PMID- 34049484
OWN - NLM
STAT- MEDLINE
DCOM- 20210601
LR  - 20220531
IS  - 1129-2377 (Electronic)
IS  - 1129-2369 (Print)
IS  - 1129-2369 (Linking)
VI  - 22
IP  - 1
DP  - 2021 May 28
TI  - Shift from high-frequency to low-frequency episodic migraine in patients treated 
      with Galcanezumab: results from two global randomized clinical trials.
PG  - 48
LID - 10.1186/s10194-021-01222-w [doi]
LID - 48
AB  - BACKGROUND: Patients with episodic migraine (EM) with a higher-frequency of 
      migraine headache days (HFEM: 8-14 migraine headache days/month) have a greater 
      disease burden and a higher risk of progressing to chronic migraine (CM) with 
      associated acute treatment overuse versus those with low-frequency EM (LFEM: 4-7 
      migraine headache days/month). In this post hoc analysis, we assessed the 
      proportions of patients who shifted from HFEM to LFEM and to very low-frequency 
      EM (VLFEM: 0-3 migraine headache days/month) status following treatment with 
      galcanezumab versus placebo. METHODS: EVOLVE-1 and EVOLVE-2 were double-blind, 
      Phase 3 studies in patients with EM. Patients (18-65 years) were randomized 
      (2:1:1) to subcutaneous monthly injections of placebo, galcanezumab 120 mg 
      (240 mg loading dose) or 240 mg, for up to 6 months. Data were pooled and 
      endpoints were change from baseline in number of migraine headache days/month and 
      patients who shifted from HFEM to LFEM or VLFEM status. Impact of change in HFEM 
      status on migraine headache days/month, quality of life and disability was also 
      assessed. RESULTS: A total of 66% (1176/1773) patients from EVOLVE studies had 
      HFEM status at baseline and were included in this analysis; placebo: 592, 
      galcanezumab 120 mg: 294 and galcanezumab 240 mg: 290. At each month, both doses 
      of galcanezumab resulted in a higher proportion of patients who shifted to 0-7 
      monthly headache days/month (VLFEM or LFEM status). Patients who shifted from 
      HFEM at baseline to VLFEM status at Month 3, a relatively larger proportion of 
      patients on galcanezumab 120 mg versus placebo remained at VLFEM status at Months 
      4-6; Months 4-5 for galcanezumab 240 mg versus placebo. Among the 
      galcanezumab-treated patients who did-not-shift or shifted to LFEM or VLFEM 
      status for >/=3 consecutive months until the end of the study, patients who shifted 
      from HFEM to VLFEM status experienced the largest reduction in migraine headache 
      days/month and the largest clinically meaningful improvements in daily 
      functioning (MSQ-RFR) and disability (MIDAS). CONCLUSIONS: In patients with HFEM, 
      treatment with galcanezumab (120 mg and 240 mg) significantly reduced migraine 
      headache days/month, maintained remission status at subsequent months until the 
      end of the study, and improved patients' quality of life versus placebo. TRIAL 
      REGISTRATION: ClinicalTrials.gov Identifier: EVOLVE-1, NCT02614183 ; EVOLVE-2, 
      NCT02614196 .
FAU - Jedynak, Jakub
AU  - Jedynak J
AUID- ORCID: 0000-0001-7291-3632
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA. jjedynak@lilly.com.
FAU - Eross, Eric
AU  - Eross E
AD  - Phoenix Headache Institute, Scottsdale, USA.
FAU - Gendolla, Astrid
AU  - Gendolla A
AD  - Praxis Gendolla, Essen, Germany.
FAU - Rettiganti, Mallikarjuna
AU  - Rettiganti M
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA.
FAU - Stauffer, Virginia L
AU  - Stauffer VL
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02614183
SI  - ClinicalTrials.gov/NCT02614196
GR  - NA/Eli Lilly and Company/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210528
PL  - England
TA  - J Headache Pain
JT  - The journal of headache and pain
JID - 100940562
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 55KHL3P693 (galcanezumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized
MH  - Humans
MH  - *Migraine Disorders/drug therapy
MH  - *Quality of Life
MH  - Randomized Controlled Trials as Topic
PMC - PMC8161994
OTO - NOTNLM
OT  - Episodic migraine
OT  - MIDAS
OT  - MSQ-RFR
OT  - Migraine frequency
OT  - QoL
OT  - Sustained improvement
COIS- Jakub Jedynak, Virginia L. Stauffer, Mallik Rettiganti are employees of Eli Lilly 
      and Company and/or its subsidiaries and hold company stock. Dr. Gendolla receives 
      fees for ad boards, lectures and participation in clinical trials from Pharm 
      Allergan, Reckitt Benckiser, Bayer, Grunenthal, Mundipharma, Novartis, Eli Lilly 
      and Company, Teva, Sanofi and Hormosan. Eric Eross is a consultant and is a 
      member of the speaker bureau at Eli Lilly and Company.
EDAT- 2021/05/30 06:00
MHDA- 2021/06/02 06:00
PMCR- 2021/05/28
CRDT- 2021/05/29 05:24
PHST- 2020/11/13 00:00 [received]
PHST- 2021/03/12 00:00 [accepted]
PHST- 2021/05/29 05:24 [entrez]
PHST- 2021/05/30 06:00 [pubmed]
PHST- 2021/06/02 06:00 [medline]
PHST- 2021/05/28 00:00 [pmc-release]
AID - 10.1186/s10194-021-01222-w [pii]
AID - 1222 [pii]
AID - 10.1186/s10194-021-01222-w [doi]
PST - epublish
SO  - J Headache Pain. 2021 May 28;22(1):48. doi: 10.1186/s10194-021-01222-w.