PMID- 37955395
OWN - NLM
STAT- MEDLINE
DCOM- 20231201
LR  - 20231201
IS  - 1526-4610 (Electronic)
IS  - 0017-8748 (Linking)
VI  - 63
IP  - 10
DP  - 2023 Nov-Dec
TI  - Numbers needed to treat or harm and likelihood of being helped versus harmed for 
      fremanezumab in patients who had prior inadequate response to two to four classes 
      of migraine preventive medications: A post hoc analysis.
PG  - 1351-1358
LID - 10.1111/head.14651 [doi]
AB  - OBJECTIVE: This study aimed to determine the number needed to treat (NNT), number 
      needed to harm (NNH), and likelihood of being helped or harmed (LHH) in a post 
      hoc analysis of the phase 3b FOCUS trial. BACKGROUND: Fremanezumab, a humanized 
      monoclonal antibody that selectively targets calcitonin gene-related peptide 
      (CGRP), has demonstrated efficacy, tolerability, and safety in adults with 
      episodic migraine (EM) or chronic migraine (CM), with documented previous 
      inadequate response to two to four classes of migraine preventive medications. 
      METHODS: In the 12-week double-blind period of the FOCUS study, patients were 
      randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched 
      monthly placebo. NNT was based on responder analysis, defined as >/=50% reduction 
      in monthly average number of migraine days at 12 weeks. NNH was based on 
      discontinuations due to adverse events (AEs). RESULTS: Among patients with CM 
      (n = 509), response rates and discontinuation rates were 27% (45/169) and 0 for 
      quarterly fremanezumab, 29% (50/173) and 2% (3/173) for monthly fremanezumab, and 
      8% (13/167) and <1% (1/167) for placebo, respectively. These results translated 
      to NNTs of 5.3 and 4.7, NNHs of 1000 and 88, and LHHs of 188 and 19 for quarterly 
      and monthly fremanezumab, respectively. Among patients with EM (n = 328), 
      response rates were 47% (50/107) for quarterly fremanezumab, 43% (47/110) for 
      monthly fremanezumab, and 10% (11/111) for placebo. Discontinuation rates 
      were <1% (n = 1) in all three groups. These results translated to NNTs of 2.7 and 
      3.0, NNHs of 1000 and 1000, and LHHs of 368 and 328 for quarterly and monthly 
      fremanezumab, respectively. CONCLUSIONS: The NNT, NNH, and LHH for quarterly and 
      monthly fremanezumab compare favorably with those for traditional oral preventive 
      medications, including topiramate, valproate, and propranolol.
CI  - (c) 2023 The Authors. Headache: The Journal of Head and Face Pain published by 
      Wiley Periodicals LLC on behalf of American Headache Society.
FAU - Ashina, Messoud
AU  - Ashina M
AUID- ORCID: 0000-0003-0951-5804
AD  - Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty 
      of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
FAU - Mitsikostas, Dimos D
AU  - Mitsikostas DD
AD  - First Neurology Department, Aeginition Hospital, National and Kapodistrian 
      University of Athens, Athens, Greece.
FAU - Ramirez Campos, Verena
AU  - Ramirez Campos V
AD  - Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.
FAU - Barash, Steve
AU  - Barash S
AD  - Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.
FAU - Ning, Xiaoping
AU  - Ning X
AD  - Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.
FAU - Diener, Hans-Christoph
AU  - Diener HC
AD  - Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty of 
      the University Duisburg-Essen, Essen, Germany.
LA  - eng
GR  - Teva Pharmaceuticals/
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20231113
PL  - United States
TA  - Headache
JT  - Headache
JID - 2985091R
RN  - 0 (fremanezumab)
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Numbers Needed To Treat
MH  - Treatment Outcome
MH  - *Migraine Disorders/drug therapy/prevention & control/chemically induced
MH  - Antibodies, Monoclonal
MH  - Double-Blind Method
OTO - NOTNLM
OT  - calcitonin gene-related peptide
OT  - fremanezumab
OT  - likelihood of being helped or harmed
OT  - migraine
OT  - number needed to harm
OT  - number needed to treat
EDAT- 2023/11/13 12:45
MHDA- 2023/12/01 06:44
CRDT- 2023/11/13 08:22
PHST- 2023/08/25 00:00 [revised]
PHST- 2023/01/05 00:00 [received]
PHST- 2023/09/24 00:00 [accepted]
PHST- 2023/12/01 06:44 [medline]
PHST- 2023/11/13 12:45 [pubmed]
PHST- 2023/11/13 08:22 [entrez]
AID - 10.1111/head.14651 [doi]
PST - ppublish
SO  - Headache. 2023 Nov-Dec;63(10):1351-1358. doi: 10.1111/head.14651. Epub 2023 Nov 
      13.