OnabotulinumtoxinA for Migraine Has Long-Term Safety and Efficacy

Friday, May 04, 2018


A wealth of results showing the long-term safety and efficacy of onabotulinumtoxinA (Botox; Allergan, Dublin, Ireland) for treating patients with migraine were presented at the recent American Academy of Neurology meeting. Results from studies furthering understanding of headache disorders epidemiology and comorbidity data were also presented.

Importantly, one study showed that patients with chronic migraine and episodic migraine have a higher pattern of opioid use, making the case for a continued need to make better use of safe and effective treatments that do not have abuse potential. (Session P4 Headache Therapeutics, Abstract 127)  

In another multicenter open-label study lasting 108 weeks (COMPEL), patients with migraine were treated with onabotulinumtoxinA 155 U every 12 weeks. Treatment with onabotulinumtoxinA significantly reduced headache day frequency (n=715) by 10.7 days from baseline (P < 0.0001). Although 436 patients (60.9%) reported adverse events (AEs), only 32 patients (4.5%) discontinued treatment after experiencing AEs. Incidence of AEs decreased with repeated treatment cycles by 24.2%, 18.4% and 12.2%, after the first, fourth, and ninth cycles respectively. Common AEs included neck pain, eyelid ptosis, musculoskeletal stiffness, and injection site pain. Only 1 serious adverse event occurred. (Session P4 Headache Therapeutics, Abstract 123)

Subanalysis of the data from this study comparing response to treatment, measured by 28-day headache frequency, in patients with and without daily headache showed a reduction from baseline of 7.9 days in those with daily headache and 10.7 in those without daily headache at week 60 (P = .001 between groups).  Migraine disability questionnaires (MIDAS), a migraine-specific quality of life questionnaire, and patient global assessment of treatment questionnaire were recorded and showed improvements in patients’ quality of life. (Session P4 Headache Therapeutics, Abstract 133)

Further data from the COMPEL study also showed improvement in symptoms of depression, anxiety, sleep disturbances, and fatigue for patients with those comorbidities. (Session P4 Headache Therapeutics, Abstracts 126, 131)

In the FORWARD study, in which 282 subjects were treated with onabotulinumtoxinA (n = 141) or topiramate (n = 142), 40% of patients treated with onabotulinumtoxinA had at least a 50% reduction in the number of headache days versus 12% of those treated with topiramate (P = .001). OnabotulinumtoxinA was also better tolerated than topiramate, with 80 patients treated with topiramate switching to onabotulinumtoxinA and a greater rate of drop out among those treated with topiramate. (Session P4 Headache Therapeutics, Abstract 134)

In the larger, real-world Repose study, 3,499 doses of onabotulinumtoxinA treatments were given to 633 patients who had a mean of 20.6 headache days per month. The median dose and median number of injection sites of onabotulinumtoxinA per session were 155 U and 31 sites, respectively. Patients reported a significantly reduced number of headache days per month from baseline (P < .001) and improved quality-of-life measures. AEs occurred for 18.3% of patients and were similar to that seen in other studies described here. (Session P4 Headache Therapeutics, Abstract 150)

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