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Top-line data from the Phase 3 TEMPLE study have shown that fewer patients taking atogepant 60 mg once daily discontinued treatment due to adverse events (AEs) than those taking the highest tolerated dose of topiramate (50 mg, 75 mg or 100 mg/day). Over the 24-week double-blind treatment period in patients with a history of at …

Latest analyses from the Phase 3 PRODROME study of ubrogepant 100 mg dosed during the premonitory (prodromal) phase of migraine have shown that treatment may ameliorate common prodromal symptoms, with improvements possible as early as 1 hour post-dose. Of 1,087 screened participants, efficacy data were reported for 477, with qualifying prodromal events defined as attacks …

CGRP mAbs are as effective in people with migraine and fibromyalgia (FM) as in those with migraine alone, according to results of a retrospective, observational, cross-sectional study of 122 patients prescribed erenumab, galcanezumab, and fremanezumab, 26 of whom had FM. All the patients with migraine alone attended their 6-month check, though some of those with …

A peptide-based active immunotherapy against CGRP has been shown to promote robust antibody titres across preclinical species. Synthetic peptide immunogens formulated in adjuvants were delivered intramuscularly and serum samples then collected for antibody titre measurement and isolation of antibodies specific to CGRP. Characterisation of the immune response strongly suggested that the immunotherapy primarily stimulated a humoral …

Growing experience of dual anti-CGRP therapy, presented at AAN2025, is reinforcing its efficacy and safety in preventing and controlling migraine. Further results from the Phase 4 TANDEM open label study of atogepant 60 mg QD for migraine prevention and ubrogepant 100 mg PRN to treat breakthrough migraine attacks, together with real world experience of combined …

MEDI0618, a fully humanized PAR2 monoclonal antibody, was effective in a range of preclinical migraine models and may represent a novel therapy for migraine prevention with activity against CGRP-dependent and independent attacks, according to results recently published in Brain.1 PAR2 is a G-protein coupled receptor expressed in meningeal neurons, fibroblasts and mast cells that may …

Consistent improvements in pain and ability to function, with high levels of patient satisfaction have been reported in the prospective, real-world observational CONFIDENCE study of adults using rimegepant to treat migraine attacks. Eligible participants had 3-14 headache days within the previous 30 days and planned to treat some future attacks with rimegepant. Using the Migraine …

Anti-CGRP therapies may play a useful role in preventing headaches triggered by the weather or by fasting.1,2 A post-hoc analysis of results from the Phase 3 HALO-EM trial of fremanezumab in adults with episodic migraine (EM) used daily headache diary data from US enrolled participants and daily, region-specific weather variables (pressure, temperature, relative humidity, precipitation, …

A third of patients switching to fremanezumab from other CGRP mAbs achieved a mean monthly migraine day (MMD) reduction of ≥50% within six months in the real world, non-interventional FINESSE study in adults with episodic and chronic migraine. Clinically meaningful reductions in MMD, migraine and headache-related disability, and acute medication use occurred during the full …

Results of two systematic reviews and meta analyses each with approximately 3000 patients with migraine and medication overuse headache (MOH), highlight the efficacy of anti-CGRP therapies in reducing monthly migraine and headache days, and improving daily life.1,2 In the first analysis of 10 randomised controlled trials (RCTs) with 3925 patients, 2786 (70.98%) received CGRP mAbs, …

Cycling through two or more triptans in search of migraine control may increase use of other therapies, increase the risk of medication overuse headache, and result in more ER visits, diagnostic imaging and outpatients, leading to higher costs. These are the conclusions of a retrospective claims analysis of MarketScan Databases (January 1, 2015-February 28, 2023) …

A position statement from the International Headache Society (IHS) is aiming to raise the bar for migraine prevention and management by encouraging clinicians, healthcare providers and patients to strive for the highest possible outcomes with migraine preventive treatments. While recognising that reductions in monthly migraine or headache days are important measures in clinical trials and …

Clinicians may see progressive improvements in response rate, migraine frequency, pain severity, analgesic use, and disability over three years in patients treated with CGRP mAbs, according to latest data from the Italian Migraine Registry (I-GRAINE) study group. In the prospective, real world study of 212 patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM), …

Reassuring evidence of the cardiovascular (CV) safety of CGRP mAbs in older adults and adults with disabilities has been reported from a comparison of the incidence of CV disease in Medicare beneficiaries with migraine initiated on CGRP mAbs vs onabotulinumtoxinA in the USA. Two thirds of those initiating CGRP mAbs and over half of those …

An analysis of data across five atogepant clinical trials has confirmed the modest weight loss previously reported in the ADVANCE trial.1,2   Mean baseline body mass index was 30.0-30.7 kg/m2 in patients with episodic migraine (EM) in US trials and 25.0-25.5 kg/m2 in those with chronic migraine (CM) [East Asia, Europe, and North America]). More patients treated …

Strong support for early use of anti-CGRP mAbs including results from the largest real world mAb study and economic analyses, and latest gepant data for migraine prevention and acute treatment, were among 2024’s clinical research highlights for Professor Koen Paemeleire, from Ghent University Hospital, Belgium. “We’ve seen a huge wave of publications on the CGRP …

Novel agents targeting the vasoactive signalling molecule, pituitary adenylate cyclase-activating polypeptide (PACAP), may be used as an alternative to anti-CGRP therapies or in combination, if promising initial results are confirmed, suggested Professor Messoud Ashina, Copenhagen University Hospital, Copenhagen, Denmark, during his plenary lecture at the congress.1 This follows new data showing that PACAP-38, one of …

New data from the Phase 3 SPACE trial show that fremanezumab significantly reduced monthly migraine days (MMD) in children and adolescents aged 6-17 years with episodic migraine and there were no emergent safety signals. In the study of 237 participants, there was a significantly greater reduction in MMD with fremanezumab than placebo at 12 weeks …

Further evidence of migraine reduction with CGRP mAbs following a drug holiday comes from a retrospective, open-label, real world study of 337 outpatients treated from 2019 to 2023. Of these, 175 were treated with erenumab, 93 with galcanezumab, and 69 with fremanezumab. At baseline, monthly migraine days (MMDs) were 21 ± 7.2, with a median …

Approximately one in three women with menstrual migraine reported positive responses to gepant treatment in a real world survey of adult patients prescribed gepants at the Jefferson Headache Center, Philadelphia, USA, between June 2020 and July 2024. Of 3545 invitations to participate, 478 (13.4%) individuals (age 49.9±14.5 years, 429 (89.7%) Caucasian, 19 (4.0%) African American) …

CGRP mAb therapy appears safe and effective in patients with migraine and comorbid autoimmune disease (AD)1,2 and in patients taking immunosuppressant drugs,3 and such comorbidities and medication use should not preclude CGRP mAb treatment. However, further research is needed on the full clinical implications. These were the conclusions of the authors of a series of studies …

As many as half of patients taking CGRP mAbs may report constipation but much depends on constipation history, and few patients need to stop treatment. These are the main findings from real world studies carried out in the UK and Portugal.1,2 In the UK single-centre, retrospective audit of patients with chronic, refractory migraine who received …

Promising results of the INVESTMENT study reported in Headache support the efficacy and tolerability of galcanezumab in vestibular migraine (VM).  In the single site, prospective, double-blind, placebo controlled study of galcanezumab in patients with a diagnosis of VM or probable VM by Barany Society criteria, Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) score …

In the Phase 3 Sunrise trial carried out in a predominantly Asian population with chronic migraine, eptinezumab has been shown to significantly reduce monthly migraine days (MMDs). Over weeks 1 through 12, mean reductions in MMDs from baseline were -7.5 with eptinezumab 300 mg and -7.2 with eptinezumab 100 mg compared to -4.8 days with …

Migraine deterioration during an erenumab treatment holiday is reversible, according to data from the APOLLON long-term, flexible dosing, safety and tolerability study during which patients were able to interrupt treatment once for a drug holiday of up to 24 weeks.1 In the study, 108/701 (15.4%) patients with episodic or chronic migraine who had successfully completed …

Dual therapy with a CGRP ligand mAb and a small molecule CGRP antagonist can improve migraine symptom control by significantly reducing headache severity and aura symptoms, without significant adverse events. This is the conclusion of a retrospective matched cohort study of 90 adults with chronic migraine taking anti-CGRP therapy, 28 of whom used dual therapy …

Following inadequate initial treatment response, switching to a different CGRP mAb reduces monthly migraine days compared to returning to standard care, according to results of a controlled cohort study of 67 patients who discontinued their erenumab or fremanezumab treatment within three months of initiation. Three months after treatment discontinuation, there was a reduction of 3.9 …

Atogepant users are significantly less likely to switch to another branded preventive treatment within one year of treatment initiation than CGRP mAb users, an analysis of US claims data from over 5000 patients starting treatment from October 2022 to June 2023 has shown. The study included 641 patients who initiated treatment with atogepant and 3,594 …

Patients with high frequency episodic migraine (HFEM) treated with erenumab in the Phase 4 EMBRACE study reported significantly fewer hours with a moderate or severe headache each month, and less impact of migraine on usual activities, physical, social and emotional functioning compared to those treated with placebo. In the 510 participants with HFEM receiving erenumab …

Real world data from 25 centres contributing to the I-GRAINE registry in Italy, highlight the clinical efficacy and safety of CGRP mAbs at all adult ages and have led researchers to support their suitability in older patients with potential contraindications to other preventive agents for migraine. A total of 1890 patients with migraine took part …

Patients with ≥50% migraine response to eptinezumab 100 mg or 300 mg over weeks 1–12 continue to show improvements in monthly migraine days (MMD), headache-related impact, presenteeism, and percentage of severe migraine attacks over 72 weeks. A post hoc analysis of long term DELIVER results in 865 patients has shown that ≥50% responders treated with …

The efficacy of anti-CGRP therapies (CGRP mAbs and gepants) in migraine is well established.1 However, the precise mechanisms of action are unclear and the question of whether a central or peripheral mechanism is responsible for their efficacy remains unresolved. Dr Kuan-Po Peng, from the Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany, reviews the …

The recognition that a migraine starts neurobiologically, 1-10 electrophysiologically, 11-14 and symptomatically, 15-22 hours to days before the headache, has provided insights into the mechanisms of attack initiation and migraine pathogenesis.23 Neurologist, Dr Nazia Karsan, who works as a postdoctoral researcher in the Headache Group at King’s College London, UK, discusses recent progress in mechanism …

Top-line data from the Phase 3 SPACE trial support the efficacy and safety of fremanezumab for the prevention of episodic migraine in children and adolescents. The trial met its primary endpoint, with fremanezumab showing a statistically significantly greater reduction in monthly migraine days over 12 weeks compared with placebo. Safety data were consistent with those …

New research has shown that CGRP signalling primes interactions between meningeal lymphatic vessels (MLVs) and immune cells, supporting a previously unrecognised role for the lymphatic system in chronic migraine. “Our study has highlighted the importance of the brain’s lymphatic system in the pathophysiology of migraine pain,” said Professor Kathleen M. Caron, UNC School of Medicine, Chapel …

CGRP inhibition is associated with decreased rates of acne and rosacea compared with no inhibition or indirect inhibition in patients experiencing migraine. This is the finding from a cohort study using data from the TriNetX US Collaborative Network of 62 healthcare organisations carried out in May 2024.1 Using 1-year Cox proportional hazards models with 95% …

Atogepant is effective in preventing chronic migraine (CM), with and without acute medication overuse, according to results of a subgroup analysis of the PROGRESS trial. Of 755 study participants in the modified intent-to-treat population, 500 (66.2%) met criteria for acute medication overuse at baseline. The least squares mean difference (LSMD) (95% CI) from placebo in …

Pausing and reintroducing CGRP mAbs after 12 months of continuous use, as required by some reimbursement agencies, reduces treatment effectiveness, according to results of the fourth interim analysis of the Phase 4 PEARL trial of 220 adults with episodic or chronic migraine using fremanezumab. In the study, 196 patients stopped treatment after a mean 11.2 …

CGRP mAbs induce positive modulation of functional connectivity in the delta and theta bands in patients who respond to treatment. This is the finding from a prospective, real world, open label study in 62 patients with migraine (35 with chronic migraine) who underwent high density (HD)-EEG recordings at baseline and three and six months after …

Galcanezumab effectively reduces migraine days in patients with medication overuse headache (MOH), irrespective of whether it is combined with prednisone. Results of a prospective observational study of 75 patients with MOH which compared the effectiveness and safety of galcanezumab alone, galcanezumab+prednisone and prednisone alone, showed significant reductions in median monthly headache days (MHD) in all …

Many CGRP mAb responders who are defined as ‘late’ may in fact be ‘slow’, ie. they achieve a meaningful response at three months and improve with time. This is the conclusion of a prospective analysis of 332 outpatients with migraine, 283 (85.2%) of whom continued CGRP mAb treatment (erenumab, fremanezumab or galcanezumab) for six months. …

Over half of patients in a real world observational study carried out in Spain had a sustained response to CGRP mAbs (erenumab, fremanezumab and galcanezumab) after two years of treatment. In the study, 148 patients were included, 108 (73%) with chronic migraine. Median baseline monthly headache days (MHD) and monthly migraine days (MMD) were 18 …

Two thirds of patients using onabotulinumtoxinA to prevent chronic migraine (CM) appear to benefit from adding atogepant to their treatment. In a real world study of 234 patients with CM treated with onabotulinumtoxinA for at least one year, with a stable response for two consecutive 12 week periods between treatments, 211 completed a further 12 …

Secondary endpoint data reported from a Phase 3 study of a single dose of rimegepant 75 mg ODT in patients with migraine in China and South Korea have confirmed the efficacy of acute treatment for up to 48 hours (NCT04574362).1 In the study of 1,340 patients with 2-8 moderate or severe migraine attacks per month, …

A machine learning model developed by researchers at a US tertiary headache centre can accurately predict response to CGRP mAbs nearly 80% of the time. A deep neural network, TabNet, was trained using 145 variables based on results of questionnaires completed by 4260 adult patients with migraine during their initial and follow up headache consultations …

Eptinezumab did not reduce the frequency of episodic cluster headache (eCH) in the two weeks after treatment but improvements were seen in weekly ≥50% responder rates and patient-perceived disease improvement. These were the main findings of the Phase 3, placebo controlled ALLEVIATE trial (NCT04688775) of eptinezumab 400 mg i.v in 231 patients with eCH.1 Over …

Women and Hispanic patients with chronic migraine, and those living in some poorer areas, missed out on CGRP mAb and gepant prescriptions during roll-out at a large US migraine centre, according to results of a retrospective cohort study using data adapted from the Stanford deidentified instance of the Observational Medical Outcomes Partnership Common Data Model …

Reductions in cortical thickness and decreased functional connectivity seen in patients with migraine who respond to CGRP mAbs may indicate recovery from maladaptive neural activity in the visual, sensory and pain regions and normalisation of the hyperreactive/hyperexcitable state seen in migraine. This was the conclusion of Dr Edina Szabo from Beth Israel Deaconess Medical Center …

Macrophages and inducible nitric oxide synthase (iNOS) may contribute to the downstream effects of CGRP in migraine, according to results of a preclinical study of the impact of depleting macrophages and inhibiting iNOS prior to dural treatment with CGRP. In the study, intraperitoneal injections of clodronate liposomes (150 μL, IP) to deplete macrophages, or the …

Real world pregnancy registers have been established for fremanezumab, ubrogepant and atogepant, and interim data are reassuring.1,2 The fremanezumab migraine registry was established in the USA in 2020 (www.tevamigrainepregnancyregistry.com) and, as of 28 April 2023, 12 patients were enrolled – 10 in the fremanezumab cohort (nine prospective and one retrospective) and 2 in comparison group …