Chronic Headache Pain
Andrea Kohn Maikovich-Fong in Handbook of Psychosocial Interventions for Chronic Pain, 2019
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
Sahar Swidan, Matthew Bennett in 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.
Antibodies to watch in 2019
Published in mAbs, 2019
Hélène Kaplon, Janice M. Reichert
On May 17, 2018, the US Food and Drug Administration (FDA) approved erenumab-aooe (Aimovig) for the preventive treatment of migraine in adults. Erenumab is a human IgG2 mAb that targets calcitonin gene-related peptide (CGRP) receptor, thereby blocking the activity of CGRP, which is involved in migraine attacks. The treatment is given by once-monthly subcutaneous (SC) injections. The approval was based on data from three clinical trials that compared erenumab-aooe to placebo. Over 2000 participants were included in the studies. In the first study (STRIVE, NCT02456740), which included 955 participants with a history of episodic migraine, patients administered erenumab-aooe experienced, on average, one to two fewer monthly migraine days than those on placebo over a 6-month period. In the second study (ARISE, NCT02483585), which included 577 patients with a history of episodic migraine, patients administered erenumab-aooe experienced, on average, one fewer migraine day per month than those on placebo over a 3-month period. In the third study (NCT02066415), which evaluated 667 patients with a history of chronic migraine, patients treated with erenumab-aooe experienced, on average, 2.5 fewer monthly migraine days than those receiving placebo over a 3-month period.21 On July 26, 2018, erenumab was issued a marketing authorization in the EU for prophylaxis of migraine in adults who have at least 4 migraine days per month.
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).
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].
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