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 understanding the safety profile of AJOVY.
I’m Dr Sara Sacco and I’m the Director at the Carolinas Headache Clinic in Charlotte, North Carolina.
I’m sure you’ll agree that the safety profile of preventive migraine therapy is just as important as efficacy and considerations could include concomitant medications, over-active immune responses, constipation, hypertension, and or latex allergies in your decision-making process. As we begin this presentation, I’d like you to keep these considerations in mind when assessing AJOVY.
Today, we’ll review the safety profile of AJOVY as well as its efficacy and administration options so you can make an informed decision when prescribing.
You’ll recall AJOVY is indicated for the preventive treatment of migraine in adults. Please note AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.
I’d like to start with how AJOVY was designed. It was specifically bioengineered to reduce unwanted activation of the immune system which is achieved by its antibody type. AJOVY is a fully humanized IgG2Δa monoclonal antibody that selectively targets the CGRP ligand and no other related calcitonin family members. This is particularly helpful when deciding on preventive therapy, especially for patients needing to limit unnecessary immune activity.
AJOVY is also not metabolized by cytochrome P450 enzymes. Therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.
Before we go any further, it’s important to understand the core clinical trials that established our safety data, so you can be confident when making treatment decisions. Let’s review the study designs for the HALO and Long-term Extension studies. AJOVY was studied in HALO—two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials. Patients were randomized to either AJOVY monthly dosing, AJOVY quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, and a 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. The Long-Term Extension study was not placebo controlled, but patients were blinded as to the dosing regimen.
Let’s move on to the safety results of the HALO and Long-Term Extension studies. Shown here are the adverse reactions reported by at least 2% of the patients on AJOVY and greater than placebo. What’s notable here when keeping the side effects of preventive therapies top of mind is that less than 1% of patients experienced constipation or hypertension with AJOVY compared to less than 1% for placebo. And ≤2% of patients discontinued due to adverse events in both the AJOVY and placebo treatment arms.
In the Long-Term Extension study, you can see the adverse reactions that occurred in more than 6% of patients. I’d like to add that no new safety signals were identified in the Long-Term Extension study.
Please note, 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.
Now that we have established the safety profile of AJOVY, let me briefly remind you of the efficacy results so that you have the full picture. As a general note, we will only be discussing episodic migraine results. If you’d like to review the results of the chronic migraine trial, please visit AJOVYhcp.com.
The primary endpoint in the HALO episodic migraine trial was mean change from baseline in the monthly average number of migraine days for both monthly and quarterly dosing options during the 12-week period.
As you can see, AJOVY demonstrated a statistically significant improvement in the mean reduction from baseline of 4.3 migraine days at month 3 versus 3.1 days for placebo. The Long-Term Extension study further demonstrated a mean reduction of 5.1 migraine days with monthly dosing. Comparable results were also seen for quarterly dosing.
We’ve discussed the safety and efficacy of AJOVY. Let’s now move beyond the medicine itself to another important aspect of injectable therapy—the administration process. AJOVY is available in an autoinjector. And, 97% of healthcare professional and patient evaluators found the AJOVY Autoinjector easy to use in two Human Factor studies.
It has a button-free, push-down mechanism. For safety, the device locks after use with no visible needle. It’s also made without any natural rubber latex, which is helpful for patients who may be allergic. With AJOVY, there’s no loading dose, no dose titration, and it can be administered at home or in the office.
Let’s bring this back to your practice. Earlier I mentioned certain considerations you might make when evaluating patients for preventive migraine therapy. In summary, AJOVY may be an appropriate treatment option because it has an established safety profile, it’s not metabolized by cytochrome P450 enzymes, delivers sustained efficacy, and is available in an easy-to-use Autoinjector.
We hope you found this information helpful and consider AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine for your patients. To learn more about AJOVY or review the full Prescribing Information, please visit AJOVYhcp.com.