Abstract
BackgroundOnabotulinumtoxinA (OnabotA) is effective in Chronic Migraine (CM) during first year of treatment and longer. In real clinical setting, CM patients with acute Medication Overuse (MO) or concurrently receiving oral preventatives are treated with OnabotA. We aim to assess evolution of CM patients beyond first year on OnabotA.MethodsData were retrospectively collected in three headache units. We analyzed cases who had received at least five sessions of OnabotA according to PREEMPT protocol. We continued OnabotA therapy when a reduction of number of headache days of at least 30% was achieved.ResultsWe included 115 patients (98 females, 17 males) who completed 7.6 ± 2.3 (5–13) OnabotA procedures. Previously they had not responded to topiramate and, at least, one other preventative. Age at inclusion was 45.3 ± 12 (14–74) years, and latency between CM onset and OnabotA therapy was 43.1 ± 38.2 (6–166) months. At first OnabotA session 92 patients (80%) fulfilled MO criteria and 107 (93%) received a concurrent oral preventative. In 42 cases (36.5%) OnabotA dose was increased over 155 units. After first year in 57 out of 92 patients (61.9%) MO was discontinued. Among those receiving preventatives, in 52 out of 107 they were retired (48.6%). In 22 cases (19.1%) OnabotA administration was delayed to the fourth or fifth month and in 12 (10.4%) it was temporally stopped. Finally, in 18 patients (15.7%) OnabotA was discontinued due to lack of efficacy beyond first year of treatment.ConclusionOur results suggest that discontinuation of acute medication overuse and oral preventive therapies are achievable objectives in long-term using of OnabotA in CM patients.
Highlights
OnabotulinumtoxinA (OnabotA) is effective in Chronic Migraine (CM) during first year of treatment and longer
Other real-life studies considered patients with medication overuse [8, 10] and OnabotA efficacy did not differ between patients with or without Medication Overuse (MO) [16]
Percentage of patients fulfilling medication overuse criteria was similar than observed in PREEMPT program
Summary
OnabotulinumtoxinA (OnabotA) is effective in Chronic Migraine (CM) during first year of treatment and longer. CM patients with acute Medication Overuse (MO) or concurrently receiving oral preventatives are treated with OnabotA. CM is estimated to affect 2% of the population [2] Most of these patients (50–80%) fulfilled criteria of symptomatic medication overuse with all its somatic and psychological implications [2]. After publication of the PREEMPT clinical program [5–7], in January 2012 OnabotulinumtoxinA (OnabotA) was licensed in Spain for prophylactic treatment of CM “for patients who have not adequately responded or are intolerant to prophylactic drugs for migraine”. In a real-life setting, OnabotA can effectively reduce headache days and migraine days by at least 50%, and increase headache free days from baseline in chronic migraine sufferers [8–10]. In a real clinical practice, around 80% of CM patients respond to pericranial
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