Efficacy and Safety of Erenumab in the Preventive and Therapeutic Treatment of Patients Suffering From Migraine.
Аннотация
Migraine is a prevalent and disabling neurological disorder that significantly impairs quality of life and represents a major public health concern worldwide. Erenumab, a fully human monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, has emerged as a mechanism-based preventive therapy for migraine. This systematic review and meta-analysis evaluated the efficacy and safety of erenumab in randomized controlled trials (RCTs). Six independent RCTs involving 3,403 randomized participants were included in the quantitative synthesis. Outcome-specific denominators varied across analyses because individual trials used different efficacy and safety analysis populations and reported different outcomes. The primary outcome was the proportion of patients achieving a ≥50% reduction in monthly migraine days after 12 weeks of treatment, while secondary outcomes included changes in monthly migraine days and the incidence of adverse events. Pooled analysis demonstrated that erenumab significantly increased the likelihood of achieving a ≥50% responder rate compared with placebo (RR = 1.660, 95% CI: 1.364-2.020; p < 0.001). Erenumab also produced a significantly greater reduction in monthly migraine days compared with placebo (MD = -1.51 days/month, 95% CI: -2.03 to -0.99; p < 0.001), although substantial between-study heterogeneity was observed (I² = 76.4%). Evidence for lower-dose regimens was limited and less consistent across studies, whereas the 70-mg and 140-mg regimens demonstrated significant benefit in the included trials. The overall incidence of adverse events was comparable between the erenumab and placebo groups (RR = 0.968, 95% CI: 0.894-1.048), with low-to-moderate heterogeneity (I² = 33.2%). Similarly, no statistically significant difference was observed in serious adverse events (RR = 0.791, 95% CI: 0.463-1.349; p = 0.389; I² = 0%). These findings suggest that erenumab is effective for migraine prevention and was not associated with a statistically significant increase in adverse or serious adverse events compared with placebo in the included trials. Overall, the available evidence supports erenumab as an effective preventive treatment for patients with episodic or chronic migraine.
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