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      Eptinezumab for adolescents with chronic refractory headache: A retrospective chart review

      1 , 1 , 1
      Headache: The Journal of Head and Face Pain
      Wiley

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          Abstract

          Objective

          To evaluate the safety and efficacy of eptinezumab for the treatment of chronic refractory headache in adolescents.

          Background

          Chronic refractory headache can lead to school absences and impaired quality of life in adolescents, and currently there are no pharmacologic treatments with level A evidence for headache prevention for this population. While observational data suggest that monoclonal antibodies to calcitonin gene–related peptide or its receptor may be helpful for adolescents who have refractory primary headache disorders, evidence is lacking for the use of eptinezumab.

          Methods

          This was a single‐center, retrospective chart review. Demographic and headache phenotypic data were collected. Outcome measures included headache intensity and frequency pre‐ and post‐infusion(s), and improvement in function or in associated symptoms. Adverse events were also collected.

          Results

          Nine patients with chronic migraine and two with new daily persistent headache received a first dose of 100 mg of eptinezumab. All of them had daily headache and nine had continuous headache at baseline. After the first infusion of 100 mg, two patients were no longer having daily headache, one patient stopped having continuous headache, and four patients noted headache intensity reduction. Additionally, one patient described a reduction in nausea and vomiting, and another patient noted improvement in function. Six patients received a second eptinezumab infusion of 100 mg, three had a third one, and one patient had four infusions of 100 mg. After the second infusion, one patient noted reduction in headache frequency, one experienced lower headache intensity, and two described pain “improving.” With the third and fourth infusions, patients continued to report improvement in headache intensity. Subsequent infusions of 300 mg resulted in further reductions in headache frequency and intensity for some patients. Eptinezumab was overall well tolerated.

          Conclusion

          While this was a small sample, findings suggest that eptinezumab may be a safe and effective treatment for chronic, refractory headache in adolescents.

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          Most cited references16

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            The International Classification of Headache Disorders, 3rd edition (beta version).

            (2013)
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              ARISE: A Phase 3 randomized trial of erenumab for episodic migraine.

              Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology. Erenumab, a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, is being evaluated for migraine prevention. Methods In this randomized, double-blind, placebo-controlled, phase 3 study, 577 adults with episodic migraine were randomized to placebo or 70 mg erenumab; 570 patients were included in efficacy analyses. Primary endpoint was change in monthly migraine days. Secondary endpoints were ≥50% reduction in monthly migraine days, change in acute migraine-specific medication treatment days, and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores measured by the Migraine Physical Function Impact Diary. All endpoints assessed change from baseline at month 3. Results Patients receiving erenumab experienced -2.9 days change in monthly migraine days, compared with -1.8 days for placebo, least-squares mean (95% CI) treatment difference of -1.0 (-1.6, -0.5) ( p < 0.001). A ≥ 50% reduction in monthly migraine days was achieved by 39.7% (erenumab) and 29.5% (placebo) of patients (OR:1.59 (95% CI: 1.12, 2.27) ( p = 0.010). Migraine-specific medication treatment days were reduced by -1.2 (erenumab) and -0.6 (placebo) days, a treatment difference of -0.6 (-1.0, -0.2) ( p = 0.002). The ≥5-point reduction rates in Migraine Physical Function Impact Diary - Physical Impairment were 33.0% and 27.1% (OR:1.33 (0.92, 1.90) ( p = 0.13) and in Migraine Physical Function Impact Diary - Everyday Activities were 40.4% and 35.8% (OR:1.22 (0.87, 1.71) ( p = 0.26). Safety and adverse event profiles of erenumab were similar to placebo. Most frequent adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Conclusions As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use. (Funded by Amgen). Trial registration ClinicalTrials.gov, NCT02483585.
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                Author and article information

                Contributors
                (View ORCID Profile)
                Journal
                Headache: The Journal of Head and Face Pain
                Headache
                Wiley
                0017-8748
                1526-4610
                January 2023
                January 12 2023
                January 2023
                : 63
                : 1
                : 177-182
                Affiliations
                [1 ] UCSF Child and Adolescent Headache Program, Department of Neurology, UCSF Weill Institute for Neurosciences University of California, San Francisco San Francisco California USA
                Article
                10.1111/head.14452
                36633118
                f49f0d29-9b21-4d88-a0de-42c0cd57c7d1
                © 2023

                http://onlinelibrary.wiley.com/termsAndConditions#vor

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