- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Efficacy of erenumab in chronic migraine patients with and without ictal allodynia. (Pubmed Central) - Jan 18, 2022 P2 These findings extend evidence of erenumab's efficacy and safety to patients under-represented in previous trials.ClinicalTrials.gov identifier: NCT03333109. Erenumab's efficacy in reducing monthly migraine days and acute migraine-specific medication days in chronic migraine was not impacted by the presence of moderate-severe ictal allodynia.Trial registration: ClinicalTrials.gov NCT02066415.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Impact on monthly migraine days of discontinuing anti-CGRP antibodies after one year of treatment - a real-life cohort study. (Pubmed Central) - Jan 18, 2022 After treatment interruption, migraine frequency rose in most patients, and prophylaxis was required again in most cases.Limiting treatment to benefitting patients and confirming the need for prophylaxis periodically is reasonable. However, our data does not support the need for prescheduled treatment discontinuation after 12 months and a fixed duration of the treatment interruption of 3 months.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal, Adverse events: Restless legs-like syndrome as an emergent adverse event of CGRP monoclonal antibodies: A report of two cases. (Pubmed Central) - Jan 18, 2022 Even though caution is needed before establishing a causal relationship, these cases suggest that restless legs-like symptoms might be an emergent adverse event of CGRP antibodies, regardless of the mechanism of action. We propose that plastic changes in CGRP sensory fibers, which are very abundant in legs, induced by CGRP monoclonal antibodies could be the reason for restless legs syndrome development.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Retrospective data, Journal: Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies. (Pubmed Central) - Jan 18, 2022 P2, P3 We propose that plastic changes in CGRP sensory fibers, which are very abundant in legs, induced by CGRP monoclonal antibodies could be the reason for restless legs syndrome development. Erenumab reduced cumulative monthly migraine pain in episodic migraine and chronic migraine patients and significantly reduced monthly average migraine pain in episodic migraine, demonstrating treatment benefit beyond reduction in migraine frequency.Clinical Trial Registration: ClinicalTrials.gov, NCT02456740; ClinicalTrials.gov, NCT02066415.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Erenumab Discontinuation After 12-Month Treatment: A Multicentric, Observational Real-Life Study. (Pubmed Central) - Jan 8, 2022 Although clinical improvement was documented after retreatment, given the high frequency and degree of worsening during discontinuation, it seems plausible-even ethical-to re-evaluate current timing of discontinuation. This study provides Class III evidence that people with migraine discontinuing erenumab migraine prophylaxis after 12 months were more likely to have an increase in nonresponder status and migraine days than those who continued treatment.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Hypertension: A new safety risk for patients treated with erenumab. (Pubmed Central) - Dec 25, 2021 This case series suggest an association between elevated BP and use of erenumab. In light of our findings, the erenumab (Aimovig) prescribing information was amended to include hypertension in the Warnings and Precautions section.
- |||||||||| Journal: Migraine therapeutics differentially modulate the CGRP pathway. (Pubmed Central) - Dec 18, 2021
The therapeutic effect of agents targeting the CGRP ligand versus receptor for migraine prevention (antibodies) or acute treatment (gepants) may involve distinct mechanisms of action. These findings suggest that differing mechanisms could affect efficacy, safety, and/or tolerability in migraine patients.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Retrospective data, Journal, Real-world evidence: Real-world effectiveness and tolerability of erenumab: A retrospective cohort study. (Pubmed Central) - Dec 16, 2021 The substantial discrepancy between adverse events seen in clinical practice compared with clinical trials suggests systematic differences between clinical trial participants and patients who receive the treatment in clinical practice, or may indicate suboptimal ascertainment of adverse events in the trials. Clinicians should continue to be vigilant for adverse events in clinical practice.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal, Adverse events: Adverse effects of erenumab on cerebral proliferative angiopathy: A case report. (Pubmed Central) - Dec 16, 2021 Clinicians should continue to be vigilant for adverse events in clinical practice. The evidence presented in this case supports further investigation into potential deleterious side effects of erenumab in patients with compromised blood-brain barrier, such as individuals with intracranial vascular malformations.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Journal: Erenumab does not alter cerebral hemodynamics and endothelial function in migraine without aura. (Pubmed Central) - Dec 16, 2021 The evidence presented in this case supports further investigation into potential deleterious side effects of erenumab in patients with compromised blood-brain barrier, such as individuals with intracranial vascular malformations. Our findings demonstrate that erenumab preserves cerebral vasomotor reactivity and flow-mediated dilation in migraineurs without aura.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal, Adverse events: Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database. (Pubmed Central) - Dec 16, 2021 No specific maternal toxicities, patterns of major birth defects, or increased reporting of spontaneous abortion were found. However, because of the relatively limited number of adverse drug reactions reported and the lack of long-term safety data, continuous surveillance is required in pregnant and lactating women exposed to these drugs.
- |||||||||| Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Long-term efficacy and safety during open-label erenumab treatment in Japanese patients with episodic migraine. (Pubmed Central) - Dec 16, 2021 With that said, the cost-conscious option for patients receiving more than 1 year of treatment remains surgical trigger site deactivation. Long-term erenumab treatment in Japanese patients with EM demonstrated sustained efficacy for up to 2 years, with a safety profile similar to previous studies, supporting erenumab as a potential new therapy for EM prevention in Japan.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Aimovig (erenumab) / Amgen, Novartis, Nurtec ODT (rimegepant ODT) / Portage, Pfizer
Clinical, Journal, HEOR: Matching-adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health-related quality of life in the treatment of migraine. (Pubmed Central) - Dec 16, 2021 When adjustments were made to reflect baseline characteristics in published literature, supporting data from BHV3000-201 suggest that rimegepant every other day is an effective therapy in reducing disability and MMDs and enhancing migraine-specific HRQoL. These data support the preventive benefit observed in randomized trials of rimegepant and further validate its efficacy for both acute and preventive treatment of migraine.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date: OASIS (CM): Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (clinicaltrials.gov) - Dec 3, 2021 P3, N=286, Recruiting, The results of this registry study suggest that in addition to the effect on the monthly number of migraine days documented in clinical trials, erenumab can significantly reduce the number of headache-related sick leave days and health care visits in employed patients with migraine managed in routine clinical practice. Trial completion date: Nov 2025 --> Dec 2026
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