Abstract
BackgroundEvidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited. We herein aimed at assessing whether there is a sustained benefit and good safety with repeated onabotulinumtoxinA sessions in CM over more than three years of treatment.MethodsWe prospectively enrolled 65 CM patients, who were classified as responders after three sessions of onabotulinumtoxinA and were eligible to further continue treatment. Data documenting longitudinal changes from the trimester after the third onabotulinumtoxinA administration (T1) to the trimester after completing two years of treatment (T2) and eventually to the trimester after completing three years of treatment (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of > 4/10, and (iii) mean number of days with use of any acute headache medication, were prospectively collected from patients’ headache diaries.ResultsA total of 56 (86.1%) of 65 patients achieved to attain onabotulinumtoxinA over three years. At T3, a significant reduction in mean monthly headache days was evident, compared to T1 (3.4 ± 1.7 vs 7.2 ± 3.8; P < 0.001) with diminished mean number of monthly days with peak headache intensity of more than 4/10 and a significant change in days using acute headache medications per month between T1 and T3 (2.8 ± 1.3 vs 4.7 ± 3.2; P < 0.001). Significant changes were also noticed in all efficacy variables from T2 to T3. Therapy was safe and well tolerated with low rates of adverse events or drop-outs.ConclusionThe long -term treatment with onabotulinumtoxinA proved effective, safe and well tolerated over three years. Our findings support the strategy to consistently deliver sessions of use of onabotulinumtoxinΑ over long time in CM patients (Trial registration NTC03606356, registered retrospectively, 28 July 2018).
Highlights
Evidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited
There is a consensus that a response rate of about 65% may be expected after three courses of onabotulinumtoxinA therapy in CM patients [5, 6], but whether onabotulinumtoxinA may be continued after three sessions and for how long, has not been yet clarified
We have previously reported that 3 courses of onabotulinumtoxinA prophylactic therapy were able to effectively reduce both the mean headache days/month as well as the days with peak headache intensity > 4/10, compared to baseline, in a cohort of 81 CM patients
Summary
Evidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited. We aimed at assessing whether there is a sustained benefit and good safety with repeated onabotulinumtoxinA sessions in CM over more than three years of treatment. ΟnabotulinumtoxinA (Botox®) is the only currently approved treatment for CM prophylaxis, following the Vikelis et al The Journal of Headache and Pain (2018) 19:87 publication of results from the Phase-III randomized placebo-controlled identical clinical trials PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) I and II [3, 4]. There is a consensus that a response rate of about 65% may be expected after three courses of onabotulinumtoxinA therapy in CM patients [5, 6], but whether onabotulinumtoxinA may be continued after three sessions and for how long, has not been yet clarified
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