OnabotulinumtoxinA in chronic migraine: predictors of response. A prospective multicentre descriptive study

Domínguez, Carlos; Pozo‐Rosich, Patricia; Torres‐Ferrús, Marta; Hernández-Beltrán, Natalia; Jurado-Cobo, C.; González-Oria, C.; Santos, Sonia Barbosa dos; Monzón, M.J.; Latorre, G.; Álvaro, L.C.; Gago, Ana; Gallego, M.; Medrano, V.; Huerta, Mariano Jiménez; García-Alhama, Jessica; Belvís, R.; Leira, Yago; Leira, Rogelio

doi:10.1111/ene.13523

Cited by 73 publications

(79 citation statements)

References 39 publications

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“…However, this is not always easy due to the delay in diagnosis or in reaching specialized headache units . Other studies have found the time of migraine chronification as an important point to consider, without it being statistically significant in our study. One of the reasons for this difference, could be that the time of chronification of our cohort is much higher than that of the Dominguez et al study.…”

Section: Discussioncontrasting

confidence: 63%

“…However, we did not consider that this missingness could have a significant biasing effect in the results presented because discontinuation and treatment response rate were quite similar to published data: In the PREEMPT clinical trials, we observed that a 13.2% of patients discontinued from the trials (similar proportions of patients than in our data, 13.7%) and the change from baseline in monthly headache frequency at week 24 were also equivalent in both studies (PREEMPT: −8.3 days/month, this study: −9.1 days/month). Regarding the response rate, 75% response rate was not calculated in the PREEMPT but Dominguez et al work, the excellent response at month 12 was 27.3% (25.3% in our data).…”

Section: Discussioncontrasting

confidence: 58%

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Short and Mid‐Term Predictors of Response to OnabotulinumtoxinA: Real‐Life Experience Observational Study

et al. 2020

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Objective To identify clinical predictors of excellent response to OnabotulinumtoxinA in patients with chronic migraine (CM) at 6 and 12 months of follow‐up. Background Clinical predictors of response to OnabotulinumtoxinA are scarce and have not been clearly reproduced and analyzed in detail. So far, predictors of response to OnabotulinumtoxinA assess response in general or good response, but not an excellent response. Methods Cohort study of patients attended in a specialized Headache Clinic in treatment with OnabotulinumtoxinA were classified according to their improvement in frequency: no‐response (<25%) and excellent response (≥75%). A comparative analysis was carried out at 6 and 12 months identifying clinical predictors of excellent response to OnabotulinumtoxinA at each timepoint. Results Data were collected from 221 patients. After 6 and also 12 months, we observed a statistically significant mean reduction in frequency and analgesic intake. At month 6, independent variables associated with excellent response (OR[95%CI]) were daily headache frequency (0.32[0.14‐0.74]; P = .005), medication overuse (MO) (2.28[1.19‐4.37]; P = .013), and a higher ratio of migraine days/month (MDM) (1.20[1.10‐1.45]; P = .018) at baseline. At month 12, independent predictors of excellent response were patients with less than 30 years of migraine evolution (0.43[0.23‐0.82]; P = .011), presence of anxiety (0.44[0.23‐0.85]; P = .018), and aura (0.48[0.25‐0.92]; P = .037). Excellent responders showed a higher improvement rate in pain intensity at 6 and 12 months. Conclusions Patients with daily frequency and MO show a clinical improvement in short‐term. Patients with comorbidities who start treatment earlier in the course of the disease need a longer duration of treatment. The profile of response to treatment with OnabotulinumtoxinA determines its minimum treatment duration and the timepoint of a meaningful response.

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Section: Discussioncontrasting

confidence: 63%

Section: Discussioncontrasting

confidence: 58%

Short and Mid‐Term Predictors of Response to OnabotulinumtoxinA: Real‐Life Experience Observational Study

et al. 2020

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“…In addition, our study could help answer common questions in daily clinical practice regarding the decision on when to stop treatment with onabotulinumtoxinA due to its efficacy or futility. Moreover, our results add information to the current knowledge of treatment in real life with onabo-tulinumtoxinA; mainly [15] treating early after migraine becomes chronic is a clinical predictor of good response; the initial gain (6 months) is based on frequency and the improvement at mid to long term is based on pain intensity, leading, with a good preventative treatment, to a controlled evolution of the natural cycles of migraine.…”

Section: Discussionmentioning

confidence: 60%

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Alpuente

Gallardo

Torres‐Ferrús

et al. 2019

Euro J of Neurology

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Background and purpose The aim was to analyse the clinical characteristics of a long‐term follow‐up of patients with chronic and high‐frequency episodic migraine in treatment with onabotulinumtoxinA. Methods Patients diagnosed with high‐frequency episodic migraine (HFEM) or chronic migraine (CM) according to the International Classification of Headache Disorders 3 beta were included. A comparative analysis was carried out at each study time point identifying outcome measures according to initial diagnosis and treatment duration. Results In all, 578 patients were recruited and after 24 months outcome data were collected from 100 patients: 84.0% CM and 16.0% HFEM. After 24 months, headache frequency was significantly reduced by 10.5 days from baseline, 64.0% reported a ≥50% reduction in pain intensity and 70.0% of patients had ≥50% reduction in analgesic use. Comparing baseline diagnoses, at month 6 CM patients presented higher mean reduction in frequency (CM 44.3% ± 32.6% vs. HFEM 34.6% ± 24.8%) and analgesic use (CM 53.6% ± 35.4% vs. HFEM 39.3% ± 33.2%). At month 12, the mean reduction in frequency was similar in CM and HFEM patients (CM 44.7% ± 33.4% vs. HFEM 41.2% ± 28.2%). Improvement in pain intensity, analgesic use and Migraine Disability Assessment were proportional in both diagnoses. Conclusions OnabotulinumtoxinA efficacy is significant at 6 months in frequency and analgesic intake and remains stable during follow‐up, whilst the intensity of pain decreases in a stepwise manner at each time point of the analysis. The improvement in CM and HFEM patients is proportional and significant after 1 year of treatment.

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“…Such vulnerability is most concerning for patients with CM who may be more susceptible to CS compared to patients with episodic migraine. 13,16,45 This phenomenon may be related to a lapse in duration of effect because of the standard 12-week injection interval used in the studies. By providing a sustained therapeutic effect from optimal injection cycle durations, the goal of suppression of CS can be achieved.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, BoNTA has a dual mechanism of action with effects on sensory and motor nerves. [13][14][15][16] Of note, 2 large studies on the use of BoNTA for chronic daily headaches adopted an injection interval of 90 days. [5][6][7][8][9][10] Compared to other pharmacologic prophylactic therapies, onabotu-linumtoxinA is beneficial, for it does not require daily dosing and is not associated with common cognitive side effects.…”

Section: Introductionmentioning

confidence: 99%

Wearing Off Effect of OnabotulinumtoxinA Near the End of Treatment Cycle for Chronic Migraine: A 4‐Year Clinical Experience

et al. 2019

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Introduction.-The injection interval for onabotulinumtoxinA (BoNTA) in the management of chronic migraine (CM) is 12 weeks (78-84 days). The aim of this study was to review patient-reported wearing off effect (WOE) of the therapeutic benefit of BoNTA near the end of the treatment cycle. We intended to describe the demographics of patients at baseline and compare groups of patients with multiple episodes of WOE.Methods.-We conducted a retrospective review of patients with CM who . The data from patient-reported WOE (worsening headache variables and neck pain) that occurred during the 4 weeks (28 days) prior to the scheduled re-injection of BoNTA for treatment cycles with injection interval ≤13 weeks and without obvious confounding factors were reviewed.Results.-We identified 98 eligible patients and analyzed 471 treatment cycles. Forty-three unique patients reported at least 1 occurrence of WOE. About 24/43 patients reported 1 WOE event and 19/43 patients reported ≥2 WOE events. Between the 2 groups, anxiety disorder and opioid use for headache were statistically significantly different. In the former group, the median interquartile range (IQR) dose of BoNTA was 165 (155, 175) units and the median IQR duration of the antinociceptive effect of BoNTA was 66.5 (63, 71.5) days. In the latter group, the median IQR dose of BoNTA was 167 (155, 173.3) units and the median IQR duration of the antinociceptive effect of BoNTA was 65.3 (62.5, 68.8) days. Up to 32% of these patients reported an increase in the use of abortive therapies to manage the symptoms of WOE. Discussion.-The primary goal of BoNTA in the treatment of CM is to mitigate the development of central sensitization. Since the 12-week injection paradigm may not provide sustained antinociceptive effect in all patients, it may account for the failure of response to BoNTA. Repeated occurrences of the WOE can potentially lead to medication overuse and impact quality of life.

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OnabotulinumtoxinA in chronic migraine: predictors of response. A prospective multicentre descriptive study

Abstract: This study confirmed the effectiveness of treatment with OnabotulinumtoxinA after 1 year of treatment. The chances of a good outcome may be increased by starting treatment in the first 12 months after chronic migraine diagnosis.

Cited by 73 publications

References 39 publications

Short and Mid‐Term Predictors of Response to OnabotulinumtoxinA: Real‐Life Experience Observational Study

Short and Mid‐Term Predictors of Response to OnabotulinumtoxinA: Real‐Life Experience Observational Study

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Wearing Off Effect of OnabotulinumtoxinA Near the End of Treatment Cycle for Chronic Migraine: A 4‐Year Clinical Experience

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