Onabotulinumtoxin-A treatment in Greek patients with chronic migraine

Abstract

BackgroundChronic migraine is a disabling condition, with limited treatment options. We conducted an open label, single arm, prospective clinical trial, to assess the efficacy and safety of onabotulinumtoxin-A in Greek patients with chronic migraine. Since recent evidence suggests that a meaningful clinical response may be delayed until after a third onabotulinumtoxin-A administration, we aimed at assessing outcomes at this time point.MethodsA total of 119 patients with CM, scheduled to be treated with Onabotulinumtoxin-A (Botox ®) every 3 months, according to the approved indication and standard clinical practice, were prospectively enrolled. Data documenting changes from baseline (T0—trimester before Onabotulinumtoxin-A first administration) to the period after its third administration (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 in a 0–10 numerical scale, and (iii) mean number of days with use of any acute headache medication, were collected from patients’ headache diaries at each visit.ResultsOf the 119 patients, a total of 81 received 3 courses of onabotulinumtoxin-A and were included in the efficacy population. In those 81 patients, there was a significant decrease in mean headache days/month between T0 and T3 (21.3 ± 5.4 vs 7.7 ± 4.8; P < 0.001); a significant decrease in days with peak headache intensity of >4/10 (11.9 ± 5.5 vs 3.7 ± 3.3; P < 0.001) and finally, the change in days using acute headache medications per month between was also significant (16.2 ± 7.8 vs 5.2 ± 4.3; P < 0.001). Adverse events were few and of non- serious nature.ConclusionOur results strongly support the use of onabotulinumtoxin-A for the prophylaxis of CM, as this intervention proved effective, safe and well tolerated in our cohort of Greek patients.

Long-term Treatment Benefits and Prolonged Efficacy of OnabotulinumtoxinA in Patients Affected by Chronic Migraine and Medication Overuse Headache over 3 Years of Therapy

“…The linear regression model slopes outpointed a significant mean improvement for all outcomes and this seems to indicate a significant, continuous and stable, OnabotA action over time. The most remarkable improvements were observed in the first year of therapy (Figure 1 ), and the results are stable over time, as pointed out also by other authors ( 24 – 26 ). The improvements of explored outcomes found out with the linear regression models were further analyzed to check their impact on clinical practice, performing the one-way analysis of variance.…”

Sustained onabotulinumtoxinA therapeutic benefits in patients with chronic migraine over 3 years of treatment

“…Treatment with onabotulinumtoxinA (Botox® 100UI/fl, Allergan-Hellas) was administered according to the PREEMPT paradigm [3], as previously described in the core study [13]. Both in the core and current extension studies, administration of additional 40UI was allowed, in line with the PREEMPT “follow the pain” paradigm, at the injector’s discretion and according to individual patients’ needs, while intervals between the treatment sessions were allowed to be adjusted according to each patient’s needs, thereby individually potentially exceeding the 3-months period indicated by the PREEMPT paradigm.…”

“…A reduced intake of acute headache medications per month was also apparent. The treatment with onabotulinumtoxinA was safe and well tolerated [13]. We herein report the long-term therapeutic benefits of onabotulinumtoxinA against CM having followed the responders (> 50% reduction in mean headache days/month) of our core study sample who received treatment over three years.…”

Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation

“…We identified a number of prospective open-label studies evaluating efficacy and safety of onabotulinumtoxinA [22–39]. In general these studies were long-term studies treating CM patients with and without medication overuse according to the PREEMPT protocol.…”