- |||||||||| Vyepti (eptinezumab-jjmr) / Teva, Lundbeck
Trial completion date, Trial primary completion date, HEOR, Real-world evidence, Real-world effectiveness, Real-world: EVEC: Real World Effectiveness of Eptinezumab in Participants With Migraine (clinicaltrials.gov) - Oct 5, 2022
P4, N=200, Recruiting,
CAS could be a clinical marker of trigeminovascular activation and thus be related to a better response to CGRP treatments. Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Oct 2023
- |||||||||| Review, Journal: Role of Calcitonin Gene-Related Peptide on the Gastrointestinal Symptoms of Migraine-Clinical Considerations: A Narrative Review. (Pubmed Central) - Sep 23, 2022
In this review, we summarize the epidemiological evidence for associations between migraine and gastrointestinal disorders, consider the possible physiological role of CGRP in these associations, and review the clinical occurrence of gastrointestinal events in patients with migraine receiving CGRP-based therapies and other migraine treatments. Because patients with migraine are at an increased risk of comorbid and treatment-related gastrointestinal effects, we also propose a patient-management strategy to mitigate these effects.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva
Review, Journal: CGRP-Targeted Therapy for Episodic and Chronic Cluster Headache. (Pubmed Central) - Sep 10, 2022
The different responses to galcanezumab between episodic and chronic CH may be due to the study design, i.e., the allowance of concomitant preventive therapies in the chronic CH study but not in the episodic CH study. Another reason for the discrepancies is the different roles and sensitivity of CGRP in chronic CH.
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva
A Case of Functional Bowel Disease Misdiagnosed as Carcinoid Syndrome (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_525;
Medications included Dextroamphetamine and Fremanezumab...The patient’s symptoms improved with mirtazapine and dicyclomine, and she regained the weight...This case shows the importance of a complete drug history, including over-the-counter medications. When the 5-HIAA is elevated, the test needs to be repeated after discontinuing all potentially interfering medications.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Journal, Real-world evidence: Brazilian descriptive study of 104 consecutive real-world migraine patients treated with monoclonal antibodies. (Pubmed Central) - Aug 26, 2022
This described analysis of migraine patients who used monoclonal antibodies presented one of the first Brazilian experiences with real-world patients. Our results may enlighten clinicians on the outcomes and ways of prescribing anti-CGRP antibodies.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Observational data, Journal: Comparison study between erenumab, fremanezumab, and galcanezumab in the preventive treatment of high frequency episodic migraine and chronic migraine. (Pubmed Central) - Aug 22, 2022
Registration studies and real life studies have shown excellent efficacy and extraordinary tolerability of these treatments. Little is known about the possible differences between the three treatments and this observational study was conducted with a view to comparing the efficacy, safety and impact that anti-CGRP monclonal antibodies have on additional parameters such as disability in social, family and work activities.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Journal: Overview on effectiveness of erenumab, fremanezumab, and galcanezumab in reducing medication overuse headache in chronic migraine patients. (Pubmed Central) - Aug 22, 2022
Little is known about the possible differences between the three treatments and this observational study was conducted with a view to comparing the efficacy, safety and impact that anti-CGRP monclonal antibodies have on additional parameters such as disability in social, family and work activities. Monoclonal antibodies inhibiting CGRP are effective in reducing monthly headache days in migraine patients with MOH.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Journal: Personality traits and efficacy of anti-CGRP monoclonal antibodies in migraine prevention. (Pubmed Central) - Aug 22, 2022
Monoclonal antibodies inhibiting CGRP are effective in reducing monthly headache days in migraine patients with MOH. Non-responders seem to have different personality traits in comparison to responders, with a higher tendency toward depressed mood and difficulty to feel pleasure previously found in migraineurs vs. non-migraineurs: the more strict certain traits are, the more difficult to treat the migraine could be.
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva
Trial completion date, Trial primary completion date: A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents (clinicaltrials.gov) - Aug 17, 2022
P3, N=550, Recruiting,
Non-responders seem to have different personality traits in comparison to responders, with a higher tendency toward depressed mood and difficulty to feel pleasure previously found in migraineurs vs. non-migraineurs: the more strict certain traits are, the more difficult to treat the migraine could be. Trial completion date: Apr 2027 --> Nov 2027 | Trial primary completion date: Dec 2026 --> Jun 2027
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Trial initiation date, Trial primary completion date: Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study (clinicaltrials.gov) - Aug 3, 2022
P=N/A, N=1500, Not yet recruiting,
Understanding patient characteristics and treatment utilization patterns among patients prescribed both a CGRP mAb and novel acute medication may provide valuable insight regarding migraine treatment selection for healthcare decision makers. Initiation date: Jun 2022 --> Sep 2022 | Trial primary completion date: Jun 2025 --> Sep 2025
- |||||||||| Qulipta (atogepant) / AbbVie
Journal: Atogepant - an orally-administered CGRP antagonist - attenuates activation of meningeal nociceptors by CSD. (Pubmed Central) - Jul 28, 2022
Initiation date: Jun 2022 --> Sep 2022 | Trial primary completion date: Jun 2025 --> Sep 2025 These findings identify differences between the actions of atogepant, a small molecule CGRP antagonist (partially inhibiting both Aδ and C-fibers) and those found previously for fremanezumab, a CGRP-targeted antibody (inhibiting Aδ fibers only) and onabotulinumtoxinA (inhibiting C-fibers only)- suggesting that these agents differ in their mechanisms for the preventive treatment of migraine.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Journal, HEOR, Real-world evidence: Real-world evidence following a mandatory treatment break after a 1-year prophylactic treatment with calcitonin gene-related peptide (pathway) monoclonal antibodies. (Pubmed Central) - Jul 27, 2022
These findings identify differences between the actions of atogepant, a small molecule CGRP antagonist (partially inhibiting both Aδ and C-fibers) and those found previously for fremanezumab, a CGRP-targeted antibody (inhibiting Aδ fibers only) and onabotulinumtoxinA (inhibiting C-fibers only)- suggesting that these agents differ in their mechanisms for the preventive treatment of migraine. A mandatory break in CGRP (pathway) monoclonal antibody therapy had a negative short-term impact on migraine patients.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Observational data, Retrospective data, Journal, HEOR: Health care resource utilization and costs associated with treatment among patients initiating calcitonin gene-related peptide inhibitors vs other preventive migraine treatments in the United States. (Pubmed Central) - Jul 26, 2022
OBJECTIVE: To compare all-cause and migraine-related HCRU and direct health care costs in patients with migraine initiating CGRP mAbs, galcanezumab (GMB), vs standard-of-care (SOC) preventive treatments in the United States...Adults (aged ≥ 18 years) with 1 or more claims for CGRP mAb (GMB, erenumab, or fremanezumab) or SOC preventive treatment between May 1, 2018, and June 30, 2019, were included...Independent analyses were conducted by IBM Watson Health. Eli Lilly and Company and IBM Watson Health collaborated on designing the study and interpreting results.
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
Review, Journal: Migraine With Comorbid Depression: Pathogenesis, Clinical Implications, and Treatment. (Pubmed Central) - Jul 24, 2022
Pharmacotherapy such as antidepressants and anti-Calcitonin Gene-Related Peptide (CGRP) monoclonal antibodies like fremanezumab were studied. Alternative treatment options such as onabotulinumtoxinA (OBTA) injections, cognitive behavioral therapy (CBT), and vagal nerve stimulations (VNS) were also appraised and the efficacies of each were compared.
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva
Fremanezumab in the cluster headache treatment. (A7) - Jul 18, 2022 - Abstract #EAN2022EAN_2599;
In our study, we cannot exclude the placebo effect. However, the non-effectiveness of anti-CGRP therapy in patients with chronic cluster headache compare d to episodic cluster headache may be due to the fact that the CGRP levels in chronic cluster headache patients are usually lower.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Use of CGRP monoclonal antibodies and patient-reported improvement: Results from the OVERCOME (EU) study (A7) - Jul 18, 2022 - Abstract #EAN2022EAN_2593;
This analysis assessed clinical and demographic characteristics in those who had ever used erenumab, fremanezumab or galcanezumab. Most respondents taking a CGRP mAb for the preventive treatment of migraine reported their migraine as better since starting the medication.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Patterns of use of monoclonal antibodies for the preventive treatment of migraine: Results from the OVERCOME (EU) study (A6) - Jul 18, 2022 - Abstract #EAN2022EAN_2408;
Reasons for starting mAbs were multiple, including physician recommendation and patient efficacy expectations. The finding that recommendation from others was the most frequent reason for switching highlights the importance of the patient-physician relationship and family support in the management of migraine.
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva
Real-world Reductions in Migraine and Headache Days for Patients With Migraine Initiating Fremanezumab in Germany (A6) - Jul 18, 2022 - Abstract #EAN2022EAN_2405;
Fremanezumab treatment was associated with significant reductions in migraine-related HCRU for migraine patients over 6 months after initiating fremanezumab treatment in a German real-world setting. Fremanezumab treatment was associated with clinically meaningful reductions in MMD and MHD for migraine patients 3 months after initiating fremanezumab treatment in a German real-world setting.
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical, P3 data, Retrospective data, Journal: Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. (Pubmed Central) - Jun 24, 2022
P3
Recruiting --> Active, not recruiting Fremanezumab demonstrated a favorable overall and cardio- and cerebrovascular safety profile in more than 2800 patients with episodic migraine or chronic migraine, regardless of cardio- and cerebrovascular medical history, CVRFs, or medication use.Trial Registrations: NCT02629861 (HALO EM, https://clinicaltrials.gov/ct2/show/NCT02629861), NCT02621931 (HALO CM, https://clinicaltrials.gov/ct2/show/NCT02621931), NCT03308968 (FOCUS, https://clinicaltrials.gov/ct2/ show/NCT03308968).
- |||||||||| Review, Journal: European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update. (Pubmed Central) - Jun 20, 2022
Fremanezumab demonstrated a favorable overall and cardio- and cerebrovascular safety profile in more than 2800 patients with episodic migraine or chronic migraine, regardless of cardio- and cerebrovascular medical history, CVRFs, or medication use.Trial Registrations: NCT02629861 (HALO EM, https://clinicaltrials.gov/ct2/show/NCT02629861), NCT02621931 (HALO CM, https://clinicaltrials.gov/ct2/show/NCT02621931), NCT03308968 (FOCUS, https://clinicaltrials.gov/ct2/ show/NCT03308968). Monoclonal antibodies targeting the CGRP pathway are recommended for migraine prevention as they are effective and safe also in the long-term.
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva
Preclinical, Journal: The Anti-CGRP Antibody Fremanezumab Lowers CGRP Release from Rat Dura Mater and Meningeal Blood Flow. (Pubmed Central) - Jun 19, 2022
In conclusion, fremanezumab lowers the CGRP release and lasts up to four weeks, thereby lowering the CGRP-dependent meningeal blood flow. The antibody may not only prevent the released CGRP from binding but may also influence the CGRP release stimulated by noxious agents relevant for the generation of migraine pain.
- |||||||||| Journal: Therapies targeting CGRP signaling for medication overuse headache. (Pubmed Central) - Jun 15, 2022
The available data indicate that anti-CGRP mAbs represent a good mechanism-based and disease-specific therapeutical option with for MOH as long as detoxification and additional nonpharmaceutical interventions are operated. Future research should focus on long-term-controlled trials in MOH populations exclusively.
- |||||||||| Journal: Treatment of migraine with monoclonal antibodies. (Pubmed Central) - Jun 11, 2022
It is essential to form multidisciplinary teams that can identify patients who will benefit from these therapies, conducting cost-effective treatments. The follow-up of these therapies in the coming years is paramount due to the lack of experience in the management of these drugs and the peculiarity of disease evolution in migraine patients.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Review, Journal: Treatment of resistant chronic migraine with anti-CGRP monoclonal antibodies: a systematic review. (Pubmed Central) - Jun 8, 2022
Simple clinical features and baseline CBF in anterior circulation might help to predict the patient's responsiveness. Anti-CGRP or anti-CGRP receptor monoclonal antibodies are a promising preventive migraine therapy which can be particularly useful for resistant chronic migraine patients.
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