TY - JOUR
T1 - Effects of onabotulinumtoxinA treatment in patients with and without allodynia
T2 - Results of the COMPEL study
AU - Young, William B.
AU - Ivan Lopez, J.
AU - Rothrock, John F.
AU - Orejudos, Amelia
AU - Manack Adams, Aubrey
AU - Lipton, Richard B.
AU - Blumenfeld, Andrew M.
N1 - Funding Information:
William B. Young has served on advisory boards for Alder, Allergan, Cipla, Lilly, and Supernus; has consulted for Allergan and Supernus; and has received research support from AGA, Alder, Allergan, Amgen, Autonomic Technology, Cumberland, Dr. Reddy’s Laboratories, Eli Lilly, eNeura, 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, Lilly, Amgen, and Supernus. He also has received funding for travel and speaking from Supernus and has received honoraria from Allergan for participating as a speaker and preceptor at Allergan-sponsored educational programs. His parent institution has received funding from Allergan, Amgen, and Dr. Reddy’s Laboratories for clinical research he has conducted. Amelia Orejudos is an employee of Allergan. Aubrey Manack Adams is an employee of Allergan 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 National Institute on Aging and National Institute of Neurological Disorders and Stroke, serves as consultant or advisory board member or has received honoraria from Alder, Allergan, Amgen, Autonomic Technologies, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy’s Laboratories, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, and Vedanta. He receives royalties from Wolff’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, Amgen, Alder, Teva, Supernus, Promius, Egalet, and Lilly and has received funding for speaking from Allergan, Amgen, Pernix, Supernus, Depomed, Avanir, and Promius.
Funding Information:
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 was funded by Allergan plc (Dublin, Ireland). All authors met ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. The authors thank the patients for their participation in the study. 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’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.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/1/22
Y1 - 2019/1/22
N2 - Background: OnabotulinumtoxinA is effective in treating chronic migraine (CM), but there are limited data assessing how allodynia affects preventive treatment responses. This subanalysis of the 108-week, multicenter, open-label COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in people with CM with and without allodynia. Methods: Patients (n = 715) were treated with onabotulinumtoxinA 155 U every 12 weeks for 9 treatment cycles. The Allodynia Symptom Checklist was used to identify patients with allodynia (scores ≥3). The primary outcome for this subanalysis was reduction in monthly headache days from baseline for weeks 105 to 108 in groups with and without allodynia. Other outcomes included assessments of moderate to severe headache days, disability (using the Migraine Disability Assessment [MIDAS] questionnaire), and health-related quality of life (Migraine-Specific Quality-of-Life Questionnaire [MSQ] v2). Adverse events and their relation to treatment were recorded. Results: OnabotulinumtoxinA was associated with a significant mean (SD) reduction in headache day frequency at week 108 relative to baseline in patients with (n = 289) and without (n = 426) allodynia (- 10.8 [7.1] and - 12.5 [7.4], respectively; both P < 0.001) that was significantly greater in patients without allodynia (P = 0.044 between-subgroup comparison). Moderate to severe headache days were significantly reduced at week 108 in patients with and without allodynia (- 9.6 [6.9] and - 10.5 [7.2]; both P < 0.001); reduction was similar between groups. MIDAS scores improved significantly at week 108 (- 53.0 [50.3] and - 37.7 [53.0]; both P < 0.001), with a significant between-group difference in favor of those with allodynia (P = 0.005). Similarly, MSQ subscale scores (Role Function Preventive, Role Function Restrictive, Emotional Function) significantly improved at week 108 for patients with and without allodynia: 20.6 (21.9) and 16.9 (20.7), 28.0 (23.3) and 24.7 (22.7), and 27.6 (26.5) and 24.9 (26.1), respectively (all P < 0.001). OnabotulinumtoxinA was well tolerated in patients with and without allodynia. Conclusion: Results indicate that onabotulinumtoxinA is associated with reductions from baseline in multiple efficacy outcomes for up to 108 weeks whether or not allodynia is present. The allodynia group showed a smaller treatment response for reduction in headache days, but a similar or greater treatment response for improvement in other measures. No new safety concerns were identified.
AB - Background: OnabotulinumtoxinA is effective in treating chronic migraine (CM), but there are limited data assessing how allodynia affects preventive treatment responses. This subanalysis of the 108-week, multicenter, open-label COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in people with CM with and without allodynia. Methods: Patients (n = 715) were treated with onabotulinumtoxinA 155 U every 12 weeks for 9 treatment cycles. The Allodynia Symptom Checklist was used to identify patients with allodynia (scores ≥3). The primary outcome for this subanalysis was reduction in monthly headache days from baseline for weeks 105 to 108 in groups with and without allodynia. Other outcomes included assessments of moderate to severe headache days, disability (using the Migraine Disability Assessment [MIDAS] questionnaire), and health-related quality of life (Migraine-Specific Quality-of-Life Questionnaire [MSQ] v2). Adverse events and their relation to treatment were recorded. Results: OnabotulinumtoxinA was associated with a significant mean (SD) reduction in headache day frequency at week 108 relative to baseline in patients with (n = 289) and without (n = 426) allodynia (- 10.8 [7.1] and - 12.5 [7.4], respectively; both P < 0.001) that was significantly greater in patients without allodynia (P = 0.044 between-subgroup comparison). Moderate to severe headache days were significantly reduced at week 108 in patients with and without allodynia (- 9.6 [6.9] and - 10.5 [7.2]; both P < 0.001); reduction was similar between groups. MIDAS scores improved significantly at week 108 (- 53.0 [50.3] and - 37.7 [53.0]; both P < 0.001), with a significant between-group difference in favor of those with allodynia (P = 0.005). Similarly, MSQ subscale scores (Role Function Preventive, Role Function Restrictive, Emotional Function) significantly improved at week 108 for patients with and without allodynia: 20.6 (21.9) and 16.9 (20.7), 28.0 (23.3) and 24.7 (22.7), and 27.6 (26.5) and 24.9 (26.1), respectively (all P < 0.001). OnabotulinumtoxinA was well tolerated in patients with and without allodynia. Conclusion: Results indicate that onabotulinumtoxinA is associated with reductions from baseline in multiple efficacy outcomes for up to 108 weeks whether or not allodynia is present. The allodynia group showed a smaller treatment response for reduction in headache days, but a similar or greater treatment response for improvement in other measures. No new safety concerns were identified.
KW - Allodynia
KW - COMPEL
KW - Disability
KW - Migraine
KW - Quality of life
KW - onabotulinumtoxinA
UR - http://www.scopus.com/inward/record.url?scp=85060398251&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85060398251&partnerID=8YFLogxK
U2 - 10.1186/s10194-018-0952-1
DO - 10.1186/s10194-018-0952-1
M3 - Article
C2 - 30669961
AN - SCOPUS:85060398251
SN - 1129-2369
VL - 20
JO - Journal of Headache and Pain
JF - Journal of Headache and Pain
IS - 1
M1 - 10
ER -