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Interview with Dr. Goadsby CGRPs

Interview with Dr. Goadsby – What to Expect of CGRP

Learn more about a new class of treatment options for migraine known as calcitonin-gene-related peptide (CGRP) from a leading expert in neurology! After the exciting discussions that took place at this year’s American Headache Society Conference, we spoke with Peter Goadsby, MD, PhD, FAHS, AHS Scientific Program Committee Chair, to get his views.

Game changers?

How are CGRPs different from other preventatives?
Several ways. First, these will be migraine preventatives that are designed for migraine. Everything else we use came from medications that were originally indicated for a different disorder such as epilepsy or depression, and those medications come with baggage of side effects. Secondly, they block the CGRP and block the receptor, there’s no question about their target. CGRP plays an important role in migraine and these new treatments are specifically for this mechanism. Thirdly, CGRP-directed treatments are very well tolerated. Apart from 5% reporting skin irritation with the injection, nothing else has emerged from the side effect profile compared to the placebo.

This would be a reassuring result from one large program – but there have been four multisite trials so that quadruples the reassurance. With current treatments we see variations on cognitive dysfunction, weight gain, dry mouth, or sleeping issues but none of those side effects were seen. This is a big difference no matter how you look at it.

In the past, antibodies were used to manipulate to respond more or respond less, so-called immune modulation. Now, the CGRPs take out the desired target, CGRP, without any effects on the immune system. The immune part of the molecule has been engineered out; it is a very important distinction for these new treatments.

How do you foresee the availability of CGRPs changing the migraine treatment options?
It will be an important addition. I don’t think giving it to everyone with migraine will happen anytime soon. However, the new treatments will provide options to people who have failed or not tolerated standard preventatives. It will be preferable to try the CGRPs before, for example any implantable neuromodulation approaches. We won’t stop tomorrow afternoon using the older medicines; although for any person who has years of getting nowhere on old medicines, it will be a huge difference when these are available.

Realistic expectations

What limitations can patients expect?
From a medical perspective, if you’re asking who is a candidate the answer would be episodic and chronic migraine patients who have disabling migraine and in whom orthodox preventives have not worked. Patients who were using Botox in the previous months were excluded to test the efficacy of CGRPs, but in practice, that would not be a limiting factor. Who is a poor candidate? Well it’s not obvious yet because no problems have arisen. It’s much trickier to say who won’t be a good candidate. Once it’s in practice, there may be a broader view in balancing risk/benefit. In clinical trials, we have not observed risks but we did observe a reduction in disabling migraine. That is such new territory.

Do you think CGRP development will lead to more focus on developing additional migraine treatment options?
I’m trying to get younger physicians involved. I think they are getting more interested in neurology and headache disorders – they’re heading in the right direction, but I would like it to head there faster.

I think it’s an exciting time. Initially, CGRPs will be offered as subcutaneous injections or intravenously administered. Allergan has Phase II clinical trials for oral form of a CGRP blocker, a tablet. One of the good things about having success is it teaches people that success is possible, that there are a lot of people with migraine, and a lot opportunities. The road map will lead to research growth.

What should a patient’s realistic expectations be?
If you look across the range – a realistic expectation is 40-50% of people with migraine will have a 50% reduction in their migraine. Half the people with migraine will have it halved. If you’re in the glass half full mode, 20-30% of the participants in the clinical trials had a 75% reduction in their migraine days. For 10-15% of the participants, their migraine days went away all together.

To communicate the data would show half of the people saw great improvement. Cautious but real optimism is a good way to look at this.

For more on migraine, visit the American Migraine Foundation.

Comments

  • cailee
    8 months ago

    After chronic migraines for the past thirty years plus, now taking AJOVY has given me my life back! Maybe twice a month, I will get a migraine that is not debilitating; instead of everyday! I am only 100 pounds, but I will eat even less to pay the enormous prices!

  • Joanna Bodner moderator
    8 months ago

    This is fantastic to hear @cailee! May these good results continue! I wanted to mention the Ajovy savings program in case you had not explored it already. You can learn more about it here, but they are offering great savings for those with commercial insurance. Good luck & if you can keep us posted on your progress!

  • cailee
    8 months ago

    I am on Medicare and the discount offers don’t apply, unfortunately!

  • litoria76
    1 year ago

    I started Aimovig on 8/23 and so far have had only one day without migraine (I currently experience them 27/30 days per month). Does it take time for these drugs to kick in or am I just one of the unlucky ones?

  • Tom Picerno moderator
    7 months ago

    @litoria I’ve been told by my neurologist that the CGRP drug efficacy continues to improve for 6 months or more based on what she’s been reading. I am in month four with Ajovy and we’ve set a target for my therapy at six months. Some people, Ive read, find relief in as little as one week! Thant has not been my case. I do, however, have a great deal of hope for the CGRP therapies. I hope you find the relief you desire soon!

  • nursekort
    8 months ago

    I have been on Aimovig since October 2018 and I still have approx 27/30 days too. I have never found anything except Imitrex does still help if I take it immediately – nothing preventative…was thinking about trying to do the 140 or change to other one, but the company is giving it to me for the first year since my insurance is nazi-ish about all things migraine…

  • desertmary
    1 year ago

    I will not be able to afford. I Have 20 plus migraines a month. This would definitely improve my quality of life

  • Marcia Kavulich moderator author
    1 year ago

    Hi desertmary. Cost is certainly a concern for the majority of people with migraine. The company offering this medication right now has coupon codes and copay support on their website in case you haven’t checked it out: https://www.aimovigcopaysupport.com/ Hoping it works out for you. Warmly, Marcia (Migraine.com Team)

  • Nicci
    2 years ago

    FDA is Fast-tracking at least Lilly’s CGRP-MAB for the application of Cluster Headache. Why not us, too? I’m facing my last dose in a trial. It’s the drug has been so successful for me that it’s like having someone holding a gun to my face ready to shoot in a couple of months. I’m sure the anxiety of THAT does nothing for helping the study results. Why can’t we at least have compassion doses? They are at FDA… what more do they need? I’m already lining up alternatives. My study has a period where I just can’t have their drug. OK, well what if one of the others makes it out?

    Well, I need to take a look at my contract, because the minute my Sx increase, a change in meds is happening. I don’t want to skew study results for all of us, but being disabled and then more, but not fully able, and facing back to disabled? It’s a cruel rollercoaster ride.

  • Holly Baddour moderator
    2 years ago

    Great article and interview!!! Thanks!

  • Kate
    2 years ago

    I’m most curious on what the insurance restrictions will be. I could see these being even more restricted than Botox (where insurers often require a chronic migraine diagnosis, pain log for a month, and multiple failed preventatives).

    Plus there will be the cost; it sounds likely this will be a doctor-administered injection, so most folks will have a high deductible + co-insurance (similar to Botox), instead of a low prescription co-pay.

    Still, this is the most promising treatment we have had in a long time.

    I’m still waiting for insurance to cover Cefaly – I’m surprised they are getting out of that somehow even though it is FDA approved.

  • nursekort
    8 months ago

    self injection – very easy a prefilled syringe
    as far as insurance lol – good luck, but mine is a bit of a pain. I finally got the botox approved after i had 27 med failures, phys therapy, chiropr., and MRI showing both frontal lobes have damage “due to migraines” – so that is what I have to deal with. Plus I have to go to Birmingham from Louisiana to even have a decent Neurologist at UAB- but, the cost is around like $4500(cash price) per my pharmacist friend. I obv see her often since I take a ton of imitrex like at least one daily or one every other day, she said they have several other pts on Aimovig and one on the other, all are having good result, except ME~I have maybe a day or 2 that is a one time thing for 2 days in a month w/out headache. Hope the 140mg will be better for me when we go up on the dose…

  • Nicci
    2 years ago

    My fear, too. Patient can weigh in at FDA, fi d you know?

  • seteakell
    2 years ago

    Why does the FDA take so long to approve a drug that has data that shows it helps people and has minimal side effects. Ugh this drug has already been submitted and the data is there. Why can we get it NOW!!!!

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