MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention
Robert Belvís 1 , Pablo Irimia 2 , Patricia Pozo-Rosich 3 4 , Carmen González-Oria 5 , Antonio Cano 6 , Javier Viguera 7 , Belén Sánchez 8 , Francisco Molina 9 , Isabel Beltrán 10 , Agustín Oterino 11 , Elisa Cuadrado 12 , Angel Gómez-Camello 13 , Miguel Alberte-Woodward 14 , Carmen Jurado 15 , Teresa Oms 16 , David Ezpeleta 17 , Javier Díaz de Terán 18 , Noemí Morollón 19 20 , Germán Latorre 21 , Marta Torres-Ferrús 3 4 , Alicia Alpuente 3 4 , Raquel Lamas 5 , Carlos Toledano 2 , Rogelio Leira 22 , Sonia Santos 23 , Margarita Sánchez Del Río 24
Background: Erenumab was approved in Europe for migraine prevention in patients with ≥ 4 monthly migraine days (MMDs). In Spain, Novartis started a personalized managed access program, which allowed free access to erenumab before official reimbursement.
The Spanish Neurological Society started a prospective registry to evaluate real-world effectiveness and tolerability, and all Spanish headache experts were invited to participate. We present their first results.
Methods: Patients fulfilled the ICHD-3 criteria for migraine and had ≥ 4 MMDs. Sociodemographic and clinical data were registered as well as MMDs, monthly headache days, MHDs, prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and patient-reported outcomes (PROs): headache impact test (HIT-6), migraine disability assessment questionnaire (MIDAS), and patient global improvement change (PGIC). A > 50% reduction of MMDs after 12 weeks was considered as a response.
Results: We included 210 patients (female 86.7%, mean age 46.4 years old) from 22 Spanish hospitals from February 2019 to June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Patients had failed a mean of 7.8 preventive treatments at baseline (botulinum toxin type A-BoNT/A-had been used by 95.2% of patients). Most patients (67.6%) started with erenumab 70 mg. Sixty-one percent of patients were also simultaneously taking oral preventive drugs and 27.6% were getting simultaneous BoNT/A. Responder rate was 37.1% and the mean reduction of MMDs and MHDs was -6.28 and -8.6, respectively.
Changes in PROs were: MIDAS: -35 points, HIT-6: -11.6 points, PIGC: 4.7 points. Predictors of good response were prior HIT-6 score < 80 points (p = 0.01), ≤ 5 prior preventive treatment failures (p = 0.026), absence of MOH (p = 0.039), and simultaneous BoNT/A treatment (p < 0.001). Twenty percent of patients had an adverse event, but only two of them were severe (0.9%), which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%).
Conclusions: In real-life, in a personalized managed access program, erenumab shows a good effectiveness profile and an excellent tolerability in migraine prevention in our cohort of refractory patients.
CITATION J Headache Pain. 2021 Jul 17;22(1):74. doi: 10.1186/s10194-021-01267-x