Daily Headache in Chronic Migraine Is a Predictive Factor of Response in Patients Who Had Completed Three Sessions of OnabotulinumtoxinA

Abstract

OnabotulinumtoxinA is one of the main preventive treatments for chronic migraine. Despite that up to one third of patients with chronic migraine suffer from daily headache, these individuals have hardly been studied. We conducted a prospective cohort study, including patients with chronic migraine and treated with OnabotulinumtoxinA according to the PREEMPT paradigm. The primary endpoint was to assess whether patients with chronic migraine and daily headache had a different response after three sessions of OnabotulinutoxinA than patients without daily headache. The secondary endpoint was to analyse the presence of predictive factors that could be associated with a higher response to OnabotulinumtoxinA. Patients with daily headache had a reduction of 14.9 (SD: 9.7) headache days per month, patients with 22–29 headache days a reduction of 10.6 (SD: 9.9) days, and patients with 15–21 headache days a reduction of 8.6 (SD: 7.1) days (p < 0.001). In the univariate regression analysis, a higher number of headache days per month at baseline was associated with higher odds of reduction in the number of headache days per month after OnabotulinumtoxinaA treatment (OR: 0.474, 95% CI: 0.278–0.670, p < 0.001). This association was maintained in the multivariate regression analysis (OR: 0.540, 95% CI: 0.333–0.746, p < 0.001). In our sample, daily headache was not associated with a worse response to OnabotulinumtoxinA treatment. A higher frequency of headache at baseline was a predictor of better response to OnabotulinumtoxinA treatment.

Dramatic Effect of Botox Injection in Disabling Chronic Migraine Secondary to Inoperable Cerebral Arteriovenous Malformation

“…Botox injection was approved by the FDA in 2010 for the treatment of chronic migraine. Chronic migraine is defined as having unilateral headache on at least 15 days per month, with eight of these having migraine symptoms, for at least three months [10].…”

Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors

“…Total responders were less than 1% during all BT-A cycles. Anyhow, the stability of this outcome suggests that BT-A action lasts in time, as already assessed in the open-label phase of the PREEMPT trial [ 29 ]; however, patients obtaining a 50% or even a 75% response compared with the baseline might indeed have a substantial number of days with headache and, consequently, a high headache-related disability: many patients would still have >8 debilitating HDs per month, configuring resistance to BT-A [ 6 , 25 ]. The proportion of frequency-based excellent responders was about 4% and, indeed, this criterion is far more restrictive.…”

“…An interesting population is that of patients with ≥75% decrease in monthly headache days compared with the baseline, i.e., excellent responders. Previous studies dealt with the determination of the predictors of response to BT-A, according to different definitions, but with conflicting results [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 ]. The main limitation of the current literature is that the excellent responders are a limited proportion of the treated patients; hence, large collaborations are needed to report reliable results.…”

“…Furthermore, another possible definition of “excellent responders”, based on the absolute number of residual headache days, could be explored. Indeed, even a patient who reports a ≥75% decrease in monthly headache days could still have a great impairment, especially if the number of headache days at the baseline was very high, thus presenting the same limitations of the 50% of responders [ 25 ].…”

Migraine treatment with biological therapies. The state of the art

“…Studies demonstrating reductions in headache days as well as improvement in all sources of secondary endpoints flourish with, indeed, a better performance for patients suffering with higher frequencies and daily headaches. 50 In addition, new treatment paradigms, using lower dosages and fewer injection points were recently published suggesting that a less expensive approach may show efficacy as well. 51 However, a trend for botox recommendation in larger populations of patients has also been released.…”