• Robert Belvís, Pablo Irimia, Patricia Pozo-Rosich, Carmen González-Oria, Antonio Cano, Javier Viguera, Belén Sánchez, Francisco Molina, Isabel Beltrán, Agustín Oterino, Elisa Cuadrado, Angel Gómez-Camello, Miguel Alberte-Woodward, Carmen Jurado, Teresa Oms, David Ezpeleta, de TeránJavier DíazJDHospital Universitario La Paz, Madrid, Spain., Noemí Morollón, Germán Latorre, Marta Torres-Ferrús, Alicia Alpuente, Raquel Lamas, Carlos Toledano, Rogelio Leira, Sonia Santos, and Del RíoMargarita SánchezMSClínica Universitaria de Navarra, Madrid, Spain..
• Headache and Neuralgia Unit, Department of Neurology, Hospital de La Santa Creu I Sant Pau, C/ Mas Casanova 90, CP08025, Barcelona, Spain. rbelvis@santpau.cat.
• J Headache Pain. 2021 Jul 17; 22 (1): 74.

BackgroundErenumab 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.MethodsPatients 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.ResultsWe 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%).ConclusionsIn 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.© 2021. The Author(s).

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