P047 | ONABOTULINUMTOXIN-A EFFECTIVENESS EVALUATION IN CHRONIC MIGRAINE PATIENTS WITH SHORT OR LONG DISEASE HISTORY AND PSYCHIATRIC COMORBIDITIES: AN ITALIAN MULTICENTRIC STUDY (THE BACH STUDY)
F. Vernieri1|2, P. Pasqualetti3, M. Marcosano1|2, N. Brunelli4, L. Fofi1, D. Antonio Montisano5, L. Grazzi5, R. Ornello6, C. Rosignoli6, A. Doretti7, E. Colombo7, M. Albanese8, G. Viticchi9, S. Migliore6, S. Sacco6, C. Altamura1|2 | 1Headache and Neurosonology Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Roma, Italy; 2Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Italy; 3Section of Health Statistics and Biometry, Department WHES (Wellbeing, Health & Environmental Sustainability), Sapienza University of Rome, Italy; 4Department of Neurology, Vall d’Hebron Research Institute, Barcelona, Spain; 5Headache Center, IRCCS Fondazione Istituto Neurologico "Carlo Besta", Milano, Italy; 6Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, Italy; 7Department of Systems Medicine, University of Rome Tor Vergata, Italy; 8IRCCS Istituto Auxologico Italiano, Milano, Italy; 9Neurological Clinic, Experimental and Clinical Medicine Department, Marche Polytechnic University, Ancona, Italy
Abstract
Background. Onabotulinumtoxin-A (OBT-A) is a worldwide approved preventive treatment for patients suffering from Chronic Migraine (CM). The aim of the study was to o investigate whether the disease duration for over or less than 10 years can predict OBT-A effectiveness in patients with CM and to evaluate if psychopathological profile may influence their outcome.
Methods. We considered consecutive CM patients undergoing OBT-A treatment for the first time and collected Monthly Headache Days (MHDs), number of Monthly Acute Medications (MAMs), pain intensity by Numerical Rating Score (NRS), Head Impact Test (HIT-6) and Migraine Disability Assessment questionnaire (MIDAS) scores at baseline and after 3, 6, 9 and 12 months. The psychopathological profile was evaluated by Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI-Y), Toronto Alexithymia Scale (TAS-20) at baseline, 6 and 12 months. Effectiveness of OBT-A was also evaluated by the 4D Migraine composite scale, including 4 parameters: MHD, MAMs, NRS and MIDAS scores.
Results. We enrolled 183 patients (mean age 46.8 yrs, SD 15.7; 158 female); at baseline 67% had a CM history longer than 10 years, 37% were affected by depression, 36% by alexithymia and 9% by anxiety. The MHD, MAMs, MIDAS, HIT-6, NRS and 4D scores significantly decreased (p<.001) across the follow-up in the whole sample. In almost all cases, the trend was not influenced by disease duration, psychiatric comorbidities, or by their combination (p>0.05). Also TAS, STAI and BDI scores decreased during the one-year follow-up, suggesting a positive effect of OBT-A treatment also on psychiatric comorbidities. Those three scores decreased more in alexithymic, anxious and depressed patients beyond what expected for the regression-to-the-mean effect. However, those patients who presented BDI higher scores at 12 months in our sample tended to have lower benefit from the OBT-A treatment in the long term.
Conclusions. In our study OBT-A effectiveness was neither affected by disease history nor by psychiatric comorbidities. People with higher BDI scores at 12 months tended to have less benefit from the treatment.
Methods. We considered consecutive CM patients undergoing OBT-A treatment for the first time and collected Monthly Headache Days (MHDs), number of Monthly Acute Medications (MAMs), pain intensity by Numerical Rating Score (NRS), Head Impact Test (HIT-6) and Migraine Disability Assessment questionnaire (MIDAS) scores at baseline and after 3, 6, 9 and 12 months. The psychopathological profile was evaluated by Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI-Y), Toronto Alexithymia Scale (TAS-20) at baseline, 6 and 12 months. Effectiveness of OBT-A was also evaluated by the 4D Migraine composite scale, including 4 parameters: MHD, MAMs, NRS and MIDAS scores.
Results. We enrolled 183 patients (mean age 46.8 yrs, SD 15.7; 158 female); at baseline 67% had a CM history longer than 10 years, 37% were affected by depression, 36% by alexithymia and 9% by anxiety. The MHD, MAMs, MIDAS, HIT-6, NRS and 4D scores significantly decreased (p<.001) across the follow-up in the whole sample. In almost all cases, the trend was not influenced by disease duration, psychiatric comorbidities, or by their combination (p>0.05). Also TAS, STAI and BDI scores decreased during the one-year follow-up, suggesting a positive effect of OBT-A treatment also on psychiatric comorbidities. Those three scores decreased more in alexithymic, anxious and depressed patients beyond what expected for the regression-to-the-mean effect. However, those patients who presented BDI higher scores at 12 months in our sample tended to have lower benefit from the OBT-A treatment in the long term.
Conclusions. In our study OBT-A effectiveness was neither affected by disease history nor by psychiatric comorbidities. People with higher BDI scores at 12 months tended to have less benefit from the treatment.
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