Efficacy of onabotulinumtoxinA Treatment in Episodic Migraine

Abstract

AbstractBackgroundOnabotulinumtoxinA (BoNT-A) is approved as a prophylactic treatment of chronic migraine (CM) only. The aim was to assess the efficacy and safety of BoNT-A in the treatment of episodic migraine(EM).MethodsThis is a longitudinal observational study describes the efficacy and safety of BoNT-A in adult patients with EM. The study included patients with a diagnosis of migraine (with and without aura) according to the third edition of the International Classification of Headache Disorders, 3rd edition (ICHD-3), aged 18–65 years, and completed one year treatment with BoNT-A. Patients received 4 BoNT-A treatment approximately every 12 weeks guided by the PREEMPT injection paradigm. Patient’s headache was assessed by headache dairy at baseline, before every injection at months 4, 8 and at one year following BoNT-A injection. Migraine Specific Quality of Life Questionnaire (MSQ) and work productivity were collected at baseline and in their last visit. Adverse events (AEs) were observed to assess the safety of BoNT-A.ResultsThe study recruited 210 patients with EM under BoNT-A treatment. Mean age was 45.04 ± 8.92 years and females presented 183 patients (87.1%). Between baseline and the final visit, there were a significant reduction in migraine days and analgesic consumption days (9.54 ± 1.70 versus 4.58 ± 2.77,P < 0.001 ), (8.47 ± 1.49 versus 2.98 ± 0.21,P < 0.001 ) days respectively. After BoNT-A treatment, there were significant reduction in headache severity (8.37 ± 0.72versus 2.54 ± 0.18,P < 0.001 ), 51.4% reduction in migraine days by 50% after 4 BoNT-A treatment cycles. Treatment with BoNT-A significantly improved the MSQ scores at last visit versus baseline visit. For MSQ Role Function- Restrictive (51.55 ± 29.12 vs.26.89 ± 17.42 (; P < 0.001, MSQ Role Function-Preventive( 56.07 ± 24.73 vs. 30.64 ± 15.25;P < 0.001), and for MSQ Emotional Function (76.47 ± 115.29 vs. 35.12 ± 20.83;P < 0.001). BoNT-A improved the work productivity (4.63 ± 2.39 versus 6.26 ± 2.04;P < 0.001) and reduced the mean number of hours missed from work and daily activities over a 7-day period 4.63 ± 2.39 versus 6.26 ± 2.04,P < 0.001; (2.24 ± 3.30 versus 3.94 ± 3.45,;P < 0.001). 54 patients (14.4%) experienced mild and short-lasting AEs. The most common treatment related adverse event was eyelid ptosis 12 patients (5.7%).ConclusionsBoNT-A is an effective and well tolerated therapy in the prophylaxis of EM. It improved MSQ and WPAI in our cohort. No new safety signals were identified.