Pain relief: Mother-of-three Diane Brookes
Diane Brookes used to lose two-and-a-half days every week to crippling migraines. The throbbing pain and violent sickness dominated her life, leaving her incapable of getting out of bed.
‘It was torture. Our family life was taken over by migraine,’ recalls the 48-year-old, who lives near Stoke-on-Trent with husband Allen, 46, a company director, and their three children aged 25, five and four.
‘I couldn’t even look after the children. My husband would take them to their parties and send me a video of them playing. It was heartbreaking.’
Over the past 25 years Diane has tried more than a dozen drugs and various devices and alternative treatments, yet nothing gave her effective relief.
But now a monthly injection has transformed her life, she says.
Diane took part in a trial for one of a new wave of drugs that are the first specifically developed to prevent migraines.
She received jabs of erenumab, which cut the number, duration and intensity of her migraines by around 80 per cent.
About 8 million people in the UK suffer from migraine, which typically causes throbbing pain and symptoms such as nausea and sensitivity to light.
Painkillers often have little effect during an attack — and even if they work, sufferers may have sufficiently frequent attacks to need a preventative treatment.
However, current preventatives reduce the frequency or severity of attacks by only 50 to 60 per cent, and for some people there will be relatively little benefit.
This makes the new wave of drugs the most significant development in migraine treatment for 30 years, says Professor Anne MacGregor, a specialist in headaches and women’s health in the NHS and Harley Street.
‘It’s a big revolution, as there is no drug worldwide that is solely for migraine prevention,’ she says. ‘Every one was originally developed for another condition.’
The main problem with this is the side-effects. Beta-blockers, for example, which can help migraine sufferers by preventing dilation of blood vessels in the brain (which causes pain) were developed for high blood pressure and can also trigger nightmares, hallucinations and tiredness.
Another common preventative drug is amitriptyline. Developed as an antidepressant, it is thought to prevent migraine by blocking reabsorption of the brain chemical serotonin, which plays a role in pain. But it can cause a dry mouth, drowsiness and weight problems.
The new drugs, however, are specifically targeted at migraine — and the studies with erenumab show it has minimal side-effects, with patients given it having lower rates of adverse effects than people taking a placebo (the most common side-effects were headache and chest infection).
During a migraine attack, blood vessels on the surface of the brain dilate, releasing inflammatory chemical messengers that trigger pain. Erenumab is thought to work by blocking a chemical called CGRP (calcitonin gene-related peptide)to prevent the blood vessels dilating.
Erenumab is part of a group of drugs known as CGRP monoclonal antibodies: there are three others — eptinezumab, galcanezumab and fremanezumab.
Studies suggest erenumab can reduce both episodic migraine (attacks that occur for up to 14 days a month) and chronic migraine, where symptoms occur on 15 days or more.
Research presented at the Congress of the International Headache Society last month, funded by the drug company Novartis, gave details of a three-month, gold-standard global trial of 667 patients who had not responded to other treatments.
About 8 million people in the UK suffer from migraine, which typically causes throbbing pain and symptoms such as nausea and sensitivity to light (picture posed by model)
The patients were divided into three groups, receiving either a placebo, 70mg or 140mg of erenumab once a month.
For those on the higher dose, erenumab cut the average number of migraine days by seven per month, and 41 per cent of patients given the higher dose found their number of headache days had halved or more than halved. The placebo group had an average reduction of 2.7 days a month.
Another global trial, published in the Journal of Neurology, Neurosurgery and Psychiatry, involved 955 patients who averaged eight migraine days a month. It reported an average reduction of almost four days of migraine a month on the higher eremutab dose of 140mg. Those on 70mg had 3.2 fewer days of migraine a month. Patients in the placebo group reported an improvement of fewer than two days a month.
There was a range of responses to the treatment, with some patients seeing a major improvement while others reported a much smaller change, says Professor MacGregor, who was not involved in the trial. ‘For those with a good response, their quality of life will markedly change.’
Diane’s migraines started 25 years ago after the birth of her first daughter, Jessica.
As well as being forced to take to her bed at least two days a week, she had several days of general headache each week. Over the years she tried many treatments. Besides beta-blockers, she took triptans — painkillers developed for migraine that narrow blood vessels in the head.
She also tried acupuncture, which some believe can reduce transmission of pain, and a headband device called Cefaly, which claims to interrupt brain activity associated with migraine. Yet nothing could prevent an attack or stop it once it took hold.
One day, while reading her local paper, Diane spotted an ad that was to change her life.
‘It gave details of a clinical trial into migraine that was recruiting patients,’ she recalls.
Diane was accepted for the trial and received the monthly injections into her stomach at the University Hospitals of North Midlands NHS Trust for 15 months, finishing late last year. Within the first month her weekly migraines were down to one bout lasting a few hours: it also stopped the continual violent vomiting that would normally accompany an attack, and reduced the severity of the pain. The other headaches she suffered for about two days a week disappeared.
‘The difference was huge,’ says Diane. ‘It massively reduced the intensity and I went from being bedridden for two-and-a-half days a week to just sitting on the sofa for a couple of hours. Then I could get on with my day.’
Fayyaz Ahmed, a consultant neurologist at Hull and East Yorkshire Hospitals NHS Trust, says new treatments such as erenumab will add to the options available to people with chronic migraine. ‘For some people they will make an awful lot of difference,’ says Dr Ahmed, who was involved in the clinical trial. ‘What’s most exciting is the lack of side-effects.’
Monthly injections under the skin, likely done by the patient at home, could also be more attractive to sufferers than another treatment: Botox.
This involves more than 30 injections of the muscle-paralysing drug into the head and neck during every three-month session.
It is not fully understood why Botox works, but it is thought to affect the pathways that pain uses to travel through nerve cells in the brain.
That the new drugs can be given as a monthly injection also means that patients are more likely to stick to a treatment plan than those taking daily pills, adds Brendan Davies, a consultant neurologist at the University Hospitals of North Midlands NHS Trust and a trustee of the Migraine Trust.
Dr Davies, who has been involved in trials of all four new drugs, says: ‘This is a very exciting development for migraine sufferers.’
But there is concern that when erenumab is licensed for use in the UK (possibly late next year) it may be extremely expensive.
While the price of the medication has yet to be revealed, Dr Ahmed suggests the high cost of developing the drugs means pharmaceutical companies are likely to make them expensive.
Professor MacGregor shares that view, adding that ‘it is not going to be made immediately available to everyone’.
Doctors also caution that even if it is approved for the NHS, it will not be available in the UK for at least a year.
Diane says she will definitely need the drug again. The trial finished a year ago and the effect is starting to wear off.
‘I will pay privately for it if I have to,’ she says. ‘Going back to how it was before is unimaginable.’