scholarly journals The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Stephen D. Silberstein ◽  
Joshua M. Cohen ◽  
Michael J. Seminerio ◽  
Ronghua Yang ◽  
Sait Ashina ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Medication Overuse ◽  
Humanized Monoclonal Antibody ◽  
Acute Medication ◽  
Calcitonin Gene ◽  
Acute Headache ◽  
Post Hoc ◽  
The Impact ◽  
Adjusted Least Squares

Abstract Background We evaluated the efficacy of fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, in patients with chronic migraine (CM) with and without medication overuse (MO). Methods In a 12-week, phase 3 trial, patients with CM were randomized to fremanezumab quarterly (675 mg/placebo/placebo), monthly (675 mg/225 mg/225 mg), or placebo. Post hoc analyses assessed the impact of fremanezumab in patients with and without MO (monthly use of acute headache medication ≥15 days, migraine-specific acute medication ≥10 days, or combination medication ≥10 days) on efficacy outcomes, including headache days of at least moderate severity (HDs), and six-item Headache Impact Test (HIT-6) and Migraine-Specific Quality of Life (MSQoL) questionnaire scores. Results Of 1130 patients enrolled, 587 (51.9%) had baseline MO. Fremanezumab reduced placebo-adjusted least-squares mean (95% confidence interval) monthly HDs (− 2.2 [− 3.1 to − 1.2] and − 2.7 [− 3.7 to − 1.8]; P < 0.0001) in patients with MO and without MO (quarterly − 1.4 [− 2.3 to − 0.5], P = 0.0026; monthly − 1.4 [− 2.3 to − 0.6], P = 0.0017). Significantly more fremanezumab-treated patients had ≥ 50% reduction in HDs versus placebo, regardless of baseline MO (with: quarterly 70/201 [34.8%], monthly 78/198 [39.4%] vs placebo 26/188 [13.8%]; without: quarterly 71/174 [40.8%], monthly 75/177 [42.4%] vs placebo 41/183 [22.4%]). Fremanezumab improved HIT-6 and MSQoL scores. Significantly more fremanezumab-treated patients reverted to no MO (quarterly 111/201 [55.2%], monthly 120/198 [60.6%]) versus placebo (87/188 [46.3%]). Conclusions Fremanezumab is effective for prevention of migraine in patients with CM, regardless of MO, and demonstrated a benefit over placebo in reducing MO. Trial registration ClinicalTrials.gov NCT02621931 (HALO CM), registered December 12, 2012.

scholarly journals P.033 Eptinezumab reduced acute medication use in patients with chronic migraine and medication-overuse headache: subgroup analysis of Promise-2

2021 ◽  
Vol 48 (s3) ◽  
pp. S29-S29
Author(s):  
MJ Marmura ◽  
H Diener ◽  
J Hirman ◽  
R Cady ◽  
T Brevig ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Medication Overuse ◽  
Medication Overuse Headache ◽  
Baseline Period ◽  
Migraine Treatment ◽  
Medication History ◽  
Medication Class ◽  
The Us ◽  
Acute Headache ◽  
The Impact

Background: Eptinezumab is a preventive migraine treatment approved in the US. We evaluated the impact of eptinezumab on acute headache medication (AHM) use in patients diagnosed with chronic migraine (CM) and medication-overuse headache (MOH) in PROMISE-2. Methods: PROMISE-2 randomized patients with CM to eptinezumab 100mg, 300mg, or placebo for 2 intravenous doses administered every 12 weeks. Trained investigators diagnosed MOH at screening using 3-month medication history and ICHD-3b criteria. Endpoints included days/month of any AHM use (days of ≥1 medication class), total AHM use (summed days for each medication class), and triptan use over Weeks 1-12 and 13-24. AHM classes included triptan, ergot, opioid, simple analgesic, and combination analgesic. Results: Of 1072 PROMISE-2 patients, 431 (40.2%) were diagnosed with MOH (100mg, n=139; 300mg, n=147; placebo, n=145). During the 28-day baseline period, mean days of any AHM was ~16.4, total AHM was ~20.4, and triptan was ~8.9 across treatment arms. Over Weeks 1-12, mean days/month of any AHM was 8.8 (100mg), 9.9 (300mg), and 11.8 (placebo); total AHM was 10.8, 12.2, and 14.8; triptan was 4.3, 4.4, and 6.4. Similar or lower rates were observed over Weeks 13-24. Conclusions: In patients diagnosed with both CM and MOH, eptinezumab treatment reduced AHM use.

scholarly journals Pooled retrospective analysis of 70 mg erenumab in episodic and chronic migraine: a two tertiary headache centers experience during clinical practice

2021 ◽  
Author(s):  
P. Storch ◽  
P. Burow ◽  
B. Möller ◽  
T. Kraya ◽  
S. Heintz ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Retrospective Analysis ◽  
Medication Overuse ◽  
Real Life ◽  
Clinical Trial Data ◽  
Headache Intensity ◽  
Acute Medication ◽  
Calcitonin Gene ◽  
Before And After ◽  
Male Patients

AbstractErenumab is a monoclonal antibody, targeted against the calcitonin gene-related peptide (CGRP) receptor. Clinical studies have demonstrated prophylactic efficacy in both episodic (EM) and chronic migraine (CM). The aim of the present study is to evaluate the efficacy of treatment in tertiary headache centers under real-life conditions. In a retrospective analysis, the period of 3 months before and after initiation of erenumab therapy was compared. Relevant parameters (headache days, headache intensity, headache duration, acute medication, previous prophylaxis treatments) were collected from medical charts of all migraine patients (N = 82) who started treatment with erenumab between November 1st 2018 and May 1st 2019 at two tertiary headache centers in Germany. The sample included 68 female (82.9%) and 14 male patients aged between 22 and 78 years (mean 51.1 years, SD 10.5 years). Of these patients, 57.3% met the criteria for CM and 56.9% overused acute medication. Under therapy with erenumab, a significant reduction of headache days was observed from the first month on. The effect was most pronounced in the third month with a decrease in monthly headache days from 16.6 to 11.6 days (p < 0.001). There was also a significant reduction in reported headache intensity (p = 0.004) and average duration of headache attacks (p = 0.016). The 50% responder rate in patients with CM was lower in the first month compared to EM but then increased similarly to EM. Patients with medication overuse (MO) also responded to the therapy. There was a reduction in medication overuse from 57% at baseline to 29% after therapy (p = 0.011). Overall, a positive result of treatment with erenumab can be shown in a highly selected sample with severely affected migraine patients and a refractory course prior to treatment. This re-confirms the clinical trial data also for this highly selected group.

scholarly journals Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stewart J Tepper ◽  
Messoud Ashina ◽  
Uwe Reuter ◽  
Yngve Hallström ◽  
Gregor Broessner ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Medication Overuse Headache ◽  
Medication Use ◽  
Electronic Diary ◽  
Double Blind ◽  
Acute Medication ◽  
Specific Medication ◽  
Acute Headache ◽  
Post Hoc ◽  
Change In Mean

Abstract Background In patients with migraine, overuse of acute medication, including migraine-specific medication (MSM) such as triptans and ergots, can lead to adverse health outcomes, including development of medication overuse headache. Here, we examined the effect of erenumab on reducing acute medication use, in particular MSM, in patients with episodic migraine (EM) and chronic migraine (CM). Methods The current post-hoc analyses were based on data from the double-blind treatment phase (DBTP) of two erenumab studies, a pivotal EM (N = 955) and a pivotal CM (N = 667) trial, and their respective extensions. Patients were administered subcutaneous placebo or erenumab (70 or 140 mg) once monthly. Daily acute headache medication use (including MSM and non-MSM) was recorded using an electronic diary during a 4-week pretreatment baseline period until the end of the treatment period. Outcome measures included change in monthly acute headache medication days (HMD) in acute headache medication users at baseline, and changes in monthly MSM days (MSMD) in MSM users at baseline and non-MSMD in non-MSM users at baseline. Results In total, 60 and 78 % of patients (all acute headache medication users) with EM and CM used MSM at baseline, respectively. For acute headache medication users, the change in mean monthly acute HMD over Months 4, 5 and 6 compared with the pre-DBTP was 1.5, 2.5, and 3.0 for placebo, erenumab 70 mg and 140 mg, respectively for the EM study. The respective change in monthly MSMD in MSM users was 0.5, 2.1 and 2.8, and in monthly non-MSMD in non-MSM users was 2.3, 2.6, and 2.7. In the acute headache medication users at baseline, the change in monthly acute HMD at Month 3 compared with pre-DBTP was 3.4, 5.5, and 6.5 for placebo, erenumab 70 mg and 140 mg, respectively for the CM study. The respective change in monthly MSMD in MSM users was 2.1, 4.5, and 5.4, and in monthly non-MSMD in non-MSM users was 5.9, 6.4, and 6.6. Reductions in MSMD versus placebo were sustained in the extension periods of both studies. Erenumab was also associated with a higher proportion of MSM users achieving ≥ 50 %, ≥ 75 and 100 % reduction from baseline in monthly MSMD versus placebo in both EM and CM. Conclusions In both EM and CM, treatment with erenumab is associated with a significant and sustained reduction in the use of acute headache medication, in particular MSM. Trial registrations NCT02456740; NCT02066415; NCT02174861.

Utility of Topiramate for the Treatment of Patients with Chronic Migraine in the Presence or Absence of Acute Medication Overuse

Cephalalgia ◽  
2009 ◽  
Vol 29 (10) ◽  
pp. 1021-1027 ◽  
Author(s):  
H-C Diener ◽  
DW Dodick ◽  
PJ Goadsby ◽  
ME Bigal ◽  
G Bussone ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Sleep Disturbances ◽  
Medication Overuse ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
Efficacy And Safety ◽  
Acute Medication ◽  
Preventive Medication ◽  
The Usa ◽  
Acute Headache

Chronic migraine has been linked to the excessive use of acute headache medications. Medication overuse (MO) is commonly considered the most significant risk factor for the progression of migraine from an episodic to a chronic condition. Managing MO is a challenge. Discontinuation of the acute medication can result in withdrawal headache, nausea, vomiting and sleep disturbances. This review summarizes the results from two similarly designed, randomized, placebo- controlled, multicentre studies of chronic migraine conducted in the USA and European Union. Both studies demonstrate the efficacy and safety of the migraine preventive medication, topiramate, for the treatment of chronic migraine in patient populations both with and without MO. These studies may have important implications for the future of chronic migraine management, suggesting that detoxification prior to initiating prophylactic therapy may not be required in all patients if MO is present.

scholarly journals A Prospective Observational Cohort Study on Pharmacological Habitus, Headache-Related Disability and Psychological Profile in Patients with Chronic Migraine Undergoing OnabotulinumtoxinA Prophylactic Treatment

Toxins ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 504 ◽  
Author(s):  
Gandolfi ◽  
Donisi ◽  
Marchioretto ◽  
Battista ◽  
Smania ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Coping Strategies ◽  
Chronic Migraine ◽  
Prophylactic Treatment ◽  
Moderate Intensity ◽  
Psychological Profile ◽  
Factors Affecting ◽  
Acute Medication

Chronic Migraine (CM) is a disabling neurologic condition with a severe impact on functioning and quality of life. Successful therapeutic management of patients with CM is complex, and differences in therapeutic response could be attributable to genetically determined factors, sensitivity to pharmacological treatment, psychosocial and relational factors affecting the patient’s compliance and approach on the therapeutic treatment. The aim of this prospective observational study was to explore self-efficacy, coping strategies, psychological distress and headache-related disability in a cohort of 40 patients with CM (mean age: 46.73; standard deviation 13.75) treated with OnabotulinumtoxinA and the relationship between these clinical and psychological aspects and acute medication consumption during OnabotulinumtoxinA prophylactic treatment. Patients presented an overall significant reduction in the Headache Index (HI) (p < 0.001), HI with severe intensity (p = 0.009), and total analgesic consumption (p = 0.003) after the prophylactic treatment. These results are in line with the literature. Despite this, higher nonsteroidal anti-inflammatory drugs consumption was associated with higher psychological distress, higher HI with severe and moderate intensity, and worse quality of life. Conversely, triptans consumption was correlated with HI of mild intensity, and problem-focused coping strategies. To conclude, the psychological profile, and in particular, the psychological distress and specific coping strategies might influence the self-management of acute medication.

Low cognitive reserve is associated with chronic migraine with medication overuse and poor quality of life

Cephalalgia ◽  
2014 ◽  
Vol 35 (8) ◽  
pp. 683-691 ◽  
Author(s):  
Marian Gómez-Beldarrain ◽  
Ane Anton-Ladislao ◽  
Urko Aguirre-Larracoechea ◽  
Isabel Oroz ◽  
Juan Carlos García-Moncó
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Cognitive Reserve ◽  
Medication Overuse ◽  
Univariate Analysis ◽  
Poor Quality ◽  
Anxiety And Depression ◽  
Cross Sectional ◽  
Sf 36

Objective The objective of this article is to test the hypothesis that cognitive reserve (CR) is related to migraine chronification, medication overuse and poor quality of life in migraineurs. Design/methods A cross-sectional study on patients with chronic migraine with medication overuse (CM-MOH), episodic migraine (EM), and controls, matched by sex, age and education, was carried out. CR was assessed by a specific questionnaire, and quality of life was measured by general and specific questionnaires (SF-36 and MSQoL). Migraine Disability Assessment Scale and Beck questionnaires for depression and anxiety were used. Medication dependence was evaluated by the medication-dependence questionnaire in headache (MDQ-H). Results Fifty-five individuals were enrolled: 18 CM-MOH patients (32.73%), 22 EM patients (40%) and 15 controls (27.27%). Fifty (90.91%) of them were females and aged 43.53 (7.54) years. Univariate analysis showed a significant association between the study group and CR, and all items of the SF-36, anxiety and depression questionnaires, MSQoL and MDQ-H. The lower CR and CM-MOH group were related to a worse quality of life, more anxiety and depression and the highest medication dependence scores. Multivariate analysis showed that higher CR scores were related to higher quality of life as measured by the physical and mental composite scores of the SF-36, and to lower anxiety (beta = −1.08, p = 0.001) and depression (beta = −0.56, p = 0.03) levels. Focusing on MSQoL, the increase in CR was predictive of a better quality of life (beta = 1.88, p < 0.0001). By all the models, the explained variance of the sample ranged from 39% (mental composite score) to 58% (MSQoL). Conclusions Low CR appears to be an independent factor associated with the deterioration of quality of life, the presence of anxiety and depression, and drug dependence and medication overuse in CM-MOH.

Erenumab in prophylaxis of migraine – pilot study

Ból ◽  
2020 ◽  
Vol 20 (4) ◽  
pp. 1-4
Author(s):  
Marcin Kopka
Keyword(s):  
Chronic Migraine ◽  
Primary Endpoint ◽  
Migraine Headache ◽  
Critical Role ◽  
Preventive Treatment ◽  
Tolerability Profile ◽  
Good Tolerability ◽  
New Class ◽  
Calcitonin Gene

The aim of preventive treatment of episodic and chronic migraine is to reduce the frequency and severity of attacks and thereby improve patient’s quality of life. It is suggested that calcitonin gene related peptide (CGRP) plays a critical role in migraine patophysiology. In last few decades a new class of drugs was developed – monoclonal antibodies against CGRP. One of them is erenumab, which has been available in Poland since November 2018. The aim of this study was to assess the efficacy and tolerability of erenumab in migraine prophylaxis in polish patients with episodic and chronic migraine. Adult patients diagnosed with migraine (according to ICHD 3) with at least 4 migraine headache days in month were included in this study. The primary endpoint was the proportion of patients with more than 50% reduction in number of migraine headache days after the first month of treatment. From December 2018 to April 2019 9 women (24–66 years; average 43.8 years) were included. The average migraine headache days in this study group was 9 (5–20). The participants were treated with subcutaneously delivered erenumab in daily dose of 70 mg. After the first month of treatment in 7 from 9 women (77.5 %) primary endpoint was reached. In 3 of 9 (30%) patients itch was noted. The results of this study suggest efficacy and good tolerability profile of erenumab in polish patients with episodic and chronic migraine. The future study are needed with larger groups of participants.

scholarly journals Anti-CGRP monoclonal antibodies in chronic migraine with medication overuse: real-life effectiveness and predictors of response at 6 months

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edoardo Caronna ◽  
Victor José Gallardo ◽  
Alicia Alpuente ◽  
Marta Torres-Ferrus ◽  
Patricia Pozo-Rosich
Keyword(s):  
Monoclonal Antibodies ◽  
Chronic Migraine ◽  
Medication Overuse ◽  
Real Life ◽  
Daily Practice ◽  
Headache Frequency ◽  
Electronic Diary ◽  
Life Effectiveness ◽  
Medication Intake ◽  
Acute Medication

Abstract Background In daily practice, anti-CGRP monoclonal antibodies (MAbs) may be useful in chronic migraine (CM) with medication overuse (MO), but data is limited. We evaluated their effectiveness in a real-life clinical cohort. Methods This is a prospective study conducted in CM patients with and without medication overuse treated with monthly MAbs during 6 months (erenumab/galcanezumab). We collected headache characteristics, including acute medication intake, through an electronic diary. We compared patients (1) with and without MO at baseline, (2) with and without ongoing MO after treatment, defining MO resolution as < 10 or 15 days/month of acute medication intake, according to analgesic type, during the 6-month treatment. Results Of 139 CM patients completing 6-month treatment with anti-CGRP MAbs, 71.2% (99/139) had MO at baseline. After 6 months, patients with and without MO at baseline had significant and similar proportions of ≥50% reduction in migraine days/month (MO: 63.6% vs. non-MO: 57.5%, p = 0.500). 60.6% (60/99) no longer satisfied MO definition. Reduction in headache frequency compared to baseline occurred in both MO-ongoing and MO-resolution group, although those who stopped overusing had a greater improvement (headache days/month: − 13.4 ± 7.6 vs. -7.8 ± 7.2, p < 0.0001). No differences in MO resolution were observed according to the MAbs used. Baseline lower pain severity was associated with MO resolution (OR [95%]:0.236[0.054–0.975]; p = 0.049). Conclusions In real-life anti-CGRP MAbs are as effective in CM patients with MO as in patients without it and facilitate MO cessation. Reduction in headache frequency and acute medication days/month occurs regardless of whether patients stop overusing or not.

The clinical and public health implications and risks of widening the definition of chronic migraine

Cephalalgia ◽  
2019 ◽  
Vol 40 (4) ◽  
pp. 407-410 ◽  
Author(s):  
Martina Guglielmetti ◽  
Alberto Raggi ◽  
Raffaele Ornello ◽  
Simona Sacco ◽  
Domenico D’Amico ◽  
...  
Keyword(s):  
Public Health ◽  
Chronic Migraine ◽  
High Frequency ◽  
Episodic Migraine ◽  
Headache Frequency ◽  
Allocation Of Resources ◽  
Independent Entity ◽  
Definition Of ◽  
The Impact

Background The definition of chronic migraine has long been debated. Recently, it was suggested to define subjects with at least 8/migraine days as chronic migraine; that is, incorporating so-called high frequency episodic migraine (eight or more migraine days but less than 15 headache days per month). Methods We addressed the possible problems that might arise based on this proposal accounting for clinical, pathophysiological, impact and public health aspects. Results and conclusions Defining chronic migraine on the basis of headache frequency alone does not account for clinical and pathophysiological aspects, as well as for the impact of chronic migraine in terms of disability and quality of life. Moreover, it is potentially harmful for patients in terms of allocation of resources. These issues are discussed in the present manuscript, and we support the idea of defining high frequency episodic migraine as an independent entity as a viable path to follow.

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