A real‐world prospective observational study of eptinezumab in Asian patients with migraine DOI Creative Commons
Yi Jing Zhao, Jonathan Ong, Sumit Kumar Sonu

et al.

Headache The Journal of Head and Face Pain, Journal Year: 2024, Volume and Issue: 64(7), P. 810 - 824

Published: May 24, 2024

Abstract Objective To evaluate the real‐world effectiveness of eptinezumab for migraine prevention in Asian patients. Background Eptinezumab is a monoclonal antibody that targets calcitonin gene‐related peptide (CGRP), potent vasodilator with an important role pathophysiology. Although there robust clinical evidence from pivotal Phase 3 placebo‐controlled trials efficacy prevention, are limited data on patient cohorts. Methods This was non‐interventional, prospective, multisite cohort study adults (International Classification Headache Disorders, 3rd edition criteria) Singapore who were prescribed (100 mg at baseline and Month 3, administered intravenously) followed until 6. The primary endpoint change monthly days (MMDs) Secondary endpoints ≥30% ≥50% responder rates, Impact Test‐6 (HIT‐6), Migraine Disability Assessment (MIDAS), Migraine‐Specific Quality Life (MSQ), patient‐identified most bothersome symptom (PI‐MBS), acute medication use 6, safety. Results Enrolled patients (completed = 29/30) had average 3.4 (SD 2.9) previous preventive treatments; 29/30 trialed least one treatment without benefit. Most previously oral preventives (87%, 26/30) anti‐CGRP (70%, 21/30). Relative to baseline, mean MMDs decreased by 4.3 (95% CI 2.1–6.4; p < 0.001) 4.9 2.1–7.7; At 14/30 (47%) 15/29 (52%) responders, 6/30 (20%) 8/29 (28%) respectively. number severe life impairment based HIT‐6 score (total 60–78) 24/30 (80%) 19/30 (63%) 19/29 (66%) MIDAS 24.6 points 2.82–46.38; 0.028) MSQ increased 12.2 5.18–19.20; 13.6 4.58–22.66; 0.004) reported improvement PI‐MBS (73%, 22/30) 6 (55%, 16/29). Acute headache relief 3.3 days/month 1.0–5.6; 0.007) 4.7 1.7–7.7; 0.003) Treatment‐emergent adverse events (TEAEs) 16/30 (54%) patients, mostly mild/moderate severity. No serious TEAEs led discontinuation. Conclusion Quarterly administration effective well‐tolerated chronic migraine.

Language: Английский

Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial DOI
Messoud Ashina, Michel Lantéri‐Minet, Patricia Pozo‐Rosich

et al.

The Lancet Neurology, Journal Year: 2022, Volume and Issue: 21(7), P. 597 - 607

Published: June 15, 2022

Language: Английский

Citations

93
Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: A systematic review and network meta-analysis DOI Creative Commons
Roberta Messina, Eva‐Maria Huessler, Francesca Puledda

et al.

Cephalalgia, Journal Year: 2023, Volume and Issue: 43(3)

Published: Feb. 14, 2023

Background Direct comparisons of the tolerability and safety migraine preventive treatments targeting calcitonin gene-related peptide pathway are lacking. This study aimed to compare anti-calcitonin monoclonal antibodies gepants in prevention. Methods A network meta-analysis phase 3 randomized controlled trials assessing (erenumab, eptinezumab, fremanezumab, or galcanezumab) (atogepant, rimegepant) prevention was performed. Primary outcomes were treatment-emergent adverse events serious events. Secondary included any events, leading treatment discontinuation individual Results We 19 trials, comprising 14,584 patients. Atogepant 120 mg (OR 2.22, 95% CI [1.26, 3.91]) galcanezumab 240 1.63, [1.33, 2.00]) showed largest odds compared placebo. While eptinezumab 30 had greater 2.62, [1.03,6.66]). No significant differences found between active Eptinezumab associated with lowest placebo, whereas erenumab quarterly fremanezumab due Conclusion Monoclonal a safe well tolerated option for

Language: Английский

Citations

76
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 DOI Creative Commons
Peter Holzer,

Ulrike Holzer‐Petsche

Frontiers in Physiology, Journal Year: 2022, Volume and Issue: 12

Published: Jan. 11, 2022

The development of small-molecule calcitonin gene-related peptide (CGRP) receptor antagonists (gepants) and monoclonal antibodies targeting the CGRP system has been a major advance in management migraine. In randomized controlled trials before regulatory approval, safety these anti-CGRP migraine therapeutics was considered favorable to stay within expected profile. Post-approval real-world surveys reveal, however, constipation be adverse event which may affect more than 50% patients treated with erenumab (an antibody receptor), fremanezumab or galcanezumab (antibodies CGRP). this review article we address question whether caused by inhibition signaling can mechanistically deduced from known pharmacological actions pathophysiological implications digestive tract. gut is expressed two distinct neuronal populations: extrinsic primary afferent nerve fibers neurons intrinsic enteric nervous system. particular, messenger sensory response mucosal stimulation activate both ascending excitatory descending inhibitory pathways that enable propulsive (peristaltic) motor activity take place. addition, able stimulate ion water secretion into intestinal lumen. motor-stimulating prosecretory combine accelerating transit, an profile confirmed ability induce diarrhea mice, dogs humans. We therefore conclude elicited its results interference physiological function small large intestine it contributes maintenance peristaltic activity, transit.

Language: Английский

Citations

55
Monoclonal Antibodies against Calcitonin Gene-Related Peptide for Migraine Prophylaxis: A Systematic Review of Real-World Data DOI Creative Commons
Antun R. Pavelić, Christian Wöber, Franz Riederer

et al.

Cells, Journal Year: 2022, Volume and Issue: 12(1), P. 143 - 143

Published: Dec. 29, 2022

Objective: To perform a systematic review of real-world outcomes for anti-CGRP-mAbs. Methods: Following the PRISMA guidelines, we searched PubMed data erenumab, galcanezumab, fremanezumab, or eptinezumab in patients with migraines. Results: We identified 134 publications (89 retrospective), comprising 10 pharmaco-epidemiologic and 83 clinic-based studies, 38 case reports, 3 other articles. None studies provided follow-up over more than one year 200 patients. Findings suggest that there are reductions health insurance claims days sick-leave as well better treatment adherence Effectiveness, reported 77 was comparable to randomized controlled trials. A pause associated an increase migraine frequency, switching another antibody resulted response some Adverse events safety issues were addressed 86 papers, including 24 single reports. Conclusion: Real-world on anti-CGRP-mAbs limited by retrospective collection, small patient numbers, short periods. The majority papers seem support good effectiveness tolerability setting. There is unmet need large prospective providing long-term follow-ups treated

Language: Английский

Citations

38
Switching anti-CGRP monoclonal antibodies in chronic migraine: real-world observations of erenumab, fremanezumab and galcanezumab DOI
Jamie Talbot,

Rebecca Stuckey,

Natasha Wood

et al.

European Journal of Hospital Pharmacy, Journal Year: 2024, Volume and Issue: unknown, P. ejhpharm - 003779

Published: Jan. 5, 2024

Objectives

The anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAb) are effective in migraine; however, few studies have examined the benefit of switching from one anti-CGRP-mAb to another. In order better inform clinical practice this situation, we present our real-world findings chronic migraine.

Methods

Individuals with migraine that switched treatment (erenumab, fremanezumab or galcanezumab) due ineffectiveness adverse effects were retrospectively identified. Headache diary data before and up 6 months after switch analysed. Main outcome measures monthly red days (days headaches limiting activity requiring triptans), headache any kind headache), triptan use, other analgesic use disability (Headache Impact Test-6 (HIT-6) score) at 3 months.

Results

analysis included 66 instances among 54 individuals. There non-significant reductions −1.2 (−2.7, 0.3) baseline months, 10 individuals (15%) showing ≥50% improvement 22 (33%) experiencing a ≥30% improvement. Improvements days, painkiller HIT-6 score non-significant. When side excluded analysis, significant (Friedman p=0.044) trend for p=0.083) observed. With regard effects, on 12 occasions these improved resolved different anti-CGRP-mAb, while new symptoms reported eight following switch.

Conclusion

We recorded modest improvements outcomes, although results only observed those ineffectiveness. Switching may therefore be viable option

Language: Английский

Citations

11
Real-world effectiveness of Anti-CGRP monoclonal antibodies compared to OnabotulinumtoxinA (RAMO) in chronic migraine: a retrospective, observational, multicenter, cohort study DOI Creative Commons
Licia Grazzi, Riccardo Giossi, Danilo Antonio Montisano

et al.

The Journal of Headache and Pain, Journal Year: 2024, Volume and Issue: 25(1)

Published: Feb. 2, 2024

Abstract Background Chronic migraine (CM) is a disabling condition with high prevalence in the general population. Until recent approval of monoclonal antibodies targeting calcitonin gene-related peptide (Anti-CGRP mAbs), OnabotulinumtoxinA (BoNT-A) was only treatment specifically approved for CM prophylaxis. Direct comparisons between two treatments are not available so far. Methods We performed an observational, retrospective, multicenter study Italy to compare real-world effectiveness Anti-CGRP mAbs and BoNT-A. Patients who had received either according Italian prescribing regulations were extracted from clinical databases. Efficacy outcomes included change baseline monthly headache days (MHD), MIgraine Disability ASsessment test (MIDAS), acute medications (MAM) evaluated at 6 12 months follow-up. The primary outcome MHD months. Safety serious adverse events (SAE) discontinuation. Unadjusted adjusted models used analyses. Results Two hundred sixteen potentially eligible patients screened; 183 (86 mAbs; 97 BoNT-A) included. One seventy-one (80 91 154 (69 85 efficacy analysis follow-up, respectively. BoNT-A both resulted mean reduction (-11.5 -7.2 days, respectively; unadjusted difference -4.3; 95%CI -6.6 -2.0; p = 0.0003) (-11.9 -7.6, -4.4; -6.8 0.0002) Similar results observed after adjusting confounders. showed significant MIDAS (-31.7 -19.2 points, 0.0001 0.0296, respectively) MAM (-5.1 -3.1 administrations, 0.0023 0.0574, compared No SAEs reported. patient receiving fremanezumab discontinued due arthralgia. Treatment discontinuations, mainly inefficacy, comparable. Conclusion Both effective presenting higher effect magnitude, comparable safety. Still, remains valuable option contraindications or frail categories candidates local therapy limited risk systemic administration. Graphical

Language: Английский

Citations

10
Pharmacological management of migraine: current strategies and future directions DOI Creative Commons
Lanfranco Pellesi, Thien Phu, Anders Hougaard

et al.

Expert Opinion on Pharmacotherapy, Journal Year: 2024, Volume and Issue: 25(6), P. 673 - 683

Published: April 12, 2024

Introduction Migraine is a complex neurological disorder that affects significant portion of the global population. As traditional pharmacological approaches often fall short in alleviating symptoms, development innovative therapies has garnered interest. This text aims to summarize current options for managing migraine and explore potential impact novel therapies.

Language: Английский

Citations

9
Pharmacological differences and switching among anti‐CGRP monoclonal antibodies: A narrative review DOI Open Access
Giorgio Dalla Volta, Antonio Munafò, Andrea Burgalassi

et al.

Headache The Journal of Head and Face Pain, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 17, 2025

Abstract Antibodies targeting either the calcitonin gene–related peptide (CGRP), such as galcanezumab, fremanezumab, and eptinezumab, or receptor (erenumab) have been approved for prevention of episodic chronic migraine. Although widely used generally effective, a proportion patients discontinue treatment due to lack efficacy. In both randomized controlled trials observational studies, all anti‐CGRP monoclonal antibodies (mAbs) consistently demonstrated comparable efficacy tolerability, suggesting pharmacological class effect. However, differences in therapeutic targets, structure, pharmacokinetic characteristics may influence their safety differently. Therefore, not achieving clinically meaningful response with one antibody, switching different antibody be viable option. This review examines distinctions among mAbs, highlighting mechanisms action profiles, along clinical data switching. Finally, we summarize suggestions from international guidelines.

Language: Английский

Citations

1
Long-term safety, tolerability, and efficacy of eptinezumab in chronic cluster headache (CHRONICLE): an open-label safety trial DOI
Cristina Tassorelli,

Rigmor H Jensen,

Peter J. Goadsby

et al.

The Lancet Neurology, Journal Year: 2025, Volume and Issue: 24(5), P. 429 - 440

Published: April 16, 2025

Language: Английский

Citations

1
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale DOI Open Access
Fred Cohen, Hsiangkuo Yuan, Stephen D. Silberstein

et al.

BioDrugs, Journal Year: 2022, Volume and Issue: 36(3), P. 341 - 358

Published: April 27, 2022

Language: Английский

Citations

29