Abstract
Introduction: OnabotulinumtoxinA (BT-A) quarterly was the first treatment approved specifically for chronic migraine (CM). It is unclear whether three cycles are better than two to assess early BT-A response. Methods: We performed a retrospective analysis on real-life prospectively collected data in 16 European headache centers. All the centers provided data on patients treated with BT-A for CM over the first three cycles of treatment. For each treatment cycle we defined patients as “good responders” if reporting a ≥ 50% reduction in monthly headache days compared with the three months before starting BT-A, “partial responders” if reporting a 30–49% reduction in monthly headache days, and “non-responders” if reporting a < 30% reduction in monthly headache days or stopping the treatment before the third cycle. Results: We included 2879 patients. Seven hundred and eighty-four (64.6%) of the 1213 patients reporting a good response during the first and/or the second cycle had a good response during the third cycle; 309 (49.3%) of the 627 patients reporting a partial response (but no good response) during the first and/or the second cycle had a good response during the third cycle; only 65 (6.3%) of the 1039 patients who did not respond during both the first two cycles achieved a good response during the third cycle. Multivariate analyses showed that partial or good response during the first or the second cycle were independently associated with good response during the third cycle. Conclusions: Our data suggest that patients with CM responding to BT-A during the first two cycles will likely benefit from the third cycle of treatment, while the probability that non-responders to the first two cycles start responding during the third cycle is low. These results can help guide the individual decision to stop or continue treatment after the second cycle in patients who have not responded to the first two cycles.
| Original language | English |
|---|---|
| Pages (from-to) | 637-650 |
| Number of pages | 14 |
| Journal | Pain and Therapy |
| Volume | 10 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jun 2021 |
Keywords
- Chronic migraine
- Multicenter study
- OnabotulinumtoxinA
- Real-life evidence
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In: Pain and Therapy, Vol. 10, No. 1, 06.2021, p. 637-650.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Early Management of OnabotulinumtoxinA Treatment in Chronic Migraine
T2 - Insights from a Real-Life European Multicenter Study
AU - Ornello, Raffaele
AU - Ahmed, Fayyaz
AU - Negro, Andrea
AU - Miscio, Anna Maria
AU - Santoro, Antonio
AU - Alpuente, Alicia
AU - Russo, Antonio
AU - Silvestro, Marcello
AU - Cevoli, Sabina
AU - Brunelli, Nicoletta
AU - Vernieri, Fabrizio
AU - Grazzi, Licia
AU - Baraldi, Carlo
AU - Guerzoni, Simona
AU - Andreou, Anna P.
AU - Lambru, Giorgio
AU - Frattale, Ilaria
AU - Kamm, Katharina
AU - Ruscheweyh, Ruth
AU - Russo, Marco
AU - Torelli, Paola
AU - Filatova, Elena
AU - Latysheva, Nina
AU - Gryglas-Dworak, Anna
AU - Straburzynski, Marcin
AU - Butera, Calogera
AU - Colombo, Bruno
AU - Filippi, Massimo
AU - Pozo-Rosich, Patricia
AU - Martelletti, Paolo
AU - Sacco, Simona
N1 - Funding Information: Raffaele Ornello reports speaker fees from Novartis and Eli Lilly, travel grants from Teva, and support for publication from Novartis and Allergan. Simona Sacco reports personal fees from Allergan-AbbVie, AstraZeneca, Abbott, Teva, Novartis, and Eli Lilly. Alicia Alpuente has received honoraria for educational projects from Allergan-Abbvie, Novartis, and Teva. Patricia Pozo-Rosich has received honoraria as a consultant and speaker for Allergan-Abbvie, Almirall, Amgen, Biohaven, Chiesi, Eli Lilly, Medscape, Neurodiem, Novartis, and Teva; her research group has received research grants from Allergan, and has received funding for clinical trials from Alder, Allergan-Abbvie, electroCore, Eli Lilly, Novartis, and Teva; she is a trustee member of the board of the International Headache Society, member of the Council of the European Headache Society; she is on the editorial board of Revista de Neurologia, associate editor of Cephalalgia, Headache, Neurologia, and Frontiers in Neurology, and advisor for The Journal of Headache and Pain; she is a member of the Clinical Trials Standing Committee of the International Headache Society; she has edited the Guidelines for the Diagnosis and Treatment of Headache of the Spanish Neurological Society; she is the founder of www.midolordecabeza.org ; she does not own stocks from any pharmaceutical company. Andrea Negro has received speaking honoraria and has served on the advisory boards of Allergan, Eli Lilly and Company, and Novartis. Paolo Martelletti has received speaker’s honoraria and has served on the advisory boards of Allergan, Eli Lilly and Company, Novartis, and Teva Pharmaceuticals; he is also an EMA Expert and has served as Editor-in-Chief of The Journal of Headache and Pain and as Editor-in-Chief of SN Comprehensive Clinical Medicine; he also declares royalties received from Springer Nature. Massimo Filippi is Editor-in-Chief of the Journal of Neurology and Associate Editor of Neurological Sciences; received compensation for consulting services and/or speaking activity from Bayer, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme, Takeda, and Teva Pharmaceutical Industries; and receives research support from Biogen Idec, Merck Serono, Novartis, Teva Pharmaceutical Industries, Roche, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and ARiSLA (Fondazione Italiana di Ricerca per la SLA). Elena Filatova reports speaker fees from Novartis and Teva. Nina Latysheva reports speaker fees from Novartis and Allergan. Carlo Baraldi has received travel grants and honoraria from Allergan, Novartis, Teva, and Ely Lilly. Licia Grazzi has received consultancy and advisory fees from Allergan, electroCore LLC, Novartis, and Eli Lilly, and collaborates in trials sponsored by Eli Lilly, Teva, and PharmInd. Simona Guerzoni has received travel grants and honoraria from Allergan, Eli Lilly, Teva, and Novartis. Sabina Cevoli has received honoraria as speaker, for participating on advisory boards, or for clinical investigation studies from Teva, Allergan, Novartis, Lilly, and Ibsa. Fayyaz Ahmed has received honorarium from Allergan for being on their advisory board and is paid to the charitable organizations. Giorgio Lambru has received speaker honoraria and funding for travel, and has received honoraria for participation on advisory boards sponsored by Allergan, Novartis, Eli Lilly, and Teva; he has also received speaker honoraria and funding for travel from electroCore, Nevro Corp., and Autonomic Technologies. Anna P. Andreou has received speaker honoraria and funding for travel from Allergan, Eli Lilly, and eNeura, honoraria for participation on advisory boards sponsored by Allergan and Eli Lilly, sponsorship for educational purposes from eNeura, Allergan, Autonomic Technologies, and Novartis, and an equipment grant from eNeura. Antonio Russo has received speaker honoraria from Allergan, Lilly, Novartis, and Teva, and serves as an associate editor of Frontiers in Neurology (Headache Medicine and Facial Pain session). Marcello Silvestro has received speaker honoraria from Lilly, Novartis, and Teva. Ruth Ruscheweyh has received travel grants and/or honoraria from Allergan, Hormosan, Lilly, Novartis, and Teva. Fabrizio Vernieri has received travel grants, honoraria for advisory boards, and speaker panels from Allergan, Angelini, Lilly, Novartis, and Teva. Marcin Straburzynski has received personal fees from Novartis and Teva. Katharina Kamm has received travel grants and/ or honoraria from Lilly, Novartis, and Teva. Paola Torelli has received travel grants and/or honoraria from Allergan, Lilly, Novartis, and Teva. Anna Gryglas-Dworak has received honoraria as a speaker and travel grants from Allergan and honoraria as a speaker from Novartis. Ilaria Frattale, Anna Maria Miscio, Antonio Santoro, Nicoletta Brunelli, Bruno Colombo, Calogera Butera, and Marco Russo declare no conflicts of interest. Funding Information: No funding or sponsorship was received for this study or publication of this article. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. The Authors wish to thank V?ctor Jos? Gallardo L?pez from the Vall d?Hebron Institute of Research (VHIR), Barcelona, Spain, for statistical advice. Preliminary results of the present work were presented in poster form at the 34th congress of the Italian Society for the Study of Headaches (SISC), virtual edition, 23?26 September, 2020, and at the 51st congress of the Italian Neurological Society (SIN), virtual edition, 20?30 November, 2020. Raffaele Ornello reports speaker fees from Novartis and Eli Lilly, travel grants from Teva, and support for publication from Novartis and Allergan. Simona Sacco reports personal fees from Allergan-AbbVie, AstraZeneca, Abbott, Teva, Novartis, and Eli Lilly. Alicia Alpuente has received honoraria for educational projects from Allergan-Abbvie, Novartis, and Teva. Patricia Pozo-Rosich has received honoraria as a consultant and speaker for Allergan-Abbvie, Almirall, Amgen, Biohaven, Chiesi, Eli Lilly, Medscape, Neurodiem, Novartis, and Teva; her research group has received research grants from Allergan, and has received funding for clinical trials from Alder, Allergan-Abbvie, electroCore, Eli Lilly, Novartis, and Teva; she is a trustee member of the board of the International Headache Society, member of the Council of the European Headache Society; she is on the editorial board of Revista de Neurologia, associate editor of Cephalalgia , Headache , Neurologia , and Frontiers in Neurology , and advisor for The Journal of Headache and Pain ; she is a member of the Clinical Trials Standing Committee of the International Headache Society; she has edited the Guidelines for the Diagnosis and Treatment of Headache of the Spanish Neurological Society; she is the founder of www.midolordecabeza.org ; she does not own stocks from any pharmaceutical company. Andrea Negro has received speaking honoraria and has served on the advisory boards of Allergan, Eli Lilly and Company, and Novartis. Paolo Martelletti has received speaker?s honoraria and has served on the advisory boards of Allergan, Eli Lilly and Company, Novartis, and Teva Pharmaceuticals; he is also an EMA Expert and has served as Editor-in-Chief of The Journal of Headache and Pain and as Editor-in-Chief of SN Comprehensive Clinical Medicine ; he also declares royalties received from Springer Nature. Massimo Filippi is Editor-in-Chief of the Journal of Neurology and Associate Editor of Neurological Sciences ; received compensation for consulting services and/or speaking activity from Bayer, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme, Takeda, and Teva Pharmaceutical Industries; and receives research support from Biogen Idec, Merck Serono, Novartis, Teva Pharmaceutical Industries, Roche, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and ARiSLA (Fondazione Italiana di Ricerca per la SLA). Elena Filatova reports speaker fees from Novartis and Teva. Nina Latysheva reports speaker fees from Novartis and Allergan. Carlo Baraldi has received travel grants and honoraria from Allergan, Novartis, Teva, and Ely Lilly. Licia Grazzi has received consultancy and advisory fees from Allergan, electroCore LLC, Novartis, and Eli Lilly, and collaborates in trials sponsored by Eli Lilly, Teva, and PharmInd. Simona Guerzoni has received travel grants and honoraria from Allergan, Eli Lilly, Teva, and Novartis. Sabina Cevoli has received honoraria as speaker, for participating on advisory boards, or for clinical investigation studies from Teva, Allergan, Novartis, Lilly, and Ibsa. Fayyaz Ahmed has received honorarium from Allergan for being on their advisory board and is paid to the charitable organizations. Giorgio Lambru has received speaker honoraria and funding for travel, and has received honoraria for participation on advisory boards sponsored by Allergan, Novartis, Eli Lilly, and Teva; he has also received speaker honoraria and funding for travel from electroCore, Nevro Corp., and Autonomic Technologies. Anna P. Andreou has received speaker honoraria and funding for travel from Allergan, Eli Lilly, and eNeura, honoraria for participation on advisory boards sponsored by Allergan and Eli Lilly, sponsorship for educational purposes from eNeura, Allergan, Autonomic Technologies, and Novartis, and an equipment grant from eNeura. Antonio Russo has received speaker honoraria from Allergan, Lilly, Novartis, and Teva, and serves as an associate editor of Frontiers in Neurology (Headache Medicine and Facial Pain session). Marcello Silvestro has received speaker honoraria from Lilly, Novartis, and Teva. Ruth Ruscheweyh has received travel grants and/or honoraria from Allergan, Hormosan, Lilly, Novartis, and Teva. Fabrizio Vernieri has received travel grants, honoraria for advisory boards, and speaker panels from Allergan, Angelini, Lilly, Novartis, and Teva. Marcin Straburzynski has received personal fees from Novartis and Teva. Katharina Kamm has received travel grants and/ or honoraria from Lilly, Novartis, and Teva. Paola Torelli has received travel grants and/or honoraria from Allergan, Lilly, Novartis, and Teva. Anna Gryglas-Dworak has received honoraria as a speaker and travel grants from Allergan and honoraria as a speaker from Novartis. Ilaria Frattale, Anna Maria Miscio, Antonio Santoro, Nicoletta Brunelli, Bruno Colombo, Calogera Butera, and Marco Russo declare no conflicts of interest. The present analysis was approved by the Internal Review Board of the University of L?Aquila with protocol number 23/2020. Patients did not have to sign an additional informed consent as no additional data were required for the present analyses. The data sets analyzed during the current study are available from the participant centers upon reasonable request. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - Introduction: OnabotulinumtoxinA (BT-A) quarterly was the first treatment approved specifically for chronic migraine (CM). It is unclear whether three cycles are better than two to assess early BT-A response. Methods: We performed a retrospective analysis on real-life prospectively collected data in 16 European headache centers. All the centers provided data on patients treated with BT-A for CM over the first three cycles of treatment. For each treatment cycle we defined patients as “good responders” if reporting a ≥ 50% reduction in monthly headache days compared with the three months before starting BT-A, “partial responders” if reporting a 30–49% reduction in monthly headache days, and “non-responders” if reporting a < 30% reduction in monthly headache days or stopping the treatment before the third cycle. Results: We included 2879 patients. Seven hundred and eighty-four (64.6%) of the 1213 patients reporting a good response during the first and/or the second cycle had a good response during the third cycle; 309 (49.3%) of the 627 patients reporting a partial response (but no good response) during the first and/or the second cycle had a good response during the third cycle; only 65 (6.3%) of the 1039 patients who did not respond during both the first two cycles achieved a good response during the third cycle. Multivariate analyses showed that partial or good response during the first or the second cycle were independently associated with good response during the third cycle. Conclusions: Our data suggest that patients with CM responding to BT-A during the first two cycles will likely benefit from the third cycle of treatment, while the probability that non-responders to the first two cycles start responding during the third cycle is low. These results can help guide the individual decision to stop or continue treatment after the second cycle in patients who have not responded to the first two cycles.
AB - Introduction: OnabotulinumtoxinA (BT-A) quarterly was the first treatment approved specifically for chronic migraine (CM). It is unclear whether three cycles are better than two to assess early BT-A response. Methods: We performed a retrospective analysis on real-life prospectively collected data in 16 European headache centers. All the centers provided data on patients treated with BT-A for CM over the first three cycles of treatment. For each treatment cycle we defined patients as “good responders” if reporting a ≥ 50% reduction in monthly headache days compared with the three months before starting BT-A, “partial responders” if reporting a 30–49% reduction in monthly headache days, and “non-responders” if reporting a < 30% reduction in monthly headache days or stopping the treatment before the third cycle. Results: We included 2879 patients. Seven hundred and eighty-four (64.6%) of the 1213 patients reporting a good response during the first and/or the second cycle had a good response during the third cycle; 309 (49.3%) of the 627 patients reporting a partial response (but no good response) during the first and/or the second cycle had a good response during the third cycle; only 65 (6.3%) of the 1039 patients who did not respond during both the first two cycles achieved a good response during the third cycle. Multivariate analyses showed that partial or good response during the first or the second cycle were independently associated with good response during the third cycle. Conclusions: Our data suggest that patients with CM responding to BT-A during the first two cycles will likely benefit from the third cycle of treatment, while the probability that non-responders to the first two cycles start responding during the third cycle is low. These results can help guide the individual decision to stop or continue treatment after the second cycle in patients who have not responded to the first two cycles.
KW - Chronic migraine
KW - Multicenter study
KW - OnabotulinumtoxinA
KW - Real-life evidence
UR - http://www.scopus.com/inward/record.url?scp=85103373254&partnerID=8YFLogxK
U2 - 10.1007/s40122-021-00253-0
DO - 10.1007/s40122-021-00253-0
M3 - Article
AN - SCOPUS:85103373254
SN - 2193-8237
VL - 10
SP - 637
EP - 650
JO - Pain and Therapy
JF - Pain and Therapy
IS - 1
ER -