The Comprehensive Benefit of OnabotulinumtoxinA in Adults With Migraine

Woman with migraine talking to doctor
This post hoc analysis assessed the effect of onabotulinumtoxinA on clinically meaningful changes in headache severity, headache-related impact, and QOL in adults with chronic migraine.

Among patients with chronic migraine, treatment with botulinum toxin type A (onabotulinumtoxinA) was associated with clinically significant improvement in the number of headache days, along with beneficial effects on headache-related impact and severity and improved quality of life (QOL), according to study results published in Pain and Therapy.

OnabotulinumtoxinA was shown to be effective and tolerable for headache prevention in the Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials of adults with chronic migraine. The objective of the current post hoc analysis was to determine the impact of onabotulinumtoxinA on changes in headache severity, impact, function, and QOL.

Using 24-week data from PREEMPT 1 and 2 on men and women aged 18 to 65 years with migraine, researchers assessed headache days, defined as a day with 4 or more continuous hours of headache. In addition, the researchers assessed the effect of headaches, measured with the Headache Impact Test (HIT)-6 total score; health-related QOL, according to the Migraine-Specific Quality of Life Questionnaire–Role Function-Restrictive (MSQ-RFR) domain score; and headache severity, measured using the Average Daily Headache Severity (ADHS) score.

The pooled analysis included 1384 patients, of which 688 (mean age, 41.1±10.4 years; 88% women) were treated with onabotulinumtoxinA and 696 (mean age, 41.5±10.7  years; 85% women) received placebo.

Response to treatment on HIT-6 was significantly more common in patients treated with onabotulinumtoxinA compared with patients receiving placebo (40.8% vs 25.3%, respectively). Similarly, significantly more patients receiving onabotulinumtoxinA than placebo were responders on the MSQ-RFR (59% vs 40.2%, respectively) and ADHS (35.5% vs 22.4%, respectively) measures.

The proportion of patients meeting responder criteria for the change in headache days, defined as patients who had at least a 50% reduction in headache-day frequency, was higher in patients treated with onabotulinumtoxinA compared with placebo (44.8% vs 34.2%, respectively).

Most patients met at least 1 or more responder criterion (72.1% of patients treated with onabotulinumtoxinA vs 56.6% of patients receiving placebo), whereas 20.4% of patients in the onabotulinumtoxinA group and 8.6% of the patients in the placebo group met all 4 responder criteria (HIT-6, MSQ-RFR, ADHS, and change in headache days).

The study has several limitations, including lack of an active comparator group; relatively high placebo response rates; and the exploratory, post hoc analyses without prespecified multiplicity adjustments.

“When taking into account clinically meaningful improvements of impact, function, and severity, we observed a more accurate reflection of the comprehensive benefit of onabotulinumtoxinA,” wrote the researchers.

Disclosure: This clinical trial was supported by Allergan, Inc. Please see the original reference for a full list of authors’ disclosures.


Diener HC, Dodick DW, Lipton RB, Manack Adams A, DeGryse RE, Silberstein SD. Benefits beyond headache days with onabotulinumtoxinA treatment: a pooled PREEMPT analysis. Published online Oct 7, 2020. Pain Ther. doi: 10.1007/s40122-020-00198-w