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- Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
Efficacy and Disability Outcomes of Fremanezumab in Patients With Prior OnabotulinumtoxinA Treatment Failure: Pooled Results of 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_2748;
Fremanezumab treatment resulted in clinically meaningful reductions in MMD and significant improvements in disability outcomes in patients with prior onabotulinumtoxinA treatment failure.
- Ajovy (fremanezumab) / Otsuka, Teva
Changes in Heart Rate and Blood Pressure in Participants Treated With Fremanezumab for Migraine: A Pooled Analysis of Phase 3 Studies (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_2747;
Fremanezumab treatment resulted in clinically meaningful reductions in MMD and significant improvements in disability outcomes in patients with prior onabotulinumtoxinA treatment failure. This pooled analysis showed that, at the end of 12 weeks of double-blind treatment, fremanezumab treatment resulted in minimal increases in HR and decreases in SBP and DBP from baseline that were not clinically significant and were comparable to those observed in the placebo group among individuals with migraine.
- Ajovy (fremanezumab) / Otsuka, Teva
Six-month Safety and Efficacy of Fremanezumab in Migraine: Pooled Analysis from the Phase 3 FOCUS and HALO Studies () - Mar 6, 2022 - Abstract #AAN2022AAN_2312;
This pooled analysis showed that, at the end of 12 weeks of double-blind treatment, fremanezumab treatment resulted in minimal increases in HR and decreases in SBP and DBP from baseline that were not clinically significant and were comparable to those observed in the placebo group among individuals with migraine. Fremanezumab was safe and well-tolerated in participants with migraine, with ongoing reductions in MMD, over 6 months of treatment.
- Qulipta (atogepant) / AbbVie
Atogepant – an orally-administered CGRP antagonist – attenuates activation of meningeal nociceptors by Cortical Spreading Depression (CSD) () - Mar 6, 2022 - Abstract #AAN2022AAN_2306;
Fremanezumab was safe and well-tolerated in participants with migraine, with ongoing reductions in MMD, over 6 months of treatment. These findings suggest that atogepant can partially prevent activation of both the Aδ -fiber and C-fiber meningeal nociceptors (by CSD), which differs from results found in similar models for fremanezumab, a CGRP-targeted mAb, and onabotulinumtoxinA.
- Qulipta (atogepant) / AbbVie, Nurtec ODT (rimegepant ODT) / Portage, Pfizer
Rimegepant Versus Atogepant and Monoclonal Antibody Treatments for the Prevention of Migraine: A Systematic Literature Review and Network Meta-analysis ([VIRTUAL]) - Mar 6, 2022 - Abstract #AAN2022AAN_2045;
The evidence base consisted of placebo-controlled trials in patients with episodic migraine, for FDA approved doses of the following treatments: rimegepant, atogepant, erenumab, galcanezumab, eptinezumab, and fremanezumab. Rimegepant, atogepant, and mAbs were all effective treatment options for the prevention of migraine when compared vs placebo and generally showed similar effects when compared to one another.
- || Retrospective data, Review, Journal: Efficacy and safety of anti-calcitonin gene-related peptide monoclonal antibodies for treatment of chronic migraine: A systematic review and network meta-analysis. (Pubmed Central) - Mar 5, 2022
Rimegepant, atogepant, and mAbs were all effective treatment options for the prevention of migraine when compared vs placebo and generally showed similar effects when compared to one another. Although all doses of anti-CGRP mAbs have comparable efficacy, safety and tolerability based on uncertainties in indirect comparisons for all outcomes, the calculated effect estimates numerically favored high doses of subcutaneous fremanezumab and intravenous eptinezumab as the effective therapy with acceptable safety and tolerability for short term prevention of chronic migraine.
- ||||| Ajovy (fremanezumab) / Otsuka, Teva
Trial termination: A Study to Test the Effectiveness and Safety of Fremanezumab on Patients With Fibromyalgia (clinicaltrials.gov) - Mar 4, 2022
P2, N=190, Terminated, Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Although all doses of anti-CGRP mAbs have comparable efficacy, safety and tolerability based on uncertainties in indirect comparisons for all outcomes, the calculated effect estimates numerically favored high doses of subcutaneous fremanezumab and intravenous eptinezumab as the effective therapy with acceptable safety and tolerability for short term prevention of chronic migraine. Recruiting --> Terminated; Met pre-specified criteria for futility at interim analysis
- || Clinical, Retrospective data, Review, Journal: The Safety and Efficacy of Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibodies for the Preventive Treatment of Migraine: A Protocol for Multiple-Treatment Systematic Review and Meta-Analysis. (Pubmed Central) - Mar 1, 2022
Recruiting --> Terminated; Met pre-specified criteria for futility at interim analysis This study will provide evidence to health professionals on the efficacy and safety of different monoclonal antibodies against CGRP on the outcomes studied.
- | Ajovy (fremanezumab) / Otsuka, Teva
Trial withdrawal: Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL (clinicaltrials.gov) - Feb 28, 2022
P2, N=0, Withdrawn, Sponsor: Mayo Clinic
This study will provide evidence to health professionals on the efficacy and safety of different monoclonal antibodies against CGRP on the outcomes studied. Not yet recruiting --> Withdrawn
- ||| Ajovy (fremanezumab) / Otsuka, Teva
P2/3 data, P2b data, Clinical Trial,Phase III, Journal: Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients. (Pubmed Central) - Feb 17, 2022
P2/3
Not yet recruiting --> Withdrawn These results suggest that fremanezumab has an early onset of action, as noted in previous post hoc analyses of anti-CGRP monoclonal antibodies.
- || Ajovy (fremanezumab) / Otsuka, Teva
PK/PD data, Journal: A Pharmacokinetic Bioequivalence Study of Fremanezumab Administered Subcutaneously Using an Autoinjector and a Prefilled Syringe. (Pubmed Central) - Feb 16, 2022
The incidence of treatment-emergent antidrug antibody response was low and evenly distributed between the autoinjector (n = 3; 3%) and prefilled syringe (n = 4; 4%) groups. These results indicate that the fremanezumab autoinjector presentation provides an easy-to-use bioequivalent PK profile with a similar safety and tolerability profile to that of the prefilled syringe.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: Efficacy and safety of fremanezumab for episodic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. (Pubmed Central) - Feb 15, 2022
These results indicate that the fremanezumab autoinjector presentation provides an easy-to-use bioequivalent PK profile with a similar safety and tolerability profile to that of the prefilled syringe. Fremanezumab prevents episodic migraine in Japanese and Korean patients to a similar extent than in previously reported populations with no new safety concerns.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: Efficacy and safety of fremanezumab for chronic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. (Pubmed Central) - Feb 15, 2022
Fremanezumab effectively prevents CM in Japanese and Korean patients and was well tolerated. No safety signal was detected.
- ||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical, P3 data, Journal, HEOR: Improvements in quality of life and work productivity with up to 6 months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine-preventive medications in the phase 3b FOCUS study. (Pubmed Central) - Feb 15, 2022
No safety signal was detected. Among patients with EM or CM and prior inadequate response to multiple migraine-preventive medication classes, progressive improvements in MSQoL, depression, and work productivity were achieved during 6 months of fremanezumab treatment.
- | Journal: New Anti-CGRP Medications in the Treatment of Vestibular Migraine. (Pubmed Central) - Feb 15, 2022
Results demonstrated a trend toward improvement, suggesting that the CGRP medications appear to be a decent treatment option for VM. A prospective study evaluating CGRP medications in patients with VM would provide further information about this treatment option.
- | Retrospective data, Journal: Network meta-analysis on efficacy and safety of different anti-CGRP monoclonal antibody regimens for prophylaxis and treatment of episodic migraine. (Pubmed Central) - Feb 9, 2022
Network meta-analysis results suggested that in the comparison of the average migraine days per month, Erenumab (140 mg), Galcanezumab (120 mg, 240 mg), Fremanezumab (225 mg, 675 mg) were superior to placebo, Erenumab(7 mg), and the difference was statistically significant; Fremanezumab (225 mg, 675 mg) was superior to Erenumab (21 mg, 70 mg), and the difference was statistically significant; in the comparison of average medication days of acute migraine-specific drug per month, Erenumab (70 mg, 140 mg), Galcanezumab (120 mg, 240 mg), Fremanezumab (225 mg, 675 mg) was superior to placebo, and Erenumab (140 mg) and Galcanezumab (120 mg, 240 mg) were superior to Erenumab (70 mg), and the difference was statistically significant; there was no statistically significant difference in the average migraine days in the last month or in the medication days of acute migraine-specific drug. Fremanezumab (225 mg) and Galcanezumab (120 mg) may be the best clinical protocol after a comprehensive assessment.
- | Qulipta (atogepant) / AbbVie
Journal: Atogepant (Qulipta) for migraine prevention. (Pubmed Central) - Feb 8, 2022
Fremanezumab (225 mg) and Galcanezumab (120 mg) may be the best clinical protocol after a comprehensive assessment. No abstract available
- || topiramate / Generic mfg.
Retrospective data, Review: Indirect Comparison of Topiramate and Monoclonal Antibodies Against CGRP or Its Receptor for the Prophylaxis of Episodic Migraine: A Systematic Review with Meta-Analysis. (Pubmed Central) - Feb 4, 2022
However, the safety profile is in favor of the CGRP(R) mAbs, with a higher likelihood to help than to harm compared with topiramate. The diversity of endpoint determination and the heterogeneity between studies for some endpoints cause some limitations for this study.
- || Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Review, Journal: Constipation Caused by Anti-calcitonin Gene-Related Peptide Migraine Therapeutics Explained by Antagonism of Calcitonin Gene-Related Peptide's Motor-Stimulating and Prosecretory Function in the Intestine. (Pubmed Central) - Jan 29, 2022
The motor-stimulating and prosecretory actions of CGRP combine in accelerating intestinal transit, an activity profile that has been confirmed by the ability of CGRP to induce diarrhea in mice, dogs and humans. We therefore conclude that the constipation elicited by antibodies targeting CGRP or its receptor results from interference with the physiological function of CGRP in the small and large intestine in which it contributes to the maintenance of peristaltic motor activity, ion and water secretion and intestinal transit.
- | Botox (onabotulinumtoxin A) / GSK, AbbVie
Journal, HEOR, Real-world evidence: Real-World Evidence for the Safety and Efficacy of CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment for Migraine Prevention in Adult Patients With Chronic Migraine. (Pubmed Central) - Jan 26, 2022
Of those who discontinued, the majority reported lack of insurance coverage as a reason. Prospective real-world and controlled trials are needed to further evaluate the safety and potential benefits of this combination treatment paradigm for people with CM.
- || Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies in the Treatment of Patients With Concussion. (Pubmed Central) - Jan 4, 2022
There was a subset of patients with a more robust response. Switching anti-CGRP mAbs was beneficial in some patients.
- || Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal, HEOR: Deterioration of headache impact and health-related quality of life in migraine patients after cessation of preventive treatment with CGRP(-receptor) antibodies. (Pubmed Central) - Jan 4, 2022
The observed deterioration is above the established minimally clinically important differences for each of the questionnaires and can therefore be considered clinically meaningful. Monitoring HRQoL during a discontinuation attempt could facilitate the decision whether or not to resume preventive treatment with CGRP(-R) mAbs.
- || Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Clinical, Journal: Evaluation of the Safety of Calcitonin Gene-Related Peptide Antagonists for Migraine Treatment Among Adults With Raynaud Phenomenon. (Pubmed Central) - Dec 25, 2021
The results of this study indicate that microvascular complications of CGRP antagonist use in patients with underlying RP are uncommon. The incidence of serious adverse events, although rare, warrant caution when considering the use of these agents in patients with RP.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Observational data, Retrospective data, Journal, HEOR, Real-world evidence: Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States. (Pubmed Central) - Dec 22, 2021
The incidence of serious adverse events, although rare, warrant caution when considering the use of these agents in patients with RP. Significant reductions in headache frequency, MPI, and HCRU were observed after fremanezumab initiation in patients with migraine in a US real-world setting.
- ||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical, P3 data, Clinical Trial,Phase III, Journal: Impact of age and sex on the efficacy of fremanezumab in patients with difficult-to-treat migraine: results of the randomized, placebo-controlled, phase 3b FOCUS study. (Pubmed Central) - Dec 21, 2021
P3
Significant reductions in headache frequency, MPI, and HCRU were observed after fremanezumab initiation in patients with migraine in a US real-world setting. These results demonstrate the efficacy of fremanezumab in patients with difficult-to-treat migraine for reducing migraine and headache days, acute medication use, and disability, regardless of age or sex.
- | Ajovy (fremanezumab) / Otsuka, Teva
Preclinical, Journal: CGRP monoclonal antibody prevents the loss of diffuse noxious inhibitory controls (DNIC) in a mouse model of post-traumatic headache. (Pubmed Central) - Dec 21, 2021
Additionally, evaluation of the conditioned pain modulation/diffuse noxious inhibitory controls response may serve as a biomarker of vulnerability for chronic/persistent pain. These findings suggest that early anti-calcitonin-gene related peptide intervention has the potential to be effective both for the treatment of mild traumatic brain injury-induced post-traumatic headache, as well as inhibiting mechanisms that may promote post-traumatic headache persistence.
- | 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.
- | Ajovy (fremanezumab) / Otsuka, Teva
Preclinical, Journal: Characterization and preclinical evaluation of a protease activated receptor 2 (PAR2) monoclonal antibody as a preventive therapy for migraine. (Pubmed Central) - Dec 17, 2021
Activation of protease activated receptor 2, therefore, contributes to both calcitonin gene-related peptide-dependent and -independent mechanisms in promoting migraine-like pain. Therapeutic targeting of protease activated receptor 2 receptors may represent an anti-migraine pain strategy with a potentially broad efficacy profile.
- | Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo
Journal: Drug Profile: Galcanezumab for Prevention of Cluster Headache. (Pubmed Central) - Dec 16, 2021
The prevention of CH with CGRP inhibition represents a novel advance for a condition with a significant unmet need. The negative trial results of galcanezumab for chronic cluster headache [CCH] may be due to the refractory nature and sheds light on the critical need to investigate the underlying biology and therapeutic options.
- ||| 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.
- || Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie
Review, Journal: Anti-CGRP monoclonal antibodies for migraine prevention: A systematic review and likelihood to help or harm analysis. (Pubmed Central) - Dec 16, 2021
This analysis showed that anti-CGRP mAbs exhibit a more favourable benefit-risk ratio than established treatments for episodic and chronic migraine. Head-to-head studies are needed to confirm these results.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: Effects of fremanezumab in patients with chronic migraine and comorbid depression: Subgroup analysis of the randomized HALO CM study. (Pubmed Central) - Dec 16, 2021
Head-to-head studies are needed to confirm these results. Fremanezumab demonstrated efficacy in the preventive treatment of CM and reduced headache impact in patients with comorbid depression.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: Fremanezumab for the Preventive Treatment of Migraine: Subgroup Analysis by Number of Prior Preventive Treatments with Inadequate Response. (Pubmed Central) - Dec 16, 2021
P3
Fremanezumab demonstrated efficacy in the preventive treatment of CM and reduced headache impact in patients with comorbid depression. Significant improvements in efficacy were observed with fremanezumab compared with placebo, even in patients who had previously experienced inadequate response to 4 different classes of migraine preventive medications.ClinicalTrials.gov identifier: NCT03308968.
- ||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical, P1 data, P3 data, PK/PD data, Journal: Dose selection for fremanezumab (AJOVY) phase 3 pediatric migraine studies using pharmacokinetic data from a pediatric phase 1 study and a population pharmacokinetic modeling and simulation approach. (Pubmed Central) - Dec 16, 2021
P1
Significant improvements in efficacy were observed with fremanezumab compared with placebo, even in patients who had previously experienced inadequate response to 4 different classes of migraine preventive medications.ClinicalTrials.gov identifier: NCT03308968. Using exposure matching to the effective adult fremanezumab dose (225 mg subcutaneous monthly), modeling and simulations predict recommended dose of 120 mg in pediatric patients weighing < 45 kg.Registration: The phase 1 study of this report is registered at EudraCT with the identifier 2018-000734-35.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: Reduction in the severity and duration of headache following fremanezumab treatment in patients with episodic and chronic migraine. (Pubmed Central) - Dec 16, 2021
Using exposure matching to the effective adult fremanezumab dose (225 mg subcutaneous monthly), modeling and simulations predict recommended dose of 120 mg in pediatric patients weighing < 45 kg.Registration: The phase 1 study of this report is registered at EudraCT with the identifier 2018-000734-35. These analyses demonstrated that quarterly or monthly treatment with fremanezumab significantly reduced headache severity and duration in patients with CM or EM, including in patients with documented inadequate response to two to four prior migraine preventive medication classes.
- || Botox (onabotulinumtoxin A) / GSK, AbbVie
Clinical, Journal: Effectiveness of dual migraine therapy with CGRP inhibitors and onabotulinumtoxinA injections: case series. (Pubmed Central) - Dec 16, 2021
Patients with suboptimal response to onabotulinumtoxinA may benefit from CGRP inhibitors' addition to their migraine regimens. Placebo-controlled randomized studies are advised to corroborate this finding.
- ||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical, P3 data, Journal: Efficacy and safety of fremanezumab in clinical trial participants aged ≥60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies. (Pubmed Central) - Nov 29, 2021
P3
This pooled subgroup analysis demonstrates that fremanezumab treatment is efficacious and well-tolerated over 12 weeks in participants aged ≥60 years with EM or CM. These data may help healthcare providers with clinical decision making and preventive treatment selection for older patients with migraine.
- | Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
Retrospective data, Journal: Safety and Tolerability of 3 CGRP Monoclonal Antibodies in Practice: A Retrospective Cohort Study. (Pubmed Central) - Nov 17, 2021
These data may help healthcare providers with clinical decision making and preventive treatment selection for older patients with migraine. In patients with chronic migraine, the 3 CGRP monoclonal antibodies were well tolerated, and reduced the number of severe headache days.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: No 'Wearing-off Effect' Seen in Quarterly or Monthly Dosing of Fremanezumab: Sub-analysis of a Randomized Long-term Study. (Pubmed Central) - Nov 17, 2021
P3
In patients with chronic migraine, the 3 CGRP monoclonal antibodies were well tolerated, and reduced the number of severe headache days. This analysis of data from a long-term, phase 3 study showed that patients receiving quarterly fremanezumab or monthly fremanezumab did not experience a wearing-off effect toward the end of the dosing interval.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Retrospective data, Journal: Reversion From Chronic Migraine to Episodic Migraine in Patients Treated With Fremanezumab: Post Hoc Analysis From HALO CM Study. (Pubmed Central) - Nov 17, 2021
This analysis of data from a long-term, phase 3 study showed that patients receiving quarterly fremanezumab or monthly fremanezumab did not experience a wearing-off effect toward the end of the dosing interval. Fremanezumab may offer the benefit of reversion from CM to EM, based on a reduction in the number of headache days over 3 months of treatment.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: COVID-19 pneumonia during long-term migraine prophylaxis with fremanezumab: a case report. (Pubmed Central) - Nov 12, 2021
Fremanezumab may offer the benefit of reversion from CM to EM, based on a reduction in the number of headache days over 3 months of treatment. No abstract available
- || Nurtec ODT (rimegepant ODT) / Portage
Clinical, Journal: Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. (Pubmed Central) - Nov 10, 2021
Rimegepant, when used as an oral acute treatment in patients receiving CGRP mAbs as preventive treatment, was well tolerated; no safety issues were identified. Studies involving larger patient populations are needed to confirm these findings.
- ||||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Real-world evidence: This #OpenAccess #ClinicalTrial protocol outlines Phase IV research across 100 sites in 11 European countries assessing the real-world efficacy of #fremanezumab in treating #Migraine. More here: https://t.co/0RfX2EXMZk And here: https://t.co/kwM9pL5osp @MessoudAshina #Pain (Twitter) - Nov 10, 2021
- || Ajovy (fremanezumab) / Otsuka, Teva
Retrospective data, Review, Journal: Monthly versus quarterly fremanezumab for the prevention of migraine: a systemic review and meta-analysis from randomized controlled trials. (Pubmed Central) - Nov 7, 2021
Monthly administration of fremanezumab shows better outcomes for preventing migraines than quarterly fremanezumab and will not let to more adverse events. Patients with episodic migraine (EM) benefit more from monthly fremanezumab than patients with chronic migraine (CM).
- ||| Journal, Adverse events: The impact of CGRPergic monoclonal antibodies on prophylactic antimigraine therapy and potential adverse events. (Pubmed Central) - Nov 6, 2021
Moreover, because of their physicochemical properties, these agents are hepato-friendly and do not cross the blood-brain barrier (highlighting the relevance of peripheral mechanisms in migraine). Nevertheless, apart from potential cardiovascular side effects, the interaction with AMY receptors and immunogenicity induced by autoantibodies against mAbs could be a concern for the safety of long-term treatment with these molecules.
- ||||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Observational data, Real-world evidence: @MessoudAshina and colleagues outline their protocol for the PEARL observational study on real world effectiveness of #Fremanezumab against migraine in 1100 participants over 24 months. We look forward to the results! https://t.co/Cd8OsYFjCV #Migraine #Pain (Twitter) - Nov 4, 2021
- || Ajovy (fremanezumab) / Otsuka, Teva
Retrospective data, Review, Journal: Comment on: Gao B, Lu Q, Wan R, Wang Z, Yang Y, Chen Z, Wang Z. "Monthly versus quarterly fremanezumab for the prevention of migraine: a systemic review and meta-analysis from randomized controlled trials". Naunyn Schmiedebergs Arch Pharmacol. 2021 Apr;394(4):819-828. Epublished November 2020. (Pubmed Central) - Nov 4, 2021
Furthermore, in the corrected subgroup analyses by type of migraine, there were no significant differences in mean change from baseline in MMD between monthly fremanezumab and quarterly fremanezumab (chronic migraine, P = 0.50; episodic migraine, P = 0.69). Overall, results from our corrected meta-analyses show that there is no significant difference in migraine prevention efficacy between monthly and quarterly fremanezumab dosing.
- ketorolac / Generic mfg., dexamethasone / Generic mfg., indomethacin / Generic mfg.
[VIRTUAL] Severe Unremitting Headache Unresponsive to Indomethacin After Receiving Second-Dose of COVID-19 Mrna Vaccine in Patient with Hemicrania Continua: A Case Report () - Nov 1, 2021 - Abstract #AAPMR2021AAPMR_611;
This case-report demonstrates HC exacerbation after COVID-19 vaccination, now unresponsive to indomethacin and other conventional treatments. Further studies regarding adverse-events and related mechanisms of COVID-19 vaccine in patients with chronic headache and HC is warranted.
- | Nurtec ODT (rimegepant ODT) / Portage
Journal: Rimegepant: acute treatment for migraine headaches. (Pubmed Central) - Oct 30, 2021
Rimegepant is one of these newly approved agents for acute migraine treatment in adults with or without aura. Rimegepant has been found to decrease pain and symptoms associated with migraine attacks and is generally well-tolerated.
- || Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal, Real-world evidence: PEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine. (Pubmed Central) - Oct 30, 2021
PEARL is being conducted in approximately 100 centers in 11 European countries (estimated n = 1100). PEARL will generate important real-world data on effectiveness of fremanezumab and treatment patterns in patients with chronic migraine or episodic migraine.