allergan migraine team in collaboration with headache scientists and clinicians. These trials and collaborations ultimately led to improvements in CM classifications. In 2010, onabotulinumtoxinA became the first medication and first biologic approved specifically to prevent headaches in patients with CM. Approval was based on 2 similarly designed phase 3, double-blind, randomized, placebo-controlled, multicenter clinical studies. Both studies showed significantly greater improvements in mean change from baseline in headache-day frequency in patients with CM receiving onabotulinumtoxinA compared with those receiving placebo. The safety and effectiveness of onabotulinumtoxinA have been established globally in \u3e5000 patients with CM with or without medication overuse treated in clinical and observational studies. Benefits also include improvements in quality of life, fewer psychiatric comorbidities, and reduced healthcare resource utilization. Across studies, onabotulinumtoxinA was well tolerated; adverse events tended to be mild or moderate in severity and to decline over subsequent treatment cycles

Female leaders' 360-degree self -perception accuracy for leadership competencies and skills

Leaders with more self-accurate ratings have been found to be more effective and more successful than those leaders with self-evaluations that are not aligned with others (Atwater & Yammarino, 1992; Bass & Yammarino, 1991). Several reports from the 1980's suggest that women underrate their own performance as leaders and managers (Parsons, Meece, Adler, & Kaczala, 1982; LaNoue & Curtis, 1985, Meehan & Overton, 1986 as cited in Van Velsor, Taylor, & Leslie, 1993; Beyer, 1990) despite the lack of specific data to substantiate these inferences. The conclusion that others likely draw from these repeated messages is that female leaders have poor self-awareness, and therefore are less effective. Strong inferential statements, such as those present in the literature today, may be contributing to ongoing negative stereotypical assumptions about female leaders' potential, and thus, may be contributing to the lack of female leaders advancing to executive business ranks, i.e., the 'glass ceiling'. Only one study that reported data from nearly two decades ago has refuted the suggestion that women underrate their leadership competencies (Van Velsor, Taylor & Leslie, 1993). This study examined contemporary data to test whether female leaders working in today's business environment under-rated their own performance as leaders. Ex Post Facto research using data from an existing, large database was used to investigate the relationships of female leaders' self-assessment and the assessments of other raters (including direct reports, peers, managers and others). The database was analyzed to test whether female leaders under-rated, over-rated, or were in-agreement with how others rated their leadership skills and behaviors using the High Impact Leadership Model™ (Linkage, 2003)