Comparative Effectiveness and Tolerability of the Pharmacology of Monoclonal Antibodies Targeting the Calcitonin Gene-Related Peptide and Its Receptor for the Prevention of Chronic Migraine: a Network Meta-analysis of Randomized Controlled Trials

2021 ◽  
Author(s):  
Chun-Pai Yang ◽  
Bing-Yan Zeng ◽  
Ching-Mao Chang ◽  
Po-Hsuan Shih ◽  
Cheng-Chia Yang ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Randomized Controlled Trials ◽  
Chronic Migraine ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Calcitonin Gene Related Peptide ◽  
Controlled Trials ◽  
Related Peptide ◽  
Randomized Controlled ◽  
Calcitonin Gene

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.

Safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine – a meta-analysis of randomized controlled trials

Cephalalgia ◽  
2019 ◽  
Vol 39 (9) ◽  
pp. 1164-1179 ◽  
Author(s):  
Da Xu ◽  
Deng Chen ◽  
Li-na Zhu ◽  
Ge Tan ◽  
Hai-jiao Wang ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Injection Site ◽  
Meta Analysis ◽  
Peptide Binding ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Serious Adverse Events ◽  
Related Peptide ◽  
Calcitonin Gene

Aim To systematically evaluate the safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies from the results of randomized controlled trials. Methods Online databases were searched on calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine. Overall withdrawal, withdrawal due to adverse events, adverse events, serious adverse events and specific adverse events were extracted from the included studies. A meta-analysis was performed with Revman 5.3.0 software. Results Ten studies that investigated four drugs (galcanezumab, erenumab, fremanezumab and eptinezumab) with 5817 participants were included in this study. Serious adverse events, overall withdrawals, withdrawal due to adverse events and any adverse events were not significantly associated with monoclonal antibody treatment. Injection site pain and erythema were significantly higher in the calcitonin-gene-related peptide binding monoclonal antibodies treatment group than in the placebo group. The rates of serious adverse events were significantly higher in the galcanezumab 120 mg group. Injection site erythema was associated with galcanezumab 120 mg and 240 mg. Injection site pain and nasopharyngitis were associated with galcanezumab 150 mg and 5 mg, respectively. Overall adverse events were significantly higher with erenumab 70 mg and 140 mg. Treatment-related adverse events were significantly higher with fremanezumab 225 mg/month and 675 mg/quarter. Conclusions This study provides data on the safety and tolerability profiles of calcitonin-gene-related peptide binding monoclonal antibodies and confirms their potential use as preventive treatments for episodic migraine. In addition to the acceptable withdrawal rates, serious adverse events were rare, and the severity of most adverse events was mild to moderate. Injection site reaction may be the major adverse event associated with galcanezumab.

Comparative effectiveness of systemic treatments for metastatic castration-sensitive prostate cancer: A parametric survival network meta-analysis of randomized controlled trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5532-5532
Author(s):  
Lin Wang ◽  
Channing Judith Paller ◽  
Hwanhee Hong ◽  
Anthony De Felice ◽  
Caleb Alexander ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trials ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Time Varying ◽  
Randomized Controlled ◽  
Systemic Treatments ◽  
Parametric Survival

5532 Background: Treatment decision-making for metastatic castration-sensitive prostate cancer (mCSPC) is complicated by the unclear comparative effectiveness and widely varying costs of competing strategies. Objective: To compare the effectiveness and safety of systemic treatments for mCSPC. Methods: We searched bibliographic databases, regulatory documents, and trial registries for randomized controlled trials testing active drugs added to androgen deprivation therapy (ADT) for mCSPC. We used Cochrane risk-of-bias tool (version 2) to assess trial quality and Bayesian network meta-analysis (NMA) to estimate the relative effects of competing treatments. In addition to combing published time-invariant hazard ratios (HRs), we reconstructed survival data from Kaplan Meier curves to enable parametric survival NMA that allows time-varying HR. Results: Seven trials with 7,236 patients were included comparing six treatments (Table). Risk of bias is a concern for trials with open label (N=4), missing data (N=3), or unprespecified analysis (N=3). Ordered from the most to the least effective, treatments significantly improving overall survival (OS) include abiraterone acetate, apalutamide, and docetaxel; treatments significantly improving radiographic progression-free survival (rPFS) include enzalutamide, abiraterone, apalutamide, and docetaxel. (see HRs in Table) Allowing time-varying HR produced similar treatment rankings. Serious adverse events (SAE) were substantially increased for docetaxel (odds ratio [OR] 104.17, 95% credible interval [CI] 24.85-1012.32) and slightly increased for abiraterone (OR 1.42, 95% CI 1.11-1.83). Conclusions: Abiraterone provided the largest OS benefit with slightly increased risk of SAE. Apalutamide offered comparable OS benefit with abiraterone without increasing SAE risk. Although enzalutamide delayed rPFS to the greatest extent, longer follow-up is needed to examine its OS benefit. [Table: see text]

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