Gabriel Salazar, Marta Fragoso, Antoni Rey, Lourdes Sánchez and Manuela Gonzalez Navarro
Background: OnabotulinumtoxinA has proven efficacious as a preventive treatment in patients with chronic migraine. However, non-response and tolerability problems were reported for some patients. This open-label study investigated long-term treatment with incobotulinumtoxinA in chronic migraine patients who were non-responsive to onabotulinumtoxinA injections.
Methods: Patients received pericranial injections of 200 U incobotulinumtoxinA (fixed dose) into 20 injection sites (10 U/site) using a dilution of 10 U/0.1 ml saline every three months for 18 months. They were subsequently switched back to onabotulinumtoxinA (200 U fixed dose into 20 injection sites with 10 U/site every 3 months) and were followed for another six months (length of study 24 months). The primary efficacy endpoints were monthly migraine episodes, pain intensity, the impact of migraine on functioning in daily life and consumption of pain relief drugs.
Results: Twenty-six patients (mean age 32 ± 4 years, 84.6% female) were included. IncobotulinumtoxinA significantly reduced mean monthly frequency of migraine episodes from 17.2 ± 2.1 to 4.3 ± 1.0 (p<0.05), pain intensity during these episodes from 9.3 ± 0.8 to 6.3 ± 0.9 (p<0.05) and consumption of acute pain medication from 32 ± 2 tablets to 5 ± 0.9 tablets after 18 months of treatment (all p<0.05). Patients’ daily functioning improved from severe (29 ± 3 points) to mild disability (8.2 ± 1.2; p<0.05). Six months after switching back to onabotulinumtoxinA, the frequency of monthly migraine episodes was 4.1 ± 1.0 (p<0.05), pain intensity 5.8 ± 0.9 (p<0.05), and consumption of acute pain medication 4 ± 0.9 tablets (p<0.05). Patients’ daily functioning was 8.2 ± 1.2 points (p<0.05; all p vs. baseline). Five mild adverse events were reported in the incobotulinumtoxinA treatment period.
Conclusions: Both botulinum toxin type A preparations were administered at a higher total dose at fewer injection sites in higher concentrations (10 U/0.1 ml) than previously described. This treatment regimen resulted in long-term benefits in incobotulinumtoxinA treated chronic migraine patients who were non-responsive to previous onabotulinumtoxinA injections. These improvements could be sustained after switching back to onabotulinumtoxinA. Treatment was well tolerated.
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