Twelve-month safety, tolerability and susceptibility to adverse events of prophylactic migraine therapy with erenumab: a retrospective real-world study

Abstract

Background Erenumab is a monoclonal antibody (mAb) against the calcitonin gene related peptide (CGRP) receptor and is commonly used in migraine prophylaxis. Pivotal and open-label studies show a good safety and tolerability. However, little is known about possible predictors, dose dependence and time course of development of adverse events (AEs) during the treatment under real-world conditions. Methods Clinical routine data of 128 patients with migraine treated in the West German Headache Center Essen were analyzed regarding AEs during a treatment interval of up to 12 months (3mo n = 128, 6mo n = 105, 9mo n = 74, 12mo n = 54). Patients obtained subcutaneous erenumab injections with either 70 mg or 140 mg per month. The occurrence and alterations of AEs were evaluated. All reported AEs, regardless of their severity, were included. AEs were graded using the common terminology criteria for adverse events (CTCAE). Possible parameters that could influence the occurrence of AEs (sex, episodic or chronic migraine, medication overuse headache, aura and the dosage of erenumab) were analyzed using the Chi-squared test, alpha adjustment was done using the Bonferroni’s correction (6 tests, adjusted alpha = 0.0083). Results The proportion of patients who reported at least one AE were stable over the course of 12 months (after 3mo = 37%, 6mo = 36%, 9mo = 32%, 12mo = 35%). All reported AEs were grade 1 according to CTCAE with one exception (grade 2). Throughout the interval, five AEs were mostly reported: constipation, skin reactions, fatigue, sleep disturbances and nausea/emesis. Discontinuation of erenumab therapy was rarely caused by AEs (5/49). Increasing the dosage from 70 mg to 140 mg per month caused no higher frequency of AEs (Chi-squared test, p = 0.57). Significant more AEs were reported by females and by patients with aura (Chi-squared test, p < 0.001, respectively). Conclusion In general, erenumab is well tolerated up to a treatment interval of 12 months and reported AEs rarely lead to discontinuation of therapy. A higher dosage does not increase the patient reported AEs. Furthermore, no habituation of AEs is observed. Nevertheless, females and patients with aura seem to be more prone to have AEs. Trial registration No registration, retrospective analysis.

Real-world observations and impacts of Chinese herbal medicine for migraine: results of a registry-based cohort study

“…The incidence rate of AEs was comparatively lower than those reported for erenumab (37%) and onabotulinumtoxinA (25%) based on realworld observations (Matharu et al, 2017;Schenk et al, 2022). In addition, among the instances, 18 (35.29%) of the patient-reported AEs were gastrointestinal discomforts, and these discomforts were also the most commonly reported AEs in previous reports (Schenk et al, 2022;Silberstein et al, 2023). Moreover, no severe AEs were reported in the current study.…”

First Report of Symmetrical Drug-related Intertriginous and Flexural Exanthema (SDRIFE or Baboon Syndrome) After Erenumab Application for Migraine Prevention

“…Nevertheless, no similar skin reactions in the sense of SDRIFE after triptan administration have been described to date. On the contrary, local skin reactions at the injection site are among the most frequent side effects after use of erenumab [20][21][22][29][30][31][32][33][34]. SDRIFE has also been described as a side effect after treatment with other monoclonal antibodies [35][36][37][38].…”

“…Erenumab is the first monoclonal antibody targeting the receptor of CGRP approved for the prevention of migraine [13][14][15][16][17][18][19][20][21][22]. The substance is injected subcutaneously in 4-week intervals by patients using an autoinjector.…”

Novel protein interaction network of human calcitonin receptor-like receptor revealed by label-free quantitative proteomics

“…The roles for CLR function in other than skin tissues, and its implication in diseases and disorders such as clear cell renal cell carcinoma (CCRCC), acute myeloid leukaemia (AML), stroke and migraine have been reported (Angenendt et al, 2019;Edvinsson et al, 2018;Gluexam et al, 2019;Herlambang et al, 2021;Koyama et al, 2017;Larrue et al, 2021;Nikitenko, Leek, et al, 2013). The use of monoclonal antibody-based drugs targeting CLR-mediated function for migraine prophylaxis, such as erenumab and galcanezumab, has been associated with impaired wound healing in skin, along with development of skin reactions and side effects such as swelling, rashes or pruritus (Bangs et al, 2020;Wurthmann et al, 2020;Göbel et al, 2022;Schenk et al, 2022).…”