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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 …

The intranasal, small molecule CGRP receptor antagonist, zavegepant, has demonstrated a favourable safety and tolerability profile in a 1-year, phase 2/3 open-label safety study in acute migraine (NCT04408794). Of 608 people who entered the long-term treatment phase, 603 were treated with zavegepant 10 mg nasal spray for up to 52 weeks. The treated population had …

Extensive results from the Phase 3 PROGRESS trial of atogepant in chronic migraine prevention presented at MTIS 2022 included data showing early and sustained reductions in monthly migraine days (MMDs),1 and efficacy in patients with medication overuse.2 Modified intent-to-treat data from 755 participants with baseline MMDs from 18.6 to 19.2 showed mean MMD changes at …

Younger patients and those with fewer days of headache, without depression, with accompanying symptoms, or with a good response to triptans have responded best to galcanezumab in a real-world study of chronic migraine (CM) carried out in Korea. In the prospective study of 238 patients with CM with and without medication overuse, treated with monthly …

Many patients with chronic migraine (CM) taking fremanezumab revert to episodic migraine but nearly all need to continue treatment for a second year. This is the real-world experience of British migraine specialists who monitored the impact of fremanezumab treatment in 300 patients with CM. All patients had tried and failed at least six treatments, with …

First clinical evidence that cAMP-evoked migraine attacks act downstream of the CGRP receptor, apparently independent of CGRP-receptor activation, has been reported by Danish Headache Center researchers. “These findings open new avenues for mechanism-based drug development for migraine,” they conclude. In the study, the CGRP and phosphodiesterase 3 inhibitor, cilostazol, was used to provoke migraine in …

CGRP mAbs should be among first-line preventive treatments for migraine, with consideration given to which patients are most likely to benefit, levels of patient disability and medication costs. This was the broad consensus that emerged from a Controversies in Headache debate at the EAN 2022 congress, and it was in line with recommendations in the …

Eptinezumab treatment reduces monthly migraine days (MMDs) over weeks 1-12 of treatment compared to placebo in patients with episodic migraine (EM), chronic migraine (CM), medication overuse headache (MOH) or at least two previous treatment failures. These findings from exploratory analyses of selected sub groups of patients in the Phase 3b DELIVER trial of eptinezumab 100 …

Erenumab has shown sustained superior efficacy compared with standard of care (SOC) oral preventives in patients with episodic migraine (EM) who had previously failed one or two migraine preventives. Results of the APPRAISE global, prospective, randomised, open-label study in 621 patients with EM showed that a significantly higher proportion of patients stayed on erenumab at …

Daily headache was an exclusion criterion in registration trials of CGRP mAbs but is common in clinical practice. Results of a real world study of 47 patients with chronic migraine treated at the headache unit of a tertiary hospital have shown that patients respond to galcanezumab irrespective of whether they have daily headache. Patients had …

An interim analysis of data from the two-year Pan-European Real World (PEARL) prospective, observational study of fremanezumab has shown that 54.7% of patients with episodic or chronic migraine had a reduction in monthly migraine days (MMDs) of at least 50% over the six-month period from the start of treatment. Improvements were also seen in migraine-related …

Plasma CGRP levels more than doubled after six months treatment with erenumab, according to results of a study carried out in patients with migraine, the majority of whom had chronic migraine.1 In the 42 patients who took erenumab 70 mg for at least six months, the average number of headache days per month decreased from …

Migraine symptoms related to peripheral trigeminal sensitisation may predict response (>50%) and super-response (>75%) to anti-CGRP monoclonal antibodies (mAbs). In an analysis of 864 patients with high frequency episodic migraine (HFEM) or chronic migraine (CM), treated with erenumab, galcanezumab or fremanezumab for more than 24 weeks, unilateral pain (UP) + unilateral cranial autonomic symptoms (UAs) …

Nearly two thirds (63%) of patients with migraine who report at least four monthly headache days (MHDs) have never used preventive medication, according to data from the US cohort in the 2021 Chronic Migraine Epidemiology and Outcomes-International (CaMEO-I) study. A further 14.5% had discontinued preventive medication, and only 22.5% said they were currently on preventive …

More than 80% of patients with migraine who took rimegepant as both preventive and acute treatment achieved ≥50% reduction in moderate or severe monthly migraine days (MMDs) in weeks 49-52 of an open label extension (OLE) study reported at the congress.1 Through the 52 week OLE phase, MMD frequency consistently declined – by a mean …

Patients with episodic migraine who achieve an initial ≥50% reduction in monthly migraine days (MMDs) with atogepant generally sustain this response over 12 and 52 weeks of continued treatment, according to post hoc analyses of two Phase 3 trials of efficacy and safety (NCT03777059 and NCT03700320). In the 12-week, ADVANCE study, 70.8-81.1% of participants who …

Latest analysis of data from the COURAGE study of ubrogepant in combination with onabotulinumtoxinA has shown that seven out of 10 patients with high levels of migraine disability were satisfied with treatment. Of 116 patients, 81 (69.8%) were satisfied (16.7% extremely satisfied, 24.1% very satisfied, 19% satisfied). Of respondents, 86.9% had severe or very severe …

Growing evidence of the efficacy and tolerability of combined CGRP mAb and gepant treatment is emerging from clinical practice. Results of a retrospective chart review of 55 adult patients carried out at a New York practice showed that adding fremanezumab to gepant therapy reduced average monthly migraine days (MMDs) by -6.5 days (standard deviation [SD] …

A higher resilience score is inversely correlated with Migraine Disability Assessment (MIDAS) score, and greater levels of anxiety and depression are associated with increased levels of headache-related disability. In a study carried out to explore discordance between MIDAS scores and functional ability in practice, 160 patients with primary headache disorders completed five validated measures in …

Vydura (rimegepant) has received EU marketing authorisation in the acute treatment of migraine with or without aura, and for the prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. Vydura orally disintegrating tablet is the first medicine approved for both acute and prophylactic treatment of migraine in the EU. “Vydura’s …