TY - JOUR
T1 - Reversion From Chronic Migraine to Episodic Migraine in Patients Treated With Fremanezumab
T2 - Post Hoc Analysis From HALO CM Study
AU - Lipton, Richard B.
AU - Cohen, Joshua M.
AU - Bibeau, Kristen
AU - Galic, Maja
AU - Seminerio, Michael J.
AU - Ramirez Campos, Verena
AU - Halker Singh, Rashmi B.
AU - Ailani, Jessica
N1 - Funding Information:
This study was funded by Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.We thank the patients who have participated in this study and their families; all investigators, site personnel, and the coordinating investigators; and Norah Yudong Yao, PhD (Chameleon Communications International with funding from Teva Pharmaceutical Industries Ltd.) for editorial assistance in the preparation of this report. We also thank Ronghua Yang (Teva Pharmaceuticals, Frazer, PA, USA) and Kristen Bibeau (former employee of Teva Branded Pharmaceutical Products R&D, Inc, USA) for conducting statistical analysis.
Publisher Copyright:
© 2020 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society
PY - 2020/11/1
Y1 - 2020/11/1
N2 - Background: Migraine preventive medications are used to reduce headache frequency, severity, and duration. In patients with chronic migraine (CM), reversion to episodic migraine (EM) is an important treatment goal. Objective: To evaluate the effect of fremanezumab on the rate of reversion from CM to EM. Methods: This phase 3, randomized, double-blind, placebo-controlled, parallel-group trial included a 28-day pretreatment period and a 3-month treatment period. Patients with CM received subcutaneous fremanezumab quarterly (675 mg at baseline) or monthly (675 mg at baseline; 225 mg at Weeks 4 and 8), or placebo. Post hoc analyses evaluated the proportion of patients who reverted from CM to EM, defined as either a reduction to an average of <15 headache days per month during the 3-month treatment period or a reduction to <15 headache days per month in all 3 months of the treatment period. Results: This analysis included data from 1088 CM patients (quarterly, n = 366; monthly, n = 365; placebo, n = 357). More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P =.108; monthly: 53.7% [196/365], P =.012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P =.008; monthly: 33.7% [123/365], P =.001; vs placebo: 22.4% [80/357]). Patients with CM who reported previous topiramate or onabotulinumtoxinA use, concomitant preventive medication use, or medication overuse were less likely to revert to EM. Conclusions: Fremanezumab may offer the benefit of reversion from CM to EM, based on a reduction in the number of headache days over 3 months of treatment.
AB - Background: Migraine preventive medications are used to reduce headache frequency, severity, and duration. In patients with chronic migraine (CM), reversion to episodic migraine (EM) is an important treatment goal. Objective: To evaluate the effect of fremanezumab on the rate of reversion from CM to EM. Methods: This phase 3, randomized, double-blind, placebo-controlled, parallel-group trial included a 28-day pretreatment period and a 3-month treatment period. Patients with CM received subcutaneous fremanezumab quarterly (675 mg at baseline) or monthly (675 mg at baseline; 225 mg at Weeks 4 and 8), or placebo. Post hoc analyses evaluated the proportion of patients who reverted from CM to EM, defined as either a reduction to an average of <15 headache days per month during the 3-month treatment period or a reduction to <15 headache days per month in all 3 months of the treatment period. Results: This analysis included data from 1088 CM patients (quarterly, n = 366; monthly, n = 365; placebo, n = 357). More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P =.108; monthly: 53.7% [196/365], P =.012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P =.008; monthly: 33.7% [123/365], P =.001; vs placebo: 22.4% [80/357]). Patients with CM who reported previous topiramate or onabotulinumtoxinA use, concomitant preventive medication use, or medication overuse were less likely to revert to EM. Conclusions: Fremanezumab may offer the benefit of reversion from CM to EM, based on a reduction in the number of headache days over 3 months of treatment.
KW - all headache
KW - all pain
KW - clinical trials randomized controlled
KW - migraine
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U2 - 10.1111/head.13997
DO - 10.1111/head.13997
M3 - Article
C2 - 33179323
AN - SCOPUS:85096660729
SN - 0017-8748
VL - 60
SP - 2444
EP - 2453
JO - Headache
JF - Headache
IS - 10
ER -