scholarly journals CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta-analysis

2019 ◽  
Vol 9 (2) ◽  
pp. e01215 ◽  
Author(s):  
Lin Han ◽  
Yao Liu ◽  
Hai Xiong ◽  
Peiwei Hong
2021 ◽  
Vol 12 ◽  
Author(s):  
Yao-Yao Chen ◽  
Xiao-Qian Ye ◽  
Tai-Chun Tang ◽  
Tian-Wei She ◽  
Min Chen ◽  
...  

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.


2019 ◽  
Author(s):  
Hong Deng ◽  
Gai-gai Li ◽  
Hao Nie ◽  
Yang-yang Feng ◽  
Guang-yu Guo ◽  
...  

Abstract Background: Migraine is one of the most common neurological disorders that leads to disabilities. However, the conventional drug therapy for migraine is unsatisfactory. Therefore, this meta-analysis aimed to evaluate the efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibody (CGRP mAb) for the preventive treatment of episodic migraine, and provide high-quality clinical evidence for migraine therapy. Methods: A systematic electronic database search was conducted to identify the potentially relevant studies. Two independent authors performed data extraction and quality appraisal. Mean difference (MD) and risk ratio (RR) were pooled for continuous and dichotomous data, respectively. The significance levels, weighted effect sizes and homogeneity of variance were calculated. Results: Eleven high-quality randomized control trials that collectively included 4402 patients were included in this meta-analysis. Compared to placebo group, CGRP mAb therapy resulted in a reduction of monthly migraine days [weighted mean difference (WMD) = −1.44, 95% CI = (−1.68,−1.19)] and acute migraine-specific medication days [WMD = −1.28, 95% CI = (−1.66,−0.90)], with an improvement in 50% responder rate [RR = 1.51, 95% CI =(1.37,1.66)]. In addition, the adverse events (AEs) and treatment withdrawal rates due to AEs were not significantly different between CGRP mAb and placebo groups. Similar efficacy and safety results were obtained for erenumab, fremanezumab, and galcanezumab in subgroup analysis. Conclusions: The current body of evidence reveals that CGRP mAb is an effective and safe preventive treatment for episodic migraine. Keywords: calcitonin gene-related peptide monoclonal antibody, episodic migraine, efficacy, safety, meta-analysis


Author(s):  
Diego Swerts ◽  
Mario Peres

BackgroundThe preventive management of headaches has different routes of administration (Oral, Subcutaneous, Intravenous, and Application to the head). Placebo effect is a powerful determinant of health outcomes in several disorders, Meta-analysis of clinical trials in pain conditions such as fibromyalgia and osteoarthritis shows placebo effect can contribute to up to 75% of the overall treatment effect. The placebo effect on different routes of administration is poorly described. Thus, we seek to analyze in this meta-analysis the difference between the routes of administration in the placebo effect in the management of chronic migraine.MethodsWe conducted a meta-analysis with 8 randomized , double blind, Placebo Clinical trials, with 2498 persons. Men and Women over 18 who suffer from chronic migraine (over 15 migraine episodes per month for 3 months) without associated comorbidities. We compared those who received placeboadministered agent for preventive treatment of chronic migraine SC, EV or oral against those who received placebo-administered head injection. The primary outcome was reduction in the number of days with migraine in the month assessed at 12 weeks of treatment compared with baseline.ResultsOur study showed that placebo responses were greater when botulinum toxin type A was applied in the head, followed by intravenous injection of an anti-CGRP monoclonal antibody eptinezumab. Oral topiramate and subcutaneous Mabs had no difference, being inferior to other routes of administration. Also, our analysis shows that much of the effect of drugs in the treatment of migraine is still due to the high placebo effect, which contributes about 80% of the therapeutic gain.ConclusionsAdministration route affects placebo responses in CM preventive treatment but not therapeutic gain as much. Elucidating the underlying mechanisms that mediate placebo effect in migraine treatment is beneficial to clinical practice and drug development.


2020 ◽  
Author(s):  
Hui Zheng ◽  
Shi-Le Huang ◽  
Yao-Yao Chen ◽  
Tai-Chun Tang ◽  
Di Qin ◽  
...  

Abstract Background Botulinum neurotoxin A (BoNT-A) was the primary choice for preventive treatment of chronic migraine. Topiramate and acupuncture showed promising effect for the condition, but their effectiveness relative to BoNT-A was rarely studied. We aimed to perform a network meta-analysis to compare the effectiveness and acceptability between BoNT-A, topiramate, and acupuncture.Methods We searched OVID Medline, Embase, the Cochrane register of controlled trials (CENTRAL), the Chinese Clinical Trial Register, and clinicaltrials.gov for randomized controlled trials (RCTs) that compared BoNT-A, topiramate, and acupuncture with any of them or placebo in the preventive treatment of chronic migraine. Two independent reviewers screened RCTs, extracted data, and assessed risk of bias. A network meta-analysis was performed by using a frequentist approach and a random-effects model. The primary outcomes were reduction in monthly headache days and monthly migraine days at week 12. Acceptability was assessed by adverse event rate. The effect size of the primary outcomes was measured by using standard mean difference (SMD).Results We included 15 RCTs (n = 2545). Eleven RCTs were at low risk of bias. The network meta-analyses (n = 2061) showed that acupuncture (2061 participants; SMD − 1.61, 95%CI -2.35 to -0.87) and topiramate(582 participants; SMD − 0.4, 95%CI -0.75 to -0.04) ranked the most effective in the reduction of monthly headache days and migraine days, respectively; but they were not significantly superior over BoNT-A. Topiramate caused the most treatment-related adverse events and the highest rate of dropouts owing to adverse events.Conclusions Topiramate and acupuncture were not superior over BoNT-A. In terms of acceptability and accessibility of treatments, BoNT-A was still the primary choice for preventive treatment of chronic migraine.


2021 ◽  
Vol 12 ◽  
Author(s):  
Jiajie Lu ◽  
Quanquan Zhang ◽  
Xiaoning Guo ◽  
Wei Liu ◽  
Chunyang Xu ◽  
...  

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.


2020 ◽  
Author(s):  
Lindsay M Frerichs ◽  
Deborah I Friedman

Migraine is a common and disabling disorder affecting approximately 1.02 billion people worldwide. Calcitonin gene-related peptide (CGRP) has been identified as playing an important role in the pathophysiology of migraine and several migraine-specific therapies targeting the CGRP ligand or its receptor have been approved since 2018 for the acute and preventive treatment of migraine. This review focuses on the pharmacology, clinical efficacy and safety/tolerability of galcanezumab, an anti-CGRP monoclonal antibody approved for the prevention of migraine.


Author(s):  
Hui Zheng ◽  
Shi‐Le Huang ◽  
Yao‐Yao Chen ◽  
Tai‐Chun Tang ◽  
Di Qin ◽  
...  

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