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- | Journal: What's New in the Treatment of Migraine. (Pubmed Central) - Jun 18, 2020
Many new and exciting therapies exist for the treatment of migraine. Keeping up with this rapidly evolving field is important in reducing disability from the common disease of migraine.
- ||| Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Clinical: Never mind, eh, migraine only costs the economy €27 bn in Europe, $20 bn in the US. We hope for a sea change w recent 👍 for Ajovy on the NHS in the UK. Vital for @NICEComms to approve Aimovig too following appeal as pts often super-respond to Aimovig when Ajovy does nothing. (Twitter) - Jun 16, 2020
- | Journal: Calcitonin Gene-Related Peptide (CGRP) Antagonists and Their Use in Migraines. (Pubmed Central) - Jun 14, 2020
The trials have resulted in positive efficacy and safety data. The purpose of this review is to evaluate the seven CGRP antagonists and their future place in therapy.
- || Aimovig (erenumab) / Amgen, Novartis
Review, Journal: The role of erenumab in the treatment of migraine. (Pubmed Central) - Jun 13, 2020
Erenumab exists in two different doses (70 mg and 140 mg) and it is administered with monthly subcutaneous injections. This review summarises erenumab pharmacological characteristics, clinical trials data, focusing on the potential role of this treatment in clinical practice.
- || Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open, Trial completion date, Trial primary completion date: STOP Ros: Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea (clinicaltrials.gov) - Jun 11, 2020
P2, N=30, Recruiting, Sponsor: Messoud Ashina
This review summarises erenumab pharmacological characteristics, clinical trials data, focusing on the potential role of this treatment in clinical practice. Not yet recruiting --> Recruiting | Trial completion date: Mar 2021 --> Aug 2021 | Trial primary completion date: Jun 2020 --> Mar 2021
- ||| Aimovig (erenumab) / Amgen, Novartis
Clinical: Do you have a sub analysis of the 13% tension type-like PTH patients and their response to erenumab? It would be interesting @MessoudAshina @hmru_cph (Twitter) - Jun 6, 2020
- || Aimovig (erenumab-aooe) / Amgen, Novartis
New P2 trial: STOP Ros: Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea (clinicaltrials.gov) - Jun 4, 2020
P2, N=30, Not yet recruiting, Sponsor: Messoud Ashina
- |||| Aimovig (erenumab) / Amgen, Novartis
Clinical: HMRU news🌟 An open-label study demonstrates that the CGRP receptor antibody erenumab reduces the number of monthly headache days in patients with post-traumatic headache. For more info: https://t.co/4buAiSGgF1 @Rigshospitalet @h_ashina @HenrikSchytz @MessoudAshina #PTH #headache (Twitter) - Jun 4, 2020
- | Aimovig (erenumab) / Amgen, Novartis
do we know any more about Aimovig? Thanks for all you do (Twitter) - Jun 3, 2020
- || Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment change, Trial withdrawal, HEOR: COMIG: Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab (clinicaltrials.gov) - May 31, 2020
P3, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting | Trial completion date: Mar 2021 --> Aug 2021 | Trial primary completion date: Jun 2020 --> Mar 2021 N=300 --> 0 | Not yet recruiting --> Withdrawn
- | Journal: CGRP, Amylin, Immunology, and Headache Medicine. (Pubmed Central) - May 29, 2020
To better understand potential immunogenic risks and off-target toxicities of the anti-CGRP monoclonal antibodies, this review discusses immunology and CGRP and reviews IgG structure and function, monoclonal antibody production, ligand-antigen-antibody relationships, and clinical CGRP mAb specifics. Upon completion, the reader should better summarize CGRP antagonist fundamentals, recall antibody structure and function, restate therapeutic mAbs attributes, and appraise immunogenic risks.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Sustained Efficacy and Safety of Erenumab in Patients with Episodic Migraine Who Failed 2–4 Prior Preventive Treatments: 2-year Interim Results of the LIBERTY Open-label Extension Study () - May 25, 2020 - Abstract #AHS2020AHS_52;
P3
Long-term treatment with erenumab showed sustained reductions in migraine frequency in EM patients with between 2-4 prior preventive treatment failures in patients continuously treated with erenumab and those initiating erenumab treatment groups during the OLTP. Erenumab was well tolerated and had a good safety profile with no new safety signals detected over the extended treatment period.
- Emgality (galcanezumab) / Eli Lilly, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] A Real World Comparison of Erenumab and Galcanezumab in a Tertiary Headache Center () - May 25, 2020 - Abstract #AHS2020AHS_26;
The most common reason for discontinuation in both groups for lack of efficacy, but insurance issues and side effects also contributed. Constipation was reported much more commonly in the erenumab group compared to the galcanezumab group.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Efficacy and Tolerability of CGRP Monoclonal Antibody Medications in Patients with Chronic Migraine Undergoing Treatment with OnabotulinumtoxinA () - May 25, 2020 - Abstract #AHS2020AHS_16;
Patients with CM on onabot can experience a significant further reduction in MHDs and pain severity with the addition of a CGRP mAb medication, with side effects similar to those reported in the CGRP mAb clinical trials. Future prospective studies evaluating combination therapy are warranted.
- | Aimovig (erenumab) / Amgen, Novartis
Journal: Erenumab During Breastfeeding. (Pubmed Central) - May 25, 2020
Future prospective studies evaluating combination therapy are warranted. No abstract available
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Sustained efficacy and safety of erenumab in episodic migraine patients failing 2–4 prior preventive treatments: 2-year in- terim results of the LIBERTY open-label () - May 24, 2020 - Abstract #EAN2020EAN_3649;
P3
Efficacy of erenumab was sustained over long-term treatment in EM patients with 2–4 PPTF both in patients continuously treated with erenumab and those initiating erenumab during the OLTP. Erenumab was well tolerated with no new safety signals.
- | Journal: Targeting CGRP for migraine treatment: mechanisms, antibodies, small molecules, perspectives. (Pubmed Central) - May 22, 2020
Gepants are a safe alternative to triptans for the acute management of migraine and are currently being tested for prevention, thus representing the first transitional molecules for disease therapy. In the future, it might be possible to adapt the treatment according to patients' characteristics and disease phenotype even combining the two treatments targeting the CGRP pathway.
- ||| Aimovig (erenumab) / Amgen, Novartis
#NeuroUp2020 @juliopascualg ¿que nos van a ofrecer los anticuerpors en la PC diaria? Este estudio con erenumab es importante la dosis (70/140) si observamos en el 6º mes tiene un beneficio para el paciente del 55% incluso en los pacientes refractarios con toxina botulíca tipo A (Twitter) - May 22, 2020
- || Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Vascular safety of erenumab for migraine prevention. (Pubmed Central) - May 19, 2020
P1, P2, P3
Selective blockade of the canonical calcitonin gene-related peptide receptor with erenumab for migraine prevention had a vascular safety profile comparable to that of placebo over 12 weeks, with no increased emergence of events over time. Further study of long-term safety of erenumab in patients with migraine is needed.
- || Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo
Trial completion date, Trial initiation date, Trial primary completion date: A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist (clinicaltrials.gov) - May 18, 2020
P4, N=60, Not yet recruiting, Sponsor: Eli Lilly and Company
Further study of long-term safety of erenumab in patients with migraine is needed. Trial completion date: Jun 2020 --> Oct 2020 | Initiation date: Mar 2020 --> Jul 2020 | Trial primary completion date: Jun 2020 --> Oct 2020
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Treatment response to erenumab in refractory migraine patients (ePoster) - May 17, 2020 - Abstract #EAN2020EAN_3075;
- topiramate / Generic mfg., Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Characteristics of the first head-to-head randomized, double-blind, double-dummy trial of erenumab and topiramate for the prevention of episodic and chronic migraine (Room Vienna) - May 17, 2020 - Abstract #EAN2020EAN_2500;
Trial completion date: Jun 2020 --> Oct 2020 | Initiation date: Mar 2020 --> Jul 2020 | Trial primary completion date: Jun 2020 --> Oct 2020 This analysis will provide insights into the patient population enrolled in the first head-to-head trial comparing the tolerability and efficacy of erenumab and topiramate.
- ||| Aimovig (erenumab-aooe) / Amgen, Novartis
Biomarker, Trial completion date, Trial initiation date, Trial primary completion date: INTERROGATE: Biomarker and Genetic Predictors of Erenumab Treatment Response (clinicaltrials.gov) - May 11, 2020
P4, N=2000, Not yet recruiting, Sponsor: Amgen
This analysis will provide insights into the patient population enrolled in the first head-to-head trial comparing the tolerability and efficacy of erenumab and topiramate. Trial completion date: Oct 2021 --> Jan 2022 | Initiation date: Apr 2020 --> Jul 2020 | Trial primary completion date: Oct 2021 --> Jan 2022
- || Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Vascular safety of erenumab for migraine prevention. (Pubmed Central) - May 10, 2020
Trial completion date: Oct 2021 --> Jan 2022 | Initiation date: Apr 2020 --> Jul 2020 | Trial primary completion date: Oct 2021 --> Jan 2022 No abstract available
- Emgality (galcanezumab) / Eli Lilly
A Cost-Effectiveness Analysis of Galcanezumab use Preventative Treatment of Chronic Migraines () - May 6, 2020 - Abstract #AMCP2020AMCP_190;
Galcanezumab shows promising results for chronic migraine and has potential to be a competitive agent amongst other CGRP inhibitors (erenumab and fremanezumab) in prevention of chronic migraines. Sponsorship: None
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Indirect Comparison of the Efficacy of Fremanezumab Versus Erenumab in Episodic Migraine Patients Who Had Failed 2-4 Prior Migraine Preventive Treatments () - May 6, 2020 - Abstract #AMCP2020AMCP_185;
The results of this indirect treatment comparison indicate that, in EM patients failing 2-4 prior migraine preventive treatments/classes, fremanezumab treatment resulted in significantly greater reductions in MMD over 4 and 12 weeks as compared to erenumab treatment. Sponsorship: Teva Pharmaceuticals.
- Incidence of Abortive Migraine Medication Fills after Initiation of a Calcitonin Gene-Related Peptide (CGRP) Inhibitor for Migraine Prophylaxis () - May 6, 2020 - Abstract #AMCP2020AMCP_181;
Additional claims data are needed to determine statistical significance in number of claims for abortive migraine medications before and after CGRP inhibitor initiation. Sponsorship: Highmark, Inc
- A Retrospective Claims Analysis of Calcitonin Gene-Related Peptides (CGRPs): Adherence, Persistence, Switch Rate and Impact on Acute Migraine Therapy among 4 Million Commercial Lives () - May 6, 2020 - Abstract #AMCP2020AMCP_180;
The switch rate was low, with the majority of members switching from erenumab to galcanezumab. CGRP utilization may be associated with a positive impact on triptan utilization.
- Impact of Prior Authorization Criteria on CGRP Antagonist Utilization in the Prevention of Migraine Headache () - May 6, 2020 - Abstract #AMCP2020AMCP_178;
Pending. Sponsorship: None
- Evaluation of Persistence, Switch Patterns, and Costs among Migraine Patients Utilizing Calcitonin Gene-Related Peptide (CGRP) Inhibitors in a U.S. Medicaid Population () - May 6, 2020 - Abstract #AMCP2020AMCP_176;
Claims analysis comparing 6-months pre- and post- index date demonstrated that pharmacy expenses attributed to migraine increased, while medical visits and expenses decreased. Sponsorship: None
- Migraine Rescue and Preventive Therapy Utilization before and after Initiation of CGRP-Targeted Therapies () - May 6, 2020 - Abstract #AMCP2020AMCP_173;
While CGRP-t therapy increased total migraine medication costs, the decrease in the number of prescriptions for rescue therapy suggests fewer migraines requiring acute treatment post initiation of therapy. Sponsorship: This research was funded internally by Conduent, Richmond, VA.
- || Aimovig (erenumab) / Amgen, Novartis
Aimovig Injection Time https://t.co/dbxO1IoKn1 via @Novartis @Amgen (Twitter) - May 5, 2020
- ||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment closed, Head-to-Head: HER-MES: Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine (clinicaltrials.gov) - May 3, 2020
P4, N=831, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Sponsorship: This research was funded internally by Conduent, Richmond, VA. Recruiting --> Active, not recruiting
- || Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date, Trial primary completion date: EMBRACE: Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine (clinicaltrials.gov) - Apr 30, 2020
P4, N=576, Not yet recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022
- ||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment closed, Trial completion date, Trial primary completion date: Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine (clinicaltrials.gov) - Apr 29, 2020
P4, N=340, Active, not recruiting, Sponsor: Amgen
Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022 Recruiting --> Active, not recruiting | Trial completion date: Mar 2022 --> Jun 2022 | Trial primary completion date: Mar 2022 --> Jun 2022
- ||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment closed: OASIS (EM): Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine (clinicaltrials.gov) - Apr 29, 2020
P3, N=456, Active, not recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting | Trial completion date: Mar 2022 --> Jun 2022 | Trial primary completion date: Mar 2022 --> Jun 2022 Recruiting --> Active, not recruiting
- ||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment closed: OASIS (CM): Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (clinicaltrials.gov) - Apr 29, 2020
P3, N=286, Active, not recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment closed: A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache (clinicaltrials.gov) - Apr 27, 2020
P4, N=687, Active, not recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | Journal: Monoclonal antibodies for the prevention of migraine. (Pubmed Central) - Apr 23, 2020
mAbs are also effective in patients with medication overuse and with comorbid depression or anxiety disorders. Taken together, mAbs are likely to usher in a new era in migraine prevention and provide significant value to patients.
- | Aimovig (erenumab-aooe) / Amgen, Novartis
New trial: Neurophysiological, Biomolecular and Psychological Aspects of Erenumab Treatment in Chronic Migraine (clinicaltrials.gov) - Apr 23, 2020
P, N=40, Recruiting, Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
- || Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache (clinicaltrials.gov) - Apr 16, 2020
P4, N=687, Recruiting, Sponsor: Amgen
Taken together, mAbs are likely to usher in a new era in migraine prevention and provide significant value to patients. Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Jun 2022 --> Sep 2022
- | Aimovig (erenumab) / Amgen, Novartis
Journal: Erenumab: A First-in-Class Monoclonal Antibody for Migraine Prevention. (Pubmed Central) - Apr 16, 2020
It is also effective for patients who have previously failed migraine preventive therapy. Erenumab has a favorable adverse effect profile, which may improve patient adherence.
- | Aimovig (erenumab) / Amgen, Novartis
FDA event, Journal: Discovery of the Migraine Prevention Therapeutic Aimovig (Erenumab), the First FDA-Approved Antibody against a G-Protein-Coupled Receptor. (Pubmed Central) - Apr 9, 2020
These efforts led to the discovery of erenumab which has demonstrated the desired efficacy and safety profiles in multiple clinical studies for the prevention of migraine. The innovation developed in the discovery of erenumab furthers the ability to target G-coupled protein receptors using antibody approaches.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Benefit of Migraine Prevention with Erenumab in Patients Receiving Background Standard-of-Care Acute Treatment (Room Oslo) - Apr 9, 2020 - Abstract #EAN2020EAN_2261;
P2, P3
This study demonstrated that preventive treatment with erenumab plus AMSMs as needed significantly reduced MMD, AMSM use, and disability compared with AMSMs alone. These findings suggest a clinical benefit of effective prevention with erenumab over acute treatment alone in patients using AMSMs at baseline.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Changes in Acute Migraine-Specific Medications after Initiating Erenumab: Results from a Real-World Retrospective Cohort Study in the United States (Room Oslo) - Apr 9, 2020 - Abstract #EAN2020EAN_2256;
These findings suggest a clinical benefit of effective prevention with erenumab over acute treatment alone in patients using AMSMs at baseline. In this US-focused real-world study, a proportion of patients completing an adequate trial of erenumab discontinued and/or reduced consumption of their AMSMs.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Real-world evidence data characterizing the use of the monoclonal antibody Erenumab in daily clinical routine in Germany from the treating physician’s perspective (Room Oslo) - Apr 9, 2020 - Abstract #EAN2020EAN_2254;
In this US-focused real-world study, a proportion of patients completing an adequate trial of erenumab discontinued and/or reduced consumption of their AMSMs. The TELESCOPE study provides real world data for erenumab in Germany regarding treatment routines, typical patient profiles and the effect on daily functioning and quality of life, both outcomes with great impact on migraine patients.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Erenumab in real life: a multicentric italian observational study (Room Oslo) - Apr 9, 2020 - Abstract #EAN2020EAN_1602;
The data confirm erenumab efficacy in migraine prophylaxis. Over 70% of patients documented a significant progressive and sustained improvement, from week 4 to week 36, in headache days, analgesics consumption, pain intensity and migraine related disability.
- Botox (onabotulinumtoxin A) / GSK, AbbVie, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Treatment with Onabotulinumtoxin A versus Erenumab for Patients with Acquired/Post-traumatic Chronic Migraine (Room Oslo) - Apr 9, 2020 - Abstract #EAN2020EAN_1600;
Over 70% of patients documented a significant progressive and sustained improvement, from week 4 to week 36, in headache days, analgesics consumption, pain intensity and migraine related disability. Both onabotulinumtoxin A and erenumab appear to be safe and well-tolerated treatments for acquired/ posttraumatic chronic migraine, and with either treatment over a period of 6 months approximately half of patients will experience a meaningful reduction in monthly headache frequency.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Analysis of the patient population for the assessment of long-term safety and tolerability of the monoclonal antibody Erenumab and the frequency of drug holidays in the German treatment algorithm (Main Auditorium) - Apr 9, 2020 - Abstract #EAN2020EAN_1585;
P4
APOLLON is a 128-week open-label study of erenumab treatment, assessing long-term safety and tolerability data of migraine patients in Germany who previously participated in a head-to-head trial comparing the tolerability of erenumab and topiramate (NCT03828539). This analysis will provide insights into the patient population as regards the assessment of long-term safety and tolerability of erenumab and the frequency and timeline for drug holidays during erenumab treatment in the treatment algorithm of approximately 80 German headache centers.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] The importance of considering the patient’s and treating physician’s view to generate comprehensive und unbiased real-world evidence data. (Main Auditorium) - Apr 9, 2020 - Abstract #EAN2020EAN_1584;
These analyses indicate differences and overlaps in the patients and physicians perception of therapy outcomes in migraine treatment. The comparison highlights the importance of understanding limitations of the interviewed population and thus shows that only considering both sides will generate comprehensive real-world evidence for treatment options.