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      One-Time Use of Galcanezumab or Fremanezumab for Migraine Prevention

      research-article
      1 , , 2 , 1 , 1 , 1
      ,
      Cureus
      Cureus
      one-time use, headache, migraine, calcitonin gene-related peptide-related monoclonal antibodies, adherance

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          Abstract

          Background

          There are no reports on the effectiveness of one-time use of the calcitonin gene-related peptide-related monoclonal antibodies (CGRP-mABs) evaluated at one and three months for migraine prevention. Here, we present the real-world data of one-time administration of CGRP-mABs, galcanezumab and fremanezumab, for migraine prevention.

          Methodology

          We retrospectively investigated eight migraine patients treated with one-time administration of galcanezumab 240 mg or fremanezumab 225 mg. Monthly headache days (MHD), monthly acute medication intake days (AMD), and Headache Impact Test-6 (HIT-6) scores before, one, and three months after one-time CGRP-mABs administration were evaluated.

          Results

          A total of five women and three men were included (median age = 46.5 years, range = 19-63 years). Overall, six were episodic migraine, and two were chronic migraine. Five patients received one-time administration of fremanezumab and three received galcanezumab. In total, six (75.0%) patients experienced therapeutic effectiveness one month after the one-time administration. Five of the six maintained the therapeutic effect until three months, but one had aggravation. As a result, six (75.0%) patients reached or maintained therapeutic conditions three months after the one-time administration of CGRP-mABs without side effects. All patients continued previously used oral prophylaxis during the observational period. Significant reductions in MHD, AMD, and HIT-6 scores were observed three months after the initial administration (p = 0.008, p = 0.005, and p < 0.001, respectively).

          Conclusions

          Six of the eight patients experienced or maintained therapeutic effectiveness at three months despite the one-time administration of CGRP-mABs. Our results suggest that one-time use of CGRP-mABs may be a new treatment option in combination with oral prophylaxis.

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          Most cited references20

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          Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition

          (2018)
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            No Adjustments Are Needed for Multiple Comparisons

            Adjustments for making multiple comparisons in large bodies of data are recommended to avoid rejecting the null hypothesis too readily. Unfortunately, reducing the type I error for null associations increases the type II error for those associations that are not null. The theoretical basis for advocating a routine adjustment for multiple comparisons is the "universal null hypothesis" that "chance" serves as the first-order explanation for observed phenomena. This hypothesis undermines the basic premises of empirical research, which holds that nature follows regular laws that may be studied through observations. A policy of not making adjustments for multiple comparisons is preferable because it will lead to fewer errors of interpretation when the data under evaluation are not random numbers but actual observations on nature. Furthermore, scientists should not be so reluctant to explore leads that may turn out to be wrong that they penalize themselves by missing possibly important findings.
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              A six-item short-form survey for measuring headache impact: the HIT-6.

              Migraine and other severe headaches can cause suffering and reduce functioning and productivity. Patients are the best source of information about such impact. To develop a new short form (HIT-6) for assessing the impact of headaches that has broad content coverage but is brief as well as reliable and valid enough to use in screening and monitoring patients in clinical research and practice. HIT-6 items were selected from an existing item pool of 54 items and from 35 items suggested by clinicians. Items were selected and modified based on content validity, item response theory (IRT) information functions, item internal consistency, distributions of scores, clinical validity, and linguistic analyses. The HIT-6 was evaluated in an Internet-based survey of headache sufferers (n = 1103) who were members of America Online (AOL). After 14 days, 540 participated in a follow-up survey. HIT-6 covers six content categories represented in widely used surveys of headache impact. Internal consistency, alternate forms, and test-retest reliability estimates of HIT-6 were 0.89, 0.90, and 0.80, respectively. Individual patient score confidence intervals (95%) of app. +/-5 were observed for 88% of all respondents. In tests of validity in discriminating across diagnostic and headache severity groups, relative validity (RV) coefficients of 0.82 and 1.00 were observed for HIT-6, in comparison with the Total Score. Patient-level classifications based in HIT-6 were accurate 88.7% of the time at the recommended cut-off score for a probability of migraine diagnosis. HIT-6 was responsive to self-reported changes in headache impact. The IRT model estimated for a 'pool' of items from widely used measures of headache impact was useful in constructing an efficient, reliable, and valid 'static' short form (HIT-6) for use in screening and monitoring patient outcomes.
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                Author and article information

                Journal
                Cureus
                Cureus
                2168-8184
                Cureus
                Cureus (Palo Alto (CA) )
                2168-8184
                25 January 2023
                January 2023
                : 15
                : 1
                : e34180
                Affiliations
                [1 ] Department of Neurosurgery, Itoigawa General Hospital, Itoigawa, JPN
                [2 ] Department of Neurology, Itoigawa General Hospital, Itoigawa, JPN
                Author notes
                Article
                10.7759/cureus.34180
                9951121
                36843788
                25487cb3-eb5c-49c5-a656-50728422e86a
                Copyright © 2023, Katsuki et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 25 January 2023
                Categories
                Internal Medicine
                Neurology
                Pain Management

                one-time use,headache,migraine,calcitonin gene-related peptide-related monoclonal antibodies,adherance

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