MAB-MIG : registry of the spanish neurological society of erenumab for migraine prevention
Belvís, Roberto (Institut d'Investigació Biomèdica Sant Pau)
Irimia, Pablo (Clínica Universidad de Navarra)
Pozo-Rosich, Patricia (Hospital Universitari Vall d'Hebron)
González-Oria, Carmen (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Cano, Antonio (Hospital de Mataró. Consorci Sanitari del Maresme)
Viguera, Javier (Hospital Universitario Virgen Macarena (Sevilla, Andalusia))
Sánchez, Belén (Hospital Quirónsalud Zaragoza)
Molina, Francisco (Hospital Universitari Son Espases (Palma de Mallorca, Balears))
Beltrán, Isabel (Hospital General Universitario de Alicante (Alacant, País Valencià))
Oterino, Agustín (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Cuadrado-Godia, Elisa (Hospital del Mar (Barcelona, Catalunya))
Gómez-Camello, Angel (Hospital Universitario San Cecilio (Granada))
Alberte-Woodward, Miguel (Hospital Universitario Lucus Augusti (Lugo))
Jurado, Carmen (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Oms, Teresa (Hospital Dos de Maig)
Ezpeleta, David (Hospital Quironsalud Madrid)
de Terán, Javier Díaz (Hospital Universitario La Paz (Madrid))
Morollón Sánchez-Mateos, Noemí (Hospital Universitari Dexeus (Barcelona, Catalunya))
Latorre, Germán (Hospital Universitario de Fuenlabrada ( Madrid))
Torres-Ferrús, Marta (Hospital Universitari Vall d'Hebron)
Alpuente, Alicia (Hospital Universitari Vall d'Hebron)
Lamas, Raquel (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Toledano, Carlos (Clínica Universidad de Navarra)
Leira, Rogelio (Complejo Hospitalario Universitario de Santiago de Compostela)
Santos, Sonia (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Del Rio, Margarita Sanchez (Clínica Universidad de Navarra)
Universitat Autònoma de Barcelona

Fecha:	2021
Resumen:	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. 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. 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%). 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.
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Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Erenumab ; Migraine ; Monoclonal antibody ; Preventive treatment ; Registry
Publicado en:	Journal of headache and pain, Vol. 22 (july 2021) , ISSN 1129-2377

DOI: 10.1186/s10194-021-01267-x
PMID: 34273947

8 p, 761.9 KB

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