Erenumab Is Well Tolerated for up to 12 Months, Study Results Show

Erenumab was well tolerated for up to a treatment interval of 12 months, and reported adverse events (AEs) rarely led to the discontinuation of therapy when used as a migraine prophylaxis, according to the results of a study published in The Journal of Headache and Pain.

Additionally, a higher dose of the drug does not increase patient reported AEs, and no habituation of AEs was observed.

However, individuals who are female and patients who have auras were more prone to have AEs.

The proportion of individuals who reported at least 1 AE was stable over a 12-month period.

All AEs reported were grade 1, according to the common terminology criteria for adverse events (CTCAE), with 1 exception, investigators said.

Throughout the period, constipation, fatigue, nausea, skin reactions, sleep disturbances, and vomiting were reported the most.

Just 5 individuals of the 49 discontinued therapy with erenumab, and the discontinuations were rarely caused by AEs.

Additionally, when investigators increased the dosage to 140 from 70 mg per month, they found that it caused no higher frequency in AEs.

Investigators analyzed data for 128 individuals with migraines who were treated in the West German Headache Center Essen between November 2018 and November 2020. The individuals had either chronic or episodic migraines. They were included if they had a diagnosis of a migraine according to the International Classification of Headache Disorders, a completion of at least 3 months of treatment with erenumab with a documentation to the respective timepoint if AEs occurred or not, and all individuals treated had tried at least 4, for individuals who experienced episodic migraines, and 5, for those who experienced chronic migraines, approved prophylactic drugs in the past without sufficient treatment effects and discontinued those because of AEs or were not eligible for intake because of contraindications.

Investigators said that most patients were prescribed the 70-mg dosage per month at the beginning of the therapy interval and assessed individuals every 3 months for AEs, changes in migraine characteristics, and efficacy.

The dosage was increased to 140 mg, or therapy was changed if the efficacy was evaluated as insufficient, the individual had good tolerability to allow an increase, and the patient satisfaction was improvable.

The data used assessed AEs during the treatment period of up to 12 months. Individuals reported AEs after 3, 6, 9, and 12 months.

Individuals in the study were given subcutaneous erenumab injections with either 70 or 140 mg per month. The occurrence and alterations of the AEs were evaluated. All reported AEs, regardless of severity, were included.

Investigators graded AEs using the CTCAE, and possible parameters that could influence the occurrence of AEs, including auras, chronic or episodic migraines, dosage of erenumab, medication overuse, and sex were analyzed using the chi-squared test. Additionally, alpha adjustment was done using the Bonferroni’s correction.

Reference

Schenk H, Holle D, Nsaka M, Kleinschnitz C, Glas M, Scheffler A. twelve-month safety, tolerability and susceptibility to adverse events of prophylactic migraine therapy with erenumab: a retrospective real-world study. J Headache Pain. 2022;23(1):55. doi:10.1186/s10194-022-01426-8