PMID- 38424386
OWN - NLM
STAT- MEDLINE
DCOM- 20240417
LR  - 20240425
IS  - 1590-3478 (Electronic)
IS  - 1590-1874 (Print)
IS  - 1590-1874 (Linking)
VI  - 45
IP  - 5
DP  - 2024 May
TI  - The first interim analysis of Italian patients enrolled in the real-world, 
      Pan-European, prospective, observational, phase 4 PEARL study of fremanezumab 
      effectiveness.
PG  - 2353-2363
LID - 10.1007/s10072-024-07357-3 [doi]
AB  - INTRODUCTION: In 2020, the Italian Medicines Agency (AIFA) approved the 
      reimbursement of calcitonin gene-related peptide (CGRP) pathway monoclonal 
      antibodies (mAbs), including fremanezumab, in patients with a Migraine Disability 
      Assessment Scale (MIDAS) score >/= 11, with prescription renewals for up to 
      12 months in patients with >/= 50% reduction in MIDAS score at Months 3 and 6. In 
      this sub-analysis of the Pan-European Real Life (PEARL) study, we provide 
      real-world data on fremanezumab use in Italian routine clinical practice 
      (EUPAS35111). METHODS: This first interim analysis for Italy was conducted when 
      300 enrolled adult patients with episodic or chronic migraine (EM, CM) completed 
      6 months of treatment with fremanezumab. The primary endpoint is the proportion 
      of patients achieving >/= 50% reduction in monthly migraine days (MMD) across the 
      6 months post-fremanezumab initiation. Secondary endpoints include: proportion of 
      patients achieving >/= 50% reduction in MIDAS score at Months 3 and 6, and mean 
      change from baseline across Months 1-6 in MMD and headache-related disability. 
      Safety was assessed through adverse events (AEs) reported. RESULTS: Of 354 
      patients enrolled at Italian centers, 318 (EM, 35.5%, CM, 64.5%) were included in 
      the effectiveness analysis. Of patients with available data, 109 (61.2%) achieved 
      the primary endpoint. 61.0% and 65.1% achieved >/= 50% reduction in MMDs at Months 
      3 and 6, respectively; 79.9% and 81.0% experienced >/= 50% reduction in MIDAS at 
      the same timepoints. CONCLUSION: Fremanezumab was effective and well-tolerated 
      over the first 6 months of treatment, with approximately 80% of patients meeting 
      Italian criteria for treatment continuation at Months 3 and 6.
CI  - (c) 2024. The Author(s).
FAU - Tassorelli, Cristina
AU  - Tassorelli C
AUID- ORCID: 0000-0003-1513-2113
AD  - Department of Brain & Behavioral Sciences, Headache Science and 
      Neurorehabilitation Centre, University of Pavia, Via Mondino, 2, 27100, Pavia, 
      Italy. cristina.tassorelli@unipv.it.
AD  - IRCCS C. Mondino Foundation, Pavia, Italy. cristina.tassorelli@unipv.it.
FAU - Barbanti, Piero
AU  - Barbanti P
AD  - Headache and Pain Unit, IRCCS San Raffaele, Rome, Italy.
AD  - San Raffaele University, Rome, Italy.
FAU - Finocchi, Cinzia
AU  - Finocchi C
AD  - Neurology Unit, Asl 2 San Paolo Hospital, Savona, Italy.
FAU - Geppetti, Pierangelo
AU  - Geppetti P
AD  - Department of Health Sciences, Clinical Pharmacology and Oncology Section, 
      University of Florence, Florence, Italy.
FAU - Kokturk, Pinar
AU  - Kokturk P
AD  - Teva Netherlands B.V., Amsterdam, Netherlands.
FAU - Russo, Antonio
AU  - Russo A
AD  - Headache Center, Department of Advanced Medical and Surgical Sciences, School of 
      Medicine and Surgery, University of Campania Studies "Luigi Vanvitelli", Naples, 
      Italy.
FAU - Sacco, Simona
AU  - Sacco S
AD  - Department of Biotechnological and Applied Clinical Sciences, University of 
      L'Aquila, L'Aquila, Italy.
FAU - Cepparulo, Mario
AU  - Cepparulo M
AD  - Teva Italia Srl, Milan, Italy.
CN  - PEARL study group
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Observational Study
DEP - 20240301
PL  - Italy
TA  - Neurol Sci
JT  - Neurological sciences : official journal of the Italian Neurological Society and 
      of the Italian Society of Clinical Neurophysiology
JID - 100959175
RN  - 0 (fremanezumab)
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Prospective Studies
MH  - Double-Blind Method
MH  - *Antibodies, Monoclonal/adverse effects
MH  - *Migraine Disorders/drug therapy
MH  - Treatment Outcome
PMC - PMC11021338
OTO - NOTNLM
OT  - Calcitonin gene-related peptide
OT  - Fremanezumab
OT  - Migraine
OT  - Monoclonal antibodies
OT  - Real-world data
OT  - Real-world evidence
COIS- CT has received consulting fees or speaking honoraria from AbbVie, Dompe, Lilly, 
      Lundbeck, Novartis, and Pfizer; has received financial support for attending 
      meetings from Lundbeck and Ipsen; is the past-President of the International 
      Headache Society. PB has received consulting fees from AbbVie, Allergan, 
      Angelini, Assosalute, Bayer, Eli-Lilly, Fondazione Ricerca e Salute, Lundbeck, 
      MSD, Novartis, Teva, Visufarma, and Zambon; has received payment or honoraria 
      from AbbVie, Allergan, Angelini, Bayer, Eli-Lilly, Lundbeck, MED, MSD, New Penta, 
      Novartis, Stx-Med, Teva, Visufarma, and Zambon; has received support for 
      attending meetings and/or travel from Lundbeck, Novartis, Teva, and Visufarma; 
      has participated on a data safety monitoring board or advisory board for AbbVie, 
      Allergan, Angelini, Bayer, Eli-Lilly, Lundbeck, New Penta, Novartis, Stx-Med, 
      Teva, Visufarma, and Zambon; and has received other financial or non-financial 
      interests from AbbVie, Amgen, Alder, Allergan, Biohaven, ElectroCore, Eli-Lilly, 
      GSK, Lundbeck, New Penta, Noema Pharma, Novartis, and Teva. MC is an employee of 
      Teva Pharmaceuticals and has received stock or stock options from Teva. SS has 
      received grants or contracts from Novartis, and Uriach; has received consulting 
      fees from AbbVie, Abbott, Allergan, AstraZeneca, Lilly, Lundbeck, NovoNordisk, 
      and Pfizer; has received support for attending meetings and/or travel from Lilly, 
      Lundbeck, Novartis, and Teva; is the President Elect for the European Stroke 
      Organisation and second Vice-President for the European Headache Federation; 
      and has received receipt of equipment, materials, drugs, medical writing gifts or 
      other services from AbbVie, Allergan, and NovoNordisk. AR has received speaker 
      honoraria from Allergan, Lilly, Novartis, Teva, and Pfizer, and serves as an 
      Associate Editor of Frontiers in Neurology (Headache Medicine and Facial Pain 
      session). CF has received payments or honoraria from AbbVie, Lilly, Lundbeck, 
      Novartis, and Teva, and is the President of Anircef. PK is an employee of Teva 
      Pharmaceuticals.
FIR - Ambrosini, Anna
IR  - Ambrosini A
FIR - Bandettini, Monica
IR  - Bandettini M
FIR - Bartolini, Marco
IR  - Bartolini M
FIR - Benedetto, Chiara
IR  - Benedetto C
FIR - Brighina, Filippo
IR  - Brighina F
FIR - Cevoli, Sabina
IR  - Cevoli S
FIR - Coppola, Gianluca
IR  - Coppola G
FIR - De Simone, Roberto
IR  - De Simone R
FIR - Di Fiore, Paola
IR  - Di Fiore P
FIR - D'Onofrio, Florindo
IR  - D'Onofrio F
FIR - Gori, Sara
IR  - Gori S
FIR - Granato, Antonio
IR  - Granato A
FIR - Guerzoni, Simona
IR  - Guerzoni S
FIR - Iannacchero, Rosario
IR  - Iannacchero R
FIR - Messina, Stefano
IR  - Messina S
FIR - Perini, Francesco
IR  - Perini F
FIR - Prudenzano, Maria Pia
IR  - Prudenzano MP
FIR - Rainero, Innocenzo
IR  - Rainero I
FIR - Rao, Renata
IR  - Rao R
FIR - Reggio, Ester
IR  - Reggio E
FIR - Sarchielli, Paola
IR  - Sarchielli P
FIR - Sette, Giuliano
IR  - Sette G
FIR - Usai, Susanna
IR  - Usai S
FIR - Valente, Mariarosaria
IR  - Valente M
FIR - Vernieri, Fabrizio
IR  - Vernieri F
EDAT- 2024/03/01 01:27
MHDA- 2024/04/17 06:42
PMCR- 2024/03/01
CRDT- 2024/02/29 23:36
PHST- 2023/10/26 00:00 [received]
PHST- 2024/01/23 00:00 [accepted]
PHST- 2024/04/17 06:42 [medline]
PHST- 2024/03/01 01:27 [pubmed]
PHST- 2024/02/29 23:36 [entrez]
PHST- 2024/03/01 00:00 [pmc-release]
AID - 10.1007/s10072-024-07357-3 [pii]
AID - 7357 [pii]
AID - 10.1007/s10072-024-07357-3 [doi]
PST - ppublish
SO  - Neurol Sci. 2024 May;45(5):2353-2363. doi: 10.1007/s10072-024-07357-3. Epub 2024 
      Mar 1.