Real-world data from the PREDICT trial demonstrated that long-term onabotulinumtoxinA treatment improved health-related quality of life of patients with chronic migraine. In addition, onabotulinumtoxinA treatment reduced headache days, with high physician and patient satisfaction .
Chronic migraine can affect health-related quality of life and daily functioning, resulting in social and economic burden.
PREDICT was a 2-year, multicentre, prospective, observational study in Canadian adults who were naïve to botulinum toxins for chronic migraine. The aim was to assess real-world long-term effects of onabotulinumtoxinA on quality of life in this patient population. OnabotulinumtoxinA treatment was recommended for injection every 12 weeks, up to 7 treatment cycles.
A total of 184 participants with an average age of 45 years, predominantly female (84.8%), and mostly Caucasian (94.6%) received ≥1 treatment with onabotulinumtoxinA.
At baseline, patients reported 20.9 headache days per month, which decreased over time by:
- -3.5 days at treatment 1;
- -6.5 days at treatment 4; and
- -6.3 days at treatment 7 (all timepoints vs baseline; P<0.0001).
Moderate-to-severe headache days also decreased from 12.9 days per month at baseline by:
- -3.4 days at treatment 1,
- -5.6 days at treatment 4, and
- -4.7 days at treatment 7 (all timepoints vs baseline; P<0.0001).
Significant increases in Migraine-Specific Quality of Life (MSQ) from baseline to treatment 4 (restrictive: 21.5, preventive: 19.5, emotional: 22.9) and at the final visit (restrictive: 21.3, preventive: 19.2, emotional: 27.4) were observed versus baseline. These differences exceeded the threshold for minimal clinically important differences (all P<0.0001).
With respect to safety, 77 patients (41.8%) reported 168 treatment-emergent adverse events (AEs). Of these, 38 treatment-emergent AEs in 22 patients (12.0%) were considered treatment-related. Only 4 patients (2.2%) reported 6 serious treatment-emergent AEs; none were considered treatment-related. No new safety signals were identified.
This real-world data demonstrated that long-term onabotulinumtoxinA treatment for chronic migraine improved health-related quality of life. In addition, onabotulinumtoxinA treatment reduced headache days, with high physician and patient satisfaction.
- Boudreau G. OnabotulintoxinA treatment improved health-related quality of life in adults with chronic migraine: results from a prospective, observational study (PREDICT). MTIS Virtual Symposium 2020, abstract MTV20-DP-077.
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