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The association between onabotulinumtoxinA and anti-CGRP monoclonal antibodies: a reliable option for the optimal treatment of chronic migraine

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Abstract

Chronic migraine (CM) is a great challenge for physicians dealing with headaches. Despite the introduction of the monoclonal antibodies (mAbs) acting against the calcitonin gene-related peptide (CGRP) that has revolutionized the treatment of CM, some patients still experience an incomplete relief. So, the association of two preventive treatments may be a reliable option for these patients. So, onabotulinumtoxinA (BT-A) and anti-CGRP mAbs may be used together, and some pre-clinical and clinical evidence of an additive action of the 2 drugs is emerging. In particular, since BT-A acts mainly on C-fibers and anti-CGRP mAbs on Aδ ones, their association may prevent the wearing-off phenomenon of BT-A, thus giving an additional benefit in those patients experiencing an incomplete response to BT-A alone. Despite this, the clinical studies available in the literature have a small sample size, often a retrospective design, and are heterogeneous in terms of the outcomes chosen. Considering this, the evidence of a favorable effect of the association between BT-A and anti-CGRP mAbs is still scarce. Furthermore, this association is explicitly forbidden by many National regulatory agencies, due to the high costs of both treatments. Anyway, their association could help in reducing the burden associated with the most severe cases of CM, thus relieving the direct and indirect costs of this condition. More well-designed studies with big samples are needed to unveil the real therapeutic gain of this association. Moreover, pharmacoeconomics studies should be performed, to assess the economic suitability of this association.

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Data availability

The authors take full responsibility for the data, the analysis, and interpretation of the research, and they have full access to all of the data. Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Abbreviations

BBB:

Blood-brain barrier

BT-A:

OnabotulinumtoxinA

CGRP:

Calcitonin gene-related peptide

CGRPr:

Calcitonin gene-related peptide receptor

CM:

Chronic migraine

mAb:

Monoclonal antibody

MMA:

Middle meningeal artery

MOH:

Medication-overuse headache

PREEMPT:

Phase III REsearch Evaluating Migraine Prophylaxis Therapy

SNAP-25:

Synaptosomal associated protein of 25 kDa (SNAP-25)

TG:

Trigeminal ganglion

TNC:

Trigeminal nucleus caudalis

TRPV1:

Transient receptor potential vanilloid type 1

TRPA1:

Transient receptor potential cation channel subfamily A member 1

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Authors and Affiliations

  1. Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse, Laboratory of Clinical Pharmacology and Pharmacogenomics, Department of Specialist Medicines, AOU Policlinico Di Modena, Modena, Italy

    Simona Guerzoni & Luca Pani

  2. PhD School in Neuroscience, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy

    Carlo Baraldi

  3. Pharmacology Unit, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy

    Luca Pani

  4. Department of Psychiatry and Behavioral Sciences, University of Miami, Miami, FL, USA

    Luca Pani

  5. VeraSci, Durham, NC, USA

    Luca Pani

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All authors contributed equally to the draft of the manuscript. All authors read and approved the last version of the manuscript.

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S. G. received travel grants and honorary from Allergen, Novartis, Teva, and Ely Lilly. C. B. received travel grants and honorary from Allergen, Novartis, Teva, and Ely Lilly. L. P. is the Chief Scientific Officer of EDRA-LSWR Publishing Company and of Inpeco SA Total Lab Automation Company. In the last year, he has been a scientific consultant to AbbVie, USA; BCG, Switzerland; Boehringer-Ingelheim, Germany; Compass Pathways, UK; Johnson & Johnson, USA; Takeda, USA; VeraSci, USA; Vifor, Switzerland.

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Guerzoni, S., Baraldi, C. & Pani, L. The association between onabotulinumtoxinA and anti-CGRP monoclonal antibodies: a reliable option for the optimal treatment of chronic migraine. Neurol Sci 43, 5687–5695 (2022). https://doi.org/10.1007/s10072-022-06195-5

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