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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 …

Hormone dependent changes in CGRP concentration have been identified in women with episodic migraine using tear fluid.  In a study of 180 women, those with migraine and a regular menstrual cycle had significantly higher CGRP concentrations in tear and plasma fluid during menstruation compared to participants without migraine (tear fluid: 1.20 ng/ml vs. 0.4 ng/ml, …

The National Institute for Health and Care Excellence (NICE) has not recommended that rimegepant should be available for acute or preventive treatment of migraine on the National Health Service (NHS) in England. In its appraisal consultation document, NICE concluded that evidence to support the proposed use of rimegepant for acute treatment after two or more …

The presence/absence of non-ictal cephalic allodynia has been used to identify galcanezumab responders with nearly 80% accuracy and galcanezumab non-responders with nearly 85% accuracy. Using quantitative sensory testing (QST) with strict criteria for allodynia (heat 32-40°C, cold 32-20°C, mechanical <60 g), researchers have reported a 21% incidence of pre-treatment non-ictal cephalic allodynia in 24 responders …

Emerging evidence is linking CGRP mAbs to alopecia in some patients. Two case reports and a review of data from the Food and Drug Administration Adverse Event Reporting System (FAERS) add to previous post marketing findings with erenumab that led to alopecia being included in the drug’s US label in May 2021.1,2 In the case …

Phase 3 data on the intranasal CGRP receptor antagonist, zavegepant, published in Lancet Neurology, support its efficacy, safety and tolerability in the acute treatment of migraine in adults with two to eight moderate or severe migraine attacks per month (NCT04571060).1 Two hours after a 10 mg dose of zavegepant nasal spray, 147/623 (24%) patients were …

The National Institute for Health and Care Excellence (NICE) has recommended that patients with migraine in England can be prescribed Vyepti (eptinezumab) for migraine prevention free of charge on the National Health Service (NHS) in England.1 This means that all four CGRP mAbs can now be prescribed on the NHS in England. The new NICE guidance, …

Despite being one of the top 10 causes of global disability-adjusted life-years in adolescents and second only to road injuries in those aged 10-24 years,1 childhood headache is under-evaluated around the world. Paediatric migraine is not just a ‘small version of adult migraine’, and it requires careful diagnosis and management strategies to meet the expectations …

Qulipta (atogepant) has been approved by Health Canada for the prevention of episodic migraine (< 15 migraine days per month) in adults, making Canada the second country in which the drug has been approved. “Migraine is one of the leading causes of disability in Canada and impacts a person’s ability to function and perform their …

Salivary CGRP may predict response to anti-CGRP therapies, and patients with episodic migraine, less frequent migraine and a good response to triptans are more likely to be super-responders to CGRP mAbs.1.2 These were the conclusions from two studies investigating opportunities for precision medicine for migraine that were presented at the conference. In a further reported …

Latest evidence about mandatory, annual CGRP mAb holidays suggests that migraine rapidly deteriorates in most patients and may add to anxiety.1,2  In a study of 154 patients who took erenumab, fremanezumab or galcanezumab for 12 month, 85% felt they had deteriorated during a mandatory two or three month drug holiday and, in seven per cent, …

Further evidence that some patients benefit from switching CGRP mAbs – particularly from agents active at the CGRP receptor to those affecting circulating CGRP – comes from studies in the UK and Portugal.1,2 In a prospective audit carried out at a London headache centre in the UK, 33 patients with chronic migraine received a median …

Approximately half of patients with chronic cluster headache (CCH) may benefit from galcanezumab, according to data from two small real world studies from university researchers in Seville and Valencia, Spain.1,2 In a prospective observational study of 21 patients with CCH who received at least one dose of galcanezumab 240 mg, mean monthly headache attacks were …

Brain connectivity modifications in the default mode network (DMN) have been recorded in patients with episodic and chronic migraine after three months of CGRP mAb treatment. At baseline and after three months of CGRP mAb treatment, 26 patients with migraine underwent a 128 channel HD-EEG recording with the aim of investigating connectivity changes in the …

Two thirds of people start CGRP mAbs for efficacy reasons and approximately one in seven switch medications, according to data from the OVERCOME (EU) observational survey of migraine care in 2167 patients in Germany and Spain.1 Of those in OVERCOME who switched, 62% listed access or economic reasons, and 44% listed a recommendation or request …

Erenumab is not associated with systematic wearing-off, according to a post hoc analysis of data from four pivotal randomised controlled trials in a total of 2338 patients with episodic or chronic migraine.1-5 In the full study population, mean change in weekly migraine days at week 4 compared with the average over week 1-3 ranged from 0.15 …

Erenumab did not reduce pain intensity compared with placebo in patients with trigeminal neuralgia (TN), and CGRP probably does not have an important role in paroxysmal pain, conclude Danish Headache Center researchers in a recent paper in Lancet Neurology.1 In a randomised, double-blind, placebo-controlled trial of erenumab 140 mg in 80 patients with idiopathic or …

CGRP mAbs have potential to reduce both health costs and socioeconomic burden of migraine, according to new data on patients with chronic migraine (CM), high-frequency episodic migraine (HFEM) and low-frequency episodic migraine (LFEM) collected by patient organisations and networks in Denmark, and applied to an economic model. Health economic savings from starting CGRP mAbs were …