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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 …

New data from the largest real world study of CGRP mAbs in patients with high-frequency episodic or chronic migraine (CM) have shown that more frequent and disabling migraines reduce the likelihood of a good response – underlining the importance of earlier treatment.1 In the European multicentre, prospective study, 5818 patients with a median 20 monthly …

Over 70% of patients with episodic migraine who respond initially to atogepant treatment achieve a sustained response with continued treatment, according to post hoc analyses of results from the ADVANCE trial and a separate open label long term safety study (LTS).1 The findings are comparable with recently reported long term data from the PROGRESS and …

Aquipta (atogepant) can be prescribed for migraine prevention free of charge on the National Health Service (NHS) in England, following a recommendation by the National Institute for Health and Care Excellence (NICE). Adults who have at least four migraine days per month and have previously failed on at least three preventive medicines are eligible for treatment. Physicians …

Erenumab may have potential for relieving the facial redness and flushing of rosacea, according to results of a small, open label study of 30 individuals with the condition. Study participants received monthly erenumab 140 mg sc for 12 weeks at the Danish Headache Center, Copenhagen, Denmark.  Mean days of moderate to extreme flushing were reduced …

Interim data from an open label 156 week extension study of atogepant 60 mg support its long term efficacy and safety for prevention of chronic and episodic migraine at 48 weeks. In the study of 595 patients from the earlier Phase 2 ELEVATE and PROGRESS trials, monthly migraine days (MMDs) improved by a mean 8.5 …

Early response to eptinezumab in patients who have failed on two to four previous preventive migraine treatments is sustained over 18 months, according to results of a post hoc analysis of the Phase 3 DELIVER trial. Of participants who achieved ≥50% response over the first dosing interval (weeks 1-12), 61% of those on eptinezumab 100 …

Approximately 30% of patients with migraine switch CGRP mAbs at least once, and of those prescribed gepants approximately 30% will have at least two agents, according to results of a retrospective case series analysis of nearly 3000 patients diagnosed with migraine and seen by care providers at the Jefferson Headache Center, Philadelphia, USA, between 2018 …

New research has supported the potential of fremanezumab and ubrogepant to act centrally as well as peripherally, though further studies are needed to understand the clinical implications of the results.1,2 In a study of 25 healthy volunteers, a single dose of fremanezumab 900 mg iv was administered, and plasma and CSF levels were measured for …

Acute treatment with zavegepant nasal spray, up to eight doses per month for up to 52 weeks, has been shown to reduce the use of analgesics such as ibuprofen, aspirin, paracetamol, and naproxen in patients with migraine. In a post-hoc, sub group analysis of a phase 2/3, 1-year, open label safety study in 603 participants …

The American Headache Society (AHS) has recommended that anti-CGRP therapies should be considered as first line treatment for migraine prevention.1 In a new consensus statement based on a comprehensive review of clinical trial and real-world experience, the AHS concluded that the evidence supporting the efficacy, tolerability, and safety of CGRP-targeting therapies for migraine prevention is …

A decrease in neural activity in distinct regions of the brain following erenumab 70 mg has been reported in a placebo-controlled, double-blind, randomised study of 40 patients with migraine who underwent fMRI scanning. This change was seen mainly in individuals who showed a clinical benefit from the anti-CGRP treatment. Seven out of 21 patients in …

Gepants have additional effects on CGRP-induced vasorelaxation when used with erenumab, supporting their efficacy in treating migraine attacks in patients already using erenumab as prophylaxis. These are the findings of a study investigating the effects of combination treatment in human coronary artery (HCA) and human middle meningeal artery (HMMA) segments. pA2 or pKb values were calculated to …

People with high frequency episodic migraine (HFEM) and chronic migraine (CM) who are typically excluded from randomised controlled trials (RCTs) of anti-CGRP therapies responded as well to galcanezumab over a 12-month period as those who took part in pivotal clinical trials of the drug, according to real world data from the Galca-Only Registry.1 Of the …

CGRP mAbs reduce migraine aura days as well as migraine headache days, according to data from a pilot prospective observational cohort study of 14 patients with migraine aura treated with erenumab, fremanezumab or galcanezumab and followed up for 12 months. Mean monthly aura days were reduced from a median of 13 at baseline (interquartile range: …

A change in reimbursement policy in Germany allowing earlier use of CGRP mAbs in patients with at least four migraine days per month has led to more treatment responders in clinical practice.1 Results of a retrospective cohort study of CGRP-mAb naïve patients with episodic or chronic migraine, showed a higher ≥ 50% responder rate in …

Only 16 out of 29 European countries taking part in a recent survey provided reimbursement for CGRP mAbs. In general (hospital based) neurologists were permitted to prescribe CGRP mAbs, and sometimes this was extended to headache or pain specialists. Eligibility criteria for patients ranged from at least four monthly migraine days to criteria for chronic …

Real world data from the United Arab Emirates have underlined the safety and tolerability of combining CGRP mAbs with gepants in patients with migraine in clinical practice. In the retrospective study of 516 patients with episodic or chronic migraine taking CGRP mAbs, 234 were also taking a gepant (rimegepant: 215; ubrogepant 19). During follow up, …

Older patients with migraine and those with migraine-specific clinical features are most likely to be good responders to CGRP mAbs. These are the findings from the largest real world study of CGRP mAb treatment in patients with migraine, with data on a total of 5818 patients in seven European countries. Of the total population, 84.2% …

Patients with migraine and obesity do just as well with fremanezumab as those with a normal body mass index (BMI). Results of a post hoc analysis of data from the Phase 3 HALO-LTS and FOCUS trials in a total of 2437 patients with episodic or chronic migraine show a reduction in monthly migraine days (MMD) …

Preliminary data from the RAMO study suggest that CGRP mAbs are at least as effective as botulinumtoxinA at six and 12 months in patients with chronic migraine. In the study of 154 patients who had at least two previous treatment failures, monthly migraine days (MHD) at six months were reduced by approximately 12 days with …

Patients with migraine who are anxious, stressed or have emotional problems are least likely to respond to CGRP mAbs, according to results of a study evaluating super response versus non response to preventive treatments. In the study, 116 patients with chronic or episodic migraine who had failed at least three preventive therapies underwent treatment with …

Weight based dosing with eptinezumab was generally well tolerated by children and adolescents, according to results of an open label pharmacokinetic (PK) study which used a population PK (PopPK) model adapted to a paediatric population. The 20-week open label study (NCT04537429) evaluated a single intravenous infusion of eptinezumab in children and adolescents (aged 6-17 years) …

Full results of the PRODROME trial, published last week in The Lancet, confirm that ubrogepant 100 mg taken during the prodromal phase of migraine can prevent the onset of moderate or severe headache within 24 hours and 48 hours after administration, and reduce functional disability and development of headache of any intensity within 24 hours …

Nearly half of people who do not have migraine believe the disorder is easily treatable and over a third think it is due to a person’s own unhealthy behaviour. A range of stigmatising attitudes has been revealed in OVERCOME (US), a population-based web survey carried out amongst nearly 12,000 randomly selected individuals in the USA …

A post hoc analysis of data from the Phase 3 ADVANCE trial has shown that three to four patients with migraine need to be treated with atogepant for one to achieve ≥50% reduction in monthly migraine days from baseline. In the study of 902 patients with migraine, the number needed to treat (NNT) for one …

Nearly two thirds of patients with episodic migraine treated with galcanezumab or rimegepant in the CHALLENGE-MIG study achieved ≥50% reduction in monthly migraine headache days (MHD/month) from baseline across three months. Of 580 randomised participants (galcanezumab: 287, rimegepant: 293; mean age: 42 years), 83% were female and 81% Caucasian. Galcanezumab was not superior to rimegepant …

Blocking the peripheral CGRP pathway may have secondary effects on the central nervous system, conclude researchers who tested the effects of galcanezumab on central sensitisation in patients with migraine. In the prospective, open label, single arm study in 86 patients with migraine, central sensitisation inventory (CSI) score was reduced from 36.0 at baseline to 29.7 …

Atogepant and rimegepant achieved comparable high responder rates in patients with refractory chronic migraine (CM), according to results of a retrospective chart review in a US neurology practice. Of 26 patients (24 with CM, 2 with episodic migraine) who took atogepant for three months, six (23%) achieved ≥77% reduction in total headache days (THD) for …

Further data from the UNITE study of fremanezumab treatment in 353 patients with episodic migraine and major depressive disorder (MDD) have demonstrated significant effects on disability scores.1 This follows previous reports of improvements in depression scores and monthly migraine days.2 At 12 weeks follow up, mean 6-item Headache Impact Test (HIT-6) scores had fallen by …

Bariatric surgery may not only enable patients with obesity to lose weight, it may also reduce their migraines, with an accompanying decrease in serum CGRP. In a study of 60 patients with severe obesity and chronic migraine, followed up for a mean 7.5 ± 2.5 months after bariatric surgery, significant reductions were recorded in migraine …

The site of action of CGRP inhibitors is likely to be in the periphery where the headache begins – in the meninges and possibly trigeminal ganglion. But, when the pain signal from the periphery has been eliminated, there is a secondary, indirect central effect on the excitability of neurones in the cortical, hypothalamic and possibly …

Using atogepant 60 mg once daily (QD) for prevention of episodic migraine and ubrogepant 100 mg as needed (PRN) for acute treatment appears safe and well tolerated over 12 weeks. In a Phase 4, multicentre, open US study, 262 participants were initially treated with atogepant 60 mg (QD) for 12 weeks. In period 2, with …

New data showing detection of fremanezumab in cerebrospinal fluid (CSF), and demonstrating target engagement, have fuelled the debate over whether CGRP mAbs are active centrally as well as peripherally. In an open label phase 1 study in healthy volunteers, a single dose of fremanezumab was infused (n=19; 900 mg; i.v.), and a single CSF sample and …