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

Piero Barbanti MD, PhD; Cinzia Aurilia MD; Gabriella Egeo MD, PhD; Luisa Fofi MD; Sabina Cevoli MD, PhD; Bruno Colombo MD; Massimo Filippi MD; Fabio Frediani MD; Francesco Bono MD; Licia Grazzi MD; Antonio Salerno MD; Bruno Mercuri MD, PhD; Antonio Carnevale MD; Claudia Altamura MD, PhD; Fabrizio Vernieri MD

Disclosures

Headache. 2021;61(2):363-372. 

In This Article

Methods

EARLY is a multicenter, prospective, cohort, real-life study carried out in nine Italian headache centers. We considered for enrolment all consecutive patients aged 18–65 affected by HFEM or CM with or without MO, seen from December 20, 2018 to September 30, 2019. The diagnosis was formulated according to the criteria of the International Classification of Headache Disorders, 3rd edition.[16] We did not include patients who had been previously included in any RCT with anti-CGRP mAbs.

All patients underwent a careful physical and neurological examination performed by trained neurologists, and were evaluated at baseline and every 4 weeks, with face-to-face interviews by means of shared semi-structured questionnaire. Data were collected on sociodemographic factors (age, gender, body mass index), clinical migraine features (migraine duration, MMDs, presence and duration of MO, site and quality of pain, accompanying symptoms, unilateral cranial autonomic symptoms, allodynia, and dopaminergic symptoms. Further pharmacological data were also collected including previous and current acute and preventive treatments, responsiveness to triptans and onabotulinumtoxinA, concomitant headaches, comorbidities, and concomitant medications, with special emphasis on psychiatric drugs).[17] Pain was considered unilateral if it occurred exclusively on one side of the head (regardless of any side shift or side alternance) or bilateral in all the other cases (including those with both unilateral and bilateral attacks). We considered migraine patients with dopaminergic symptoms those reporting at least one of the following symptoms during the prodromes, headache stage, or postdromes: yawning, somnolence, nausea, or vomiting.[18,19] Psychiatric comorbidities were defined as the clinical conditions ranging from affective to personality disorders diagnosed by a psychiatrist and requiring specific pharmacological treatment.

Each patient was treated with one dose of erenumab 70 mg administered subcutaneously every 4 weeks. Treatment duration was planned to last from 6 to 12 months, depending on the patient's response, in keeping with the suggestions of the European Headache Federation guidelines.[10] At week 8 the erenumab dose was increased to 140 mg in nonresponders and in responders who had become nonresponders for at least 4 weeks. We considered nonresponders migraine patients who did not reach a 50% reduction in MMDs (for patients with HFEM) or in monthly headache days (MHDs), for patients with CM, compared to baseline.

During a 28-day run-in period (baseline) and throughout the study, all patients were asked to fill a headache diary, detailing migraine days, rating pain severity with Visual Analog Scale (VAS) and assessing their analgesic intake. Migraine disability was assessed using the Headache Impact Test (HIT-6). Particular attention was paid to the possible occurrence of adverse events. Patients were visited every 4 weeks and data were collected on MMDs/MHDs, VAS, monthly analgesic intake, HIT-6 score, and possible occurrence of any adverse event.

The primary endpoint was to observe the change in the number of MMDs for HFEM and of MHDs for CM at weeks 9–12 compared to baseline. Secondary endpoints included changes in monthly analgesics intake, ≥50%, ≥75%, and 100% responder rates and variation in HIT-6 and VAS scores at weeks 9–12 compared to baseline. Safety and the occurrence of adverse events occurrence were also assessed. All patients gave their written informed consent. The study was approved by IRCCS San Raffaele Pisana Institutional Review Board (no.19/26). The approval was mutually recognized by the other local Institutional Review Boards. This study was not preregistered on any study registry site.

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