Safety efficacy and tolerability of the calcitonin gene-related peptide monoclonal antibodies for migraine prevention in a real world setting

Abstract Background:Calcitonin gene-related peptide (CGRP) monoclonal antibodies were approved as preventive treatment for migraine. We aimed to assess CGRP monoclonal antibodies efficacy and safety.Methods:Patients were diagnosed based on International Classification of Headache Disorders disorders-third edition, (ICHD-III). Eligible patients received CGRP monoclonal antibodies (mAbs) and had a follow up visits for at least three months. Primary end point was a 50% or greater reduction in mean migraine days per month at the last visit. Secondary end points were change from baseline to last visit in the mean number of migraine days per month, change in the number of days of use of analgesics, change in the severity of headache pain, and change in scores on the Quality of life (QOL) questionnaire. Safety and tolerability were reported.Results:This prospective study included 63 migraine patients, with a mean age of 44.59 years. Females represented 77.8% of the cohort. A 50% or greater reduction in the mean number of migraine days per month was achieved in 68.3% of patients. At the last visit, patients had a significant reduction in migraine days, number of days of analgesic-usage and the severity of headache (5.13+ 4.11versus 14.04 + 7.77; p < 0.01), (6.43+ 6.34 versus 15.85 +7.31; p <. 0001), (5.40 +2.48 versus 9.67+ 0.72; p < 0.001) respectively. CGRP mAb treatment significantly improved quality of life (112.20+ 12.20 versus 92.13 +15.84; P< 0.001). 14.4% reported adverse events.Conclusion:Prophylactic CGRP monoclonal antibodies treatment for migraine were efficacious and reduced the number of monthly migraine days and the use of days of analgesics.

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How much do calcitonin gene-related peptide monoclonal antibodies improve the quality of life in migraine? A patientʼs perspective

Current Opinion in Neurology ◽

10.1097/wco.0000000000000689 ◽

2019 ◽

Vol 32 (3) ◽

pp. 395-404 ◽

Cited By ~ 7

Author(s):

Marta Torres-Ferrus ◽

Alicia Alpuente ◽

Patricia Pozo-Rosich

Keyword(s):

Quality Of Life ◽

Monoclonal Antibodies ◽

Calcitonin Gene Related Peptide ◽

Related Peptide ◽

Calcitonin Gene

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Calcitonin Gene-Related Peptide Monoclonal Antibodies Versus Botulinum Neurotoxin a in the Preventive Treatment of Chronic Migraine: An Adjusted Indirect Treatment Comparison Meta-Analysis

Frontiers in Pharmacology ◽

10.3389/fphar.2021.671845 ◽

2021 ◽

Vol 12 ◽

Author(s):

Yao-Yao Chen ◽

Xiao-Qian Ye ◽

Tai-Chun Tang ◽

Tian-Wei She ◽

Min Chen ◽

...

Keyword(s):

Monoclonal Antibodies ◽

Chronic Migraine ◽

Botulinum Neurotoxin ◽

Meta Analysis ◽

Preventive Treatment ◽

Calcitonin Gene Related Peptide ◽

Controlled Trials ◽

Botulinum Neurotoxin A ◽

Related Peptide ◽

Calcitonin Gene

Purpose: Calcitonin gene-related peptide monoclonal antibodies (CGRPmAbs) are new agents approved by the US Food and Drug Administration for preventive treatment of chronic migraine. Comparison between CGRPmAbs and previously approved Botulinum neurotoxin A (BoNT-A) will inform optimal preventive treatment of chronic migraine, but head-to-head trials are lacking. We therefore aimed to perform adjusted indirect comparison between CGRPmAbs and BoNT-A through a meta-analysis.Methods: OVID MEDLINE, EMBASE and the Cochrane central register of controlled trials, clinical registries, and government websites were searched from inception to September 2019. Randomized controlled trials comparing CGRPmAbs or BoNT-A with placebo in the preventive treatment of chronic migraine were included. The primary outcomes were headache days and migraine days measured at week 12. Data were synthesized by using a frequentist approach; and the treatments were ranked by P-score.Results: We included 10 trials (n = 4,678) after screening 1049 candidates. Six trials were with low risk of bias. Fremanezumab had an effect similar to BoNT-A in the reduction of headache days at week 12 (standard mean difference [SMD] 0.08, 95%CI -0.55 to -0.7). Galcanezumab reduced more migraine days than BoNT-A at week 12 (SMD, -0.94, 95%CI −1.24 to −0.63); fremanezumab showed similar findings (SMD, −0.55, 95%CI −0.85 to −0.24). Galcanezumab and fremanezumab had better effect in mitigating headache impact at week 12. CGRPmAbs and BoNT-A had similar adverse event rate.Conclusion: CGRPmAbs and BoNT-A had similar effect in the preventive treatment of chronic migraine. BoNT-A might be preferentially selected owing to its cost-effectiveness profiles. Further studies with direct comparison of the two treatments are warranted.

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Impact of calcitonin gene-related peptide receptor antagonist on quality of life

Journal of the Neurological Sciences ◽

10.1016/j.jns.2021.119303 ◽

2021 ◽

Vol 429 ◽

pp. 119303

Author(s):

Roberto Ferri ◽

Marco Iudicello ◽

Manuela Matta ◽

Filippo De Mattei ◽

Fabiana Colucci ◽

...

Keyword(s):

Quality Of Life ◽

Receptor Antagonist ◽

Calcitonin Gene Related Peptide ◽

Peptide Receptor ◽

Related Peptide ◽

Calcitonin Gene

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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

BMC Neurology ◽

10.1186/s12883-020-01633-3 ◽

2020 ◽

Vol 20 (1) ◽

Cited By ~ 11

Author(s):

Hong Deng ◽

Gai-gai Li ◽

Hao Nie ◽

Yang-yang Feng ◽

Guang-yu Guo ◽

...

Keyword(s):

Systematic Review ◽

Monoclonal Antibodies ◽

Meta Analysis ◽

Peptide Binding ◽

Preventive Treatment ◽

Episodic Migraine ◽

Calcitonin Gene Related Peptide ◽

Efficacy And Safety ◽

Related Peptide ◽

Calcitonin Gene

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Endogenous calcitonin gene-related peptide in cerebrospinal fluid and early quality of life and mental health after good-grade spontaneous subarachnoid hemorrhage—a feasibility series

Neurosurgical Review ◽

10.1007/s10143-020-01333-z ◽

2020 ◽

Author(s):

Elisabeth Bründl ◽

Martin Proescholdt ◽

Eva-Maria Störr ◽

Petra Schödel ◽

Sylvia Bele ◽

...

Keyword(s):

Quality Of Life ◽

Mental Health ◽

Cerebrospinal Fluid ◽

Subarachnoid Hemorrhage ◽

Calcitonin Gene Related Peptide ◽

Related Peptide ◽

Calcitonin Gene ◽

Good Grade ◽

Spontaneous Subarachnoid Hemorrhage

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CGRP ligand and receptor monoclonal antibodies for migraine prevention: Evidence review and clinical implications

Cephalalgia ◽

10.1177/0333102418821662 ◽

2019 ◽

Vol 39 (3) ◽

pp. 445-458 ◽

Cited By ~ 50

Author(s):

David W Dodick

Keyword(s):

Monoclonal Antibodies ◽

Preventive Treatment ◽

Calcitonin Gene Related Peptide ◽

Long Term Outcomes ◽

Open Label ◽

Peptide Receptor ◽

Related Peptide ◽

Calcitonin Gene ◽

Open Label Extension

Background: Monoclonal antibodies that target calcitonin gene-related peptide or the canonical calcitonin gene-related peptide receptor have emerged as effective and well tolerated for the preventive treatment of migraine. These large molecules appear ideally suited for migraine prevention. They have an extended biological half-life, are administered either monthly or quarterly either by subcutaneous injection or intravenous infusion, require minimal or no dose-titration and have the potential for a rapid onset of effect compared to conventional oral preventive drugs. There is high selectivity and they target an important mediator in the pathogenesis of migraine. Investigation: Phase II and pivotal phase III studies have all yielded positive results with a favorable adverse event profile. No serious treatment-related adverse outcomes have thus far been reported in controlled or long-term open-label extension studies. This tolerability profile promises to improve adherence and, possibly, long-term outcomes. Conclusions: Calcitonin gene-related peptide monoclonal antibodies are effective and well tolerated for the preventive treatment of migraine. They have distinct advantages over currently available oral preventive drugs. While treatment-related serious adverse events have not been observed in open-label extension studies, long-term outcomes and safety will require broad exposure in heterogeneous patient populations in clinical practice. In addition, their safety in women, especially during pregnancy, will require longitudinal surveillance. Given the overlapping mechanism(s), the effectiveness of existing (triptans) and emerging (calcitonin gene-related peptide receptor antagonists) acute therapies in those using a calcitonin gene-related peptide mAb will require further study.

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Galcanezumab for the prevention of migraine

Pain Management ◽

10.2217/pmt-2020-0030 ◽

2020 ◽

Author(s):

Lindsay M Frerichs ◽

Deborah I Friedman

Keyword(s):

Monoclonal Antibody ◽

Clinical Efficacy ◽

Preventive Treatment ◽

Calcitonin Gene Related Peptide ◽

Efficacy And Safety ◽

Related Peptide ◽

Calcitonin Gene

Migraine is a common and disabling disorder affecting approximately 1.02 billion people worldwide. Calcitonin gene-related peptide (CGRP) has been identified as playing an important role in the pathophysiology of migraine and several migraine-specific therapies targeting the CGRP ligand or its receptor have been approved since 2018 for the acute and preventive treatment of migraine. This review focuses on the pharmacology, clinical efficacy and safety/tolerability of galcanezumab, an anti-CGRP monoclonal antibody approved for the prevention of migraine.

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Utilization of laser interstitial thermotherapy guided by real-time thermal MRI as an alternative to separation surgery in the management of spinal metastasis

Journal of Neurosurgery Spine ◽

10.3171/2015.2.spine141185 ◽

2015 ◽

Vol 23 (4) ◽

pp. 400-411 ◽

Cited By ~ 48

Author(s):

Claudio E. Tatsui ◽

R. Jason Stafford ◽

Jing Li ◽

Jonathan N. Sellin ◽

Behrang Amini ◽

...

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Real Time ◽

Spinal Cord Compression ◽

Spinal Metastasis ◽

Cord Compression ◽

The Mean ◽

Interstitial Thermotherapy

OBJECT High-grade malignant spinal cord compression is commonly managed with a combination of surgery aimed at removing the epidural tumor, followed by spinal stereotactic radiosurgery (SSRS) aimed at local tumor control. The authors here introduce the use of spinal laser interstitial thermotherapy (SLITT) as an alternative to surgery prior to SSRS. METHODS Patients with a high degree of epidural malignant compression due to radioresistant tumors were selected for study. Visual analog scale (VAS) scores for pain and quality of life were obtained before and within 30 and 60 days after treatment. A laser probe was percutaneously placed in the epidural space. Real-time thermal MRI was used to monitor tissue damage in the region of interest. All patients received postoperative SSRS. The maximum thickness of the epidural tumor was measured, and the degree of epidural spinal cord compression (ESCC) was scored in pre- and postprocedure MRI. RESULTS In the 11 patients eligible for study, the mean VAS score for pain decreased from 6.18 in the preoperative period to 4.27 within 30 days and 2.8 within 60 days after the procedure. A similar VAS interrogating the percentage of quality of life demonstrated improvement from 60% preoperatively to 70% within both 30 and 60 days after treatment. Imaging follow-up 2 months after the procedure demonstrated a significant reduction in the mean thickness of the epidural tumor from 8.82 mm (95% CI 7.38–10.25) before treatment to 6.36 mm (95% CI 4.65–8.07) after SLITT and SSRS (p = 0.0001). The median preoperative ESCC Grade 2 was scored as 4, which was significantly higher than the score of 2 for Grade 1b (p = 0.04) on imaging follow-up 2 months after the procedure. CONCLUTIONS The authors present the first report on an innovative minimally invasive alternative to surgery in the management of spinal metastasis. In their early experience, SLITT has provided local control with low morbidity and improvement in both pain and the quality of life of patients.

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