Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting

Abstract

Botulinum toxin was shown to be effective in treatment of chronic migraine. We wanted to explore its efficacy and tolerability in chronic application under real-life conditions. For this, 27 consecutive patients (age 45.6 ± 10.8 years, 25 females, 2 males) received altogether 176 injection series (IS) with 189.7 ± 45.8MU onabotulinumtoxinA (Botox(®)) according to the PREEMPT scheme. During the study period altogether 6.5 ± 2.9 (min 4, max 13) IS were applied per patient (total treatment time of 73.1 ± 36.9 weeks). 96 % of the patients reported benefit. Monthly headache days were reduced from 18.9 ± 3.9 to 8.7 ± 4.5 (p < 0.001, -53.7 %), migraine days from 16.8 ± 4.9 to 7.4 ± 4.6 (p < 0.001, -55.1 %), autonomic days from 8.6 ± 7.5 to 2.7 ± 4.2 (p < 0.001, -71.9 %) and medication days from 14.2 ± 4.6 to 8.3 ± 4.2 (p < 0.001, -71.1 %). Health-related quality of life improved by 0.6-1.5 standard deviations (SD) (Short Form Health Survey), migraine-related quality of life by 1.4-2.0 SD (Migraine-Specific Quality of Life Questionnaire) and by 1.9 SD (Headache Impact Test), depression by 1.1 SD (Beck Depression Inventory). Subjective global clinical improvement was 2.6 ± 0.6 (Global Clinical Improvement Scale). All improvements were stable throughout the entire study period. Adverse effects were infrequent, mild and transient. Botulinum toxin provides highly effective and safe long-term treatment of chronic migraine.

Real-life data in 115 chronic migraine patients treated with Onabotulinumtoxin A during more than one year

“…During last years, studies considering long-term experience with Onabot A in a real-life setting have been published [10, 17, 18]. OnabotA efficacy showed consistency after first year; percentage of patients in which OnabotA response was not maintained after first year were among 10 and 15% comparing our results with a quite similar series as that by Cernuda-Morollon et al [10].…”

“…Another question still open to discussion is the possibility of ending OnabotA therapy after first year in patients with a good response; it has been shown that when treatment is stopped quality of life parameters worsen [17]. In the same way that previous studies [10, 18], we found that it is not easy to interrupt OnabotA therapy, even temporally. However, in nearly 20% of cases we were able to postpone OnabotA procedures to a fourth of fifth month.…”

OnabotulinumtoxinA effectiveness on chronic migraine, negative emotional states and sleep quality: a single-center prospective cohort study

“…Significant reduction in monthly headache frequency, headache severity, number of analgesics used and MIDAS scores in our cohort support the efficacy of OnabotA in reduction of the frequency, intensity, and duration of chronic migraines as well as decreasing medication overuse among CM patients who failed on traditional preventive therapies [22, 25–27, 42–44]. …”

“…Given the similar rates of medication overuse (76.2%) in our cohort at baseline, reduction in in number of analgesics used starting from the first injection and consistently throughout the study period emphasizes the potential role of OnabotA therapy in prevention of MOH via headache episode reduction [25, 42, 48–50]. …”

“…Also, patients who respond well to therapy early have been suggested to maintain and continue these reductions over at least 2 years [27, 55–57], while limited data are available on long-term efficacy of OnabotA therapy with evaluation of efficacy only up to1 year in most of clinical trials [42, 44, 50]. …”