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Atogepant open label data support long term efficacy and safety

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 …

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Sustained response to eptinezumab over 18 months

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 …

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Fresh insights on CGRP mAb and gepant prescribing

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 …

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New data support central action for fremanezumab and ubrogepant

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 …

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Zavegepant reduces need for analgesics

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 …

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AHS recommends anti-CGRP therapies as first line for migraine prevention

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 …

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Imaging data support central effects of erenumab

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 …

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Additive effects of multiple anti-CGRP therapies seen on CGRP-induced vasorelaxation

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 …

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Future anti-CGRP therapy trials should be more inclusive

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 …

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CGRP mAbs reduce migraine aura days

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: …

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CGRP mAb reimbursement change brings better responder rate

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 …

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Around half of European countries reimburse CGRP mAb costs

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 …

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Combining CGRP mAbs with gepants

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, …

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CGRP mAb response predictors in clinical practice

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% …

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Fremanezumab efficacy and safety profile maintained in patients with obesity

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) …

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RAMO study: CGRP mAbs and BoNT-A go head-to-head

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 …

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Psychological predictors of CGRP mAb super response

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 …

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Pharmacokinetic study supports eptinezumab weight-based dosing in paediatrics

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) …

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PRODROME results published in The Lancet

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 …

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Stigmatising attitudes about migraine still persist

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 …

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ADVANCE analysis shows favourable benefit:risk analysis for atogepant

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 …

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CHALLENGE-MIG: Galcanezumab and rimegepant equally effective for migraine prevention

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 …

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Galcanezumab improves central sensitisation in patients with migraine

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 …

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Real world high responder rates for atogepant and rimegepant

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 …

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UNITE data show fremanezumab benefits on disability scores

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 …

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Migraine reduction with bariatric surgery linked to CGRP change

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 …

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CGRP antagonists 5 years on – what has been learned?

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 …

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TANDEM trial supports efficacy of dual therapy with ubrogepant and atogepant

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 …

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Do CGRP mAbs act centrally as well as peripherally?

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 …

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European registries show comparable CGRP mAb efficacy to clinical trials

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 …

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Galcanezumab superior to amitriptyline and topiramate

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 …

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Spotlight on Korea

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 …

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Aquipta (atogepant) receives EU approval for migraine prevention

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 …

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PROGRESS results for atogepant in chronic migraine published

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) …

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CGRP mAbs show efficacy in vestibular migraine

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% …

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No upper age limit for anti-CGRP therapies

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 …

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Real world evidence confirms better responses to CGRP mAbs than in clinical trials

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 …

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Atogepant benefits in episodic migraine reported from ELEVATE trial

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%, …

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Latest PEARL real world analyses support fremanezumab efficacy and persistence

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, …

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Real world head-to-head study shows equal CGRP mAb efficacy

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 …

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Fremanezumab reduces depression scores in patients with migraine

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 …

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OVERCOME survey shows reasons for CGRP mAb use

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 …

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CV risks comparable across CGRP mAbs

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),  …

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Reassuring 1-year safety data on zavegepant use with CGRP mAbs

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 …

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Eptinezumab shows sustained benefits in previous treatment failures

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 …

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Combining gepants with REN may be beneficial in acute migraine treatment

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 …

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CHALLENGE-MIG study shows similar response rates for galcanezumab and rimegepant

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 …

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Vydura (rimegepant) makes progress in UK health technology assessments

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 …

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PRODROME shows benefits of taking ubrogepant during prodromal phase of migraine

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% …

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ELEVATE study confirms atogepant efficacy after previous treatment failures

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 …

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