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- || Aimovig (erenumab) / Amgen, Novartis
Clinical, P2 data, Journal: A Randomized Phase 2 Study of Erenumab for the Prevention of Episodic Migraine in Japanese Adults. (Pubmed Central) - Jul 22, 2020
Monthly subcutaneous injections of erenumab 70 mg demonstrated statistically significant and numerically maximal efficacy with a favorable safety profile, suggesting that erenumab is a potential new therapy for migraine prevention in Japan.
- | Review, Journal: Targeting CGRP for the Prevention of Migraine and Cluster Headache: A Narrative Review. (Pubmed Central) - Jul 21, 2020
Convenient monthly dosing for the MAbs can further improve medication adherence, hence better headache control. With CGRP function-blocking therapy showing efficacy even in individuals who failed other preventives, it has become an exciting new therapeutic option in the field of migraine and CH.
- | Journal: Raynaud's Phenomenon Associated With Calcitonin Gene-Related Peptide Monoclonal Antibody Antagonists. (Pubmed Central) - Jul 16, 2020
The pathophysiology of how CGRP monoclonal antagonists might exacerbate or induce RP is discussed. The cases suggest but do not prove causation.
- || Aimovig (erenumab-aooe) / Amgen, Novartis
Trial initiation date: Erenumab for Idiosyncratic Facial Pain (clinicaltrials.gov) - Jul 16, 2020
P4, N=66, Not yet recruiting, Sponsor: David Jang, M.D.
The cases suggest but do not prove causation. Initiation date: Mar 2020 --> Aug 2020
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Trending the First Two Years of Anti-calcitonin Gene-related Peptide Class Availability for Migraine Prevention: Results from an Independent Quarterly US Survey of Neurologists and Migraine Specialists () - Jul 15, 2020 - Abstract #AHS2020AHS_286;
Preferential uptake of galcanezumab, the only agent with data for multiple response rates (i.e., ≥50%, ≥75%, ≥100%) in its label, could be tied to the increasing importance of high responder rates when selecting a therapy. Eptinezumab, a once-quarterly infusion anti-CGRP, could introduce greater competitive pressure on onabotulinumtoxinA share, specifically in the chronic migraine segment.
- Botox (onabotulinumtoxin A) / GSK, AbbVie, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Treatment with Onabotulinumtoxina versus Erenumab for Patients with Acquired/posttraumatic Chronic Migraine () - Jul 15, 2020 - Abstract #AHS2020AHS_285;
Eptinezumab, a once-quarterly infusion anti-CGRP, could introduce greater competitive pressure on onabotulinumtoxinA share, specifically in the chronic migraine segment. Both onabotulinumtoxinA 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.
- Emgality (galcanezumab) / Eli Lilly, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Treatment Patterns and Characteristics of Patients Prescribed AJOVY, Emgality, or Aimovig () - Jul 15, 2020 - Abstract #AHS2020AHS_284;
While patients prescribed AJOVY, Emgality, and Aimovig shared some similar baseline characteristics, there were several significant differences when comparing clinical features of patients prescribed Emgality or Aimovig vs AJOVY. The results from this descriptive analysis may contribute to understanding prescribing differences for these anti-CGRP pathway therapies and further optimize patient care for migraine.
- Emgality (galcanezumab) / Eli Lilly, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Super-responders and Non-responders to CGRP Monoclonal Antibodies in the Treatment of Migraine () - Jul 15, 2020 - Abstract #AHS2020AHS_264;
This data suggests that number of failed preventives, age, and gender cannot be used to predict clinical response to a CGRP mAb. Future studies tracking clinical characteristics in super-responders and non-responders to CGRP mAbs are needed.
- Ubrelvy (ubrogepant) / AbbVie
[VIRTUAL] Safety and Tolerability of Ubrogepant for the Acute Treatment of Migraine Following Co-administration with Preventive Monoclonal Antibody Treatment () - Jul 15, 2020 - Abstract #AHS2020AHS_255;
Future studies tracking clinical characteristics in super-responders and non-responders to CGRP mAbs are needed. Based on interim data, ubrogepant co-administered with erenumab or galcanezumab appears to be safe and well-tolerated with no safety concerns identified.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Real-world Persistence in Patients Treated with Onabotulinumtoxina or Calcitonin Gene-related Peptide Monoclonal Antibodies (CGRP Mabs) for Migraine: A Large US Administrative Claims Database Study () - Jul 15, 2020 - Abstract #AHS2020AHS_239;
These results were observed in both CM and EM populations. Future research is warranted to confirm these findings as more long-term data become available.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Quickest Way to 50% Less Headache Days: An Operational Research Model and Its Implementation for Chronic Migraine () - Jul 15, 2020 - Abstract #AHS2020AHS_237;
Since our model makes limited assumptions on the characteristics of disease, it can be readily applied also to episodic migraine, given the appropriate data as input. Indeed, our model can be applied to other scenarios so long as probability of success/adverse event as a function of time can be estimated.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Profiling Physicians Prescribing Concurrent Anti-calcitonin Gene-related Peptide Monoclonal Antibody and Onabotulinumtoxina for Migraine Prevention: Results from an Annual US Patient Chart Audit () - Jul 15, 2020 - Abstract #AHS2020AHS_233;
Strong early adoption of first-to-market erenumab and shorter periods of access to the other CGRP mAb at the time of review led to onabotA being most likely to be prescribed in combination with erenumab. A prospective study of concomitant treatment with a CGRP mAb and onabotA would be instructive for clinical management.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Persistence to Onabotulinumtoxina versus Calcitonin Gene-related Peptide Monoclonal Antibodies (CGRP Mabs) Among Migraine Patients in a US Electronic Health Record Database () - Jul 15, 2020 - Abstract #AHS2020AHS_225;
This finding holds true among patients with CM and among those with EM. Future research is warranted to confirm these findings over a longer period of follow-up.
- rimegepant (BHV-3000) / Portage
[VIRTUAL] Oral Rimegepant 75 Mg Is Well Tolerated When Used Concomitantly with Injectable Anti-cgrp Monoclonal Antibodies: Results from a Multicenter, Long-term, Open-label Safety Study () - Jul 15, 2020 - Abstract #AHS2020AHS_216;
P2/3
Rimegepant 75 mg, when used as an oral acute treatment for migraine in patients receiving injectable anti-CGRP mAbs for preventive treatment, demonstrated favorable tolerability and no safety issues. Studies involving larger patient populations are needed to confirm these findings.
- Emgality (galcanezumab) / Eli Lilly, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Oral Candidiasis in a Migraine Patient Taking Erenumab (Aimovig) and Galcanezumab (Emgality) () - Jul 15, 2020 - Abstract #AHS2020AHS_214;
Disruption of the IL-17 cascade from initiation of anti-CGRP medications may lead to an intrinsic proliferation of candida. The effects of long term anti-CGRP therapy on human physiology are poorly understood.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Observations on the Landscape of Migraine Social Media: A Twitter Longitudinal Infodemiology Study () - Jul 15, 2020 - Abstract #AHS2020AHS_211;
Important topics of interest for Twitter migraine sufferers include discussions on treatment options (such as CBD and/or CGRP antagonists), awareness, advocacy, and associated neurological and/or pain conditions. HCS algorithm appears to be a useful tool in categorizing hashtag topics.
- rimegepant (BHV-3000) / Portage
[VIRTUAL] Matching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant versus Placebo and Injectable Anti-cgrp-targeted Monoclonal Antibodies Examining Monthly Migraine Days in the Treatment of Migraine () - Jul 15, 2020 - Abstract #AHS2020AHS_193;
Results of the MAICs suggested oral rimegepant decreased MMD compared to placebo and showed comparability to injectable galcanezumab and erenumab in reducing MMD. While a controlled trial would be the optimal methodology for assessing relative difference, the available data demonstrate that rimegepant may be effective in the prevention of migraine.
- rimegepant (BHV-3000) / Portage
[VIRTUAL] Matching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant versus Placebo and Injectable Anti-cgrp Monoclonal Antibodies (mAb) Examining Health-related Quality of Life (HRQoL) () - Jul 15, 2020 - Abstract #AHS2020AHS_192;
In addition, results suggested rimegepant improved MSQOL compared to placebo and erenumab, and showed general comparability to galcanezumab in improving MSQOL. When adjustments were made to reflect baseline characteristics in published literature, current data suggest that rimegepant is an effective therapy in reducing disability and enhancing migraine specific HRQoL.
- [VIRTUAL] Establishing a National Real-world Data Pediatric Migraine Registry: Proof of Principle () - Jul 15, 2020 - Abstract #AHS2020AHS_149;
A pediatric migraine registry that collects real-world data is feasible to create and maintain. In addition to collecting data in a regulatory compliant manner, the registry creates a ready for use infrastructure for the conduct of future clinical trials in children and adolescents with migraine.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Erenumab Use in Refractory Adolescent Headache Disorders () - Jul 15, 2020 - Abstract #AHS2020AHS_148;
These treatments appear to be beneficial for youth with difficult to treat primary headache disorders, though rigorous controlled trials are needed to confirm this. Real-world information from a larger number of patients, seen at multiple sites, is needed and collaboration on data collection is being planned by the co-authors.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Erenumab Response in Highly Refractory Migraine Patients Followed at a Canadian Tertiary Headache Clinic: Preliminary Results of a Small Case Series at Six Months () - Jul 15, 2020 - Abstract #AHS2020AHS_147;
R also showed improvement in other headache days amongst those with CDH and 1 patient reported drastic reduction in monthly migraine aura episodes. There was an eightfold decrease in number of days using acute medication in R compared to NR.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Efficacy of Erenumab in Chronic Migraine (CM) Patients with Acute Headache Medication Overuse (MO): A Post Hoc Analysis Assessing Outcomes Using Different Definitions of Remission () - Jul 15, 2020 - Abstract #AHS2020AHS_132;
P2, P4
Across all definitions of remission, erenumab 140 mg consistently demonstrated numerically better outcomes than erenumab 70 mg. The follow-up study underway to confirm the efficacy of erenumab in patients with MOH applies the strict ICHD-3 interpretation for MOH remission assessed over 3 months.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Effects of Erenumab on Patient-reported Outcomes in a Subgroup of Patients with Episodic Migraine and Severe Functional Impairment () - Jul 15, 2020 - Abstract #AHS2020AHS_129;
P3
There was improvement across all four PRO instruments. In EM patients with severe functional impairment, treatment with erenumab reduced headache impact and migraine disability, and improved physical function and health-related quality of life
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Effect of Erenumab on Monthly Migraine Days and Monthly Migraine Attacks in Patients with Episodic Migraine () - Jul 15, 2020 - Abstract #AHS2020AHS_127;
P3
These results strongly support the preventive effect of erenumab as shown by the decrease in both MMD and MMA. The results cannot, however, be extrapolated to other CGRP monocolonal antibodies, or oral gepants for migraine prophylaxis.
- Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Cost-effectiveness Sequential Simulation Modeling of Fremanezumab versus Other Therapies for Migraine Prevention from Private and Public Payer Perspectives in Canada () - Jul 15, 2020 - Abstract #AHS2020AHS_117;
Private payer perspective In treatment-naive EM patients, cost-effectiveness of fremanezumab was $14637 (CDN dollars)/success versus $14787 and $16018 for erenumab and galcanezumab, respectively. Fremanezumab is a cost-effective preventive treatment strategy for EM and CM in both treatment-naive patients, and after failure to oral therapies.
- Botox (onabotulinumtoxin A) / GSK, AbbVie, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Combination of Erenumab (Aimovig) and Onabotulinum Toxin a (BoNT-A or Botox) Is Safe and Effective () - Jul 15, 2020 - Abstract #AHS2020AHS_109;
Fremanezumab is a cost-effective preventive treatment strategy for EM and CM in both treatment-naive patients, and after failure to oral therapies. In this small retrospective case series, the results indicate that the treatment combination of erenumab and onabotulinum toxin A is significantly better in reducing the total number of monthly headache days, as well as total number of monthly migraine days than onabotulinum toxin A alone in patients with chronic migraine.
- Emgality (galcanezumab) / Eli Lilly, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] CGRP Monoclonals: Efficacy, Side Effects, and Switching () - Jul 15, 2020 - Abstract #AHS2020AHS_102;
In this study of all 3 mAbs, efficacy was reasonable. In our limited number of patients, efficacy after 2 months somewhat predicted how patients would do after 6 months.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] CGRP Monoclonal Antibodies in the Treatment of Migraine in Elderly Patients: A Single Center Experience () - Jul 15, 2020 - Abstract #AHS2020AHS_101;
Our study only included 32 patients who were predominantly female and largely refractory, with multiple prior failed preventives. Additional studies with larger sample sizes are needed to further verify these results.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Cardiovascular Safety of Erenumab in Patients with Migraine and Aura () - Jul 15, 2020 - Abstract #AHS2020AHS_98;
Additional studies with larger sample sizes are needed to further verify these results. The vascular safety profile of long-term erenumab treatment was similar in patients both with and without history of aura and was comparable to that of placebo over 12 weeks, with no increased emergence of events over time.
- Emgality (galcanezumab) / Eli Lilly, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Calcitonin Gene-related Peptide Inhibitors in the Treatment of Trigeminal Nerve Pain () - Jul 15, 2020 - Abstract #AHS2020AHS_97;
The majority of patients who saw benefit in our sample also suffered from comorbid migraine headaches. Further investigation should be conducted to determine if this benefit is also seen in patients without comorbid migraine headaches, and if this benefit is sustained.
- Emgality (galcanezumab) / Eli Lilly, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Calcitonin Gene Related Peptide Monoclonal Antibodies in the Treatment of Migraine: Is There a Difference in Efficacy Between Inhibitors of the Ligand Compared to Inhibitors of the Receptor? () - Jul 15, 2020 - Abstract #AHS2020AHS_95;
Overall, our data found no significant differences in treatment response between patients treated with a CGRP mAb to the receptor compared to patients treated with a mAb to the CGRP ligand. Based on this this data, it appears that both mechanisms, inhibiting the ligand or inhibiting the canonical receptor are equally effective in reducing headache frequency and improving quality of life as measured by the HIT-6.
- Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Benefit of Migraine Prevention with Erenumab in Patients Receiving Background Standard-of-care Acute Treatment () - Jul 15, 2020 - Abstract #AHS2020AHS_89;
P2, P3
A post hoc analysis of AMSM users from two pivotal EM and CM trials demonstrated that preventive treatment with erenumab plus AMSM as needed significantly reduced MMDs, AMSM use, and disability (including HIT-6 and MIDAS) compared with AMSMs alone in placebo arms. These findings suggest the clinical benefit of effective prevention with erenumab over acute treatment alone in patients using AMSMs at baseline.
- || Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date, Trial primary completion date: Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients (clinicaltrials.gov) - Jul 13, 2020
P4, N=600, Recruiting, Sponsor: Amgen
These findings suggest the clinical benefit of effective prevention with erenumab over acute treatment alone in patients using AMSMs at baseline. Trial completion date: Jul 2021 --> Nov 2022 | Trial primary completion date: Jun 2021 --> Oct 2022
- | Journal: Calcitonin Gene-Related Peptide Modulators - The History and Renaissance of a New Migraine Drug Class. (Pubmed Central) - Jul 11, 2020
Eptinezumab, a CGRP neutralizing antibody given IV, shows promise in late stage clinical development. Recently, orally administered next-generation small molecule CGRP-RAs have been shown to have safety and efficacy in acute treatment (ubrogepant and rimegepant) and prevention (atogepant) of migraine, giving additional CGRP-based therapeutic options for migraine patients.
- || Clinical data, Review, Journal: CGRP, a target for preventive therapy in migraine and cluster headache: Systematic review of clinical data. (Pubmed Central) - Jul 10, 2020
Phase III trials are also currently in progress for the preventive treatment of cluster headache. Conclusion Efficacy of anti-CGRP monoclonal antibodies spells a promising future for the many patients suffering from migraine, and possibly also for the smaller but severely-affected population with cluster headache.
- ||| Aimovig (erenumab) / Amgen, Novartis
Adverse events: Sobre el CGRP y el tubo digestivo. 5 veces más receptores q en el SNC. Predicting erenumab adverse events with single-cell genomics - The Lancet https://t.co/BBI3UOb9SB (Twitter) - Jul 10, 2020
- |||| Aimovig (erenumab-aooe) / Amgen, Novartis
New P4 trial: Efficacy of Erenumab on Functional Impact of Migraine (clinicaltrials.gov) - Jul 10, 2020
P4, N=54, Not yet recruiting, Sponsor: Merle Diamond
- | Steglatro (ertugliflozin) / Pfizer, Merck (MSD)
Journal, Benefit-risk assessment: Can Standardisation of the Public Assessment Report Improve Benefit-Risk Communication? (Pubmed Central) - Jul 7, 2020
SAHPRA's use of a structured template that supports transparent and quality decision making could have a major impact in ensuring consistency in the BR assessment of new medicines. The implementation of this effective approach for communicating BR decisions will advance agency goals of being a trusted, responsive, accountable regulatory body in which all healthcare stakeholders may rely on with confidence.
- | Journal: Migraine overview and summary of current and emerging treatment options. (Pubmed Central) - Jul 5, 2020
The newly approved CGRP antagonists are erenumab, fremanezumab, and galcanezumab, while eptinezumab looks to 2020 for approval. Lasmiditan, ubrogepant, and rimegepant are currently emerging acute migraine therapies that may be added to the arsenal of current migraine management.
- || Aimovig (erenumab) / Amgen, Novartis
I am three months into taking Aimovig but no relief yet. Thank you to all those focused on helping me and my fellow #IIH sufferers! (Twitter) - Jul 2, 2020
- |||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open: OASIS (EM): Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine (clinicaltrials.gov) - Jul 1, 2020
P3, N=456, Recruiting, Sponsor: Amgen
Lasmiditan, ubrogepant, and rimegepant are currently emerging acute migraine therapies that may be added to the arsenal of current migraine management. Active, not recruiting --> Recruiting
- |||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open: OASIS (CM): Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (clinicaltrials.gov) - Jul 1, 2020
P3, N=286, Recruiting, Sponsor: Amgen
Active, not recruiting --> Recruiting Active, not recruiting --> Recruiting
- |||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial primary completion date: DRAGON: Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients (clinicaltrials.gov) - Jun 30, 2020
P3, N=550, Recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Recruiting Trial primary completion date: Feb 2022 --> Nov 2021
- ||| cilostazol / Generic mfg.
New trial: The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients (clinicaltrials.gov) - Jun 30, 2020
P=N/A, N=72, Not yet recruiting, Sponsor: Danish Headache Center
- || Aimovig (erenumab) / Amgen, Novartis
‘Abandoned’ is right. My headaches are worse even with erenumab injections and I have no idea who I can call about it. (Twitter) - Jun 30, 2020
- || Retrospective data, Review, Journal: Efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibodies for the preventive treatment of episodic migraine - an updated systematic review and meta-analysis. (Pubmed Central) - Jun 28, 2020
Trial primary completion date: Feb 2022 --> Nov 2021 The current body of evidence reveals that CGRP mAb is an effective and safe preventive treatment for episodic migraine.
- || Aimovig (erenumab) / Amgen, Novartis
@Novartis Dear all, when can we expect the Aimovig treatment to be available in Saudi Arabia? (Twitter) - Jun 27, 2020
- Tirosint (levothyroxine) / IBSA Institute Biochemical SA, sumatriptan succinate / Generic mfg., Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Resolution of Hashimoto Thyroiditis: A Case of Hashimoto Thyroiditis Evolving Into Subacute Thyroiditis and Euthyroidism () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_2172;
Early in the disease course, hyperthyroidism may result from destruction of the thyroid gland cells. HT is known to be a life-long disorder with essentially a non-functional thyroid.
- | amitriptyline / Generic mfg., Botox (onabotulinumtoxin A) / GSK, AbbVie, Aimovig (erenumab) / Amgen, Novartis
Observational data, Retrospective data, Journal: Erenumab in Chronic Migraine Patients Who Previously Failed Five First-Line Oral Prophylactics and OnabotulinumtoxinA: A Dual-Center Retrospective Observational Study. (Pubmed Central) - Jun 19, 2020
Tolerability was good, and no safety issues emerged. Erenumabis is a treatment option for CM patients who failed all first-line preventives in addition to BoNTA.
- |||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open: A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache (clinicaltrials.gov) - Jun 19, 2020
P4, N=687, Recruiting, Sponsor: Amgen
Erenumabis is a treatment option for CM patients who failed all first-line preventives in addition to BoNTA. Active, not recruiting --> Recruiting