- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal, Real-world evidence: Erenumab Efficacy on Comorbid Cluster Headache in Patients With Migraine: A Real-World Case Series. (Pubmed Central) - Sep 22, 2021 We speculate that erenumab could represent a low-risk alternative for CH patients (with or without comorbid migraine) who did not tolerate common CH preventatives therapies or for whom the therapies were not successful. Certainly, randomized trials are needed to confirm these observations and we hope that our data, showing a delayed therapeutic effect only with the highest dose of erenumab (140 mg/month), can be taken into account in designing future trials.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Safety and tolerability evaluation of erenumab for the preventive treatment of migraine. (Pubmed Central) - Sep 22, 2021 The only AE of interest that may play a role in decision making and treatment monitoring is constipation. These findings are in line with previous safety reports, further highlighting the substantial tolerability and safety profile of the modern anti-CGRP monoclonal antibodies for the prevention of migraine.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal, HEOR: Cost-Effectiveness of Erenumab for the Preventive Treatment of Migraine in Patients with Prior Treatment Failures in Sweden. (Pubmed Central) - Sep 19, 2021 Erenumab was associated with clinically relevant improvements in all efficacy endpoints and was well tolerated across all subgroups of Japanese migraine patients with/without prior preventive treatment failure(s) and with/without concomitant preventive treatment. Our analysis suggests that erenumab is a cost-effective treatment for migraine with a willingness-to-pay threshold of SEK300,000 per QALY.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Retrospective data, Journal, HEOR: Migraine Characteristics, Comorbidities, Healthcare Resource Utilization, and Associated Costs of Early Users of Erenumab in the USA: A Retrospective Cohort Study Using Administrative Claims Data. (Pubmed Central) - Sep 18, 2021 We observed reductions in claims for important migraine characteristics, comorbidities, and a shift to decreased use of acute and preventive migraine medications-observations indicative of the real-world effectiveness of erenumab. Further examination is required as persistence to erenumab, which may be influenced by dose titration, appears to be an important factor in changes to healthcare resource utilization and costs.
- |||||||||| Ubrelvy (ubrogepant) / AbbVie
COmbining UbRogepAnt and preventives for miGrainE (COURAGE) study using the Migraine Buddy application: A novel, entirely remote design for collecting real-world evidence () - Sep 15, 2021 - Abstract #PAINWeek2021PAINWeek_21; Purpose : To describe the design and interim findings from the COURAGE study, a novel, web-based mobile application (app)-based methodology to evaluate real-world effectiveness of ubrogepant when used with an anti-calcitonin gene–related peptide (CGRP) monoclonal antibody preventive (mAb) or with onabotulinumtoxinA (onabotA) or with both...The majority of these participants reported use of ubrogepant 100 mg (59.6% [115/193]) and erenumab was the most commonly used CGRP mAb (44.6% [86/193])...This entirely remote design provides a unique opportunity to continue to understand treatment value and practice patterns while keeping patients and health care providers safe during the current COVID-19 pandemic. These findings suggest that ubrogepant is effective when used in combination with a CGRP mAb; final data will help to inform practicing clinicians to optimize migraine treatment in their practices.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open: Study of Intravenous Erenumab in Patients With Status Migrainosus (clinicaltrials.gov) - Sep 8, 2021 P1, N=15, Recruiting, These findings suggest that ubrogepant is effective when used in combination with a CGRP mAb; final data will help to inform practicing clinicians to optimize migraine treatment in their practices. Not yet recruiting --> Recruiting
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date, Trial primary completion date: Imaging the Migraine Brain Pre- and Post-Erenumab (clinicaltrials.gov) - Sep 5, 2021 P4, N=50, Recruiting, This study provides Class IV evidence that erenumab increases the probability of improved pain control in patients with medication-resistant TN. Trial completion date: Jul 2021 --> Jun 2022 | Trial primary completion date: Jul 2021 --> Jun 2022
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Phase classification: Study of Intravenous Erenumab in Patients With Status Migrainosus (clinicaltrials.gov) - Sep 5, 2021 P1, N=15, Not yet recruiting, Trial completion date: Jul 2021 --> Jun 2022 | Trial primary completion date: Jul 2021 --> Jun 2022 Phase classification: P2 --> P1
- |||||||||| Journal: The locus of action of CGRPergic monoclonal antibodies against migraine: peripheral over central mechanisms. (Pubmed Central) - Sep 5, 2021
Unfortunately, further pharmaceutical development (for olcegepant and telcagepant) was interrupted due to pharmacokinetic issues observed during the Randomized Clinical Trials (RCT)...Presently, the U.S. Food and Drug Administration approved four mAbs, namely: (i) erenumab; (ii) fremanezumab; (iii) galcanezumab; and (iv) eptinezumab...Since these mAbs have a molecular weight of 150 kDa, some studies rule out the relevance of their central actions as they seem unlikely to cross the blood-brain barrier (BBB). Considering the therapeutic relevance of this new class of antimigraine compounds, the present review has attempted to summarize and discuss the current evidence on the probable sites of action of these mAbs.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date: DRAGON: Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients (clinicaltrials.gov) - Sep 1, 2021 P3, N=557, Active, not recruiting, Considering the therapeutic relevance of this new class of antimigraine compounds, the present review has attempted to summarize and discuss the current evidence on the probable sites of action of these mAbs. Trial completion date: Aug 2021 --> Jun 2024
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Retrospective data, Review, Journal, HEOR: Quality of Life Related to Functional Disability in Migraine Patients: A Systematic Review and Network-meta Analysis. (Pubmed Central) - Aug 24, 2021 No abstract available For short term prevention of migraine, fremanezumab demonstrated slightly better improvement in disability compared with other anti-CGRP mAbs in adult patients with migraine.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment closed: DRAGON: Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients (clinicaltrials.gov) - Aug 17, 2021 P3, N=557, Active, not recruiting, We conclude that this novel medication, which is not yet part of the national formulary in Cyprus, may be a cost-effective solution in reducing the disease burden of chronic migraine. Recruiting --> Active, not recruiting
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open: DRAGON: Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients (clinicaltrials.gov) - Aug 11, 2021 P3, N=550, Recruiting, The current evidence retrieved from this NMA suggests that Fremanezumab was the most effective anti-migraine medication in decreasing MHDs per month after six weeks in both chronic and episodic patients. Active, not recruiting --> Recruiting
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Early outcomes of migraine after erenumab discontinuation: data from a real-life setting. (Pubmed Central) - Aug 11, 2021 More than half patients had an early disease worsening, while the remaining patients maintained their responder status during weeks 1-4 after treatment completion. Further studies might identify predictors of prolonged response to erenumab and define the optimal treatment duration according to patients' characteristics.
- |||||||||| Clinical, Review, Journal, HEOR, Real-world evidence: Monoclonal Antibodies Targeting CGRP: From Clinical Studies to Real-World Evidence-What Do We Know So Far? (Pubmed Central) - Aug 7, 2021
Large scale randomized clinical trials confirmed that inhibition of the CGRP system attenuates migraine, while the PACAP mediated nociception is still under scientific and clinical investigation. In this review, we provide the latest clinical evidence for the use of anti-CGRP in migraine prevention with emphasis on efficacy and safety outcomes from Phase III and real-world studies.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] ERENUMAB FOLLOWING TREATMENT DISCONTINUATION. (Free Communication A) - Aug 6, 2021 - Abstract #WCN2021WCN_659; Erenumab benefit persisted for the entire treatment period. Following treatment discontinuation, a significant clinical worsening was found, despite the high clinical response during treatment, which might be due to an early interruption of a potentially disease modifying treatment.
- |||||||||| Review, Journal: Monoclonal antibodies blocking CGRP transmission: An update on their added value in migraine prevention. (Pubmed Central) - Aug 6, 2021
Putting the CGRP/rec mAbs in perspective with available preventive migraine drug treatments, their major advantage seems not to be chiefly their superior efficacy but their unprecedented efficacy over adverse event ratio. Regarding cost-effectiveness, preliminary pharmaco-economic analyses of erenumab suggest that it is cost-effective for chronic migraine compared to no treatment or to onabotulinumtoxinA, but likely not for episodic migraine unless attack frequency is high, indirect costs are considered and its price is lowered.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Use of CGRP receptor blocker erenumab in the management of post-traumatic headache: a case series of 5 women. (Pubmed Central) - Jul 30, 2021 Regarding cost-effectiveness, preliminary pharmaco-economic analyses of erenumab suggest that it is cost-effective for chronic migraine compared to no treatment or to onabotulinumtoxinA, but likely not for episodic migraine unless attack frequency is high, indirect costs are considered and its price is lowered. Erenumab appears to be safe and effective for the management of PTH.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Retrospective data, Journal: 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. (Pubmed Central) - Jul 27, 2021 P2, P3 In this chapter, we summarize the major clinical trials, pharmacokinetic insights, safety and tolerability profiles, and real-world data (if available) of the CGRP monoclonal antibodies and gepants. 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.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Journal: MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention. (Pubmed Central) - Jul 20, 2021 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. In real-life, in a personalized managed access program, erenumab shows a good effectiveness profile and an excellent tolerability in migraine prevention in our cohort of refractory patients.
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