Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic Migraine
OnabotulinumtoxinA, targeting the CGRP machinery, has been approved for the last two decades for chronic migraine prevention. The recently approved monoclonal antibodies (mAbs) directed towards the calcitonin gene-related peptide (CGRP) pathway open a new age for chronic migraine control. However, s...
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| Format: | Article |
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MDPI AG
2022-08-01
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| Series: | Toxins |
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| Online Access: | https://www.mdpi.com/2072-6651/14/8/529 |
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| author | Damiana Scuteri Paolo Tonin Pierluigi Nicotera Marilù Vulnera Giuseppina Cristina Altieri Assunta Tarsitano Giacinto Bagetta Maria Tiziana Corasaniti |
| author_facet | Damiana Scuteri Paolo Tonin Pierluigi Nicotera Marilù Vulnera Giuseppina Cristina Altieri Assunta Tarsitano Giacinto Bagetta Maria Tiziana Corasaniti |
| author_sort | Damiana Scuteri |
| collection | DOAJ |
| description | OnabotulinumtoxinA, targeting the CGRP machinery, has been approved for the last two decades for chronic migraine prevention. The recently approved monoclonal antibodies (mAbs) directed towards the calcitonin gene-related peptide (CGRP) pathway open a new age for chronic migraine control. However, some 40% patients suffering from chronic migraine is still resistant to treatment. The aim of this work is to answer the following PICOS (participants intervention comparator outcome study design) question: Is there evidence of efficacy and safety of the combined administration of anti-CGRP mAbs and onabotulinumtoxinA in chronic migraine? A systematic review and meta-analysis [Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 recommendations] was made up to 19 April 2022. The results are encouraging: the combined treatment proved to afford ≥50% monthly headache days (MHDs)/frequency reduction respect to baseline in up to 58.8% of patients; in comparison, anti-CGRP mAbs reduce MHDs of 1.94 days from baseline and botulinum toxin of 1.86 days. Our study demonstrates for the first time that the combination therapy of onabotulinumtoxinA with anti-CGRP mAbs affords a reduction of 2.67 MHDs with respect to onabotulinumtoxinA alone, with moderate certainty of evidence. Adequately powered, good-quality studies are needed to confirm the response to combination therapy in terms of efficacy and safety. PROSPERO registration: CRD42022313640. |
| first_indexed | 2024-03-09T09:47:55Z |
| format | Article |
| id | doaj.art-7f1887815d84473cb877281d05be3cf1 |
| institution | Directory Open Access Journal |
| issn | 2072-6651 |
| language | English |
| last_indexed | 2024-03-09T09:47:55Z |
| publishDate | 2022-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj.art-7f1887815d84473cb877281d05be3cf12023-12-02T00:23:24ZengMDPI AGToxins2072-66512022-08-0114852910.3390/toxins14080529Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic MigraineDamiana Scuteri0Paolo Tonin1Pierluigi Nicotera2Marilù Vulnera3Giuseppina Cristina Altieri4Assunta Tarsitano5Giacinto Bagetta6Maria Tiziana Corasaniti7Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, ItalyRegional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, ItalyGerman Center for Neurodegenerative Diseases (DZNE), 53127 Bonn, GermanyPharmaceutical Service, Provincial Health Authority (ASP), 87100 Cosenza, ItalyPharmaceutical Service, Provincial Health Authority (ASP), 87100 Cosenza, ItalyPain Therapy Center, Provincial Health Authority (ASP), 87100 Cosenza, ItalyPharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, ItalyDepartment of Health Sciences, University “Magna Graecia”, 88100 Catanzaro, ItalyOnabotulinumtoxinA, targeting the CGRP machinery, has been approved for the last two decades for chronic migraine prevention. The recently approved monoclonal antibodies (mAbs) directed towards the calcitonin gene-related peptide (CGRP) pathway open a new age for chronic migraine control. However, some 40% patients suffering from chronic migraine is still resistant to treatment. The aim of this work is to answer the following PICOS (participants intervention comparator outcome study design) question: Is there evidence of efficacy and safety of the combined administration of anti-CGRP mAbs and onabotulinumtoxinA in chronic migraine? A systematic review and meta-analysis [Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 recommendations] was made up to 19 April 2022. The results are encouraging: the combined treatment proved to afford ≥50% monthly headache days (MHDs)/frequency reduction respect to baseline in up to 58.8% of patients; in comparison, anti-CGRP mAbs reduce MHDs of 1.94 days from baseline and botulinum toxin of 1.86 days. Our study demonstrates for the first time that the combination therapy of onabotulinumtoxinA with anti-CGRP mAbs affords a reduction of 2.67 MHDs with respect to onabotulinumtoxinA alone, with moderate certainty of evidence. Adequately powered, good-quality studies are needed to confirm the response to combination therapy in terms of efficacy and safety. PROSPERO registration: CRD42022313640.https://www.mdpi.com/2072-6651/14/8/529onabotulinumtoxinAmigraineanti-CGRP monoclonal antibodiesPRISMA 2020pooled analysis |
| spellingShingle | Damiana Scuteri Paolo Tonin Pierluigi Nicotera Marilù Vulnera Giuseppina Cristina Altieri Assunta Tarsitano Giacinto Bagetta Maria Tiziana Corasaniti Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic Migraine Toxins onabotulinumtoxinA migraine anti-CGRP monoclonal antibodies PRISMA 2020 pooled analysis |
| title | Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic Migraine |
| title_full | Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic Migraine |
| title_fullStr | Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic Migraine |
| title_full_unstemmed | Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic Migraine |
| title_short | Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic Migraine |
| title_sort | pooled analysis of real world evidence supports anti cgrp mabs and onabotulinumtoxina combined trial in chronic migraine |
| topic | onabotulinumtoxinA migraine anti-CGRP monoclonal antibodies PRISMA 2020 pooled analysis |
| url | https://www.mdpi.com/2072-6651/14/8/529 |
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