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The safety and tolerability of Erenumab, a fully human monoclonal antibody, were examined in a pooled analysis of five large trials, with a focus on elderly people.
Erenumab is a well-tolerated and safe intervention for older patients diagnosed with chronic or episodic migraine.
The safety and tolerability of Erenumab, a fully human monoclonal antibody, were examined in a pooled analysis of five large trials, with a focus on elderly people.
Assessment of safety data from the 12-week double-blind treatment phase (DBTP) of 5 placebo-controlled randomized, Phase II and III trials of Erenumab in chronic or episodic migraine people was completed. Volunteers were segregated into different age groups of less than 40 years, 40-49 years, 50-59 years, and ≥ 60 years. By evaluating safety outcomes such as events resulting in discontinuation of study medication, serious adverse events (AEs), and treatment-emergent AEs, the safety of Erenumab across age groups were evaluated.
A total of 3345 patients were randomly assigned to receive placebo, 70 mg Erenumab (n = 1132), or 140 mg Erenumab (n = 854) across five trials. Of these, 94.9% finished the DBTP (n = 3176). At least one dosage of Erenumab 70 mg, Erenumab 140 mg, and placebo was given to 1122 (33.8%), 850 (25.6%), and 1349 (40.6%) respectively.
For all doses of Erenumab (70 mg or 140 mg) and placebo, the occurrence of treatment-emergent AEs was comparable across all age groups (less than 40 years, 44.0% versus 44.4%; 40-49 years, 42.5% versus 49.2%; 50 to 59 years, 46.5% versus 41.6%; ≥ 60 years, 43.8% versus 59.4%). The occurrence of treatment-emergent serious AEs overall, and stratified by age groups for both dosages and placebo, was low (less than 40 years, 0.9% versus 1.2%; 40-49 years, 1.7% versus 1.9%; and 50-59 years, 1.6% versus 1.1%). No major serious AEs were observed in persons ≥ 60 years old. No fatalities were recorded.
In adults with episodic or chronic migraine, Erenumab (70 mg or 140 mg) displayed a comparable safety profile to placebo across age groups, with no raised emergence of events attributable to advancing age. In older adults with various comorbidities, polypharmacy, and age-linked physiological changes, Erenumab was well-tolerated.
The Journal of Headache and Pain
Safety and tolerability of Erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials
Christian Lampl et al.
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