Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial

Mulleners, Wim M.; Kim, Byung-Kun; Láinez, Miguel J. A.; Lantéri-Minet, Michel; Pozo‐Rosich, Patricia; Wang, Shufang; Tockhorn‐Heidenreich, Antje; Aurora, Sheena K.; Nichols, Richard D.; Yunes-Medina, Laura; Detke, Holland C.

doi:10.1016/s1474-4422(20)30279-9

Cited by 185 publications

(217 citation statements)

References 29 publications

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“…Among them, 50 studies were deemed ineligible for the reasons listed in Figure 1. Finally, 18 studies were included in the systematic review with network meta-analysis (Bigal et al, 2015;Goadsby et al, 2017;Sun et al, 2016;Silberstein et al, 2017;Tepper et al, 2017;Detke et al, 2018;Dodick et al, 2018a;Dodick et al, 2018b;Skljarevski et al, 2018a;Skljarevski et al, 2018b;Stauffer et al, 2018;Dodick et al, 2019;Ferrari et al, 2019;Sakai et al, 2019;Ashina et al, 2020;Lipton et al, 2020;Mulleners et al, 2020;NCT02959177, 2020).…”

Section: Search Resultsmentioning

confidence: 99%

Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis

et al. 2021

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Background: The optimal monoclonal antibody against calcitonin gene-related peptide (CGRP) for adult patients with migraine has yet to be determined. Therefore, we aimed to compare the effectiveness of different monoclonal antibodies against CGRP or its receptor for adult patients with migraine through a network meta-analysis of randomized controlled trials.Methods: We systematically searched the MEDILNE, Embase, ClinicalTrials.gov, and Cochrane Library databases for relevant publications from inception until October 30, 2020. Only randomized clinical trials of adults with migraine that assessed any calcitonin gene-related peptide monoclonal antibody and reported clinical outcomes were included. The primary outcomes were changes in monthly migraine days and treatment-emergent adverse eventsResults: We initially retrieved 2,070 publications, and ultimately, 18 randomized clinical trials totaling 8,926 patients were included. In terms of efficacy, eptinezumab (MD −1.43, 95% CrI −2.59 to −0.36), erenumab (MD −1.61, 95% CrI −2.40 to −0.84), fremanezumab (MD −2.19, 95% CrI −3.15 to −1.25), and galcanezumab (MD −2.10, 95% CrI −2.76 to −1.45) significantly reduced MMDs compared with placebo. In terms of safety, only galcanezumab increased the incidences of TEAEs (RR 1.11, 95% CrI 1.01–1.22) and serious adverse events (RR 2.95, 95% CrI 1.41–6.87) compared with placebo.Conclusion: Most drugs performed similarly and were superior to placebo in most of our analyses. Further head-to-head research on different types of CGRP monoclonal antibodies is necessary to validate the present findings.

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Section: Search Resultsmentioning

confidence: 99%

Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis

et al. 2021

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“…The population pharmacokinetic analysis, which included galcanezumab doses from 5 mg to 300 mg, absorption rate, apparent clearance, and apparent volume of distribution, was independent of the dose. No pharmacokinetic drug interactions are expected [98,[100][101][102][103][104]106,107].…”

Section: Galcanezumabmentioning

confidence: 99%

Pharmacokinetics, Pharmacodynamics and Drug–Drug Interactions of New Anti-Migraine Drugs—Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies

Szkutnik-Fiedler

2020

Pharmaceutics

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In the last few years, there have been significant advances in migraine management and prevention. Lasmiditan, ubrogepant, rimegepant and monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) are new drugs that were launched on the US pharmaceutical market; some of them also in Europe. This publication reviews the available worldwide references on the safety of these anti-migraine drugs with a focus on the possible drug–drug (DDI) or drug–food interactions. As is known, bioavailability of a drug and, hence, its pharmacological efficacy depend on its pharmacokinetics and pharmacodynamics, which may be altered by drug interactions. This paper discusses the interactions of gepants and lasmiditan with, i.a., serotonergic drugs, CYP3A4 inhibitors, and inducers or breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) inhibitors. In the case of monoclonal antibodies, the issue of pharmacodynamic interactions related to the modulation of the immune system functions was addressed. It also focuses on the effect of monoclonal antibodies on expression of class Fc gamma receptors (FcγR).

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“…Full-text screening of the remaining 20 studies resulted in an elimination of 14 studies that did not match our inclusion criteria. Finally, six studies comprising 4,023 patients were included in this systematic review and meta-analysis [5,[10][11][12][13][14]. Figure 1 shows the PRISMA flowchart.…”

Section: Literature Searchmentioning

confidence: 99%

“…Pooled results were heterogeneous (I 2 =69%; p=0.01). Heterogeneity was best resolved (I 2 =50%; p=0.11) by omitting Mulleners et al' study[13], and the overall effect size still significantly favored the galcanezumab group (MD=2.19; 95% CI [1.65, 2.73]; p<0.001). For galcanezumab 240 mg versus placebo, the overall effect size significantly favored the galcanezumab group (MD=1.97; 95% CI [1.49, 2.44]; p<0.001).…”

mentioning

confidence: 93%

Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

Abu‐Zaid

AlBatati

AlHossan

et al. 2020

Cureus

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Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial

Cited by 185 publications

References 29 publications

Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis

Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis

Pharmacokinetics, Pharmacodynamics and Drug–Drug Interactions of New Anti-Migraine Drugs—Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies

Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

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