Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy

Abstract

Background: We aimed to assess the efficacy and safety of erenumab, a fully human monoclonal antibody inhibiting the calcitonin gene-related peptide receptor (CGRPr), for the prevention of migraine in a real-life setting. Main body: We included in our observational study all patients with episodic or chronic migraine treated with erenumab during the year 2019 in the Abruzzo region, central Italy, and with a 6-month follow-up. We included 89 patients; 76 (85.4%) received 6 doses of erenumab, 11 (12.4%) autonomously withdrew the drug due to perceived inefficacy, and 2 (2.2%) due to adverse events. Seventy-eight patients (87.6%) were female, with a mean age of 46.8 ± 11.2 years; 84 (94.4%) had chronic migraine, and 64 (71.9%) medication overuse. All patients had ≥2 prior preventive treatment failures. Fifty-three patients (69.7%) had a 50% decrease in monthly migraine days (MMDs) within the first three doses; 46 (71.9%) of 64 patients withdrew medication overuse. In the 76 patients who completed a 6-dose treatment, erenumab decreased median MMDs from 19 (interquartile range [IQR] 12-27.5) to 4 (IQR 2-9.5; P < 0.001), median monthly days of analgesic use from 10 (IQR 4.5-20) to 2 IQR 0-5; P < 0.001), and median monthly days of triptan use from 5 (IQR 0-15.5) to 1 (IQR 0-4; P < 0.001). We recorded 27 adverse events in 20 (22.5%) patients, the most common being constipation (13.5%). One adverse event, i.e. allergic reaction, led to treatment discontinuation in one patient. Conclusions: Our real-life data confirm the efficacy and tolerability of erenumab for the prevention of migraine in a difficult-to-treat population of patients with a high prevalence of chronic migraine and medication overuse.

Impact of Galcanezumab on Total Pain Burden: Findings From Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies in Patients with Episodic or Chronic Migraine (EVOLVE-1, EVOLVE-2, and REGAIN Trials)

“…In doing so, however, this may have inadvertently diminished the potential clinical value of assessing the impact of a treatment on the combination of frequency, severity, and duration of pain associated with migraine that may be more closely associated with the patient's overall pain experience [19,20]. Moreover, other "real-world" assessments of migraine include a variety of patient-reported outcomes (e.g., disability and quality of life) to fully assess the potential bene t of migraine treatment strategies [21,22]. Total pain burden may better re ect what clinicians and patients discuss regarding the individual's pain experience and could prove useful to further patient-centric discussions regarding treatment expectations when clinicians are evaluating options for migraine prevention.…”

Erenumab in highly therapy-refractory migraine patients: First German Real-world evidence

“…Clinical trials were only performed in migraine patients who had failed up to four prophylactic medications in the past. [2][3][4] Although there are indications of good effectiveness under real-world conditions 5,6 , data on highly therapy-refractory patients that had failed more than four prophylactic treatments are missing, yet.…”

Conversion From Chronic to Episodic Migraine in Patients Treated With Erenumab: Real-life Data From an Italian Region

“…Monoclonal antibodies directed against the calcitonin gene-related peptide (CGRP) or its receptor (CGRPr) are migraine-speci c treatments whose e cacy and safety were proven in both EM and CM [2][3][4][5]. However, the available real-life studies show that most patients treated in common clinical practice have CM [6][7][8][9][10]. In the present real-life, multicenter study, we assessed the rate and possible predictors of conversion from CM to EM in patients treated with erenumab.…”