scholarly journals 4CPS-132 Indirect treatment comparison of anti-calcitonin gene related peptide pathway antibodies in chronic migraine

2020 ◽  
Author(s):  
MDP Briceño Casado ◽  
S Fenix-Caballero ◽  
MD Gil-Sierra ◽  
M Dominguez Cantero ◽  
EJ Alegre-Del Rey
Keyword(s):  
Chronic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Related Peptide ◽  
Calcitonin Gene ◽  
Indirect Treatment

scholarly journals Calcitonin Gene–Related Peptide Monoclonal Antibody Versus Botulinum Toxin for the Preventive Treatment of Chronic Migraine: Evidence From Indirect Treatment Comparison

2021 ◽  
Vol 12 ◽  
Author(s):  
Jiajie Lu ◽  
Quanquan Zhang ◽  
Xiaoning Guo ◽  
Wei Liu ◽  
Chunyang Xu ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Botulinum Toxin ◽  
Adverse Events ◽  
Chronic Migraine ◽  
Preventive Treatment ◽  
Efficacy And Safety ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Calcitonin Gene ◽  
Indirect Treatment

Background: The previously approved botulinum toxin and nowadays promising calcitonin gene-related peptide (CGRP) monoclonal antibody have shown efficacy for preventing chronic migraine (CM). However, there is no direct evidence for their relative effectiveness and safety. In this study, we conducted an indirect treatment comparison to compare the efficacy and safety of CGRP monoclonal antibody with botulinum toxin for the preventive treatment of chronic migraine.Methods: Up to August 31, 2020, we systematically searched PubMed, Embase, and Cochrane Library Central Register of Controlled Trials (Central). Weighted mean difference (WMD) and relative risk (RR) were used to evaluate clinical outcomes. Indirect treatment comparison (ITC) software was used to conduct indirect treatment comparison.Results: Ten studies were pooled with 6,325 patients in our meta-analysis. Both botulinum toxin and CGRP monoclonal antibody demonstrated favorable efficacy in the change of migraine days, headache days, HIT-6 score, and 50% migraine responder rate compared with placebo. In indirect treatment comparison, CGRP monoclonal antibody was superior to botulinum toxin in the frequency of acute analgesics intake (WMD = −1.31, 95% CI: −3.394 to 0.774, p = 0.02113), the rate of treatment-related adverse events (AEs) (RR = 0.664, 95% CI: 0.469 to 0.939, p = 0.04047), and the rate of treatment-related serious adverse events (RR = 0.505, 95% CI: 0.005 to 46.98, p < 0.001).Conclusion: For chronic migraine patients, CGRP monoclonal antibody was slightly better than botulinum toxin in terms of efficacy and safety. In the future, head-to-head trials would be better to evaluate the efficacy and safety between different medications in the prevention of chronic migraine.

Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial

Cephalalgia ◽  
2019 ◽  
Vol 39 (9) ◽  
pp. 1075-1085 ◽  
Author(s):  
David W Dodick ◽  
Richard B Lipton ◽  
Stephen Silberstein ◽  
Peter J Goadsby ◽  
David Biondi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Migraine ◽  
Development Program ◽  
Calcitonin Gene Related Peptide ◽  
Electronic Diary ◽  
Phase 3 ◽  
Pivotal Phase ◽  
Double Blind ◽  
Related Peptide ◽  
Calcitonin Gene

Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology. We evaluated eptinezumab, an intravenous (IV) anti-calcitonin gene-related peptide monoclonal antibody, for the prevention of chronic migraine. Objective To determine the safety, tolerability, and effectiveness of four dose levels of eptinezumab and to inform the phase 3 development program. Methods This was a phase 2b, parallel-group, double-blind, randomized, placebo-controlled, dose-ranging clinical trial. Men and women (N = 616) aged 18–55 years were included if they had a diagnosis of chronic migraine, with onset at age ≤35 years and history of chronic migraine ≥1 year. During the 28-day screening period, patients must have had ≥15 headache days, including ≥8 migraine days, with ≥5 migraine attacks as recorded in the electronic diary. Patients were assigned in a 1:1:1:1:1 ratio to eptinezumab 300, 100, 30, 10 mg or placebo, administered as a single IV infusion. The primary endpoint was the percentage of patients with a ≥75% decrease in monthly migraine days over weeks 1–12 compared with the 28-day screening period. Results The ≥75% migraine responder rates over weeks 1–12 for eptinezumab 300, 100, 30, and 10 mg were 33.3%, 31.4%, 28.2%, and 26.8%, respectively, versus 20.7% for placebo ( p = 0.033, 0.072, 0.201, 0.294 vs. placebo). Secondary efficacy endpoints (e.g. ≥50% responder rate, change from baseline in frequency of migraine/headache days, and percentage of severe migraines) had results favoring the three higher eptinezumab doses versus placebo. Eptinezumab was well tolerated and adverse event rates were similar to placebo. Conclusions The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention. Trial Registration ClinicalTrials.gov identifier: NCT02275117.

Calcitonin gene-related peptide levels in tear fluid are elevated in migraine patients compared to healthy controls

Cephalalgia ◽  
2019 ◽  
Vol 39 (12) ◽  
pp. 1535-1543 ◽  
Author(s):  
Katharina Kamm ◽  
Andreas Straube ◽  
Ruth Ruscheweyh
Keyword(s):  
Chronic Migraine ◽  
Trigeminal Nerve ◽  
Plasma Concentrations ◽  
Calcitonin Gene Related Peptide ◽  
Tear Fluid ◽  
Direct Access ◽  
Healthy Controls ◽  
Significant Group ◽  
Related Peptide ◽  
Calcitonin Gene

Background Calcitonin gene-related peptide (CGRP) released from trigeminal nerve fibres indicates trigeminal activation and has a key role in migraine pathophysiology. The trigeminal nerve directly innervates the eye. Therefore, in this study, we compared Calcitonin gene-related peptide in tear fluid of migraine patients and healthy controls. Methods Calcitonin gene-related peptide concentrations in tear fluid and plasma of 48 episodic and 45 chronic migraine patients and 48 controls were assessed using ELISA. Results Calcitonin gene-related peptide levels in tear fluid (0.94 ± 1.11 ng/ml) were ∼140 times higher than plasma concentrations (6.81 ± 4.12 pg/ml). Tear fluid CGRP concentrations were elevated in interictal migraine patients (1.10 ± 1.27 ng/ml, n = 49) compared to controls (0.75 ± 0.80 ng/ml, p = 0.022). There was no difference in tear fluid CGRP levels between interictal episodic and chronic migraine patients (episodic: 1.09 ± 1.47 ng/ml, n = 30 and chronic: 1.10 ± 0.89 ng/ml, n = 19) and no correlation of tear fluid CGRP levels with headache frequency in interictal patients (rho = 0.062, p = 0.674). Unmedicated ictal migraine patients had even more elevated tear fluid CGRP levels than interictal migraine patients (1.92 ± 1.84 ng/ml, n = 13, p = 0.102), while medicated ictal migraine patients had lower levels (0.56 ± 0.47 ng/ml, n = 25, p = 0.011 compared to interictal patients), which were undistinguishable from controls ( p = 0.609). In contrast to tear fluid, no significant group differences were found in plasma CGRP levels. Conclusion To the best of our knowledge, this study shows, for the first time, increased CGRP tear fluid levels in migraine patients compared to healthy subjects. Detection of calcitonin gene-related peptide in tear fluid is non-invasive, and likely allows a more direct access to CGRP released from the trigeminal nerve than plasma sampling.

scholarly journals Calcitonin Gene-Related Peptide Monoclonal Antibodies Versus Botulinum Neurotoxin a in the Preventive Treatment of Chronic Migraine: An Adjusted Indirect Treatment Comparison Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Yao-Yao Chen ◽  
Xiao-Qian Ye ◽  
Tai-Chun Tang ◽  
Tian-Wei She ◽  
Min Chen ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Chronic Migraine ◽  
Botulinum Neurotoxin ◽  
Meta Analysis ◽  
Preventive Treatment ◽  
Calcitonin Gene Related Peptide ◽  
Controlled Trials ◽  
Botulinum Neurotoxin A ◽  
Related Peptide ◽  
Calcitonin Gene

Purpose: Calcitonin gene-related peptide monoclonal antibodies (CGRPmAbs) are new agents approved by the US Food and Drug Administration for preventive treatment of chronic migraine. Comparison between CGRPmAbs and previously approved Botulinum neurotoxin A (BoNT-A) will inform optimal preventive treatment of chronic migraine, but head-to-head trials are lacking. We therefore aimed to perform adjusted indirect comparison between CGRPmAbs and BoNT-A through a meta-analysis.Methods: OVID MEDLINE, EMBASE and the Cochrane central register of controlled trials, clinical registries, and government websites were searched from inception to September 2019. Randomized controlled trials comparing CGRPmAbs or BoNT-A with placebo in the preventive treatment of chronic migraine were included. The primary outcomes were headache days and migraine days measured at week 12. Data were synthesized by using a frequentist approach; and the treatments were ranked by P-score.Results: We included 10 trials (n = 4,678) after screening 1049 candidates. Six trials were with low risk of bias. Fremanezumab had an effect similar to BoNT-A in the reduction of headache days at week 12 (standard mean difference [SMD] 0.08, 95%CI -0.55 to -0.7). Galcanezumab reduced more migraine days than BoNT-A at week 12 (SMD, -0.94, 95%CI −1.24 to −0.63); fremanezumab showed similar findings (SMD, −0.55, 95%CI −0.85 to −0.24). Galcanezumab and fremanezumab had better effect in mitigating headache impact at week 12. CGRPmAbs and BoNT-A had similar adverse event rate.Conclusion: CGRPmAbs and BoNT-A had similar effect in the preventive treatment of chronic migraine. BoNT-A might be preferentially selected owing to its cost-effectiveness profiles. Further studies with direct comparison of the two treatments are warranted.

Interictal levels of calcitonin gene related peptide in gingival crevicular fluid of chronic migraine patients

2018 ◽  
Vol 39 (7) ◽  
pp. 1217-1223 ◽  
Author(s):  
Reza Fekrazad ◽  
Ahmadreza Sardarian ◽  
Kamran Azma ◽  
Masoumeh Karami ◽  
Afshin Borhani-Haghighi ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Gingival Crevicular Fluid ◽  
Calcitonin Gene Related Peptide ◽  
Related Peptide ◽  
Calcitonin Gene ◽  
Crevicular Fluid
Sign in / Sign up

Export Citation Format

Share Document