Chronic migraines can be debilitating and may be associated with medication overuse, which makes it important that any treatment for the condition must be effective and well-tolerated by patients. In Phase III clinical trials, onabotulinumtoxinA was shown to be safe for use as a preventative for chronic migraines.
As part of a required post-authorization safety study, researchers conducted a prospective observational study that collected data from adult patients in four European countries with chronic migraine being treated with onabotulinumtoxinA in routine clinical practice settings. With RTI Health Solutions serving as principal investigator and coordinating center for the study, researchers sought to monitor real-world utilization practices and understand the safety profile of this drug as a preventive therapy for chronic migraine.
Results showed that adverse events observed in the study were consistent with those reported during clinical trials and with product labeling. The most frequently reported adverse events were neck pain, muscle weakness, headache, facial paresis and musculoskeletal stiffness.
The study included patients who were treated with onabotulinumtoxinA for their chronic migraines and thus included patients who had previously received the drug and those who had not. Researchers saw a higher percentage of participants who had previously received onabotulinumtoxinA than they expected given that the study was initiated soon after approval of the drug for the chronic migraine indication in each participating country, so they performed a post hoc analysis that separately analyzed results from the two groups.
As for utilization, the study indicated that the drug’s use in practice appears to be in line with the Summary of Product Characteristics. No new safety signals were identified.
Read more of our research about prophylactic treatment of chronic migraines:
Matharu M, Pascual J, Nisson Remahl I, Straube A, Lum A, Davar G, Odom D, Bennett L, Proctor C, Gutierrez L, Andrews E, Johannes C. Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Cephalalgia. 2017 Dec;37(14):1384-97.
Clark M, Schwedt TJ, Tepper SJ, Harris N, Martin S, Sapra S, Shah N. Patient satisfaction with prophylactic migraine medications. Headache. 2017 Jun; 57(Suppl S3):133.