- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab-vfrm) / Teva
Journal: Treatment Outcome After Switching From Galcanezumab to Fremanezumab in Patients With Migraine. (Pubmed Central) - May 7, 2024
The treatment response to fremanezumab seems to be independent of the prior treatment response to galcanezumab. Our findings suggest that switching to another anti-CGRP mAb can be considered when a particular anti-CGRP mAb is ineffective or intolerable.
- |||||||||| Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
Clinical, Observational data, Retrospective data, Journal, Real-world evidence, Real-world effectiveness, Real-world: Reducing the Impact of Headache and Allodynia Score in Chronic Migraine: An Exploratory Analysis from the Real-World Effectiveness of Anti-CGRP Monoclonal Antibodies Compared to Onabotulinum Toxin A (RAMO) Study. (Pubmed Central) - Apr 26, 2024
In this exploratory analysis, anti-CGRP mAbs showed superior effectiveness for HIT-6 and ASC12 compared to BoNT-A. Reductions in terms of month headache days (MHD), migraine disability assessment test (MIDAS), and migraine acute medications (MAM) were clinically relevant for both treatments.
- |||||||||| Review, Journal: Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies in Migraine: Focus on Drug Interactions. (Pubmed Central) - Apr 26, 2024
However, monoclonal antibodies may worsen diseases with already weakened CGRP neurotransmission, Raynaud phenomenon and constipation. Monoclonal antibodies used for prevention of migraine do not engage in significant pharmacokinetic interactions with other drugs; however, they do engage in pharmacodynamic interactions with other anti-migraine drugs, additively augmenting their prophylactic action, but also increasing frequency and severity of adverse reactions, which are a consequence of the CGRP neurotransmission interruption.
- |||||||||| Clinical, Review, Journal: Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An American Headache Society position statement update. (Pubmed Central) - Apr 23, 2024
Monoclonal antibodies used for prevention of migraine do not engage in significant pharmacokinetic interactions with other drugs; however, they do engage in pharmacodynamic interactions with other anti-migraine drugs, additively augmenting their prophylactic action, but also increasing frequency and severity of adverse reactions, which are a consequence of the CGRP neurotransmission interruption. The CGRP-targeting therapies should be considered as a first-line approach for migraine prevention along with previous first-line treatments without a requirement for prior failure of other classes of migraine preventive treatment.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab-vfrm) / Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
Review, Journal, Adverse events, Serious adverse event: Adverse and serious adverse events incidence of pharmacological interventions for managing chronic and episodic migraine in adults: a systematic review. (Pubmed Central) - Apr 22, 2024
All drugs showed a certain incidence of infections and infestations, with Onabotulinumtoxin A (BTA) having the lowest rate...Calcitonin gene-related peptide (CGRP) monoclonal antibodies (MAbs) such as fremanezumab and galcanezumab were linked to more general disorders and administration site conditions than other drugs...We suggest conducting head-to-head RCTs to evaluate the safety profile of oral medications, BTA, and CGRP MAbs in episodic and/or chronic migraine populations. CRD42021265993.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon
Journal: Cluster Headache, SUNCT, and SUNA. (Pubmed Central) - Apr 7, 2024
However, new successful clinical trials of high-dose prednisone, high-dose galcanezumab, and occipital nerve stimulation provide additional options for patients with cluster headache...The trigeminal autonomic cephalalgias are a group of diseases that appear similar to each other and other headache disorders but have important differences. Proper diagnosis is crucial for proper treatment.
- |||||||||| Journal: Preventive Treatment of Migraine. (Pubmed Central) - Apr 7, 2024
Six drugs targeting CGRP (four monoclonal antibodies and two gepants) are now available for the preventive treatment of episodic migraine in adults. The efficacy of CGRP-targeted medications in the acute and preventive treatment of migraine, together with good safety and tolerability, has led to the emergence of new approaches to preventive treatment.
- |||||||||| Enrollment open: Migraine Medication Effects on Urinary Symptoms (clinicaltrials.gov) - Mar 29, 2024
P=N/A, N=200, Enrolling by invitation,
Further studies are needed to investigate these matters. Not yet recruiting --> Enrolling by invitation
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon
Understanding Patients' Journeys Prior to Initiating Calcitonin Gene-related Peptide Monoclonal Antibody for Migraine Prevention in the United States (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3920;
Objective:To describe experience with migraine and factors influencing the decision to seek treatment in a cohort of patients in the US initiating galcanezumab for migraine prevention.Background:Although migraine is associated with several disabling symptoms, many patients are reluctant to initiate pharmacological treatment...Patients' decisions regarding migraine prevention are influenced by past experiences involving triggers and interactions with HCPs. Increased awareness of patients' journey to treatment may help address misinformation and improve migraine care.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon
Interictal Burden Before Initiating Calcitonin Gene-related Peptide Monoclonal Antibody for Migraine Prevention (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3207;
This real-world, patient survey showed that patients with prior exposure to subcutaneous anti-CGRP mAbs had high overall satisfaction with the effectiveness of eptinezumab treatment regardless of the number and type of previous therapies used. Patients with migraine, particularly those with chronic migraine, experience moderate to severe interictal burden before initiating galcanezumab as their first CGRP mAb.
- |||||||||| The Safety and Efficacy of Dual Calcitonin Gene-related Peptide Therapies for Migraine Treatment (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3206;
The observed reduction in headache severity and frequency suggests a dual blockade is beneficial for migraine symptom control in selected patients. Safety regarding this treatment option is also supported by these findings; specifically, the small molecule antagonists appear to be the safest option to include in dual regimens.
- |||||||||| Qulipta (atogepant) / AbbVie
Benefit-Risk Assessment Based on Number Needed to Treat and Number Needed to Harm: Atogepant vs Calcitonin Gene (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3006;
The base-case analysis included data from core studies of atogepant 60 mg, erenumab 70 mg and 140 mg, galcanezumab 120 mg, eptinezumab 100 mg and 300 mg, and fremanezumab 225 mg and 675 mg. Atogepant demonstrated a favorable benefit-risk profile, with NNT and NNH values comparable with those of CGRP mAbs across all scenarios.
- |||||||||| Qulipta (atogepant) / AbbVie
Real-world Switching Rates of Atogepant Are Lower than CGRP Monoclonal Antibodies (mAbs) in Patients with Migraine Using Claims Database (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_2727;
Patients were excluded if they had ?1 claim for atogepant, rimegepant, BOTOX for migraine, or a CGRP mAb in the 12 months preceding the index date...At 12 months follow-up, 13.4% of atogepant users and 21.1% of CGRP mAb users (23.1% eptinezumab, 26.5% erenumab, 19.6% fremanezumab, 18.4% galcanezumab) initiated a different branded preventive. Compared with atogepant users, CGRP mAb users were significantly more likely to switch to another branded preventive treatment within 1 year of treatment initiation.
- |||||||||| Reasons for Discontinuation of Medical Management in Refractory Idiopathic Intracranial Hypertension (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_2471;
Our study results suggest that medical management available for IIH may not be suitable for all patients, and many may discontinue the medication due to adverse effects or no improvement in symptoms. IIH patients refractory to medical management are a challenging sub-group requiring invasive and surgical diagnostic and treatment modalities.
- |||||||||| Review, Journal, HEOR: Anti-CGRP mAbs for the Preventive Treatment of Migraine: An Overview Review and a Cost Saving Analysis in the Global Scenario. (Pubmed Central) - Mar 7, 2024
In fact, all extracted studies showed a protective risk factor exposure in monthly migraine days reduction for all the anti-CGRP mAbs, whereas the cost analysis showed that using eptinezumab, in a quarter there is a cost saving of at least $425 per patient, compared with the other anti-CGRP mAbs. With equal efficacy and equal safety, anti-CGRP mAbs should be prescribed also regard to the cost established at the negotiation, making sure to guarantee the best treatment to the patients, but at the same time impacting as little as possible to the healthcare services resources.
- |||||||||| Journal, Adverse events, Adverse drug reaction: Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System. (Pubmed Central) - Mar 6, 2024
However, hypertension with ERE, atrial fibrillation and myocardial infarction with GMB, as well as pallor, deep vein thrombosis, hot flush, and palpitations with FMB were not reported in the Summary of Product Characteristics (SmPCs). Considering this, more post-marketing analyses are needed to improve knowledge on the CV safety profiles of anti-CGRP-mAbs, especially for the last approved medication, EPT.
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov) - Mar 2, 2024
P2, N=28, Recruiting,
Considering this, more post-marketing analyses are needed to improve knowledge on the CV safety profiles of anti-CGRP-mAbs, especially for the last approved medication, EPT. Trial completion date: Mar 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024
- |||||||||| Review, Journal: Biosimilar in Breast Cancer: A Narrative Review. (Pubmed Central) - Feb 26, 2024
These findings have implications for enhancing the overall well-being and quality of life in individuals with migraines and comorbid psychiatric conditions. Trastuzumab biosimilars, such as CT-P6, Ontruzant
- |||||||||| Retrospective data, Journal: Effectiveness of Switching CGRP Monoclonal Antibodies in Non-Responder Patients in the UAE: A Retrospective Study. (Pubmed Central) - Feb 23, 2024
Fremanezumab was not included due to unavailability in the UAE...The safety of switching between CGRP classes was well observed, as any adverse events presented before the class switch did not lead to the discontinuation of treatment following the later switch. The findings of this study suggest that switching between different classes of CGRP mAbs is a potentially safe and clinically viable practice that may have some applications for those experiencing side effects on their current CGRP mAb or those witnessing suboptimal response.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Effect of anti-CGRP-targeted therapy on migraine aura: Results of an observational case series study. (Pubmed Central) - Feb 13, 2024
Conversely, these antibodies are able to counteract, via their peripheral mechanisms of action, the sensitization of the trigemino-vascular pathway which is triggered by CSD. This aforementioned might explain why in our patients, migraine aura attacks remained unchanged in their frequencies, but the headache phases were either reduced or absent.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon
Preclinical, Journal: Anti-CGRP antibody galcanezumab modifies the function of the trigeminovascular nocisensor complex in the rat. (Pubmed Central) - Jan 24, 2024
Galcanezumab treatment is followed by multiple changes in the release of neuropeptides and histamine in the trigeminal nocisensor complex, which may contribute to the migraine preventing effect of anti-CGRP antibodies. These changes affecting the communication between the components of the trigeminal nocisensor complex may reduce pain susceptibility in migraine patients treated with CGRP targeting monoclonal antibodies.
- |||||||||| Journal, Adverse events, Real-world evidence, Real-world: Adverse event reporting of four anti-Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: a real-world study based on the FDA adverse event reporting system. (Pubmed Central) - Jan 24, 2024
In addition, there are new AEs that were not listed in the drug instructions but occurred concurrently with multiple drugs, such as Raynaud's phenomenon, weight increase, menstrual disorders, throat tightness, and paraesthesia oral. Common AE signals of the four anti-CGRP mAbs and new AE signals were found to provide a reference for clinical drug selection in clinical practice.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Retrospective data, Journal, Real-world evidence, Real-world: Characteristics associated with response to subcutaneously administered anti-CGRP monoclonal antibody medications in a (Pubmed Central) - Jan 22, 2024
Common AE signals of the four anti-CGRP mAbs and new AE signals were found to provide a reference for clinical drug selection in clinical practice. In this real-world setting, anti-CGRP preventives reduced MDM persistently and had similar and large effect sizes on MDM reduction; however, clinical and genetic factors influenced response.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal, Real-world evidence, Real-world: Switching anti-CGRP monoclonal antibodies in chronic migraine: real-world observations of erenumab, fremanezumab and galcanezumab. (Pubmed Central) - Jan 6, 2024
We recorded modest improvements in headache outcomes, although significant results were only observed in those that switched anti-CGRP-mAb due to ineffectiveness. Switching may therefore be a viable option for these individuals.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Observational data, Journal: Are anti-calcitonin gene-related peptide monoclonal antibodies effective in treating migraine aura? A pilot prospective observational cohort study. (Pubmed Central) - Dec 13, 2023
Our aim was to determine the effects of the anti-CGRP-mAb galcanezumab on cortical thickness after 3-month treatment of patients with high-frequency episodic or chronic migraine...This conclusion is further supported by our recent study showing that 3 Our findings suggest that anti-CGRP mAbs are highly effective in migraine with aura, both in reducing mean monthly aura days and mean monthly days with headache.
- |||||||||| Empaveli (pegcetacoplan SC) / Apellis, SOBI
Review, Journal: Paroxysmal Nocturnal Hemoglobinuria: Current Management, Unmet Needs, and Recommendations. (Pubmed Central) - Dec 12, 2023
Biosimilars of eculizumab are also now available...In addition, the use of self-administered subcutaneous and oral therapies raises concerns around treatment adherence and the risks of uncontrolled terminal complement. Given the ultra-rare nature of PNH, development is underway of a centralized international registry to capture and analyze the data as they mature for various new therapies and characterize the clinical challenges related to PNH management.
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