CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta‐analysis

Han, Lin; Liu, Yao; Xiong, Hui; Hong, Peiwei

doi:10.1002/brb3.1215

Cited by 46 publications

(44 citation statements)

References 18 publications

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“…In addition to MSMDs, we performed a subgroup analysis of the above outcomes, which showed that CGRP mAbs showed signi cant e cacy in both episode migraines and chronic migraines, and the results were reliable and stable. The results were similar to those of previous meta-analyses, which included only episodic migraines or chronic migraines [14,[35][36][37].…”

Section: Discussionsupporting

confidence: 89%

Efficacy and Safety of CGRP Monoclonal Antibodies for the Prevention of Migraine Compared with Placebo: A Systematic Review and Meta-Analysis

Chen

et al. 2020

Preprint

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Background: Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are a novel class of drugs for migraine that includes erenumab, fremanezumab, galcanezumab and eptinezumab. In clinical trials, CGRP mAbs have been reported to show good efficacy in the prevention of episodic migraines or chronic migraines. Our aim was to evaluate the efficacy and safety of CGRP monoclonal antibodies in this study.Methods: We systematically searched for randomized controlled trials in the PubMed, Embase, ClinicalTrials.gov, and Cochrane Library databases. The primary outcome was overall mean change from baseline to end of treatment in the number of monthly migraine headache days (MMHDs). The secondary outcomes included 50% response rate, in the number of monthly headache days (MHDs), in the number of monthly headache hours (MHHs), and in the number of monthly acute migraine-specific medication days (MSMDs). The safety outcomes were evaluated in terms of reported adverse events. Results: Eighteen studies including 11,099 patients were included in the meta-analysis. The meta-analysis showed that CGRP mAbs exhibited a significant benefit in reducing the number of MMHDs compared to placebo (Episodic migraine: Std. MD -0.42, 95% CI -0.47 to -0.36; Chronic migraine: Std. MD -0.28, 95% CI -0.35 to -0.21). Similarly, CGRP mAbs were superior to placebo in the secondary outcomes of 50% response rate, MHDs, MHHs, and MSMDs. With respect to safety, serious adverse events and withdrawal due to adverse events were not significantly associated with CGRP mAbs. Fremanezumab was associated with a significantly higher incidence of any adverse event compared with placebo (RR 1.10, 95% CI 1.03 to 1.17). Galcanezumab was associated with significantly higher treatment-emergent adverse events compared with placebo (RR 1.11, 95% CI 1.04 to 1.17). Constipation and injection site pain were significantly higher with erenumab than placebo. Injection site erythema and injection site induration were significantly higher with fremanezumab than placebo. Upper respiratory tract infection, injection site erythema, injection site pruritus and injection site reaction were significantly higher with galcanezumab than placebo. Conclusions: This study confirms that CGRP mAbs are effective as preventive treatments for episodic migraines and chronic migraines. Adverse reactions at the injection site were associated with erenumab, fremanezumab and galcanezumab therapy. Constipation was more common with erenumab. The risk of upper respiratory tract infection was higher with galcanezumab.Systematic review registration: Our PROSPERO protocol registration number: CRD42019125928. Registered 26 November 2019.

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Section: Discussionsupporting

confidence: 89%

Efficacy and Safety of CGRP Monoclonal Antibodies for the Prevention of Migraine Compared with Placebo: A Systematic Review and Meta-Analysis

Chen

et al. 2020

Preprint

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“…All the trials indicated better outcomes and prevention of migraine with anti-CGRP medication, but the efficacy seemed to be diversified by the different interval and period of drug administration [39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64]. Though the synthesized evidences consistently confirmed that anti-CGRP had no serious adverse events reported and the effects of anti-CGRP remain controversial due to differences in follow-up and the percentage of response rate [65,66,67,68,69]. Some previous meta-analyses and systematic reviews analyzed a small amount of the trials [67,68], and one article containing a larger amount of trials showed results with large heterogeneity by estimated analysis due to the variety of features and units of different trials [65].…”

Section: Introductionmentioning

confidence: 99%

Effects of Anti-Calcitonin Gene-Related Peptide for Migraines: A Systematic Review with Meta-Analysis of Randomized Clinical Trials

Huang

Lin

et al. 2019

IJMS

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We aimed to evaluate the response rate of migraines by using anti-calcitonin gene-related peptide (anti-CGRP) for patients with migraines. We searched three main medical databases up to 29 March 2019. No restriction on language and publication time were applied. Eligible trials included randomized clinical trials investigating a 50%, 75%, and 100% response rate of migraine patients after anti-CGRP intervention. The collected data were dichotomous, and risk ratios (RRs) with a 95% confidence interval (CI) were used to present the quantitative synthesis results. The systematic review identified 16 eligible randomized clinical trials (RCTs) with 9439 patients. Eight of the 16 trials with 2516 patients reported a 50% response rate, and the pooled results showed a significant benefit from anti-CGRP. However, the effects seem to gradually reduce from the first month (RR 1.99, 95% CI 1.59 to 2.49) to the third month (RR 1.48, 95% CI 1.26 to 1.75) of treatment. The magnitude of effect was influenced by the type of anti-CGRP, according to the test for differences between subgroups (I-square = 53%). The funnel plots and Egger’s tests did not show serious small study effects in the results. In conclusion, the current evidences confirmed that anti-CGRP treatment can reduce migraine pain in the short term (within three months), but the long-term effect should be investigated in the future. Moreover, its effects may be influenced by the type and dose of anti-CGRP. Therefore, future studies should make direct comparisons among anti-CGRP medications.

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“…Recently, a series of CGRP antagonists and monoclonal antibodies against the CGRP system demonstrated therapeutic benefits in several controlled clinical trials conducted on large populations [43,69]. However, the widespread expression of CGRP and its receptors throughout the human body [70] could lead to unwanted side effects, including a cardiovascular risk [71][72][73].…”

Section: Discussionmentioning

confidence: 99%

Double-Binding Botulinum Molecule with Reduced Muscle Paralysis: Evaluation in In Vitro and In Vivo Models of Migraine

Andreou

Leese

Greco³

et al. 2021

Neurotherapeutics

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With a prevalence of 15%, migraine is the most common neurological disorder and among the most disabling diseases, taking into account years lived with disability. Current oral medications for migraine show variable effects and are frequently associated with intolerable side effects, leading to the dissatisfaction of both patients and doctors. Injectable therapeutics, which include calcitonin gene–related peptide–targeting monoclonal antibodies and botulinum neurotoxin A (BoNT/A), provide a new paradigm for treatment of chronic migraine but are effective only in approximately 50% of subjects. Here, we investigated a novel engineered botulinum molecule with markedly reduced muscle paralyzing properties which could be beneficial for the treatment of migraine. This stapled botulinum molecule with duplicated binding domain—binary toxin-AA (BiTox/AA)—cleaves synaptosomal-associated protein 25 with a similar efficacy to BoNT/A in neurons; however, the paralyzing effect of BiTox/AA was 100 times less when compared to native BoNT/A following muscle injection. The performance of BiTox/AA was evaluated in cellular and animal models of migraine. BiTox/AA inhibited electrical nerve fiber activity in rat meningeal preparations while, in the trigeminovascular model, BiTox/AA raised electrical and mechanical stimulation thresholds in Aδ- and C-fiber nociceptors. In the rat glyceryl trinitrate (GTN) model, BiTox/AA proved effective in inhibiting GTN-induced hyperalgesia in the orofacial formalin test. We conclude that the engineered botulinum molecule provides a useful prototype for designing advanced future therapeutics for an improved efficacy in the treatment of migraine.

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CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta‐analysis

Cited by 46 publications

References 18 publications

Efficacy and Safety of CGRP Monoclonal Antibodies for the Prevention of Migraine Compared with Placebo: A Systematic Review and Meta-Analysis

Efficacy and Safety of CGRP Monoclonal Antibodies for the Prevention of Migraine Compared with Placebo: A Systematic Review and Meta-Analysis

Effects of Anti-Calcitonin Gene-Related Peptide for Migraines: A Systematic Review with Meta-Analysis of Randomized Clinical Trials

Double-Binding Botulinum Molecule with Reduced Muscle Paralysis: Evaluation in In Vitro and In Vivo Models of Migraine

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