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Chronic Headache Pain
Published in Andrea Kohn Maikovich-Fong, Handbook of Psychosocial Interventions for Chronic Pain, 2019
RuthAnn R. Lester, Eleanor S. Brammer, Allison Gray
Very recently, the FDA approved a new medication for the preventive treatment of migraine, Aimovig (erenumab-aooe) (U.S. Food & Drug Administration, 2018). The medication is given by monthly injections and has a novel mechanism of action whereby it blocks the activity of calcitonin gene-related peptide (CGRP), a molecule implicated in migraine attacks. Initial data from clinical trials is promising, but post-marketing data will be important in understanding this drug’s efficacy and safety long term.
Headache Disorders
Published in Sahar Swidan, Matthew Bennett, Advanced Therapeutics in Pain Medicine, 2020
In recent years, four monoclonal antibodies targeting CGRP or the CGRP receptor have been tested in humans for the prevention of migraine: galcanezumab, eptinezumab, erenumab, and fremanezumab.31 High-quality RCTs have demonstrated the efficacy of these antibodies in decreasing migraine days in episodic migraine as well as chronic migraine. Fremanezumab showed efficacy in reducing monthly migraines in a phase III trial of 1130 patients with chronic migraine.32 Erenumab—the only monoclonal antibody that targets the CGRP receptor—demonstrated similar efficacy for episodic migraine in addition to chronic migraine.33 The reported reduction in monthly migraine has been approximately three to six episodes per month and significantly greater than placebo. Of note, patients with chronic migraine were excluded from the previously cited studies if they had failed preventative treatment with two to three prophylactic medications. Despite the promising results of these positive trials, additional studies are needed to determine the long-term efficacy, safety, and cost-effectiveness of monoclonal antibodies. An analysis of a 5-year study of erenumab revealed sustained treatment effect and safety at week 64, with 25% of patients reporting 100% reduction in monthly migraine days.34 Erenumab, galcanezumab, and fremanezumab are all currently FDA-approved for migraine prevention. The long-term safety is still questioned, as well as the role of these agents as first-line treatments or only after multiple medications failures. As CGRP is an essential vasodilatory protein for cerebral and coronary arteries, its potential contraindication in patients with coronary artery disease, past stroke, or uncontrolled hypertension for example has not been well-studied but should be taken into consideration when there is a thought of prescribing these agents.
Brazilian descriptive study of 104 consecutive real-world migraine patients treated with monoclonal antibodies
Published in Postgraduate Medicine, 2022
Abouch Krymchantowski, Raimundo Pereira Silva-Néto, Carla Jevoux, Ana Gabriela Krymchantowski
Regarding tolerability, real-world studies demonstrated a higher percentage of adverse events in the population of patients [29,35–38] when compared to literature data. In this series, nearly 20% of the patients experienced adverse events mainly related to injection site reactions and constipation with erenumab. In the patients from the Italian sample for instance, 13.7% presented adverse events at week 12, but 8.8% had constipation [36]. However, the retrospective evaluation of chronic migraineurs from an American sample studied at the University of New York revealed a much higher incidence of adverse reactions. Although, again, constipation and injection site reactions were the most observed, 2/5 (40%) patients having used erenumab 70 mg, 32/46 (69.6%) with erenumab 140 mg, 15/23 (65.2%) with galcanezumab and 8/16 (50%) who have used fremanezumab presented any side effect [38]. Fortunately, the report of serious adverse events is low with the mAbs anti-CGRP [13,38].
Safety and tolerability of preventive treatment options for chronic migraine
Published in Expert Opinion on Drug Safety, 2021
Amanda Tinsley, John Farr Rothrock
As evidenced by low discontinuation rates (<5%) due to treatment emergent adverse events in the pivotal trials for both episodic and chronic migraine, these four mabs are generally well tolerated [20,21,53–59]. The most common class adverse event reported was local injection site reaction (i.e. pain, induration, erythema, pruritus), with 2–7% more patients in the treatment groups experiencing injection site reactions compared to those in the placebo groups in the pivotal trials, injection site reactions were reported by approximately one-third of participants in open-label long-term clinical trials [60]. Other side effects include hypersensitivity reactions, nasopharyngitis, upper respiratory tract infections and, most notably in the case of erenumab 140 mg, constipation. The last can be severe and require therapeutic intervention (including immediate discontinuation of the mab).
Fremanezumab for the preventive treatment of migraine
Published in Expert Opinion on Biological Therapy, 2019
Stephen D. Silberstein, Joshua M. Cohen, Paul P. Yeung
Erenumab-aooe (Aimovig™; Amgen and Novartis) is an approved human immunoglobulin G2 (IgG2) monoclonal antibody that binds to the canonical CGRP receptor and prevents CGRP from binding to this receptor [20–22]. Erenumab is administered monthly via subcutaneous injection, with a recommended dosage of 70 mg or 140 mg (two consecutive injections of 70 mg) once monthly [20]. Galcanezumab-gnlm (Emgality®; Eli Lilly and Company) is an approved humanized monoclonal antibody (IgG4) that targets the CGRP ligand and is administered monthly by subcutaneous injection, with a recommended initial loading dose of 240 mg (two consecutive injections of 120 mg), followed by 120 mg monthly [23]. Eptinezumab (Alder BioPharmaceuticals) is an investigational humanized monoclonal antibody (IgG1) that targets the CGRP ligand and is administered quarterly (every 3 months) via intravenous infusion [24].