The evolving understanding of risk with calcitonin gene‐related peptide monoclonal antibodies based on real‐world data: A focus on hypertension and Raynaud phenomenon

Author(s):  
Ilana D. Breen ◽  
Aaron R. Mangold ◽  
Juliana H. VanderPluym
2021 ◽  
Author(s):  
Messoud Ashina ◽  
Faisal Mohammad Amin ◽  
Pinar Kokturk ◽  
Joshua M Cohen ◽  
Martijn Konings ◽  
...  

Fremanezumab is a humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide and is approved in Europe for migraine prevention in adults with ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month, prospective, observational study of fremanezumab in chronic or episodic migraine. End points include proportion of patients with ≥50% reduction in monthly migraine days during 6 months of treatment (primary); changes in monthly migraine days, disability scores and acute headache medication use; adherence and persistence; and effectiveness in patients switching from another calcitonin gene-related peptide pathway-targeting monoclonal antibody. 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.


2021 ◽  
Vol 10 (1) ◽  
pp. 48-51
Author(s):  
Haneen Ahmed Khouja ◽  
Rawan Awadh Alshehri ◽  
Hussain Mirza Alhalal ◽  
Hassan Dhafer Alabisi ◽  
Salhah Mohammad Alajmi ◽  
...  

1990 ◽  
Vol 134 (1) ◽  
pp. 87-94 ◽  
Author(s):  
D.P. Andrew ◽  
T.D. Bidgood ◽  
C. Bose ◽  
D. Brown ◽  
G. Galfre ◽  
...  

2012 ◽  
Vol 15 (7) ◽  
pp. A461-A462
Author(s):  
E.M. van Rooijen ◽  
N. van der Linden ◽  
C. van Gils ◽  
M. Oppe ◽  
C. Uyl-de Groot

Cephalalgia ◽  
2019 ◽  
Vol 39 (9) ◽  
pp. 1164-1179 ◽  
Author(s):  
Da Xu ◽  
Deng Chen ◽  
Li-na Zhu ◽  
Ge Tan ◽  
Hai-jiao Wang ◽  
...  

Aim To systematically evaluate the safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies from the results of randomized controlled trials. Methods Online databases were searched on calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine. Overall withdrawal, withdrawal due to adverse events, adverse events, serious adverse events and specific adverse events were extracted from the included studies. A meta-analysis was performed with Revman 5.3.0 software. Results Ten studies that investigated four drugs (galcanezumab, erenumab, fremanezumab and eptinezumab) with 5817 participants were included in this study. Serious adverse events, overall withdrawals, withdrawal due to adverse events and any adverse events were not significantly associated with monoclonal antibody treatment. Injection site pain and erythema were significantly higher in the calcitonin-gene-related peptide binding monoclonal antibodies treatment group than in the placebo group. The rates of serious adverse events were significantly higher in the galcanezumab 120 mg group. Injection site erythema was associated with galcanezumab 120 mg and 240 mg. Injection site pain and nasopharyngitis were associated with galcanezumab 150 mg and 5 mg, respectively. Overall adverse events were significantly higher with erenumab 70 mg and 140 mg. Treatment-related adverse events were significantly higher with fremanezumab 225 mg/month and 675 mg/quarter. Conclusions This study provides data on the safety and tolerability profiles of calcitonin-gene-related peptide binding monoclonal antibodies and confirms their potential use as preventive treatments for episodic migraine. In addition to the acceptable withdrawal rates, serious adverse events were rare, and the severity of most adverse events was mild to moderate. Injection site reaction may be the major adverse event associated with galcanezumab.


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