Placebo response with subcutaneous injections in calcitonin gene-related peptide receptor monoclonal antibody migraine preventative trials – A systematic review and meta-analysis

Background: The majority of CGRP monoclonal antibodies for migraine prevention are administered subcutaneously. Therefore, we attempted to calculate the pooled placebo response with subcutaneous placebo injections in this systematic review and meta-analysis. Methods: We identified 16 randomized cont...

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Published inCephalalgia reports Vol. 5
Main Authors Gorantla, Sasikanth, Gopireddy, Murali Mohan Reddy, Bhat, Archana, Ayyasamy, Lavanya, Jaishankar, Sarath Kumar Jaganathan, Kherallah, Bassil, Nersesyan, Hrachya
Format Journal Article
LanguageEnglish
Published London, England SAGE Publications 2022
Sage Publications Ltd
SAGE Publishing
Subjects
Calcitonin
Calcitonin gene-related peptide
Clinical trials
Headache
Meta-analysis
Migraine
Monoclonal antibodies
Placebos
Systematic review
CGRP antagonists
placebo response
subcutaneous injections
migraine headache
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Abstract Background: The majority of CGRP monoclonal antibodies for migraine prevention are administered subcutaneously. Therefore, we attempted to calculate the pooled placebo response with subcutaneous placebo injections in this systematic review and meta-analysis. Methods: We identified 16 randomized controlled trials that met our inclusion and exclusion criteria through a comprehensive search in five electronic databases (PubMed Central, EMBASE, MEDLINE, Cochrane library and clinicaltrials.gov). The risk of bias was assessed for all included studies. Random effects model was used to calculate pooled mean monthly migraine days and 50% response rates. Results: A total of 4240 subjects were included from 16 studies in this meta-analysis. The pooled mean monthly migraine day reduction with subcutaneous placebo injections was 2.15 (95% CI: 1.60–2.69). The pooled proportion of patients achieving a 50% reduction in mean monthly headache days was 26% (95% CI: 20%–31%). Placebo response accounted for more than 50% of therapeutic gain in our study. Conclusion: A substantial placebo response was noted with subcutaneous injections in migraine CGRP monoclonal antibody clinical trials. This meta-analysis may serve as a reference point to calculate sample size in clinical trials using subcutaneous interventions for migraine prevention. We registered our study at PROSPERO (CRD42020185300).
AbstractList Background: The majority of CGRP monoclonal antibodies for migraine prevention are administered subcutaneously. Therefore, we attempted to calculate the pooled placebo response with subcutaneous placebo injections in this systematic review and meta-analysis. Methods: We identified 16 randomized controlled trials that met our inclusion and exclusion criteria through a comprehensive search in five electronic databases (PubMed Central, EMBASE, MEDLINE, Cochrane library and clinicaltrials.gov ). The risk of bias was assessed for all included studies. Random effects model was used to calculate pooled mean monthly migraine days and 50% response rates. Results: A total of 4240 subjects were included from 16 studies in this meta-analysis. The pooled mean monthly migraine day reduction with subcutaneous placebo injections was 2.15 (95% CI: 1.60–2.69). The pooled proportion of patients achieving a 50% reduction in mean monthly headache days was 26% (95% CI: 20%–31%). Placebo response accounted for more than 50% of therapeutic gain in our study. Conclusion: A substantial placebo response was noted with subcutaneous injections in migraine CGRP monoclonal antibody clinical trials. This meta-analysis may serve as a reference point to calculate sample size in clinical trials using subcutaneous interventions for migraine prevention. We registered our study at PROSPERO (CRD42020185300).
Background: The majority of CGRP monoclonal antibodies for migraine prevention are administered subcutaneously. Therefore, we attempted to calculate the pooled placebo response with subcutaneous placebo injections in this systematic review and meta-analysis. Methods: We identified 16 randomized controlled trials that met our inclusion and exclusion criteria through a comprehensive search in five electronic databases (PubMed Central, EMBASE, MEDLINE, Cochrane library and clinicaltrials.gov). The risk of bias was assessed for all included studies. Random effects model was used to calculate pooled mean monthly migraine days and 50% response rates. Results: A total of 4240 subjects were included from 16 studies in this meta-analysis. The pooled mean monthly migraine day reduction with subcutaneous placebo injections was 2.15 (95% CI: 1.60–2.69). The pooled proportion of patients achieving a 50% reduction in mean monthly headache days was 26% (95% CI: 20%–31%). Placebo response accounted for more than 50% of therapeutic gain in our study. Conclusion: A substantial placebo response was noted with subcutaneous injections in migraine CGRP monoclonal antibody clinical trials. This meta-analysis may serve as a reference point to calculate sample size in clinical trials using subcutaneous interventions for migraine prevention. We registered our study at PROSPERO (CRD42020185300).
Author Ayyasamy, Lavanya
Gorantla, Sasikanth
Jaishankar, Sarath Kumar Jaganathan
Kherallah, Bassil
Gopireddy, Murali Mohan Reddy
Bhat, Archana
Nersesyan, Hrachya
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CitedBy_id crossref_primary_10_1021_acs_molpharmaceut_4c01166
crossref_primary_10_1080_14712598_2024_2354386
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Keywords CGRP antagonists
placebo response
subcutaneous injections
migraine headache
Language English
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Snippet Background: The majority of CGRP monoclonal antibodies for migraine prevention are administered subcutaneously. Therefore, we attempted to calculate the pooled...
Background: The majority of CGRP monoclonal antibodies for migraine prevention are administered subcutaneously. Therefore, we attempted to calculate the pooled...
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SubjectTerms Calcitonin
Calcitonin gene-related peptide
Clinical trials
Headache
Meta-analysis
Migraine
Monoclonal antibodies
Placebos
Systematic review
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Title Placebo response with subcutaneous injections in calcitonin gene-related peptide receptor monoclonal antibody migraine preventative trials – A systematic review and meta-analysis
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Volume 5
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