Patients experienced significantly more migraine-free days with AJOVY vs placebo in the HALO + Long-Term Extension Studies1,3-5
See Study Design
Consider limitations of Long-Term Extension study design when interpreting efficacy results.
Patients randomized to monthly dosing had a mean baseline of 12.8 headache days of at least moderate severity per month and experienced, on average1:
5.1 fewer headache days at month 3 vs 3.3 with placebo (P<0.001).1,3
Patients randomized to quarterly dosing had a mean baseline of 13.2 headache days of at least moderate severity per month and experienced, on average1:
4.7 fewer headache days at month 3 vs 3.3 with placebo (P<0.001).1,3
*Mean baseline of 12.8 headache days of at least moderate severity per month with monthly dosing.1
†Reduction in monthly average number of headache days from the Long-Term Extension study was 6.4 with quarterly dosing.3
No evidence of “wearing off” with AJOVY was
observed from one dose to the next2
POST HOC WEEKS 1-3 VS 4
Mean number of weekly migraine days during weeks 1-3 vs week 4 at months 3, 6, 9, and 15 with monthly dosing2‡
POST HOC WEEKS 1-2 VS 11-12
Mean number of weekly migraine days in weeks 1-2 vs weeks 11-12 with quarterly dosing2‡
For all post hoc analyses, no determination of statistical significance can be made and no conclusions should be drawn.
‡Study design: Of the patients who rolled over from the HALO studies, 611 from the HALO CM study (monthly, n=305; quarterly, n=306) and 432 from the HALO EM study (monthly, n=215; quarterly, n=217) had received AJOVY injection during the respective HALO study and were included in post hoc analyses during the long-term, open-label extension study.2
Dr Cooper discusses what to look for and why you should consider AJOVY for patients new to preventive therapy.Show Transcript
Hello, thank you for joining us to learn more about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine. Today we’ll talk about why AJOVY should be considered as a first choice for patients new to preventive migraine therapy for whom an injectable treatment is appropriate.
My name is Dr Wade Cooper and I’m a board-certified neurologist and clinical associate professor of neurology and anesthesiology at the University of Michigan.
You’ve likely had this experience: your patient has chronic or episodic migraine and you conclude that it is time to move them to a preventive therapy. You now have to choose a treatment.
Why should you start with AJOVY?
We will answer this question by looking at a few topics. First we’ll go over How is AJOVY different, we’ll review the clinical profile of AJOVY, then its safety profile, and we’ll conclude with administration and dosing information.
Let’s get into it then, shall we?
AJOVY is indicated for the preventive treatment of migraine in adults. As we continue, please note that AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.
How is AJOVY different?
Let’s start with its antibody type. AJOVY is a fully humanized IgG2Δa monoclonal antibody. It was specifically bioengineered to reduce unwanted activation of the immune system.
Bhakta et al studied the selectivity of the molecule and found that AJOVY only binds to what it’s supposed to target—that is, the CGRP ligand—and not to other related calcitonin family members.
It’s helpful when first starting your patients on a preventive migraine therapy to know that AJOVY behaves as it was intended to. It’s also helpful to know that AJOVY was made in a way that avoids triggering your patients’ immune system.
As we move on to look at the clinical profile of AJOVY, it’s important to note that hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.
To be confident of AJOVY as the right choice for your patients and to assure ourselves of the reliability of the clinical data we’re about to explore, let’s briefly review the study designs of the HALO and Long-Term Extension studies that investigated AJOVY.
AJOVY was studied in HALO—two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials.
Patients were randomized in either AJOVY Monthly dosing, AJOVY Quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, run-in period, followed by a 12-week intervention period, with a final evaluation at Week 12.
Some of the patients in the 12-week HALO studies rolled over into the Long-Term Extension study—a 12-month, multicenter, randomized, double-blind, parallel-group clinical trial.
Please note that the long-term extension study was not placebo controlled, but patients were blinded as to the dosing regimen.
Now that we’ve gone over the study designs, let’s dive into the clinical results…
…that established sustained efficacy with no evidence of “wearing off” for AJOVY. Today, we’ll specifically look at patients with chronic migraine. If you’d like to review the results for episodic migraine, please visit AJOVYhcp.com.
The primary endpoint investigated in the HALO chronic migraine trial was the mean change from baseline in the monthly average number of headache days of at least moderate severity for both monthly and quarterly dosing options during the 12-week period.
In the HALO Chronic Migraine study, AJOVY monthly dosing demonstrated a statistically significant improvement, with a mean reduction from baseline of 5.1 headache days at month 3 versus 3.3 days for placebo as we see here. In the long-term extension study, the mean reduction was 6.8 headache days with monthly dosing. Comparable results were seen in patients with episodic migraine in both the HALO and Long-Term Extension study.
Let us now take it a step further and review the published post hoc analyses that investigated “wearing off” for selected dosing periods of AJOVY.
To assess AJOVY over these selected dosing periods, data for patients with chronic and episodic migraine from the HALO trials who rolled over into the Long-Term Extension study were included in the post hoc analyses. Let’s again focus in on patients with chronic migraine.
The analyses looked at the mean number of weekly migraine days in patients on monthly dosing during months 3, 6, 9, and 15. Each of these months—3, 6, 9, and 15—was split into two: weeks 1 through 3, or the beginning of the dosing period, versus week 4, the end of the dosing period. Let’s look at the figures for the weekly average number of migraine days during weeks 1 through 3. And now let’s compare them with the number of migraine days during week 4. As the chart indicates, the weekly number of migraine days was similar between the beginning and end of the dosing period, across all the months shown. Note, for all post hoc analyses, no determination of statistical significance can be made and no conclusions should be drawn.
As we’ve just seen, there is no evidence of “wearing off” for AJOVY from one dose to the next. You can give your patients the chance to experience lasting protection against migraine with AJOVY. Is this not the reason for putting them on a preventive therapy? It’s something to ask yourself.
Alongside efficacy, we know when starting a patient on preventive migraine therapy that safety is often top of mind. Here we’ll look at the safety profile of AJOVY to ensure that you know what to expect when making the change.
Shown here are the adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo from the HALO trials.
Furthermore, less than 1% of patients experienced constipation, and less than 1% of patients experienced hypertension compared to less than 1% for placebo.
How does this information compare to what you’re seeing in your clinical experience? It’s something to keep in mind.
Now looking at the Long-Term Extension study, you can see the adverse reactions that occurred in more than 6% of patients.
What’s worth noting is that no new safety signals were identified in the Long-Term Extension study.
Another interesting fact about AJOVY is that it’s not metabolized by cytochrome P450 enzymes,…
…therefore interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.
Having looked at the safety profile of AJOVY, let’s look at some administration and dosing information that may help your patients in their transition to a preventive therapy.
AJOVY is available in an autoinjector. And, as a matter of fact, 97% of HCP and patient evaluators found the AJOVY Autoinjector easy to use in two Human Factor studies.
It has a button-free, push-down mechanism and it locks after use. It’s also not made with natural rubber latex.
When taking AJOVY, there’s no loading dose, no dose titration, and it can be administered at home or in office.
Patients have an option to take AJOVY either monthly or quarterly. Having such options may lend itself to your patients, especially if their circumstances better allow for one dosing option over the other. It’s a decision that you and your patients can make together at the appropriate time.
We hope the information provided here helps you in deciding to start your patients new to preventive migraine therapy on AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine. Living with migraine is a burden we understand, so we hope your patients get the care they need. For more information on AJOVY, please visit AJOVYhcp.com, where you can consult the full Prescribing Information. Thank you for taking the time to watch our video presentation.