Galcanezumab can start to improve migraines within a day
Galcanezumab (Emgality) is one of the three injectable monoclonal antibodies approved for the prevention of migraines. Pharmacological studies show that it takes up to a week for these drugs to reach their highest concentration. However, it does not mean that it takes a week for them to start helping. Many of my patients report feeling better within a day. A new study of galcanezumab indicates that such a rapid onset of action is not just due to the placebo effect.
The authors analyzed the results of two large studies of patients with episodic migraines that were submitted to the FDA to gain its approval. The first study enrolled 858 patients and the second, 915. Patients were given monthly injections of galcanezumab 120 mg (with 240 mg loading dose) or 240 mg or placebo for up to 6 months. In both studies, the onset of effect was present the day after the injection.
I do tell my patients that they might start feeling better the day after they receive their first injection (the initial dose of two 120 mg injections), but it is more likely that they will begin to improve within a week or even later. Some patients notice only minimal relief even at the end of the first month and require 2 or 3 monthly shots before any significant improvement occurs. This is true for all three injectable CGRP monoclonal antibodies.
Vyepti, the fourth drug in this family, which was just approved and will be available in a month, is given intravenously. This may result in an even faster onset of action.
After more than 2 years on the market, Emgality has not caused any heart or other side effects. Stopping an effective drug after a year makes sense if a patient is completely free of migraine headaches. If, on the other hand, headaches still occur at least once a month, stopping the drug is likely to result in worsening.
Hi Dr. I have been on Emgality for almost 12 months and the drug has significantly helped with my migraine pain. However, my neurologist wants me to to do a trial discontinuation after 12 months to see if improvement will occur and also because of potential long term side effects (to heart and arteries). Why discontinue if the drug is working? Is this standard protocol? Thank you.
Yes, they are in the same class but more importantly have a very similar safety profile in large clinical trials.
Would you suggest patients to go for the CGRP drugs approved earlier because their real world safety for them is better established now? Or is the distinction in safety going to be trivial since they are all from the same class and yo?
You may also want to try eptindzumab (Vyepti) when it becomes available, which should be in about a month. It’s given intravenously every 3 months.
Thank you for this post! I am very interested to know that clinical trials for Emgality included one group who received 240 mg monthly. That is the regimen that my neurologist and I are trying right now (after limited results from120 mg monthly), and it seems to be working. I’ve gone from 20-24 headache days/month to 12-14 headache days/month. It’s a huge improvement in quality of life! My concern is convincing my insurance company (United Healthcare) to cover the extra dose each month. So far I’ve benefited from samples from my doctor, but that’s a short-term solution. If the clinical trials included one group taking 240 mg monthly, perhaps that means my doctor can convince United to cover it.