European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update

Sacco, Simona; Amin, Faisal Mohammad; Ashina, Messoud; Bendtsen, Lars; Deligianni, Christina; Gil‐Gouveia, Raquel; Katsarava, Zaza; MaassenVanDenBrink, Antoinette; Martelletti, Paolo; Mitsikostas, Dimos‐Dimitrios; Ornello, Raffaele; Reuter, Uwe; Río, Margarita Sánchez del; Sinclair, Alexandra J; Terwindt, Gisela M.; Uludüz, Derya; Versijpt, Jan; Lampl, Christian

doi:10.1186/s10194-022-01431-x

Cited by 171 publications

(112 citation statements)

References 82 publications

Supporting

Mentioning

104

Contrasting

Unclassified

Order By: Relevance

“…Patients measured headache-related impact using the HIT-6 [26,27], which comprises items for pain severity, activity limitation, wish to lie down, too tired to do work or daily activities, feeling tired or fed up and concentration limitation. Each of the six items is rated using a Likert-type scale with the following response options: never (6), rarely (8), sometimes (10), very often (11) or always (13), from which a total score is summed (possible range 36-78). Life impact category is derived from the total score: ≥60, severe; 56-59, substantial; 50-55, some; ≤49, little to none.…”

Section: Patient-reported Outcome Measuresmentioning

confidence: 99%

Eptinezumab improved patient‐reported outcomes and quality of life in patients with migraine and prior preventive treatment failures

Goadsby

Barbanti

Lambru

et al. 2023

Euro J of Neurology

View full text Add to dashboard Cite

Background and purpose: In the phase 3b, randomized, double-blind, placebo-controlled DELIVER clinical trial, eptinezumab reduced migraine frequency and headache in adults with two to four prior preventive treatment failures. Here, the effect of eptinezumab on coinciding patient-reported outcomes is reported.Methods: Adults were randomized to receive eptinezumab 100, 300 mg or placebo intravenously at weeks 12 and 24. The EQ-5D-5L, measuring overall patient health, and the six-item Headache Impact Test were completed every 4 weeks. The Patient Global Impression of Change was completed at weeks 4, 12 and 24. Patient-identified most bothersome symptom and the Migraine-Specific Quality of Life Questionnaire were administered at weeks 12 and 24.Results: Eptinezumab improved patient-reported outcomes more than placebo, starting at week 4 and at all subsequent time points. By week 12, patients' overall health (EQ-5D-5L visual analog scale score) improved with eptinezumab treatment (difference from placebo in change from baseline: 100 mg, 5.1, 95% confidence interval [CI] 2.2, 8.1, p < 0.001; 300 mg, 7.5, 95% CI 4.5, 10.4, p < 0.0001). At week 12, eptinezumab improved headache-related quality of life (difference from placebo in change from baseline in Headache Impact Test total score: 100 mg, −3.8, 95% CI −5.0, −2.5, p < 0.0001; 300 mg, −5.4, 95% CI −6.7, −4.2, p < 0.0001), including each Migraine-Specific Quality of Life Questionnaire domain (p ≤ 0.0001, all comparisons). Over twice as many patients receiving eptinezumab than placebo reported much or very much improvement on the Patient Global Impression of Change and patient-identified most bothersome symptom. Conclusion:Patients with two to four prior preventive treatment failures receiving eptinezumab versus placebo reported greater improvements in well-being, quality of life and most bothersome symptoms compared to placebo.

show abstract

Section: Patient-reported Outcome Measuresmentioning

confidence: 99%

Eptinezumab improved patient‐reported outcomes and quality of life in patients with migraine and prior preventive treatment failures

Goadsby

Barbanti

Lambru

et al. 2023

Euro J of Neurology

View full text Add to dashboard Cite

show abstract

“…Desde su aprobación, los anticuerpos monoclonales se han empezado a pautar en las unidades y consultas monográficas de cefalea, y diversas sociedades científicas han ido desarrollando sus guías y protocolos propios con sus particularidades y diferencias. En este sentido, se dispone de documentos elaborados por la European Headache Federation (EHF) 27 , la American Headache Society (AHS) 28 o profesionales de ámbito nacional como el Grupo de Consenso de Navarra y Aragón 21 .…”

Section: Justificación De La Elaboración Del Documentounclassified

“…Su finalidad es proporcionar recomendaciones, pero no sirven como guías de práctica clínica, pues son afirmaciones generales que se deberán adaptar a las condiciones específicas de cada región, a las particularidades de los diferentes sistemas de salud y a las condiciones específicas de financiación. El documento más actual lo publicó hace unos meses la EHF, intentando actualizar los datos y los estamentos de consenso de las primeras publicaciones 27 .…”

Section: Kranion Kranionunclassified

“…La Agencia Española de Medicamentos y Productos Sanitarios solo ha aprobado los tres primeros, estando pendiente el último. evidencia y las tasas de respuesta, así como el buen perfil de seguridad en comparación con los fármacos preventivos clásicos, podrían emplearse como tratamiento de primera línea 27 . Se sabe que estos fármacos son eficaces, bien tolerados y seguros, pero su coste podría limitar su uso en casos de migraña de baja frecuencia.…”

Section: Revisión De Consensos Internacionales E Informe De Posiciona...unclassified

“…En casos de una respuesta subóptima, se podría mantener y reevaluar a los 6 meses. Si el fármaco no es eficaz, debe suspenderse 27 . En pacientes con enfermedad crónica de larga duración o comorbilidad importante, como fibromialgia o síndrome ansioso-depresivo mal controlado, podría plantearse de entrada evaluar la respuesta a los 6 meses, puesto que existe mayor probabilidad de respuesta tardía.…”

Section: Seguimiento: Evaluación De La Eficaciaunclassified

See 2 more Smart Citations

Consenso sobre anticuerpos monoclonales en migraña del Grupo de Estudio de Cefaleas de la Asociación Madrileña de Neurología

González¹,

García²,

Miguel³

et al. 2024

KRANION

View full text Add to dashboard Cite

Introducción: A finales de 2018 fue autorizado en España el uso de los primeros anticuerpos monoclonales contra el péptido relacionado con el gen de la calcitonina (CGRP) o su receptor como tratamiento preventivo de la migraña. Su posología y mecanismo de acción los diferencian de los fármacos orales actuales. El acceso a estos tratamientos requiere el cumplimiento de unas condiciones especiales para su financiación en nuestro medio. En este documento se revisan los aspectos fundamentales de estos fármacos. Además, se han elaborado una serie de recomendaciones prácticas sobre su manejo basadas en los principales consensos internacionales y en nuestra experiencia actual en la práctica clínica.

show abstract

Early Use of Erenumab vs Nonspecific Oral Migraine Preventives

Pozo-Rosich,

Dolezil,

Paemeleire

et al. 2024

JAMA Neurol

Self Cite

View full text Add to dashboard Cite

ImportancePatients with migraine often cycle through multiple nonspecific preventive medications due to poor tolerability and/or inadequate efficacy leading to low adherence and increased disease burden.ObjectiveTo compare the efficacy, tolerability, patient adherence, and patient satisfaction between erenumab and nonspecific oral migraine preventive medications (OMPMs) in patients with episodic migraine (EM) who had previously failed 1 or 2 preventive treatments.Design, Setting, and ParticipantsThe 12-month prospective, interventional, global, multicenter, active-controlled, randomized clinical trial comparing sustained benefit of 2 treatment paradigms (erenumab qm vs oral prophylactics) in adult episodic migraine patients (APPRAISE) trial was a 12-month open-label, multicenter, active-controlled, phase 4 randomized clinical trial conducted from May 15, 2019, to October 1, 2021. This pragmatic trial was conducted at 84 centers across 17 countries. Overall, participants 18 years or older with a 12-month or longer history of migraine, and 4 or more but fewer than 15 monthly migraine days (MMDs) were included.InterventionsPatients were randomized (2:1) to receive erenumab or OMPMs. Dose adjustment was permitted (label dependent).Main Outcomes and MeasuresThe primary end point was the proportion of patients completing 1 year of the initially assigned treatment and achieving a reduction of 50% or greater from baseline in MMDs at month 12. Secondary end points included the cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders according to the Patients’ Global Impression of Change (PGIC) scale at month 12 for patients taking the initially assigned treatment.ResultsA total of 866 patients were screened, of whom 245 failed the screening and 621 completed the screening and baseline period. Of the 621 randomized patients (mean [SD] age, 41.3 [11.2] years; 545 female [87.8%]; 413 [66.5%] in the erenumab group; 208 [33.5%] in the OMPM group), 523 (84.2%) completed the treatment phase, and 98 (15.8%) discontinued the study. At month 12, significantly more patients assigned to erenumab vs OMPM achieved the primary end point (232 of 413 [56.2%] vs 35 of 208 [16.8%]; odds ratio [OR], 6.48; 95% CI, 4.28-9.82; P &lt;.001). Compared with OMPMs, treatment with erenumab showed higher responder rate (314 of 413 [76.0%] vs 39 of 208 [18.8%]; OR, 13.75; 95% CI, 9.08-20.83; P &lt;.001) on the PGIC scale (≥5 at month 12). Significant reduction in cumulative average MMDs was reported with erenumab treatment vs OMPM treatment (−4.32 vs −2.65; treatment difference [SE]: −1.67 [0.35] days; P &lt; .001). Substantially fewer patients in the erenumab arm compared with the OMPM arm switched medication (9 of 413 [2.2%] vs 72 of 208 [34.6%]) and discontinued treatment due to adverse events (12 of 408 [2.9%] vs 48 of 206 [23.3%]). No new safety signals were identified.Conclusions and RelevanceResults of this randomized clinical trial demonstrated that earlier use of erenumab in patients with EM who failed 1 or 2 previous preventive treatments provided greater and sustained efficacy, safety, and adherence than continuous OMPM.Trial RegistrationClinicalTrials.gov Identifier: NCT03927144

show abstract

European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update

Cited by 171 publications

References 82 publications

Eptinezumab improved patient‐reported outcomes and quality of life in patients with migraine and prior preventive treatment failures

Eptinezumab improved patient‐reported outcomes and quality of life in patients with migraine and prior preventive treatment failures

Consenso sobre anticuerpos monoclonales en migraña del Grupo de Estudio de Cefaleas de la Asociación Madrileña de Neurología

Early Use of Erenumab vs Nonspecific Oral Migraine Preventives

Contact Info

Product

Resources

About