Robert Belvís1, Pablo Irimia2, Patricia Pozo-Rosich3,4, Carmen González-Oria5, Antonio Cano6, Javier Viguera7, Belén Sánchez8, Francisco Molina9, Isabel Beltrán10, Agustín Oterino11, Elisa Cuadrado12, Angel Gómez-Camello13, Miguel Alberte-Woodward14, Carmen Jurado15, Teresa Oms16, David Ezpeleta17, Javier Díaz de Terán18, Noemí Morollón19,20, Germán Latorre21, Marta Torres-Ferrús3,4, Alicia Alpuente3,4, Raquel Lamas5, Carlos Toledano2, Rogelio Leira22, Sonia Santos23, Margarita Sánchez Del Río24. 1. 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. 2. Clínica Universitaria de Navarra, Pamplona, Spain. 3. Headache Unit, Neurology Department, Hospital Universitari Vall D´Hebron, Barcelona, Spain. 4. 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. 5. Hospital Universitario Virgen del Rocío, Sevilla, Spain. 6. Hospital de Mataró, Barcelona, Spain. 7. Hospital Universitario Virgen de La Macarena, Sevilla, Spain. 8. Hospital Quironsalud, Zaragoza, Spain. 9. Hospital Son Espases, Palma de Mallorca, Spain. 10. Hospital General Universitario de Alicante, Alicante, Spain. 11. Hospital Universitario Marqués de Valdecilla, Santander, Spain. 12. Hospital del Mar, Barcelona, Spain. 13. Hospital Universitario San Cecilio, Granada, Spain. 14. Hospital Universitario Lucus Augusti, Vigo, Spain. 15. Hospital Universitario Reina Sofía, Córdova, Spain. 16. Hospital Dos de Maig, Barcelona, Spain. 17. Hospital Quironsalud, Madrid, Spain. 18. Hospital Universitario La Paz, Madrid, Spain. 19. Headache and Neuralgia Unit, Department of Neurology, Hospital de La Santa Creu I Sant Pau, C/ Mas Casanova 90, CP08025, Barcelona, Spain. 20. Hospital Universitario Dexeus, Barcelona, Spain. 21. Hospital Universitario de Fuenlabrada, Madrid, Spain. 22. Hospital Universitario de Santiago de Compostela, de Compostela, Spain. 23. Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. 24. Clínica Universitaria de Navarra, Madrid, Spain.
Abstract
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.
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.
Authors: Cristina Tassorelli; Hans-Christoph Diener; David W Dodick; Stephen D Silberstein; Richard B Lipton; Messoud Ashina; Werner J Becker; Michel D Ferrari; Peter J Goadsby; Patricia Pozo-Rosich; Shuu-Jiun Wang Journal: Cephalalgia Date: 2018-03-04 Impact factor: 6.292
Authors: Zsolt Hepp; David W Dodick; Sepideh F Varon; Jenny Chia; Nitya Matthew; Patrick Gillard; Ryan N Hansen; Emily Beth Devine Journal: Cephalalgia Date: 2016-11-12 Impact factor: 6.292
Authors: Pablo Irimia; David García-Azorín; Mercedes Núñez; Sílvia Díaz-Cerezo; Pepa García de Polavieja; Tommaso Panni; Aram Sicras-Navarro; Antoni Sicras-Mainar; Antonio Ciudad Journal: J Headache Pain Date: 2022-07-07 Impact factor: 8.588