Real-World Safety and Efficacy of 156 U – 195 U OnabotulinumtoxinA in Adults With Chronic Migraine: Results From the REPOSE Study
Bibliographic record
Abstract
BACKGROUND: The phase 3 PREEMPT clinical trials confirmed the efficacy and safety of 155 U - 195 U onabotulinumtoxinA for individuals with chronic migraine (CM) and is the licensed dose in Canada and Europe. This analysis aimed to analyze the efficacy and safety parameters of 155 U - 195 U onabotulinumtoxinA in participants with CM from the real-world REPOSE study. METHODS: REPOSE (NCT01686581) was a 2-year, prospective, observational, noninterventional, open-label study that described the real-world use of onabotulinumtoxinA in adults with CM in Europe. Participants received onabotulinumtoxinA approximately every 12 weeks and were monitored for 24 months after starting treatment. Data on participant-estimated mean headache-day frequency in the last month (MHD), Migraine-Specific Quality of Life Questionnaire (MSQ) scores, and adverse events (AEs) were collected at each treatment visit. Participants in the safety analysis population (those who received at least one dose of onabotulinumtoxinA) were stratified into two groups based on the dosage received at four or more treatment visits: 155 U onabotulinumtoxinA and 156 U - 195 U onabotulinumtoxinA groups. RESULTS: A total of 641 participants were enrolled at 77 centers. Of those, 218 participants received 155 U ≥ 4 treatment visits, and 77 participants received 156 U-195 U onabotulinumtoxinA ≥ 4 treatment visits. Between-group baseline characteristics were similar. Reductions from baseline in MHD frequency were observed at both doses (156 U - 195 U range, -8.7 to -14.2 MHDs; 155 U range, -8.2 to -11.9 MHDs). Mean change from baseline in MSQ domain scores improved across administration visits for both 155 U onabotulinumtoxinA and 156 U - 195 U onabotulinumtoxinA groups. Treatment with 156 U - 195 U onabotulinumtoxinA was safe and generally well-tolerated with no new safety signals identified. Adverse drug reactions (ADR) were reported in 51/218 in the 155 U group and 10/77 participants in the 156 U - 195 U group; serious adverse drug reactions were 3/218 and 1/77, respectively. The most frequently reported ADR across both dose groups was eyelid ptosis, followed by neck pain, musculoskeletal stiffness. CONCLUSIONS: These real-world findings of the safety and efficacy of the 155 U - 195 U onabotulinumtoxinA doses are consistent with data from the PREEMPT clinical trials as a treatment option for CM patients. TRIAL REGISTRATION: NCT01686581. Name of registry: ClinicalTrials.gov. URL of registry: Date of retrospective registration: September 18, 2012. Date of enrolment of first patient: July 23, 2012.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".