Real-world effectiveness of onabotulinumtoxinA treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study

Stark, Catherine; Stark, Richard; Limberg, Nicole; Rodrigues, Julian P.; Cordato, Dennis; Schwartz, Raymond; Jukic, Robert

doi:10.1186/s10194-019-1030-z

Cited by 24 publications

(33 citation statements)

References 25 publications

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“…The phase 3 PREEMPT trials demonstrated that onabotulinumtoxinA significantly reduced the frequency of headaches and migraine days compared with placebo 30–32. Our findings concurred with those from many observational studies that have confirmed the safety and efficacy of onabotulinumtoxinA for the prevention of chronic migraine 16 18–23. The proportion of patients achieving a ‘good response’ (defined as ≥50% reduction in headache days per month) in our study was 88%, which was notably higher than the ‘good response’ rate reported in other real-world evidence studies (74% reported by Stark et al ,23 46% for headache reduction and 74% for migraine reduction reported by Kalil et al 19 and 39.5% at week 24% and 61.1% at week 108 reported by the COMPEL study 18.…”

Section: Discussionsupporting

confidence: 91%

“…Currently, onabotulinumtoxinA treatment is one of the most successful management approaches for chronic migraine 18–23. Three recent studies found that prophylactic onabotulinumtoxinA treatment for chronic migraine was associated with statistically significant improvements in depression and anxiety symptoms16–18 and that this improvement in comorbid depression and anxiety may be independent of the reduction in headache frequency.…”

Section: Introductionmentioning

confidence: 99%

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Cognitive effects of onabotulinumtoxinA in chronic migraine

Darby

Bear³

2020

BMJ Neurol Open

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BackgroundChronic migraine is a disabling condition, often associated with comorbidities including cognitive dysfunction, anxiety and depression. It is unclear whether cognitive complaints are associated with the underlying migraine pathophysiological process or related to drugs or comorbidities of depression and anxiety.ObjectiveTo evaluate cognitive changes in chronic migraine and assess reversibility of cognitive dysfunction following effective migraine treatment using onabotulinumtoxinA.MethodsThis was a prospective real-world study of 60 patients with chronic migraine treated with onabotulinumtoxinA. Headache diaries recorded total headache days at baseline and duration of 12 weeks post-treatment. Computerised cognitive tests of reaction time and working memory (WM) speed and accuracy using a purpose-specific website was implemented at baseline, 6 weeks and 12 weeks. The Patient Health Questionnaire (PHQ-9) and Penn State Worry Questionnaire-Past Week (PSWQ-PW) were administered for depression and anxiety levels. Associations between clinical response, cognitive parameters, PHQ-9 and PSWQ-PW were analysed.ResultsAt 6 weeks post-treatment, 88% patients achieved good response (≥50% reduction in headache frequency) with improvement of PHQ-9, PSWQ-PW, cognitive speed tests and WM accuracy compared with baseline (all p<0.05). There was no overall correlation between good headache response and improved cognitive measures and no association between good headache response and improved PHQ-9 and PSWQ-PW scores. Improved WM accuracy correlated with reduced PSWQ-PW (p=0.047). There was no correlation between improved WM accuracy and reduced PHQ-9.ConclusionsOnabotulinumtoxinA treatment for chronic migraine improved anxiety, depression and cognitive performances but these improvements did not correlate with reduction in headache and migraine frequency. Improved WM accuracy was significantly associated with reduced anxiety level.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Cognitive effects of onabotulinumtoxinA in chronic migraine

Darby

Bear³

2020

BMJ Neurol Open

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“…Onabotulinumtoxin A (BT-A) is a safe and effective preventive treatment for CM, as shown in the Phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials [8][9][10][11][12]. Several real-life studies confirmed its safety and efficacy in clinical practice [13][14][15][16][17][18][19][20][21][22] and showed that a shorter disease duration, some characteristics of headache (ocular, imploding), allodynia, and the absence of medication overuse and depressive symptoms are predictors of clinical response [23][24][25][26][27][28][29][30][31][32][33]. However, it is common experience to observe fluctuations in the clinical response to BT-A as to other preventive treatments.…”

Section: Introductionmentioning

confidence: 97%

Sustained response to onabotulinumtoxin A in patients with chronic migraine: real-life data

et al. 2020

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Background: Treatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM). Several studies assessed possible predictors of response to treatment with BT-A, but there is little knowledge on the frequency and predictors of sustained response. The aim of this study was to evaluate sustained response to BT-A in patients with CM. Main body: In this prospective open-label study, 115 patients with CM and treated with BT-A were consecutively enrolled in two Italian headache centers and followed up for 15 months. Anytime responders were defined as those patients who achieved a ≥ 50% reduction in headache days during any three-month treatment cycle compared with the 3 months prior to initiation of BT-A treatment. Sustained responders were defined as those who achieved a ≥ 50% reduction in headache days within the third treatment cycle and maintained response until the end of follow-up. Non-responders were defined as those patients who never achieved a ≥ 50% reduction in headache days during the follow-up. Headache characteristics prior to BT-A treatment were assessed in order to evaluate their ability in predicting treatment response. The 115 enrolled patients (84.3% female; median age 50 years) had a median migraine duration of 30 years (interquartile range 22-38). At the end of follow-up, 66 patients (57.4%) were classified as anytime responders. Among the 51 patients who achieved a clinical response within the third month of treatment, 33 (64.7%) were sustained responders. Patients with sustained response had a lower CM duration (median 31 vs 65 months; P = 0.030) and a lower number of headache days (median 25 vs 30; P = 0.013) at baseline compared with nonresponders. Conclusions: About two thirds of patients who gain ≥50% response to BT-A within the third cycle of treatment maintain this positive response over time. More recent onset of CM and more headache-free days at baseline are associated with sustained response. We suggest not to delay preventive treatment of CM with BT-A, in order to increase the likelihood to achieve sustained clinical response.

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“…Onabotulinumtoxin A (BT-A) is a safe and effective preventive treatment for CM, as shown in the Phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials [7][8][9][10][11]. Several real-life studies confirmed its safety and efficacy in clinical practice [12][13][14][15][16][17][18][19][20][21] and showed that a shorter disease duration, some characteristics of headache (ocular, imploding), allodynia, and the absence of medication overuse and depressive symptoms are predictors of clinical response [22][23][24][25][26][27][28][29][30][31][32]. However, it is common experience to observe fluctuations in the clinical response to BT-A as to other preventive treatments.…”

Section: Introductionmentioning

confidence: 97%

Sustained Response To Onabotulinumtoxin A In Patients With Chronic Migraine: Real-Life Data

Ornello

Guerzoni

Baraldi

et al. 2020

Preprint

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Background Treatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM). Several studies assessed possible predictors of response to treatment with BT-A, but there is little knowledge on the frequency and predictors of sustained response. The aim of this study was to evaluate sustained response to BT-A in patients with CM. Main body In this prospective open-label study, 115 patients with CM and treated with BT-A were consecutively enrolled in two Italian headache centers and followed up for 15 months. Anytime responders were defined as those patients who achieved a ≥50% reduction in headache days during any three-month treatment cycle compared with the three months prior to initiation of BT-A treatment. Sustained responders were defined as those who achieved a ≥50% reduction in headache days within the third treatment cycle and maintained response until the end of follow-up. Non-responders were defined as those patients who never achieved a ≥50% reduction in headache days during the follow-up. Headache characteristics prior to BT-A treatment were assessed in order to evaluate their ability in predicting treatment response. The 115 enrolled patients (84.3% female; median age 50 years) had a median migraine duration of 30 years (interquartile range 22-38). At the end of follow-up, 66 patients (57.4%) were classified as anytime responders. Among the 51 patients who achieved a clinical response within the third month of treatment, 33 (64.7%) were sustained responders. Patients with sustained response had a lower CM duration (median 31 vs 65 months; P=0.030) and a lower number of headache days (median 25 vs 30; P=0.013) at baseline compared with non-responders. Conclusions About two thirds of patients who gain ≥50% response to BT-A within the third cycle of treatment maintain this positive response over time. More recent onset of CM and more headache-free days at baseline are associated with sustained response. We suggest not to delay preventive treatment of CM with BT-A, in order to increase the likelihood to achieve sustained clinical response.

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Real-world effectiveness of onabotulinumtoxinA treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study

Cited by 24 publications

References 25 publications

Cognitive effects of onabotulinumtoxinA in chronic migraine

Cognitive effects of onabotulinumtoxinA in chronic migraine

Sustained response to onabotulinumtoxin A in patients with chronic migraine: real-life data

Sustained Response To Onabotulinumtoxin A In Patients With Chronic Migraine: Real-Life Data

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