Is There a Gender Difference in the Response to onabotulinumtoxinA in Chronic Migraine? Insights from a Real-Life European Multicenter Study on 2879 Patients
Ornello, Raffaele (University of L'Aquila. Department of Applied Clinical Sciences and Biotechnology)
Ahmed, Fayyaz (Hull University Teaching Hospitals. Department of Neurosciences)
Negro, Andrea (Sapienza University. Department of Clinical and Molecular Medicine)
Miscio, Anna Maria (Fondazione IRCCS "Casa Sollievo della Sofferenza". Unit of Neurology)
Santoro, Antonio (Fondazione IRCCS "Casa Sollievo della Sofferenza". Unit of Neurology)
Alpuente, Alicia (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Russo, Antonio (University of Campania "Luigi Vanvitelli". Department of Medical, Surgical, Neurological, Metabolic, and Aging Sciences)
Silvestro, Marcello (University of Campania "Luigi Vanvitelli". Department of Medical, Surgical, Neurological, Metabolic, and Aging Sciences)
Cevoli, Sabina (IRCCS Istituto delle scienze Neurologiche di Bologna)
Brunelli, Nicoletta (Campus Bio-Medico University Hospital. Headache and Neurosonology Unit)
Vernieri, Fabrizio (Campus Bio-Medico University Hospital. Headache and Neurosonology Unit)
Grazzi, Licia (IRCCS Foundation "Carlo Besta" Neurological Institute. Neurology Department)
Baraldi, Carlo (University of Modena and Reggio Emilia. Department of Biomedical, Metabolic and Neural Sciences)
Guerzoni, Simona (University of Modena and Reggio Emilia. Department of Biomedical, Metabolic and Neural Sciences)
Andreou, Anna P. (Guy's and St Thomas' NHS Foundation Trust. Headache Service)
Lambru, Giorgio (Guy's and St Thomas' NHS Foundation Trust. Headache Service)
Kamm, Katharina (Ludwig Maximilians University München. Department of Neurology)
Ruscheweyh, Ruth (Ludwig Maximilians University München. Department of Neurology)
Russo, Marco (Azienda USL-IRCCS di Reggio Emilia. Neuromotor and Rehabilitation Department)
Torelli, Paola (University of Parma. Headache Center)
Filatova, Elena (Sechenov First Moscow State Medical University (Sechenov University). Department of Neurology)
Latysheva, Nina (Sechenov First Moscow State Medical University (Sechenov University). Department of Neurology)
Gryglas-Dworak, Anna (Headache Center Wroclaw)
Straburzyński, Marcin (Headache Clinic (Warsaw, Poland))
Butera, Calogera (IRCCS San Raffaele Scientific Institute. Neurophysiology Service)
Colombo, Bruno (IRCCS San Raffaele Scientific Institute (Milà, Itàlia). Neurology Unit)
Filippi, Massimo (IRCCS San Raffaele Scientific Institute. Neurorehabilitation Unit)
Pozo-Rosich, Patricia (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Martelletti, Paolo (Sapienza University. Department of Clinical and Molecular Medicine)
Sacco, Simona (University of L'Aquila. Department of Applied Clinical Sciences and Biotechnology)
Universitat Autònoma de Barcelona

Date:	2021
Abstract:	Migraine is mostly a female disorder because of its lower prevalence in men. Less than 20% of patients included in the available studies on migraine treatments are men; hence, the evidence on migraine treatments might not apply to men. The aims of the present study were to provide reliable information on the effectiveness of onabotulinumtoxinA (BT-A) for chronic migraine in men and to compare clinical benefits between men and women. We performed a pooled patient-level gender-specific analysis of real-life data on BT-A for chronic migraine of patients followed-up to 9 months. We reported the 50% responder rates during each BT-A cycle, defined as percentage of reduction in monthly headache days (MHDs) compared to baseline, along with 75% and 30% responder rates. We also reported the mean decrease in MHDs and in days of acute medication use (DAMs) during each BT-A cycle as compared to baseline. We also evaluated the reasons for stopping the treatment within the third cycle. We included an overall cohort of 2879 patients, 522 of whom (18. 1%) were men. In men, 50% responder rates were 27. 7% during the first BT-A cycle, 29. 2% during the second, and 35. 6% during the third cycle; in women, the corresponding rates were 26. 6%, 33. 5%, and 41. 0%. In the overall cohort, responder rates did not differ between men and women during the first two cycles; during the third cycle, the distribution was different (P < 0. 001) mostly because of higher rates of treatment stopping and non-responders in men. In the propensity score matched cohort, the trend was maintained but lost its statistical significance. Both men and women had a significant decrease in MHDs and in DAMs with BT-A treatment (P < 0. 001). There were no gender differences in those changes with the only exception of MHD decrease which, during the third cycle, was lower in men than in women (7. 4 vs 8. 2 days, P = 0. 016 in the overall cohort and 9. 1 vs 12. 5 days, P = 0. 009 in the propensity score matched cohort). At the end of follow-up, 152 men and 485 women stopped BT-A treatment (29. 1% vs 20. 6%; P < 0. 001). The relative proportion of patients stopping treatment because of inadequate response (less than 30% decrease in MHDs from baseline) was higher in men than in women (42. 8% vs 39. 6%), while the proportion of patients stopping because of adverse events was higher in women than in men (5. 6% vs 0%; P = 0. 031). Our pooled analysis suggests that the response to BT-A is significant in both men and women with a small gender difference in favor of women. Men tended to stop the treatment more frequently than women. We emphasize the need for more gender-specific data on migraine treatments from randomized controlled trials and observational studies. The online version contains supplementary material available at 10. 1007/s40122-021-00328-y.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Estudi clínic ; recerca ; Versió publicada
Subject:	Migraine ; OnabotulinumtoxinA ; Chronic migraine ; Men ; Gender difference
Published in:	Pain and Therapy, Vol. 10 (september 2021) , p. 1605-1618, ISSN 2193-651X

DOI: 10.1007/s40122-021-00328-y
PMID: 34564833

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