European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention

Abstract

Background and aimMonoclonal antibodies acting on the calcitonin gene-related peptide or on its receptor are new drugs to prevent migraine. Four monoclonal antibodies have been developed: one targeting the calcitonin gene-related peptide receptor (erenumab) and three targeting the calcitonin gene-related peptide (eptinezumab, fremanezumab, and galcanezumab). The aim of this document by the European Headache Federation (EHF) is to provide an evidence-based and expert-based guideline on the use of the monoclonal antibodies acting on the calcitonin gene-related peptide for migraine prevention.MethodsThe guideline was developed following the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. The working group identified relevant questions, performed systematic review and analysis of the literature, assessed the quality of available evidence, and wrote recommendations. Where the GRADE approach was not applicable, expert opinion was provided.ResultsWe found low to high quality of evidence to recommend eptinezumab, erenumab, fremanezumab, and galcanezumab in patients with episodic migraine and medium to high quality of evidence to recommend erenumab, fremanezumab, and galcanezumab in patients with chronic migraine. For several clinical questions, there was not enough evidence to provide recommendations using the GRADE approach and recommendations relied on experts’ opinion.ConclusionMonoclonal antibodies acting on the calcitonin gene-related peptide are new drugs which can be recommended for migraine prevention. Real life data will be useful to improve the use of those drugs in clinical practice.

Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials

“…Results from this subgroup analysis demonstrate that galcanezumab 120 and 240 mg versus placebo is efficacious across multiple end-points in patients with episodic migraine irrespective of their history of ≥1 or ≥2 prior preventive failures for efficacy and/or safety/ tolerability reasons. A large proportion of patients (25.6%) had ≥1 prior preventive failure; this is consistent with the high discontinuation rates associated with the current standard of care [7,15,16]. During the 6-month treatment period, patients with ≥1 or ≥2 prior failures experienced significantly greater overall reductions in the number of migraine headache days per month, and ≥50% and ≥75% response rates with galcanezumab versus placebo.…”

“…Findings from this subgroup analysis are important given the recently published European Headache Federation and American Headache Society treatment guidelines that recommend initiating treatments targeting the CGRP pathway when multiple criteria are met, including the inability to tolerate or an inadequate response to at least two common oral preventives [16,17]. Results from the overall populations in phase 3 RCTs targeting the CGRP pathway demonstrated efficacy and safety/tolerability in a broader population with migraine; however, the guidelines noted the need for cost-effective care and therefore restricted access.…”

“…The primary objective in EVOLVE studies was to evaluate whether galcanezumab 120mg/240mg is superior versus placebo in overall mean change from baseline in the number of monthly migraine headache days during the double-blind treatment period (months 1-6). A migraine headache day was a calendar day on which migraine headache or probable migraine headache (lasting ≥ 30 min and with features meeting the International Classification of Headache Disorders, 3rd edition beta version criteria [16]) occurred. Key secondary outcomes included here are mean proportions of patients with ≥50%, ≥75% and 100% reduction from baseline in monthly migraine headache days.…”

Erenumab Plus Subcutaneous Immunoglobulin in a Patient With Comorbid Chronic Migraine and Myasthenia Gravis

“…Even if CGRP might act as an immune mediator, anti‐CGRP monoclonal antibodies, including erenumab, are designed to avoid altering the immune system . However, anti‐drug antibodies can be detected in a minority of cases …”

Galcanezumab: a monoclonal antibody for migraine prophylaxis

“…Three recombinant monoclonal antibodies targeting calcitonin gene‐related peptide (CGRP) itself (fremanezumab and galcanezumab) or its receptor (erenumab) are now licensed for the prophylaxis of migraine in adults experiencing at least four migraine days per month. A consensus guideline from the European Headache Federation recommends their use in patients with episodic or chronic migraine “who have failed at least two of the available medical treatments or who cannot use other preventive treatments because of co‐morbidities, side‐effects or poor compliance” …”