scholarly journals Serum CGRP, VIP, and PACAP Usefulness in Migraine: A Case-Control Study in Chronic Migraine Patients in Real Clinical Practice.

2020 ◽  
Author(s):  
Sara Pérez Pereda ◽  
María Toriello-Suárez ◽  
Gonzalo Ocejo-Vinyals ◽  
Sandra Guiral-Foz ◽  
Jesús Castillo-Obeso ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chronic Migraine ◽  
Serum Levels ◽  
Diagnostic Value ◽  
Episodic Migraine ◽  
Medical Centers ◽  
Calcitonin Gene ◽  
Multinomial Modeling ◽  
Global Accuracy ◽  
Real Clinical Practice

Abstract Background: Calcitonin gene-related peptide (CGRP), vasoactive intestinal peptide (VIP) and pituitary adenylate cyclase activating polypetide-38 (PACAP-38) have relevant roles in migraine pathophysiology. Their serum levels have been proposed as biomarkers for migraine. Our aim was to assess their diagnostic value in real clinical practice in a cohort of chronic migraine (CM), episodic migraine (EM) and healthy controls (HC).Methods: We recruited subjects with CM, EM and HC at two medical centers. Blood samples were drawn under fasting conditions in the interictal period, immediately centrifuged and stored at -80º C. Serum levels were determined by ELISA. Neuropeptide levels, the effect of preventatives, correlations with clinical and demographic variables, and their diagnostic value were studied among clinical categories.Results: 296 age- and sex-matched subjects (101 CM, 98 EM and 97 HC) were included. All three neuropeptide serum levels were higher in CM [median and IQ for CGRP= 18.023 pg/ml (14.4-24.7); VIP= 121.732 pg/ml (48.72-186.72) and PACAP= 204.931 pg/ml (101.08-597.64)] vs EM [CGRP = 14.659 pg/ml (10.29-17.45); VIP = 75.603 pg/ml (28.722-107.10); and PACAP = 94.992 pg/ml (65.77-128.48)] and vs HC [CGRP = 13.988 pg/ml (10.095-17.87); VIP = 84.685 pg/ml (35.32-99.79), and PACAP = 103.142 pg/ml (59.42-123.97)]. Using multinomial modeling, only VIP (OR 1.011, 95% CI=1.003-1.018, p=0.005) and PACAP (OR=1.003, 95% CI=1.001-1.005, p=0.002) increased the risk for CM, but not for EM. CGRP did not predict CM or EM. This model could correctly classify only 62/101 (61.38%) of CM, 75/98 (76.53%) of EM, and 5/97 (4.12%) of HC [globally 147/296 (49.8%)]. Individually, PACAP performed the best for classifying clinical categories [global accuracy 150/296 (50.67%)]. In CM, neuropeptide levels were higher in those OnaBT-treated than in no-treated patients.Conclusions: Although interictal serum CGRP and VIP were higher in CM than both EM or HC, their utility to discriminate migraine categories was low. Contrary to other studies, PACAP serum levels were also higher in CM than in EM or HC and had more discriminative capability to distinguish CM from EM and HC. Further investigation is needed for determination technique standardization.

Efficacy and safety of anti-CGRP(r) monoclonal antibodies in real clinical practice: preliminary analysis after three months of therapy

2021 ◽  
Vol 13 (6) ◽  
pp. 62-66
Author(s):  
V. N. Vashchenko ◽  
D. Z. Korobkova ◽  
K. V. Skorobogatykh ◽  
Yu. E. Azimova
Keyword(s):  
Monoclonal Antibodies ◽  
Clinical Practice ◽  
Adverse Events ◽  
Chronic Migraine ◽  
Medication Overuse Headache ◽  
Efficacy And Safety ◽  
Cutaneous Allodynia ◽  
Calcitonin Gene ◽  
Headache Diary ◽  
Real Clinical Practice

Monoclonal antibodies inhibiting calcitonin gene related peptide (CGRP) or its receptor have been widely used for migraine prophylactic therapy for the past three years. Evaluation of their efficacy and safety of therapy in real clinical practice is needed.Objective: to evaluate the efficacy and safety of Erenumab, a monoclonal antibody inhibiting the CGRP receptor during three months of therapy.Patients and methods. Sixty-eight patients (58 women and 10 men, mean age 37±10.4 years) with episodic or chronic migraine who were treated with Erenumab were observed. Patients were assessed with MIDAS, WPAI, and HADS scales; the presence of cutaneous allodynia was evaluated with ASC-12 questionnaire. Patients kept a headache diary and marked adverse events during the whole treatment period.Results and discussion. 47 patients (69%) had chronic migraine and 32 (71.9%) had medication overuse headache. In 48 patients (70%) after 3 injections of Erenumab the number of days with migraine decreased by 50% or more. In 7 patients (10%), the reduction in headache days was more than 75%; 20 (29%) did not experience sufficient effect after three months of therapy. Nineteen adverse events were noted in 15 (22%) patients. Severe constipation led to discontinuation of treatment in two patients (3%).Conclusion. The study showed the efficacy and safety of Erenumab for migraine prophylaxis in both patients with episodic and chronic migraine.

scholarly journals Assessment of peripheral biomarkers potentially involved in episodic and chronic migraine: a case-control study with a focus on NGF, BDNF, VEGF, and PGE2

2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Mohammad Mozafarihashjin ◽  
Mansoureh Togha ◽  
Zeinab Ghorbani ◽  
Abolfazl Farbod ◽  
Pegah Rafiee ◽  
...  
Keyword(s):  
Growth Factor ◽  
Chronic Migraine ◽  
Case Control Study ◽  
Demographic Data ◽  
Serum Levels ◽  
Episodic Migraine ◽  
Case Control ◽  
Blood Levels ◽  
Headache Frequency ◽  
Control Study

Abstract Background Several inflammatory and vascular molecules, and neurotrophins have been suggested to have a possible role in the development of migraine. However, pathophysiological events leading to migraine onset and transformation of episodic migraine (EM) to chronic migraine (CM) are not fully understood. Thus, we aimed to assess peripheral levels of nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VEGF), and prostaglandin E2 (PGE2) in EM and CM patients, and controls. Methods From September 2017 to June 2020, 89 subjects were enrolled in a case-control study; 23 and 36 EM and CM patients, respectively, and 30 age and sex-matched controls. Demographic data and medical history were obtained from all patients. Headache characteristics were recorded at baseline visit and ensuing 30 days for persons with migraine disease. Serum levels of NGF, BDNF, VEGF, and PGE2 were measured once for controls and EM and CM patients, and adjusted for age, sex, and body mass index. Results Serum levels of NGF were significantly lower in EM patients compared to controls and CM patients (P-value=0.003 and 0.042, respectively). Serum levels of BDNF were significantly lower in EM and CM patients as opposed to controls (P-value<0.001), but comparable between EM and CM patients (P-value=0.715). Peripheral blood levels of VEGF were significantly higher in EM and CM patients as opposed to controls (P-value<0.001), but not different between EM and CM patients (P-value=0.859). Serum levels of PGE2 were significantly lower in EM patients compared to controls (P-value=0.011), however similar between EM and CM patients (P-value=0.086). In migraine patients, serum levels of NGF and PGE2 positively correlated with headache frequency (NGF: ρ = 0.476 and P-value<0.001; PGE2: ρ = 0.286 and P-value=0.028), while corresponding levels of BDNF and VEGF did not correlate with headache frequency (BDNF: ρ = 0.037 and P-value=0.778; VEGF: ρ= -0.025 and P-value=0.850). Conclusions Our findings suggest that NGF, BDNF, PGE2, and VEGF may play a significant role in migraine pathogenesis and/or chronification, and therefore might bear potential value for novel targeted abortive and prophylactic migraine therapy. Further prospective cohort studies with larger sample sizes can more robustly evaluate the implications of these findings.

scholarly journals Evaluation of rituximab therapy in real clinical practice (according to the OREL registry of patients with rheumatoid arthritis

2019 ◽  
Vol 57 (3) ◽  
pp. 274-279 ◽  
Author(s):  
A. S. Avdeeva ◽  
A. M. Satybaldyev ◽  
N. V. Demidova ◽  
N. Yu. Nikishina ◽  
E. V. Gerasimova ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Disease Activity ◽  
Acute Phase ◽  
Active Rheumatoid Arthritis ◽  
Serum Levels ◽  
Biologic Agent ◽  
Acute Phase Reactants ◽  
Reactive Protein ◽  
Real Clinical Practice

Objective:to analyze therapy with rituximab (RTM) in real clinical practice according to the data available in OREL registry of patients with active rheumatoid arthritis (RA).Subjects and methods. The analysis included 349 patients. All the patients received RTM: 340 – the original drug (MabThera®) and 9 – the biosimilar Acellbia®. 263 patients (75.4%) received RTM in combination with disease-modifying anti-rheumatic drugs (DMARDs) and 86 (24.6%) – RTM as monotherapy.Results and discussion. Of the 349 patients included in the analysis, 272 (77.9%) patients received RTM as the first biologic agent (BA) (263 patients were treated with the original drug and 9 – with the biosimilar) and 77 (22.1%) patients had previously used the BA. The majority of patients (n=205 (58.7%)) received three or more; 109 (31.2%) patients – one, and 35 (10%) – two RTM courses of RTM therapy. RTM caused a significant reduction in disease activity just after the first therapy course and in the levels of acute-phase reactants (C-reactive protein (CRP) and ESR); after the fifth therapy course, median CRP concentration decreased by 1.4 times and amounted to 7 [1.2; 17.9] mg/l and that of ESR reduced by 1.8 times and was 10 [5; 20] mm/hr (p<0.05).Conclusion.The analysis of RTM therapy in RA patients in real clinical practice demonstrated that in most cases RTM was given as the first BA, in combination with DMARDs, the main agent of which was methotrexate. The use of RTM was accompanied by a significant reduction in disease activity and in the serum levels of acute-phase reactants and autoantibodies.

Anti-CGRP monoclonal antibodies for migraine prevention: A systematic review and likelihood to help or harm analysis

Cephalalgia ◽  
2021 ◽  
pp. 033310242198960
Author(s):  
Konstantina Drellia ◽  
Lili Kokoti ◽  
Christina I Deligianni ◽  
Dimitrios Papadopoulos ◽  
Dimos D Mitsikostas
Keyword(s):  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Chronic Migraine ◽  
Episodic Migraine ◽  
Randomised Clinical Trials ◽  
Migraine Prevention ◽  
Number Of Patients ◽  
Calcitonin Gene ◽  
Using Data ◽  
Risk Ratios

Introduction and objective Monoclonal antibodies targeting the calcitonin gene-related peptide pathway (anti-CGRP mAbs) have shown promising efficacy in randomised clinical trials for the prevention of episodic and chronic migraine, but no head-to-head comparisons with established treatments are available. We aimed to examine absolute differences in benefit-risk ratios between anti-CGRP mAbs, topiramate and propranolol for the prevention of episodic migraine and between anti-CGRP mAbs, topiramate and onabotulinumtoxinA for the prevention of chronic migraine using a likelihood to help versus harm analysis. Methods The number of patients needed to be treated for a patient to achieve ≥ 50% reduction in migraine days (NNTB50%) was used as an effect size metric of efficacy. The number of patients needed to be treated for a patient to experience an adverse event that led to treatment discontinuation (NNTHD-AE) was used as a measure of risk. Likelihood to help versus harm values – which are the ratios of NNTH:NNTB – were calculated using data from phase 3 randomised clinical trials. Results All agents tested were more likely to be beneficial than harmful (likelihood to help versus harm > 1) with the exception of topiramate at 200 mg per day for the prevention of episodic migraine. Anti-CGRP mAbs in all tested doses had higher LHH values than propranolol or topiramate for episodic migraine and onabotulinumtoxinA or topiramate for chronic migraine prevention. Fremanezumab had the highest LHH ratio in episodic migraine and galcanezumab in chronic migraine. Conclusion 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.

Hypersensitivity to calcitonin gene-related peptide in chronic migraine

Cephalalgia ◽  
2020 ◽  
pp. 033310242098166
Author(s):  
Afrim Iljazi ◽  
Håkan Ashina ◽  
Zixuan Alice Zhuang ◽  
Cristina Lopez Lopez ◽  
Josefin Snellman ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Pain Threshold ◽  
Pressure Pain Threshold ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Trigeminal System ◽  
Pressure Pain ◽  
Related Peptide ◽  
Calcitonin Gene ◽  
Historic Cohort

Objective To investigate if calcitonin gene-related peptide infusion induces migraine-like attacks in chronic migraine patients. Methods Fifty-eight patients with chronic migraine, either with or without headache on the experimental day, were assessed for the incidence of migraine-like attacks after an intravenous infusion with calcitonin gene-related peptide 1.5 µg/min over 20 min. The primary endpoint was the incidence of migraine-like attacks after calcitonin gene-related peptide. Exploratory endpoints were the association between the incidence of migraine-like attacks and presence of headache on the experimental day, and headache frequency in the past month. Migraine-like attack data was compared to a historic cohort of 91 episodic migraine patients without headache on the experimental day. Total tenderness score, pressure-pain threshold and supra-threshold pressure pain at baseline were investigated in relation to incidence of migraine-like attacks and presence of headache on the experimental day. Results In total, 83% of the 58 chronic migraine patients developed migraine-like attacks after calcitonin gene-related peptide infusion. Migraine-like attacks were found in 92% of chronic migraine patients with headache on the experimental day compared to 65% of chronic migraine patients without headache on the experimental day ( p = 0.035). No differences were observed in total tenderness score and pressure-pain threshold between chronic migraine patients with and without headache on the experimental day. The incidence of migraine-like attacks following calcitonin gene-related peptide in chronic migraine patients without headache (65%) was equal to the historic cohort of 91 episodic migraine patients without headache (67%) on the experimental day. Conclusions Chronic migraine patients are hypersensitive to calcitonin gene-related peptide. The potency of calcitonin gene-related peptide as a migraine inductor is increased in chronic migraine patients with ongoing headache. We suggest that calcitonin gene-related peptide, besides being a migraine trigger also acts as a modulator of nociceptive transmission in the trigeminal system.

scholarly journals Assessment of immunogenicity from galcanezumab phase 3 trials in patients with episodic or chronic migraine

Cephalalgia ◽  
2020 ◽  
Vol 40 (9) ◽  
pp. 978-989 ◽  
Author(s):  
James M Martinez ◽  
Nada Hindiyeh ◽  
Greg Anglin ◽  
Kavita Kalidas ◽  
Michael E Hodsdon ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Antibody Titer ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Phase 3 ◽  
Related Peptide ◽  
Antidrug Antibody ◽  
Calcitonin Gene ◽  
Antidrug Antibodies

Background This analysis characterizes the immunogenicity profile of galcanezumab, a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and inhibits its activity, in phase 3 migraine trials. Methods Immunogenicity data were analyzed from baseline and double-blind, placebo-controlled phases of the 3-month chronic migraine study REGAIN, the 6-month episodic migraine studies EVOLVE-1 and EVOLVE-2, and from baseline and open-label phases of the 12-month chronic and episodic migraine Study CGAJ. The incidence of baseline antidrug antibodies, treatment-emergent antidrug antibodies, neutralizing antidrug antibodies, and the effect of antidrug antibody titer on pharmacokinetics and pharmacodynamics were assessed. The relationship between antidrug antibody status and efficacy was explored using average change in monthly migraine headache days. Safety analyses assessed the potential relationship between treatment-emergent antidrug antibodies and hypersensitivity events or adverse events related to injection sites. Findings Across studies, 5.9–11.2% of patients had baseline antidrug antibodies. The incidence of treatment-emergent antidrug antibodies was 2.6–12.4% in the galcanezumab group and 0.5–1.7% in the placebo group. The majority of treatment-emergent antidrug antibodies were detected approximately 3–6 months after first study drug dose. Overall, the observed antidrug antibody titer did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or galcanezumab efficacy. There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies. Interpretation These data showed that immunogenicity did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or the efficacy and hypersensitivity profile of galcanezumab in patients with migraine.

Investigating the role of adipokines in chronic migraine

Cephalalgia ◽  
2016 ◽  
Vol 37 (11) ◽  
pp. 1067-1073 ◽  
Author(s):  
Elisa Rubino ◽  
Alessandro Vacca ◽  
Flora Govone ◽  
Annalisa Gai ◽  
Silvia Boschi ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Chronic Migraine ◽  
Plasma Concentrations ◽  
Hdl Cholesterol ◽  
Serum Levels ◽  
Episodic Migraine ◽  
Markers Of Inflammation ◽  
Total Adiponectin ◽  
Inflammatory Processes ◽  
Chronic Migraineurs

Background and aims Adiponectin, leptin, and resistin are adipocyte-derived secretory factors involved in endothelial function, weight, inflammation, and insulin resistance. Recent studies suggested a role for adipokines in episodic migraine as mediators of inflammatory processes. The aim of this study was to investigate plasma concentrations of adiponectin, leptin, and resistin in patients with chronic migraine. Materials and methods Twenty-seven chronic migraineurs (20 females, 7 males; mean age 49.0 ± 9.0 yrs) and 37 healthy controls (23 females, 14 males; mean age 49.8 ± 15.0 yrs) were selected for the study. Fasting plasmatic levels of total adiponectin, leptin, and resistin were measured using ELISA kits during a pain-free period. Fasting glucose, insulin, total and HDL-cholesterol, triglycerides, and ESR were also determined. Results Serum levels of adiponectin and resistin were significantly increased in chronic migraineurs in comparison with controls ( p = 0.001 and p = 0.032, respectively). After correction for BMI, sex and age, leptin levels were significantly increased in chronic migraineurs ( p = 0.007). A positive correlation between leptin concentrations and both indices of insulin resistance and markers of inflammation was found. Discussion Our data suggest that adiponectin and resistin are altered in non-obese chronic migraineurs. Further studies are needed to elucidate the neurobiological mechanisms underlying adipokine dysfunction in migraine.

Relationship between serum levels of VIP, but not of CGRP, and cranial autonomic parasympathetic symptoms: A study in chronic migraine patients

Cephalalgia ◽  
2016 ◽  
Vol 37 (9) ◽  
pp. 823-827 ◽  
Author(s):  
N Riesco ◽  
E Cernuda-Morollón ◽  
P Martínez-Camblor ◽  
AI Pérez-Alvarez ◽  
L Verano ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Significant Positive Correlation ◽  
Vascular System ◽  
Serum Levels ◽  
Spearman Correlation ◽  
Pain Pathways ◽  
Calcitonin Gene ◽  
Intestinal Peptides ◽  
Vasoactive Intestinal Peptides ◽  
Rate Of Activation

Background Cranial autonomic parasympathetic symptoms (CAPS) appear in at least half of migraine patients theoretically as a result of the release of peptides by the trigemino-vascular system (TVS). Cranial pain pathways become sensitised by repeated episodes of TVS activation, leading to migraine chronification. Objective The objective of this article is to correlate the presence of CAPS with serum levels of vasoactive intestinal peptides (VIP) and calcitonin gene-related peptide (CGRP). Patients and methods Patients with chronic migraine (CM) were asked about the presence – during migraine attacks – of five CAPS, which were scored from 0 to 10 by using a quantitative scale. Serum VIP and CGRP levels were determined by ELISA. Results We interviewed 87 CM patients (82 females; mean age 44.7 ± 10.6 years). Seventeen had no CAPS, while 70 reported at least one CAPS. VIP levels ranged from 20.8 to 668.2 pg/ml (mean 154.5 ± 123.2). There was a significant positive correlation between scores in the CAPS scale and VIP levels (Spearman correlation coefficient = 0.227; p = 0.035). VIP levels were significantly higher in CM patients by at least one point in the scale vs those with 0 points ( p = 0.002). Analysing symptoms individually, VIP levels were numerically higher in those patients with symptoms, though they were significantly higher only in those patients with lacrimation vs those without it ( p = 0.013). There was no significant correlation between CGRP levels and the score in the CAPS scale. Conclusions Serum VIP, but not CGRP, levels seem to reflect the rate of activation of the parasympathetic arm of the TVS in migraine.

Serum CGRP, VIP, and PACAP usefulness in migraine: a case–control study in chronic migraine patients in real clinical practice

2020 ◽  
Vol 47 (9) ◽  
pp. 7125-7138
Author(s):  
Sara Pérez-Pereda ◽  
María Toriello-Suárez ◽  
Gonzalo Ocejo-Vinyals ◽  
Sandra Guiral-Foz ◽  
Jesús Castillo-Obeso ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chronic Migraine ◽  
Case Control Study ◽  
Case Control ◽  
Control Study ◽  
Real Clinical Practice
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