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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 …

Real world registry data on nearly 5000 patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) treated with CGRP mAbs in seven European countries since January 2019 have confirmed the efficacy, tolerability and safety seen in clinical trials.1,2 At baseline, patients had 20.0 (14.0, 28.0) headache days per month (HDM), 15.0 (10.0, 20.0) migraine …

More patients with migraine have a clinically meaningful response to galcanezumab than amitriptyline and topiramate, according to results of TRIUMPH, an ongoing, international observational study in patients with migraine with ≥4 migraine headache days in the 30 days before they were initiated or switched to a preventive medication. Data on a total of 2879 patients from …

This educational activity is supported by an educational grant from H. Lundbeck A/S, who has had no influence on or input into the development or the performance of the educational activity. Migraine appears to be less common in the Republic of Korea than in many western countries, but this may be due partly to differences …

The European Commission has approved Aquipta (atogepant) for migraine prophylaxis in adults who have four or more migraine days per month. The decision makes atogepant the first once-daily oral CGRP receptor antagonist (gepant) for prevention of chronic and episodic migraine in the EU. The approval is supported by data from the Phase 3  PROGRESS and …

Results of the Phase 3 PROGRESS trial demonstrating the efficacy and safety of atogepant in the treatment of chronic migraine (CM) have been published in the Lancet.1 In the study of 778 patients in 16 countries, baseline mean monthly migraine days (MMD) were 18.6 (SE 5.1), with atogepant 30 mg twice a day, 19.2 (5.3) …

CGRP mAbs reduce headache and vertigo frequency, and migraine-related clinical burden, in patients with vestibular migraine (VM), according to data from a prospective observational cohort study evaluating the efficacy of erenumab, fremanezumab and galcanezumab. In the study of 50 patients with VM, 90% had ≥50% reduction in vertigo frequency at 18 months, 86% had ≥50% …

There is no upper age limit for use of anti-CGRP therapies in migraine, concluded researchers who investigated treatment effectiveness and safety in 114 patients over 65 years and 114 sex-matched controls under 55 years. Among cases treated with erenumab, fremanezumab or galcanezumab, 84.2% (96/114) were women, 79.8% (91/114) had chronic migraine and mean age was …

Real world evidence from the prospective, multicentre I-NEED study has confirmed that patients with migraine respond at least as well to CGRP mAbs (erenumab/fremanezumab/galcanezumab) in clinical practice as they do in clinical trials.1,2 Consecutive patients with high frequency episodic migraine (HFEM) or chronic migraine (CM) who had received more than one dose of a CGRP …

Further data on responder rates and quality of life measures from the ELEVATE trial continue to support the efficacy of atogepant 60 mg once daily in patients with episodic migraine who have failed two to four classes of conventional oral medication.1-3 Compared with placebo, significantly greater treatment effects were seen with atogepant (≥25%, ≥30%, ≥50%, …

Sustained reductions in monthly migraine days (MMD) up to 12 months of treatment with fremanezumab have been reported in the latest analysis of data from the real world PEARL study of 968 patients, two thirds with chronic migraine.1 More than half of patients achieved the primary endpoint of ≥50% reduction in MMD at six months, …

Galcanezumab, fremanezumab and erenumab have shown equal efficacy over 12 months in a prospective observational study of 140 patients with chronic or episodic migraine. Researchers reported mean reductions in monthly migraine days from baseline of -12.1 (-9.8,-14.5) with galcanezumab, -13.0 (-10.8,-15.2) with fremanezumab and -11.8 (-9.4,-14.1) with erenumab (all p<0.001 vs baseline). There were also …

Treating patients with migraine and major depressive disorder with fremanezumab is associated with significant reductions in Hamilton Depression Rating Scale-17 Items (HAMD-17) and Patient Health Questionnaire-9 (PHQ-9) scores over eight weeks, with effects maintained for 24 weeks.1 These are the key findings of the UNITE study (NCT04041284) – a Phase 4, 12-week double-blind, placebo controlled study …

CGRP mAb use is significantly associated with current antidepressant use for migraine (odds ratio [OR]=2.25; 95% confidence interval [CI]: 1.94–2.62), having a contraindication to triptans (OR=2.12; 95% CI: 1.87-2.41), current use of cardiovascular medication for migraine (OR=2.00; 95% CI: 1.71-2.34), and current use of 2+ recommended non-CGRP mAb preventive medications (OR=1.31; 95% CI: 1.05-1.65) The …

Real world cardiovascular and cerebrovascular event risks for patients with migraine are comparable with erenumab and other migraine preventive therapies, including other CGRP mAbs. This is the conclusion from an analysis of US prescription claims data for 53,877 new users of migraine prevention medications (erenumab, n=19,220; other mAbs, n=23,244; onabotulinumtoxinA, n=11,413). The relative risk (RR),  …

A subgroup analysis of 1-year safety data for acute migraine treatment with zavegepant 10 mg nasal spray supports the drug’s safety and tolerability when used concomitantly with CGRP mAbs for preventive treatment.1 Of the 603 patients treated with zavegepant in the original Phase 2/3, 1-year open label study,2 39 (6.5%) reported current or concomitant use …

Marked and sustained reductions in monthly migraine days (MMDs) and improvements in migraine severity and burden for up to 18 months have been reported from the DELIVER study of eptinezumab in patients with migraine who had two to four documented preventive treatment failures (NCT04418765). In an analysis of 782/865 (90.4%) of patients who completed the 48 …

Combining remote electrical neuromodulation (REN) with gepants for the acute treatment of migraine may be more effective than REN alone. This conclusion is supported by results of a prospective real world study of REN to treat migraine attacks, with or without a gepant. At the onset of treatment, and two hours later, REN users were …

Top-line data from the head-to-head CHALLENGE-MIG study of galcanezumab and rimegepant in episodic migraine in adults have shown that galcanezumab did not achieve statistical superiority. In the three month, double blind study, 580 patients were randomised to either four injections of galcanezumab 120 mg (a loading dose of two injections followed by two additional monthly …

The National Institute for Health and Care Excellence (NICE) has recommended that  Vydura (rimegepant) can be prescribed for prevention of episodic migraine in adults, free of charge on the National Health Service (NHS) in England. The new NICE guidance, which is expected to be published in its final form in July 2023, states that rimegepant …

Vydura (rimegepant) has been approved by the Scottish Medicines Consortium for restricted use on the National Health Service (NHS) for acute treatment of migraine with or without aura.1 Doctors in Scotland will be able to prescribe rimegepant free to patients who have had inadequate symptom relief after trials of at least two triptans or in …

Taking ubrogepant 100 mg during the prodromal phase of migraine can prevent the onset of moderate or severe headache and reduce functional disability.1-3 Primary endpoint data from 477 qualifying patients in the PRODROME study showed that in 45.5% of ubrogepant-treated qualifying prodrome events, moderate/severe intensity headache was absent within 24 hours.1 This compared with 28.6% …

Atogepant 60 mg once daily (QD) significantly reduces mean monthly migraine days (MMDs) in patients with episodic migraine who have failed previous preventive therapies, according to data from the Phase 3 ELEVATE trial.1 Of 309 adults enrolled in the study, 56% had previously failed two classes of oral migraine preventive medications due to lack of …

Pooled zavegepant data from two randomised, placebo-controlled trials with over 2000 patients (NCT03872453, NCT04571060) show that the gepant nasal spray relieves migraine irrespective of attack frequency and whether or not patients experience aura.1,2 In patients experiencing fewer than four migraine attacks per month during the three months prior to study entry, 24.0% of patients using …

At least one in five patients treated with erenumab at a tertiary US headache department between 2018 and 2021 had worsening of blood pressure as defined by American Heart Association guidance. Of 335 patients, 70 (20.9%) had pre-existing hypertension at baseline. After a mean 30.6 weeks follow-up, 78/335 (23.3%) of all patients had worsening of …

Real world fremanezumab data and clinical trial results for eptinezumab show no evidence of ‘wearing off’ with either agent.1,2 A retrospective, observational US healthcare claims analysis of 3217 monthly dosing cycles in adult patients with at least two fremanezumab monthly claims showed no increase in migraine-related health care resource use (HCRU) or acute medication use …

Gepants may be an effective acute treatment for migraine in paediatric patients and appear safe and well-tolerated, though larger prospective, randomised trials are needed, conclude researchers who carried out a retrospective chart review of 13 patients under 18 who were prescribed rimegepant or ubrogepant for acute migraine at a single institution from January 2020 to …

Non-ictal allodynia has been shown to predict galcanezumab responders with nearly 80% accuracy, and galcanezumab non-responders with nearly 85% accuracy. Quantitative sensory testing was used to detect the presence or absence of cephalic and/or extracephalic allodynia during the pre-treatment non-ictal phase of migraine, with allodynia criteria of <40 degrees C for heat, >20 degrees C …

Immunisation with UB-313, a vaccine designed to stimulate production of endogenous CGRP antibodies, has induced a robust antibody response in preclinical studies. Affinity purified antibodies from immunised animals bound to human CGRP with high affinity (KD in the low pM range) and showed a dose-dependent functional inhibition of CGRP (EC50 in the low nM range) …

The US Food and Drug Administration (FDA) has approved an expanded indication for Qulipta (atogepant) 60 mg for the preventive treatment of chronic migraine in adults. The drug is the first oral CGRP receptor antagonist to be approved for prevention of both episodic and chronic migraine. “The FDA approval is an important milestone, providing those …

Multiple randomised controlled trials support the safety and efficacy of CGRP mAbs as the first target-driven treatment for migraine prevention,1-9 and a growing body of real world evidence supports these findings and provides key information about the use of CGRP mAbs in a more heterogeneous population. However, as Dr Alicia Alpuente from Vall d’Hebron University …

In a network meta-analysis of data from seven studies with nearly 13,000 patients with migraine, the 5-HT1F receptor agonist, lasmiditan, had a greater effect on two-hour pain freedom compared to placebo, than was  seen with rimegepant and ubrogepant. However, lasmiditan was linked to significantly greater odds of adverse events, such as dizziness, nausea and somnolence. …

New data support a role for trigeminal activation in the pathophysiology of headache in patients with COVID-19.1 CGRP levels were 30% higher in hospitalised COVID-19 patients with acute headache than in a similar group of infected individuals without headache. In both groups, CGRP levels were higher than in healthy controls. In 25 inpatients with COVID-19 …

Zavzpret (zavegepant) nasal spray has been approved by the US Food and Drug Administration for the acute treatment of migraine with or without aura in adults, making it the first approved intranasal formulation of an anti-CGRP therapy. The FDA approval is supported by research including a Phase 3 clinical trial, published in Lancet Neurology, in …