Dataset Information

One-Time Use of Galcanezumab or Fremanezumab for Migraine Prevention.

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.

SUBMITTER: Katsuki M

PROVIDER: S-EPMC9951121 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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One-Time Use of Galcanezumab or Fremanezumab for Migraine Prevention.

Katsuki Masahito M Kashiwagi Kenta K Kawamura Shin S Tachikawa Senju S Koh Akihito A

Cureus 20230125 1

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. Month ...[more]

PMID: 36843788

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Project description:BackgroundMonoclonal antibodies (mAbs) targeting the CGRP pathway are safe and efficacious therapies for the prevention of migraine. In this study we assessed the effects of discontinuation of preventive erenumab and galcanezumab treatment in patients with chronic migraine.MethodsThis retrospective pooled analysis included completers of the open-label extension study phase for the preventive treatment of chronic migraine with galcanezumab (NCT02614261; 9 months) and erenumab (NCT02174861; 12 months) in a single headache center. We compare migraine data until week 12 after open-label treatment completion, when patients did not have any pharmacological preventive medication, to study baseline values of the double-blind trial period, and to the last 4 weeks of the open-label extension. The assessment included changes in monthly migraine days, headache hours, days with severe headache and acute headache medication use.ResultsData from 16 patients after galcanezumab (n = 9) and erenumab (n = 7) open-label treatment completion were analyzed. The mean number of monthly migraine days was 18.38 ± 3.74 at baseline, and 12.19 ± 4.53 in the last 4 weeks of the open-label extension (p < 0.001). Monthly migraine days remained significantly reduced compared to baseline during the entire 12-week observation period after open-label termination (p = 0.002), with a reduction of 5.38 ± 4.92 in weeks 1-4 (p = 0.001), 4.75 ± 4.15 in weeks 5-8 (p = 0.001), and 3.93 ± 5.45 in weeks 9-12 (p = 0.014). There was no significant difference in monthly migraine days between the 12 weeks after open-label termination and the last 4 weeks of the open-label phase (p = 0.228). All other analyses revealed numerical improvement through week 12 in comparison to baseline.ConclusionsIn this small, self-selected cohort, the results indicate a therapeutic effect of monoclonal antibodies targeting the CRGP pathway in chronic migraine prevention after treatment termination up to 12 weeks.

Project description:ImportanceFremanezumab, a fully humanized monoclonal antibody that targets calcitonin gene-related peptide, may be effective for treating episodic migraine.ObjectiveTo assess the efficacy of fremanezumab compared with placebo for prevention of episodic migraine with a monthly dosing regimen or a single higher dose.Design and settingRandomized, double-blind, placebo-controlled, parallel-group trial conducted at 123 sites in 9 countries from March 23, 2016 (first patient randomized), to April 10, 2017, consisting of a screening visit, 28-day pretreatment period, 12-week treatment period, and final evaluation at week 12.ParticipantsStudy participants were aged 18 to 70 years with episodic migraine (6-14 headache days, with at least 4 migraine days, during 28-day pretreatment period). Patients who had previous treatment failure with 2 classes of migraine-preventive medication were excluded.InterventionsPatients were randomized 1:1:1 to receive subcutaneous monthly dosing of fremanezumab (n = 290; 225 mg at baseline, week 4, and week 8); a single higher dose of fremanezumab, as intended to support a quarterly dose regimen (n = 291; 675 mg of fremanezumab at baseline; placebo at weeks 4 and 8); or placebo (n = 294; at baseline, week 4, and week 8).Main outcomes and measuresThe primary end point was mean change in mean number of monthly migraine days during the 12-week period after the first dose.ResultsAmong 875 patients who were randomized (mean age, 41.8 [SD, 12.1] years; 742 women [85%]), 791 (90.4%) completed the trial. From baseline to 12 weeks, mean migraine days per month decreased from 8.9 days to 4.9 days in the fremanezumab monthly dosing group, from 9.2 days to 5.3 days in the fremanezumab single-higher-dose group, and from 9.1 days to 6.5 days in the placebo group. This resulted in a difference with monthly dosing vs placebo of -1.5 days (95% CI, -2.01 to -0.93 days; P < .001) and with single higher dosing vs placebo of -1.3 days (95% CI, -1.79 to -0.72 days; P < .001). The most common adverse events that led to discontinuation were injection site erythema (n = 3), injection site induration (n = 2), diarrhea (n = 2), anxiety (n = 2), and depression (n = 2).Conclusions and relevanceAmong patients with episodic migraine in whom multiple medication classes had not previously failed, subcutaneous fremanezumab, compared with placebo, resulted in a statistically significant 1.3- to 1.5-day reduction in the mean number of monthly migraine days over a 12-week period. Further research is needed to assess effectiveness against other preventive medications and in patients in whom multiple preventive drug classes have failed and to determine long-term safety and efficacy.Trial registrationclinicaltrials.gov Identifier: NCT02629861.

Project description:ImportanceMigraine is a disabling neurological disease characterized by severe headache attacks. Treatment options reduce migraine frequency for many patients, but adverse effects lead to discontinuation in many patients.ObjectiveTo demonstrate that galcanezumab is superior to placebo in the prevention of episodic migraine with or without aura.Design, setting, and participantsThe EVOLVE-1 (Evaluation of LY2951742 in the Prevention of Episodic Migraine 1) trial was a double-blind, randomized, placebo-controlled (January 11, 2016, to March 22, 2017) trial comparing galcanezumab (120 mg and 240 mg) vs placebo. Patients received treatments once monthly for 6 months (subcutaneous injection via prefilled syringe) and were followed up for 5 months after their last injection. It was a multicenter, clinic-based study involving 90 sites in North America. Participants in the study were adults (aged 18 to 65 years) with at least a 1-year history of migraine, 4 to 14 migraine headache days per month and a mean of at least 2 migraine attacks per month within the past 3 months, and were diagnosed prior to age 50 years. During the study, no other preventive medications were allowed. A total of 1671 patients were assessed; 809 did not meet study entry or baseline criteria, and 858 were included in the intent-to-treat population.InterventionsPatients were randomized (2:1:1) to monthly placebo, galcanezumab, 120 mg, and galcanezumab, 240 mg.Main outcomes and measuresThe primary outcome was overall mean change from baseline in the number of monthly migraine headache days during the treatment period. Secondary measures included at least 50%, at least 75%, and 100% reduction in monthly migraine headache days, migraine headache days with acute medication use, and scores from the Migraine-Specific Quality of Life questionnaire, Patient Global Impression of Severity, and Migraine Disability Assessment. Treatment-emergent adverse events and serious adverse events were reported.ResultsOf the 1671 patients assessed, 858 (mean age, 40.7 years; 718 women [83.7%]) met study entry criteria and received at least 1 dose of investigational product. The primary objective was met for both galcanezumab doses; treatment with galcanezumab significantly reduced monthly migraine headache days (both P < .001) by 4.7 days (120 mg) and 4.6 days (240 mg) compared with placebo (2.8 days). All key secondary objectives were also significant after multiplicity adjustment. There were no meaningful differences between 120-mg and 240-mg doses of galcanezumab on measures of efficacy. Completion rate during treatment was high (81.9%; n = 718), and the incidence of discontinuation owing to adverse events was less than 5% across all treatment groups.Conclusions and relevanceGalcanezumab 120-mg and 240-mg monthly injections provided clinical benefits and improved functioning. The incidence rate of adverse events was low, demonstrating the favorable tolerability profile of galcanezumab.Trial registrationClinicalTrials.gov Identifier: NCT02614183.

Project description:IntroductionIn the context of migraine preventive therapy, new therapeutic modalities such as monoclonal antibodies targeting the calcitonin gene-related peptide receptor (CGRP) or ligand offer potential advantages over traditional preventive treatments.MethodsThis systematic literature review gathered recent real-world evidence from Spain on the use of galcanezumab, a CGRP-targeting treatment, in migraine patients. The review included observational studies in English or Spanish, published from August 2020 to August 2023, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Cochrane guidelines.ResultsA total of 29 publications involving 2,592 Spanish adult patients were identified, reporting relevant information on clinical outcomes (treatment effectiveness and safety), treatment persistence and patterns (switching from other therapies and time to discontinuation and restart), and patient-reported outcomes (including satisfaction with treatment). The most frequently reported variables were related to the clinical effectiveness of galcanezumab, demonstrating a significant reduction in monthly migraine days and monthly headache days. Additionally, adverse impact of headache per HIT-6 (Headache Impact Test-6) and disability per MIDAS (Migraine Disability Assessment) also improve. Studies also showed that up to 12-month persistence to galcanezumab ranged from 76.8 to 59.8%. Serious adverse events were rare. None of the publications included health-related quality of life data, either generic or migraine-specific. One study highlighted that galcanezumab treatment would offer high patient satisfaction for people with migraine.ConclusionThe real-world evidence on the use of galcanezumab treatment among the Spanish population shows that its effectiveness, persistence, safety, and impact on health burden align with findings from clinical trials and observational studies conducted in other countries. Future studies should incorporate health-related quality of life data to gain a more holistic understanding of this treatment's impact.

Project description:ImportanceGalcanezumab (LY2951742), a monoclonal antibody against calcitonin gene-related peptide (CGRP), is one of a novel class of new medicines for migraine prevention.ObjectiveTo assess whether at least 1 dose of galcanezumab was superior to placebo for episodic migraine prevention.Design, setting, and participantsA randomized clinical trial was conducted in the United States (July 7, 2014, to August 19, 2015) in clinics of 37 licensed physicians with a specialty including, but not limited to, psychiatry, neurology, internal medicine, and primary care. Subcutaneous injections of galcanezumab, 5, 50, 120, or 300 mg, or placebo were given monthly during the 3-month treatment period. A total of 936 patients were assessed; 526 did not meet study entry or baseline criteria and 410 patients were randomly assigned to receive placebo or galcanezumab. Analyses were conducted on an intent-to-treat population, which included all patients who were randomized and received at least 1 dose of study drug.InterventionsShort-term migraine treatments were allowed as needed except for opioids or barbiturates.Main outcomes and measuresTo determine if at least 1 of the 4 doses of galcanezumab tested was superior to placebo for migraine prevention measured by the mean change from baseline in the number of migraine headache days 9 weeks to 12 weeks after randomization.ResultsOf the 936 patients assessed, 410 met entry criteria (aged 18-65 years with 4-14 migraine headache days per month and migraine onset prior to age 50 years) and were randomized to receive placebo or galcanezumab. For the primary end point, galcanezumab, 120 mg, significantly reduced migraine headache days compared with placebo (99.6% posterior probability -4.8 days; 90% BCI, -5.4 to -4.2 days vs 95% superiority threshold [Bayesian analysis] -3.7 days; 90% BCI, -4.1 to -3.2 days). Adverse events reported by 5% or more of patients in at least 1 galcanezumab dose group and more frequently than placebo included injection-site pain, upper respiratory tract infection, nasopharyngitis, dysmenorrhea, and nausea.Conclusions and relevanceMonthly subcutaneous injections of galcanezumab, both 120 mg and 300 mg, demonstrated efficacy (repeated-measures analysis) for the preventive treatment of migraine and support further development in larger phase 3 studies. All dosages were safe and well tolerated for the preventive treatment of episodic migraine.Trial registrationclinicaltrials.gov Identifier: NCT02163993.

Dataset Information

One-Time Use of Galcanezumab or Fremanezumab for Migraine Prevention.

Publications

One-Time Use of Galcanezumab or Fremanezumab for Migraine Prevention.

Similar Datasets

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