PMID- 37208838
OWN - NLM
STAT- MEDLINE
DCOM- 20230619
LR  - 20231121
IS  - 2162-3279 (Electronic)
VI  - 13
IP  - 6
DP  - 2023 Jun
TI  - Galcanezumab for the treatment of chronic migraine and medication overuse 
      headache: Real-world clinical evidence in a severely impaired patient population.
PG  - e2799
LID - 10.1002/brb3.2799 [doi]
LID - e2799
AB  - BACKGROUND: Galcanezumab is a monoclonal antibody acting against the calcitonin 
      gene-related peptide approved for the preventive treatment of migraine. The aim 
      of this article is to explore its effectiveness and safety of galcanezumab in 
      chronic migraine (CM) with medication overuse-headache (MOH). METHODS: 
      Seventy-eight patients were consecutively enrolled at the Modena headache center 
      and followed up for 15 months. Visits were scheduled every 3 months, and the 
      following variables were collected: the number of migraine days per month (MDM); 
      the painkillers taken per month (PM); the number of days per month in which the 
      patient took, at least, one painkiller; the six-item headache impact test; and 
      the migraine disability assessment questionnaire (MIDAS) score. Demographic 
      features of the analyzed sample were collected at the baseline and adverse events 
      (AEs) were collected at every visit. RESULTS: After 12 months, galcanezumab 
      significantly reduced the MDM, the PM, the number of days on medication, the 
      HIT-6 as well as the MIDAS scores (all p < .0001). The greatest amelioration was 
      obtained in the first trimester of treatment. A higher MDM, a higher NRS score at 
      the baseline, and a higher number of failed preventive treatments negatively 
      predict the CM relief at the year of treatment. No serious AEs were registered 
      and only one drop-out was due to AE. CONCLUSIONS: Galcanezumab is effective and 
      safe for the treatment of patients affected by CM and MOH. Patients with a higher 
      impairment at the baseline may found less benefits with galcanezumab.
CI  - (c) 2022 The Authors. Brain and Behavior published by Wiley Periodicals LLC.
FAU - Guerzoni, Simona
AU  - Guerzoni S
AD  - 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.
FAU - Baraldi, Carlo
AU  - Baraldi C
AUID- ORCID: 0000-0001-8432-1888
AD  - PhD School in Neurosciences, Department of Biomedical, Metabolic and Neural 
      Sciences, University of Modena and Reggio Emilia, Modena, Italy.
FAU - Castro, Flavia Lo
AU  - Castro FL
AD  - Post-Gradute School in Pharmacology, Department of Biomedical, Metabolic and 
      Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
FAU - Cainazzo, Maria Michela
AU  - Cainazzo MM
AD  - 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.
FAU - Pani, Luca
AU  - Pani L
AD  - 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.
AD  - Pharmacology Unit, Department of Biomedical, Metabolic and Neural Sciences, 
      University of Modena and Reggio Emilia, Modena, Italy.
AD  - Department of Psychiatry and Behavioral Sciences, University of Miami, Miami, 
      Florida, USA.
AD  - VeraSci, Durham, North Carolina, USA.
LA  - eng
PT  - Journal Article
DEP - 20230519
PL  - United States
TA  - Brain Behav
JT  - Brain and behavior
JID - 101570837
RN  - 55KHL3P693 (galcanezumab)
SB  - IM
MH  - Humans
MH  - Treatment Outcome
MH  - Double-Blind Method
MH  - *Migraine Disorders/drug therapy/prevention & control
MH  - Headache
MH  - *Headache Disorders, Secondary/drug therapy
PMC - PMC10275517
OTO - NOTNLM
OT  - chronic migraine
OT  - galcanezumab
OT  - headache days
OT  - medication overuse-headache
OT  - preventive treatment
COIS- Simona Guerzoni and Carlo Baraldi received honoraria from Allergan Eli Lilly, 
      Lundbeck, Novartsi and Teva. Flavia Lo Castro received honoraria from Allergan, 
      Lundbeck .and Novartis. Flavia Lo Castro has no conflict of interest to disclose. 
      Luca Pani 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.
EDAT- 2023/05/20 09:43
MHDA- 2023/06/19 13:08
PMCR- 2023/05/19
CRDT- 2023/05/20 00:43
PHST- 2022/08/24 00:00 [revised]
PHST- 2022/07/20 00:00 [received]
PHST- 2022/10/08 00:00 [accepted]
PHST- 2023/06/19 13:08 [medline]
PHST- 2023/05/20 09:43 [pubmed]
PHST- 2023/05/20 00:43 [entrez]
PHST- 2023/05/19 00:00 [pmc-release]
AID - BRB32799 [pii]
AID - 10.1002/brb3.2799 [doi]
PST - ppublish
SO  - Brain Behav. 2023 Jun;13(6):e2799. doi: 10.1002/brb3.2799. Epub 2023 May 19.