Erenumab in the prevention of high‐frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real‐life study

Abstract

Objective: To assess the effectiveness, safety, and tolerability of erenumab in a reallife migraine population, while trying to identify responsiveness predictors. Background: Erenumab is a fully human Ig-2 monoclonal antibody blocking the calcitonin gene-related peptide receptor, indicated for migraine prophylaxis. Phase II and III trials demonstrated that erenumab is effective, safe, and well tolerated in the prevention of episodic and chronic migraine (CM), showing an early onset of action. Methods: This is a multicenter, prospective, cohort, and real-life study. We considered for enrolment all consecutive patients aged 18-65 affected by high-frequency

MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention

“…Our study is the official registry of the Spanish Neurological Society and includes 22 centres with homogeneous representation of the country. Moreover, the average number of prior preventive drug failures was 3-5 in the Italian study [55] and superior to 7 in ours, which means that our patients are more complex and treatment-refractory than the patients of the Italian study. Despite these differences, both the Italian study [55] and the other real-world experiences [47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63] conclude, like our registry, that erenumab is useful in the prevention of EM and CM and presents a good tolerability profile.…”

“…Moreover, the average number of prior preventive drug failures was 3-5 in the Italian study [55] and superior to 7 in ours, which means that our patients are more complex and treatment-refractory than the patients of the Italian study. Despite these differences, both the Italian study [55] and the other real-world experiences [47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63] conclude, like our registry, that erenumab is useful in the prevention of EM and CM and presents a good tolerability profile. Erenumab has shown scarce adverse events in our registry (20%), like in the phase II [13][14][15][16][17][18] and phase III [19][20][21][22][23][24][25][26][27][28][29][30][31][32] clinical trials, meta-analysis [34][35][36][37][38][39], open-label extension studies [44]…”

“…Despite these differences, both the Italian study [55] and the other real-world experiences [47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63] conclude, like our registry, that erenumab is useful in the prevention of EM and CM and presents a good tolerability profile. Erenumab has shown scarce adverse events in our registry (20%), like in the phase II [13][14][15][16][17][18] and phase III [19][20][21][22][23][24][25][26][27][28][29][30][31][32] clinical trials, meta-analysis [34][35][36][37][38][39], open-label extension studies [44][45][46] and real-world experiences [46]…”

“…A huge number of real-world experiences analysing erenumab in migraine prevention are being published around the world [47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63]. These experiences already include more than 2,000 patients with migraine, and, among them, we can find eleven one-centre studies (seven prospective [48,53,54,56,57,59,61] and four retrospectives [50][51][52]62]) and five multicentre (four prospective [49,55,58,60] and one retrospective [63]). Our registry includes the second largest sample of migraine patients treated with erenumab in a multicentric prospective registry.…”

“…Mild constipation, flu-like symptoms, transient pruritus at the injection site and fatigue were the only adverse events with incidences superior to 2%. We only collected two severe adverse events related to erenumab treatment (two skin rash after injection) that represent 0.9% of our patients, a similar figure to that of clinical trials and real-world experiences (1-3%) [44][45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62].…”