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• W1444366968 abstract "OBJECTIVE: To assess the safety profile of onabotulinumtoxinA for treatment of upper limb spasticity (ULS) across a range of doses, including doses 蠅400U. BACKGROUND: OnabotulinumtoxinA is approved in the U.S. for the treatment of ULS to decrease the severity of increased muscle tone in elbow, wrist, and finger flexors in adult patients. OnabotulinumtoxinA treatment of ULS is individualized based on patients’ presentation so a range of doses may be used. Extensive ULS clinical study data allows for exploration of the safety profile across a range of doses over multiple treatments. DESIGN/METHODS: Safety data from 18 studies of onabotulinumtoxinA for ULS were integrated for analysis and were divided into 4 dose groups (<150U, 150-250U, 251-399U, 蠅400U). Treatment exposure and the incidences of adverse events (AEs), serious AEs, and AEs indicating possible distant spread of toxin (PDSOT) were assessed in patients who received 蠅1 onabotulinumtoxinA treatment; the safety profile of patients who received 4 consecutive onabotulinumtoxinA 蠅400U treatments was also assessed. RESULTS: Overall 1342 patients received 蠅1 onabotulinumtoxinA treatment; 183 received 蠅400U, with 6.6[percnt] (88/1330), 12.3[percnt] (115/936), 23.3[percnt] (113/486), and 31.2[percnt] (96/308) of patients receiving doses of 蠅400U (treatments 1, 2, 3, and 4, respectively). AE rates were similar across dose groups, with no consistent increase in incidence of any individual AE/serious AE and for PDSOT AEs at doses 蠅400U across treatments. The overall AE rate among the subset of patients with 4 consecutive 蠅400U treatments (n=51) was similar (43.1[percnt], 43.1[percnt], 43.1[percnt], 41.2[percnt]), with no overall change in profile for AEs/serious AEs with increasing treatments. CONCLUSIONS: OnabotulinumtoxinA across a range of doses, including 蠅400U, was well tolerated in ULS patients, with no consistent pattern of increase in AEs, reported systemic AEs, or change in safety profile over consecutive treatments. Study Supported by: Allergan, Inc. Disclosure: Dr. James has received personal compensation for activities with Allergan, Inc. as an employee. Dr. Dimitrova has received personal compensation for activities with Allergan as employee. Dr. Pan has received personal compensation for activities with Allergan, Inc. as an employee. Dr. Asare has received personal compensation for activities with Allergan, Inc. as an employee. Dr. Thompson has received personal compensation for activities with Allergan, Inc. as an employee." @default.
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• W1444366968 date "2015-04-06" @default.
• W1444366968 modified "2023-09-23" @default.
• W1444366968 title "Safety Profile of Repeat OnabotulinumtoxinA Doses of 400U for the Treatment of Upper Limb Spasticity (P4.334)" @default.
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