@article{d8b9674820314bd393983c77fd32c8fd,
title = "Effects of onabotulinumtoxinA treatment in chronic migraine patients with and without daily headache at baseline: Results from the COMPEL Study",
abstract = "Background: OnabotulinumtoxinA is effective in preventing chronic migraine (CM); however, the benefit of onabotulinumtoxinA in patients with CM with daily headache is unknown because these patients are typically excluded from clinical trials. This subanalysis of the COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in people with CM with and without daily headache. Methods: In total, 715 patients received onabotulinumtoxinA 155 U with or without concomitant oral preventive treatment. Patients who had complete daily diary records for the 28 days of the baseline period were stratified based on daily headache status. The primary outcome variable was reduction in headache-day frequency per 28-day period at 108 weeks (after 9 treatment cycles) relative to baseline. Exploratory outcomes included moderate to severe headache days, migraine disability (using the Migraine Disability Assessment [MIDAS] questionnaire), and health-related quality of life (Migraine-Specific Quality-of-Life Questionnaire v2 [MSQ]). Adverse events and their relatedness were recorded. Results: Overall, 641 patients had complete daily diary records at baseline. In patients with daily headache (n = 138) versus without (n = 503), treatment with onabotulinumtoxinA was associated with a significant mean (SD) reduction in 28-day headache-day frequency relative to baseline at week 108 (- 10.5 [9.2] vs - 12.2 [6.7], respectively; both P < 0.001) with no significant between-group difference (P = 0.132). The mean (SD) reduction in moderate to severe headache days at week 108 was significant in patients with and without daily headache (- 11.5 [9.4] and - 9.9 [6.4]; P < 0.001) with no significant between-group difference (P = 0.153). Mean (SD) MIDAS scores significantly improved from baseline at week 108 (- 43.3 [73.4] and - 43.6 [46.7]; both P < 0.001), with no significant between-group difference (P = 0.962). Similarly, mean (SD) MSQ subscale scores significantly improved from baseline at week 108 for patients with and without daily headache. OnabotulinumtoxinA was well tolerated in patients with and without daily headache. Conclusion: Results indicate that onabotulinumtoxinA is associated with reductions from baseline in headache-day frequency and improvements in disability and quality of life for up to 108 weeks in people with CM with daily headache; however, a longer duration of treatment was required to fully realize the treatment effect on headache. No new safety concerns were identified.",
keywords = "COMPEL, Daily headache, Disability, Migraine, OnabotulinumtoxinA, Quality of life",
author = "Young, {William B.} and {Ivan Lopez}, J. and Rothrock, {John F.} and Amelia Orejudos and {Manack Adams}, Aubrey and Lipton, {Richard B.} and Blumenfeld, {Andrew M.}",
note = "Funding Information: The authors thank the patients for their participation in the study. This study was sponsored by Allergan plc (Dublin, Ireland). Writing and editorial assistance was provided to the authors by Lee B. Hohaia, PharmD, of Complete Healthcare Communications, LLC (North Wales, PA, USA), a CHC Group company, and funded by Allergan plc (Dublin, Ireland). All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. Principal investigators for the COMPEL Study included Lawrence D. Robbins, MD; Jan L. Brandes, MD; Tamara A. Miller, MD; Roger K. Cady, MD; Jo H. Bonner, MD; Paul K. Winner, DO, FAAN; Marshall C. Freeman, MD; Kathleen B. Mullin, MD; Andrew M. Blumenfeld, MD; Eric J. Eross, DO; Amy A. Gelfand, MD; Ejaz A. Shamim, MD; William B. Young, MD; John F. Rothrock, MD; Stephen H. Landy, MD; J. Ivan Lopez, MD; George R. Nissan, DO; Soma Sahai-Srivastava, MD; Marcia Ribeiro, MD; Maria-Carmen Wilson, MD; Jose M. Casanova, MD, PhD; Laszlo L. Mechtler, MD; Richard J. Stark, MBBS, FRCAP; Andrew H. Evans, MD; John D. O{\textquoteright}Sullivan, MD, MBBS; Joseph Frasca, MBBS; Min Kyung Chu, MD, PhD; Jeong-Wook Park, MD; ByungKun Kim, MD, PhD; Seong Taek Kim, DDS, MS, PhD; Kwang Soo Lee, MD, MS, PhD; Heui-Soo Moon, MD. Funding Information: The study was sponsored by Allergan plc (Dublin, Ireland). Allergan funded the editorial and writing support and provided support for the study design, and the collection, analysis, and interpretation of the data. Other than in their role as authors, employees of Allergan did not have a role in the final decision of which data to include in the manuscript or on the decision to submit the manuscript for publication. Funding Information: William B. Young has served on advisory boards for Alder, Allergan plc, Cipla, Lilly, and Supernus; has consulted for Allergan plc and Supernus; and has received research support from AGA, Alder, Allergan plc, Amgen, Autonomic Technology, Cumberland, Dr. Reddy Laboratories, Eli Lilly, Eneura Inc., Merz, and St. Jude Medical. J. Ivan Lopez has no disclosures to report. John F. Rothrock has served on advisory boards and/or has consulted for Allergan plc, Lilly, Amgen, and Supernus. He also has received funding for travel and speaking from Supernus and has received honoraria from Allergan plc for participating as a speaker and preceptor at Allergan-sponsored educational programs. His parent institution has received funding from Allergan plc, Amgen, and Dr. Reddy for clinical research he has conducted. Amelia Oreju-dos is an employee of Allergan plc. Aubrey Manack Adams is an employee of Allergan plc and owns stock in the company. Richard B. Lipton serves on the editorial boards of Neurology and Cephalalgia and as senior advisor to Headache. He has received research support from the National Institutes of Health. He also receives support from the Migraine Research Foundation and the National Headache Foundation. He has reviewed for the NIA and NINDS; serves as consultant, advisory board member, or has received honoraria from Alder, Allergan plc, Amgen, Autonomic Technologies, Avanir, Biohaven, Biovi-sion, Boston Scientific, Dr. Reddy{\textquoteright}s Laboratories, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Pernix, Pfizer, Supernus, Teva, Vector, and Vedanta. He receives royalties from Wolff{\textquoteright}s Headache (8th Edition, Oxford University Press), Informa, and Wiley. He holds stock options in eNeura Therapeutics and Biohaven. Andrew M. Blumenfeld has served on advisory boards for Allergan plc, Amgen, Alder, Teva, Supernus, Promius, Egalet, and Lilly and has received funding for speaking from Allergan plc, Amgen, Pernix, Supernus, Depomed, Avanir, and Promius. Publisher Copyright: {\textcopyright} 2019 The Author(s).",
year = "2019",
month = feb,
day = "1",
doi = "10.1186/s10194-018-0953-0",
language = "English (US)",
volume = "20",
journal = "The journal of headache and pain",
issn = "1129-2369",
publisher = "Springer-Verlag Italia",
number = "1",
}