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

The Journal of Headache and Pain

Margarita Sánchez del Río¹  Carlos Toledano²  Pablo Irimia²  Marta Torres-Ferrús³  Patricia Pozo-Rosich³  Alicia Alpuente³  Robert Belvís⁴  Noemí Morollón⁵  Sonia Santos⁶  Teresa Oms⁷  Isabel Beltrán⁸  David Ezpeleta⁹  Belén Sánchez^1,10  Francisco Molina^1,11  Javier Díaz de Terán^1,12  Miguel Alberte-Woodward^1,13  Agustín Oterino^1,14  Carmen Jurado^1,15  Angel Gómez-Camello^1,16  Javier Viguera^1,17  Carmen González-Oria^1,18  Raquel Lamas^1,18  Germán Latorre^1,19  Rogelio Leira^2,20  Antonio Cano^2,21  Elisa Cuadrado^2,22 

[1] Clínica Universitaria de Navarra, Madrid, Spain;Clínica Universitaria de Navarra, Pamplona, Spain;Headache Unit, Neurology Department, Hospital Universitari Vall D´Hebron, Barcelona, Spain;Headache and Neurological Pain Research Group, Vall D´Hebron Pain Research Group, Vall D´Hebron Research Institute, Department of Medicine, Universitat Autónoma de Barcelona, Barcelona, Spain;Headache and Neuralgia Unit, Department of Neurology, Hospital de La Santa Creu I Sant Pau, C/ Mas Casanova 90, CP08025, Barcelona, Spain;Headache and Neuralgia Unit, Department of Neurology, Hospital de La Santa Creu I Sant Pau, C/ Mas Casanova 90, CP08025, Barcelona, Spain;Hospital Universitario Dexeus, Barcelona, Spain;Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain;Hospital Dos de Maig, Barcelona, Spain;Hospital General Universitario de Alicante, Alicante, Spain;Hospital Quironsalud, Madrid, Spain;Hospital Quironsalud, Zaragoza, Spain;Hospital Son Espases, Palma de Mallorca, Spain;Hospital Universitario La Paz, Madrid, Spain;Hospital Universitario Lucus Augusti, Vigo, Spain;Hospital Universitario Marqués de Valdecilla, Santander, Spain;Hospital Universitario Reina Sofía, Córdova, Spain;Hospital Universitario San Cecilio, Granada, Spain;Hospital Universitario Virgen de La Macarena, Sevilla, Spain;Hospital Universitario Virgen del Rocío, Sevilla, Spain;Hospital Universitario de Fuenlabrada, Madrid, Spain;Hospital Universitario de Santiago de Compostela, de Compostela, Spain;Hospital de Mataró, Barcelona, Spain;Hospital del Mar, Barcelona, Spain;

关键词: Erenumab;    Migraine;    Monoclonal antibody;    Preventive treatment;    Registry;   

DOI  :  10.1186/s10194-021-01267-x

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY