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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 …

Significant reductions in opioid use and in medication overuse headache (MOH) have been reported from an analysis of prescription claims data from a longitudinal commercial pharmacy database in the months following rimegepant initiation for migraine. Eighteen month follow up data for the opioid use analysis showed a 16.06% reduction in total opioid prescriptions filled in …

Atogepant appears to partially prevent activation of both Aδ- and C-fibre meningeal nociceptors, according to results of a mechanistic study using single-unit recordings of activity in trigeminal ganglion neurons innervating the dura in response to cortical spreading depression (CSD). Atogepant did not fully prevent activation of nociceptors (incidence of response to CSD in Aδ-fibres [vehicle 73%, …

When a patient with migraine starts ubrogepant whilst their pain is mild, they are more likely to be free of pain and other symptoms after two hours than if they delay until their pain is moderate or severe. This is the conclusion of a post-hoc, within-person analysis of efficacy data from patients who treated at …

Post-hoc analyses of data from studies of atogepant for migraine prevention have shown treatment-related, dose-dependent reductions in body weight compared with placebo and standard care.  In the ADVANCE trial, least squared (LS) mean percentage change in body weight from baseline to 12 weeks was +0.37 with placebo versus +0.14 (p=0.4138), -0.61 (p=0.0005), and -1.27 (p<0.0001) …

Patients with chronic migraine (CM) who reduce attacks to four or fewer monthly headache days achieve superior outcomes, with least need for acute medication. This is the conclusion of a post hoc analysis of data from the PROMISE-2 trial evaluating eptinezumab for CM prevention. The analysis showed that, of patient-months with ≤4 MHDs, 67.6% (561/830) …

Fremanezumab treatment resulted in clinically meaningful reductions in monthly migraine days (MMD) and significant improvements in disability outcomes in patients with prior onabotulinumtoxinA treatment failure. These were the findings from pooled data from the Phase 3 HALO EM, HALO CM, and FOCUS trials in which patients were randomized 1:1:1 to quarterly or monthly fremanezumab or …

Safety and efficacy data from the DRAGON study of erenumab 70 mg in adult patients with chronic migraine in China and other Asian countries are consistent with previous pivotal studies. In the 12-week Phase 3 study of 557 patients with chronic migraine, those in the erenumab 70 mg group had a significantly greater reduction in …

Intranasal zavegepant in doses up to 40mg per day has demonstrated good safety and tolerability in healthy adults, with doses ≥10 mg producing exposures predictive of efficacy in adults with migraine.1 These results from two Phase 1, placebo-controlled, randomised, double-blind, sequential zavegepant studies provide supportive data following previous reports of Phase 3 data demonstrating significantly …

High completion rates and sustained safety and tolerability were reported from an open access programme for galcanezumab in patients who completed the 3-month double-blind and 9-month open-label phases of the Phase III REGAIN trial (NCT02614261). Patients entered the three year continuous access programme for galcanezumab approximately five to 13 months after their last study dose. …

Qulipta (atogepant) significantly reduced mean monthly migraine days (MMDs) compared to placebo in adult patients with chronic migraine (CM), according to data announced from the Phase 3 PROGRESS trial. The results will support a submission to expand the use of atogepant to include preventive treatment of CM in the USA. The drug was approved for …

Rimegepant 75 mg orally dissolving tablet is likely to get the go ahead for EU approval, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which advises the European Medicines Agency (EMA) on product approvals. Following a CHMP opinion, an approval decision is generally made within 10 weeks. The positive …

Professor Fernando Kowacs considers which patients may benefit from CGRP monoclonal antibodies and describes the factors that influence his choice of drug for individual patients as well as his approach to follow up, and his switching strategies for poor responders.     < Previous page

Top-line data from a Phase 3 rimegepant trial for the acute treatment of migraine in 1,431 adult patients in China and South Korea have shown that the study met its co-primary endpoints. Two hours after a single dose of rimegepant 75 mg orally dissolving tablet, significant improvements were seen compared to placebo in freedom from …

Vyepti (eptinezumab) has received approval by the European Medicines Agency for migraine prevention in EU countries and will be the first intravenous CGRP monoclonal antibody (mAb) treatment available in Europe. Like other CGRP mAbs, eptinezumab has been approved for prophylactic treatment of migraine in adults who have at least four migraine days per month. The …