Abstract
Onabotulinum toxin A (OnabotA) cyclic treatment is approved for the prophylactic treatment of chronic migraine (CM), a highly disabling disorder. Although treatment response varies among patients, current guidelines suggest to stop treatment after cycle 2 if no response is achieved. This prospective study aimed to define, in real-life setting, the evolution of the response to OnabotA over five cycles of treatment among patients non-responding to cycle 1. The results of this study might help in decision-making, in particular whether prosecuting OnabotA further or not, when facing a patient not responding to cycle 1. Patients failing to respond at cycle 1 were recruited to complete five cycles. Key outcomes were: (i) a ≥50% reduction in headache days, (ii) a ≥50% reduction in total cumulative hours of headache on headache days and (iii) a ≥5-point improvement in Headache Impact Test-6 (HIT-6) scores. Overall, 56 patients were included. Mean age was 45.7 years (female 83.9%). Severe (≥60) HIT-6 score was reported at baseline by 95.8% of patients. Responders (headache days reduction of more than 50%) progressively increased cycle after cycle, doubling from cycle 2 to cycle 5 (from 27 to 48%). In addition, patients regressed from CM to episodic migraine moving on with each cycle, with 78% of them reaching less than nine migraine days/month after cycle 5. The headache days per month decreased significantly from cycle 1 to cycle 5 (overall from 23.3 ± 5.7 to 9.2 ± 3.6; p < 0.001). During 12 months (5 cycles), migraine days per month progressively abated (from 18.5 to 8.7; p < 0.001), days with symptomatic medications intake/month consistently decreased (from 17.4 to 8.1; p < 0.001), and mean HIT-6 score lowered (from 72.4 ± 5.7 to 50.2 ± 4.3; p < 0.001). The positive effect of OnabotA treatment spreads over the course of the treatment and might also manifest late in treatment course among patients with no benefit after the first two cycles. Thus, the results of this real-life study suggest to extend OnabotA treatment further, beyond cycle 2, to avoid premature withdrawal in patients who would have become responders at cycle 3, 4, or 5.
Highlights
Chronic migraine (CM) is the most disabling migraine headache disorder, involving 2% of the general population, with an estimated incidence of about 2.5% per year [1, 2]
Onabotulinum toxin A (OnabotA) is the only preventive treatment approved for CM based on efficacy and safety data from randomized controlled trials, with efficacy being confirmed in patients with medication-overuse headache (MOH) [5, 7,8,9,10]
This open-label, single-arm, prospective, observational study has been conducted in accordance with the principles of the Abbreviations: CM, chronic migraine; EM, episodic migraine; HIT-6, Headache Impact Test-6; MOH, medication-overuse headache; OnabotA, onabotulinum toxin A
Summary
Chronic migraine (CM) is the most disabling migraine headache disorder, involving 2% of the general population, with an estimated incidence of about 2.5% per year [1, 2]. CM has an outstanding impact on health-related quality of life, work productivity, and health-care resource utilization [4]. A remarkable proportion of patients overuse symptomatic medications, developing medication-overuse headache (MOH), needing detoxification and specific prophylactic treatments [3, 5]. Onabotulinum toxin A (OnabotA) is the only preventive treatment approved for CM based on efficacy and safety data from randomized controlled trials, with efficacy being confirmed in patients with MOH [5, 7,8,9,10]. OnabotA efficacy and safety have been confirmed in real-life studies, with significant positive impact on comorbid depression, anxiety, and health-related quality of life [11,12,13,14,15,16]. Several questions are unanswered: whether patients not responding to the first cycle of treatment might respond to subsequent cycles is one of the most relevant
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