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Abstract Details

Real-World Safety and Efficacy of 155-195U OnabotulinumtoxinA in Participants With Chronic Migraine: Results From the REPOSE Study
Headache
Headache Posters (7:00 AM-5:00 PM)
041
To analyze some parameters of efficacy and safety of 155-195U onabotulinumtoxinA in participants with chronic migraine (CM) from the real-world REPOSE study.
Safety and efficacy of 155-195U onabotulinumtoxinA in individuals with CM was established in the phase 3 PREEMPT clinical trials and is the licensed dose in Canada and Europe.

REPOSE (NCT01686581), a 2-year, prospective, noninterventional, observational, open-label study, described real-world use of onabotulinumtoxinA in adults with CM. Participants received onabotulinumtoxinA approximately every 12 weeks and were observed for 24 months after initiating treatment. Participant-estimated mean headache-day frequency in the last month (MHD), Migraine-Specific Quality-of-Life Questionnaire (MSQ) score, and adverse events (AEs) were collected at each treatment visit. In this analysis, participants from the safety analysis population (≥1 onabotulinumtoxinA dose) were stratified by the dose received on ≥4 treatment visits into 155U or 156-195U groups.

Of 641 enrolled participants, 633 received ≥1 onabotulinumtoxinA dose. On ≥4 treatment visits, 85 patients received 156-195U and 226 received 155U. Between-group baseline characteristics were similar. Treatment-emergent AEs (TEAEs) were reported in 10/85 participants in the 156-195U group and 51/226 in the 155U group; serious TEAEs were 1/85 and 3/226, respectively. Reductions from baseline in MHD frequency were observed at both doses (156-195U range, -8.9 to -17.3 MHDs; 155U range, -4.6 to -13.6 MHDs). Mean change from baseline in MSQ domain scores improved across treatment-administration visits in a similar fashion with 155U and 156-195U.
Treatment with 156-195U onabotulinumtoxinA was safe and generally well-tolerated in REPOSE participants, with no new safety signals identified. Between the two groups, numerically higher reductions in headache frequency and improvements in MSQ domain scores were observed with the 156-195U dose. These real-world findings in the safety and efficacy of the 155-195U onabotulinumtoxinA dose are consistent with data from the PREEMPT clinical trials as a treatment option for CM patients.
Authors/Disclosures
Katherine Sommer
PRESENTER 		Katherine Sommer has received personal compensation for serving as an employee of AbbVie. Katherine Sommer has stock in AbbVie.
Fayyaz Ahmed, MD, FRCP (Hull Royal Infirmary) Dr. Ahmed has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for allergan.
No disclosure on file
Larisa Yedigarova Larisa Yedigarova has received personal compensation for serving as an employee of AbbVie. Larisa Yedigarova has received stock or an ownership interest from AbbVie.